Archived - Processed Products Establishment Inspection Manual
Chapter 5 - Process Products

• Written master formulae are available.
• The formulae contain all details of the formulation as follows:
  • identification of specific ingredients and additives (e.g., concentration, type)
  • amounts of additives and ingredients
• The master formulae are current for the products being prepared by the establishment and meets all the requirements of the applicable regulations.

• N/A

• Formula is absent, incomplete or not current resulting in inadequate control at preparation/blending.
• Specifications and amounts of ingredients and additives are not identified in the formula or related documentation.

• Formula is absent or not current but safety is not affected.

• PPR, Schedule I, Table I and II + specific commodity requirements
• PPR, Schedule I, Standard of Identity for each specific product
• PPR, 2.1(1)(f) Requirements of Foods and Drug Regulations and also see specific commodity for standards
• PPR, 30.2(a)(ii) Formulation of food product

• Ingredients critical to product preservation are identified with their specifications and limits.

Note: Inadequate identification of critical ingredients and their specifications may indicate lack of awareness or control of critical factors that could result in product spoilage.

• Specifications and limits for critical factors are not identified in the formula or related documentation and there is no control elsewhere in the process, e.g., dice size or maximum tolerance of mushroom fines not specified in the formula, viscosity in canned cream corn (related to starch quantity and type).

• N/A

• Critical factors are not identified in the formula or related documentation but are controlled somewhere in the process and are within the limits of the process requirements and safety is not affected.

• PPR, 30.2(a) Keep written description of schedule process
• PPR, 30.2(e) Data on the development of schedule process

• The manufacturer ensures that all food additives and processing aids used are permitted for use in the particular food and meet the requirements of all applicable regulations.
• The manufacturer has specifications for all food additives and processing aids
• The manufacturer controls allergenic additives and processing aids to ensure that they are properly identified in the formulation.
• Where there are no requirements in the Food and Drugs Act and Regulations, the manufacturer requires that all food additives/processing aids be Food Chemical Codex (FCC) grade or equivalent, e.g., specification sheets, clear identification of the grade on the additive package, or blanket guarantees.
• The manufacturer has verified and can demonstrate through calculations that food additives are used within the maximum level specified in the Food and Drug Regulations.
• The manufacturer has a letter of no objection from Health Canada for non regulated processing aids.
• Processing Aids are used as per manufacturers instructions.

• Use of processing aids that are allergenic and are not declared on the label of the food product

• Manufacturer is not using FCC grade or equivalent.
• Level of additive/processing aids is violative and safety may be affected.
• Processing aids are not used according to manufacturers instructions and safety may be affected.

• Level of additive/processing aids is violative but safety is not affected.
• Additive/processing aids used is not permitted but safety is not affected.

• PPR, 2.1(1)(f) Requirements of Foods and Drug Regulations
• PPR, Schedule I, Tables I and II + specific commodity requirements
• PPR, Schedule I, Standard of Identity for each specific product

• Nutrients used are permitted in accordance with the Food and Drug Regulations.
• The nutrient content of the product is accurately reflected on the label.
• The manufacturer has specifications for nutrients.
• The manufacturer has received certification from the supplier as follows:
  • a certificate of analysis accompanies each lot of nutrient
  • for nutrients used in foods that are the sole source of nutrition, each certificate is verified through analysis
• The manufacturer has verified and can demonstrate through calculations that nutrients are used within the limits specified in the Food and Drug Regulations.

• Level of nutrient is violative and could result in permanent health consequences, e.g., inadequate fortification for foods that are a sole source of nutrition, toxic levels of fat soluble vitamins.

• Addition of incorrect amounts of nutrients.
• Levels of addition were calculated incorrectly or not at all.
• Nutrient is not permitted, or level of nutrient(s) is violative and could result in temporary health consequences.
• No system in place to adjust formulas and variations in potency noted.

• Nutrient is not permitted and safety is not affected.

• PPR 2.1(1)(f), Requirements of Food and Drug Regulations
• PPR 31 (u) and (v) Vitaminized or vitamin C added declaration

• new label review
• labels are registered if required and the establishment has a label approval file
• incoming label review for accuracy/correctness
• formulation changes/substitutions

• Omission of allergens in list of ingredients with a known history of producing anaphylactic reaction in sensitive individuals (ref - List of allergens in Appendix IX) and are not declared on the label of the food.

• Inadequate or no control of label accuracy and the sensitive ingredients (e.g. lactose, monosodium glutamate) are used in the plant.
• Omission of sensitive ingredients in list of ingredients (e.g. lactose, monosodium glutamate).

• Use of labels with inaccurate ingredient listings but no listed allergens used in the plant.
• Inadequate control of label accuracy, e.g., no new label review but no listed allergens used in the plant .
• Labels requiring registration are not registered.
• No label registration file.

• PPR, 2.1(1)(f) Requirements of Food and Drug Regulations
• F&DR B.01.008(3) Ingredients in descending order
• PPR 31(ee), List of ingredients and components
• PPR, 42, Common name on main panel
• PPR, 44(1) - Label must be registered
• PPR, 44(6) Label file

• identification of acid: type and concentration, e.g., percent of acid or grains vinegar (United States or Canada)
• amounts of acid required to prepare the brine at the appropriate concentration (dilution)
• acid concentration of the brine (pH measurement or titratable acidity)
• solid-liquid ratio (brine volume in the container, drained weight, number of whole cucumbers, etc.)

• N/A

• N/A

• Dilution method is not specified but the specifications of the brine are satisfactory.
• No written formulation.
• Acid concentration of the brine is not specified in the product formulation which may result in inadequate control of the brine concentration.
• Specifications and amount of ingredients and preservatives are not identified in the formula or related documentation ex: solid/liquid ratio.

• PPR 30.2(a)(ii), The operator must keep in the establishment, for every low-acid food product that is processed, the formulation of the food product
• F&DR, N/A

• Fermentation:
  • product/brine ratio
  • salt concentration
  • acidity and pH.
• Cover liquid (new brine)
  • type and concentration of the acid solution (i.e. Percentage of acid or number of grains of vinegar (USA))
  • quantity of acid necessary for the preparation of the brine, the concentration required
  • concentration of the acid of the brine (pH or the titratable acidity)

• N/A

• N/A

• Specifications and amounts of ingredients used in the preparation of the brine are not specified in a formula.

• PPR, 30.2(a)(ii), The operator must keep in the establishment, for every low-acid food product that is processed, the formulation of the food product

• For every low acid food, container type and size, a written description of the scheduled process, together with the name of the Process Authority responsible for its development is available upon request.
• All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process and are included in the scheduled process.
• The thermal process is established using accepted scientific methods. Details of actual experimental methods are available.
• Any changes to the product formulation or the process are validated by the Process Authority.

Process Evaluation - Process from Bulletin 26-L

• If an NFPA (National Food Processors Association) process from Bulletin 26L is used, the manufacturer verifies that the actual process including all critical factors matches all requirements of the NFPA process.
• If the actual process including all critical factors is identical to the NFPA process, heat penetration data is not necessary.
• The manufacturer ensures that the NFPA processes used are updated as new information becomes available. Updates may be available through membership in NFPA.
• If the actual process is not identical to the NFPA process, the process is treated as a non-standardized process.

Process Evaluation - Non Standardized Process

If a non-standardized process has been developed (e.g. a non-NFPA process):

• All processes are developed and evaluated by a process authority.
• All critical factors are identified, tested and evaluated during the development of the process and are included in the scheduled process.

For example:

• fill weight, e.g., vegetables, meat
• drained weight, e.g., spinach, okra
• pH, e.g., acidified foods
• solid/liquid ratio, e.g., spinach
• initial temperature
• preservatives, e.g., nitrites
• water activity, e.g., reduced moisture, cakes, puddings
• viscosity, e.g., starch is added, conduction/convection heating - broken heating curves
• moisture levels, e.g., kidney beans
• vacuum, e.g., vacuum packed corn
• headspace and agitation speed e.g., agitating retorts
• overpressure, where applicable
• cooling method, where applicable
• percent of air in steam e.g., Lagarde
• product/container orientation
• container type, size and format

Documentation is available to demonstrate that the most extreme/worst case conditions are considered in the development of the process.

• Process development takes into consideration the actual production capabilities, e.g., filler capability to deliver the weight range specified in the validated process.
• The interaction of critical factors has been evaluated.

Corrective action procedures for process deviations are validated to ensure the achievement of commercial sterility, e.g., alternative processes are validated.

Process Authority

• The process authority has sufficient knowledge, training and experience to complete thermal processing evaluations.
• The process authority has access to adequate facilities for making such determinations, e.g., a laboratory having microbiological testing capability as well as a pilot plant, processing and sterilizing equipment.

Scientific Methods

The process authority demonstrates that adequate procedures for heat penetration testing have been followed through documentation, for example:

• positioning of thermocouples in containers (cold spot)
• calibration of thermocouples
• number and location of test containers per trial
• product orientation in the can and retort
• method of calculation of F_o necessary to destroy spores of C. botulinum for each product
• equipment used to perform the experiments
• calibration of test instruments
• a sufficient number of heat penetration trials has been completed to verify that the process is adequate for the critical limits of each factor

The procedures conform to the following References; "Procedures for Carrying Out a Heat Penetration Test and Analysis of the Resulting Data", Irving J. Pflug, Ph.D., University of Minnesota; "Designation: F 1168-88 Standard Guide for Use in the Establishment of Thermal Processes for Food Packaged in Flexible Containers"; American Society for Testing and Material (ASTM); Institute For Thermal Processing Specialists (IFTPS) or equivalent.

Process Verification

• The manufacturer has written confirmation from the process authority that the heat penetration and calculated lethality of the process achieves commercial sterility.
• If the calculated lethality is below the minimum generally recognized commercial sterility F_o, additional information may be required, e.g., inoculated pack studies, preservation system, incubation studies, etc., for the purpose of conducting a health hazard evaluation.

Change Control

Any changes to the parameters on which the scheduled process was based are validated by the process authority, for example, formulation, procedure or equipment changes.

• Calibration of thermocouples:
  • number and location of test containers per trial
  • product orientation in the can and retort
  • method of calculation of F° necessary to destroy spores of C. botulinum for each product
  • equipment used to perform the experiments
  • calibration of test instruments
  • a sufficient number of heat penetration trials has been completed to verify that the process is adequate for the critical limits of each factor
• The procedures conform to the following References; "Procedures for Carrying Out a Heat Penetration Test and Analysis of the Resulting Data", Irving J. Pflug, Ph.D., University of Minnesota; "Designation: F 1168-88 Standard Guide for Use in the Establishment of Thermal Processes for Food Packaged in Flexible Containers"; American Society for Testing and Material (ASTM); Institute For Thermal Processing Specialists (IFTPS) or equivalent

• Product formulation has been changed but not validated by a Process Authority.
• The NFPA process being used is not current and safety is compromised.

• No process validation or process validation is incomplete, e.g., validation was conducted on a different formula.
• Scientific methods are deficient (equipment or procedures).
• The NFPA process being used is not current and safety may be compromised.

• The NFPA process being used is not current and safety is not compromised.

• PPR, 30.2(a), Description of a schedule process
• PPR, 30.2(e) Data for the development of a schedule process

• Temperature distribution tests are carried out upon installation and at a sufficient frequency to ensure the adequacy of the vent schedule.
• Temperature distribution tests meet the requirements of the "Government of Canada Guidelines for Temperature Distribution Studies when Processing in Steam Still Retorts Excluding Crateless Retorts".

• Temperature distribution studies have been conducted on all retort systems. (A retort system could consist of a single retort or a group of identically equipped retorts).
• Temperature Distribution studies comply with the protocol entitled, "Government of Canada Guidelines for Temperature Distribution Studies when Processing in Steam Still Retorts Excluding Crateless Retorts" or equivalent.
• Frequency
  • Upon installation.
  • After making changes as follows:
    • Changes in steam demand which reduce the header pressure since the original tests, e.g., additional or larger retorts, use of blanchers, etc.
    • Changes in steam supply which reduce the header pressure since the original tests.
    • Can size used in the original tests is no longer the smallest can packed by the manufacturer.
    • Reduction in initial temperature of product.
    • Changes in piping since the original tests, e.g., length, diameter, number of turns or elbows, number and/or size of steam spreader holes, mufflers, etc. Ideally, all retorts should be identically piped. If not, each unique piping arrangement should be tested.
    • Changes in construction of the retort crates. Ideally, all crates should be identical. If not, those likely to impede steam flow the most should have been used in the original tests.
    • Changes in busse separator sheets, e.g., hole size, pattern.
    • Changes in loading the retort crates (e.g., changing from jumble pack to busse loaded, increasing the number of layers in a busse crate).
    • Changes in the interior retort structure.
    • Retort operator log sheets indicate an unusual increase in the time required to reach vent or process temperature.
    • Changes in valve type or size.
• Temperature distribution studies are conducted every two years in the absence of an effective preventative maintenance program. The preventative maintenance program is described in sub item 4.3.3.1 and 4.3.3.2.

• Temperature distribution tests are inadequate or absent, e.g., no temperature distribution tests conducted upon installation; changes have occurred and temperature distribution tests have not been conducted.

• Temperature distribution tests are conducted but are incomplete e.g., temperature distribution is based on less than three repeatable runs, (References protocol).

• N/A

• PPR 30.2(a), Description of a schedule process;
• PPR 30.2(e), Data for the development of a schedule process

• Heat penetration records are available for each product formulation, container size and format, except for those products that are identical to those specified in a NFPA process.
• Minimum record requirements include:
  • name of process authority
  • critical factors tested and evaluated and their limits
  • worst case conditions tested
  • records to demonstrate that the deviation procedures are based on heat penetration studies
  • records of all parameters of scientific test methods
  • records of all verification tests for each product
  • records of heat penetration studies demonstCote the safety of the process for any formulation or procedure changes

Temperature Distribution

• Minimum record requirements include:
  • Retort Test Conditions
    • date, person responsible, reason for test and retort number
    • can size, can configuration in basket, number of layers, types and number of baskets used
    • initial temperature, placement of thermocouples and steam manifold/header pressure
    • calibration of thermocouples and data logger
    • description of the retort design, e.g., piping, baffles, spreaders and valves
• Temperature Distribution Test Results
  • temperature controller and data logger charts
  • time, temperature and MIG (Mercury In Glass) temperature at which thermocouple equilibrium was achieved
  • time steam on and time vent closed
  • retort temperature when vent closed
  • time process temperature was achieved

• N/A

• Records are absent, inaccurate or incomplete.
• For temperature distribution - description of the retort test conditions not complete, e.g., type of dividers not specified but only one style of divider is in the plant and the type of divider used in the temperature distribution tests is not known.
• For temperature distribution - no records; description of the retort test conditions is not complete, e.g., types of dividers used is not specified and several styles are available in the plant.
• For heat penetration - records of the parameters in the heat penetration studies are deficient, e.g., type of thermocouple used not recorded.
• For heat penetration - no records; formulation changes noted and no heat penetration study records to support safety.

• Deficiencies in records which do not affect verification of the adequacy of heat penetration or temperature distribution testing, e.g., date or signature of person conducting the test missing.

• PPR 30.2(f) Records that set out product history

• For every acid food and low water activity food, a written description of the process design is available upon request.
• The process is established using accepted scientific methods.
• All factors for each product are identified, tested and evaluated during the development of the process and are included in the process design.

For example:

• pH
• solid/liquid ratio
• additives
• water activity
• viscosity
• pressure (re flashing if required)
• pasteurization time and temperature
• fill temperature for hot filled products
• container inversion for hot filled products
• other factors

The process design includes:

• the pressure requirements in the holding tube to prevent product flashing
• the sterilization procedure for the processor, auxiliary equipment, aseptic holding tanks, aseptic product transfer lines, valves, and packaging equipment
• the factors required to maintain product and equipment commercially sterility

Any changes to the parameters on which the process design was based are validated, for example, formulation, procedure or equipment changes.

• N/A

• The manufacturer does not have a written process design for acid foods where there may be a food safety risk.
• The process design does not include the limits to sterilize the product, processing equipment, aseptic lines and tanks and packaging.
• The process design does not include the limits to maintain the system commercially sterile.

• The manufacturer does not have a written process design, for acid foods with no food safety risks.

• PPR Schedule I, Table I, Section 1 prepared by heat processing
• PPR Schedule I, Standards of identity of specific products

• For every product a written description of the process, including procedures, is available upon request.
• The process is established using accepted scientific methods and hygienic Principles. Details of actual experimental methods are available.

Acidification - Safety Concern

• Direct addition of a predetermined amount of acid to individual containers during production is a satisfactory method for acidification. All acidified food shall have an equilibrium pH of 4.6 or below, which is generally achieved within 24 hours of heat treatment (often called "pasteurization").

Heat Treatment - Quality Concern (avoid spoilage of the product)

• Every manufacturer should have standard pasteurization procedures developed by competent technical personnel. Pasteurization procedures should indicate the temperature of the food at the time it enters the pasteurizer and temperature to be achieved inside the container and holding time.
• The widely accepted heat treatment procedures for pickles having an equilibrated pH less than 4.0 are heating to 74°C (165°F) at the center of jar and holding at that temperature for 15 minutes. Any other heat treatment procedure developed by competent technical personnel would be acceptable.
  • Mathematical method: pasteurization procedure is calculated based upon details of the heat resistance of the most heat resistant microorganism which might be present and cause spoilage, and details of the rate of heat penetration to the coldest point in slowest heating container under the actual pasteurization procedures;
  • Experimental packs: Containers are inoculated with a large number of cells of the most heat resistant organisms. After pasteurization, these containers are incubated at the optimum temperature for the growth of the organism.

Critical Factors

• All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process, for example:
  • pH of brine
  • solid/liquid ratio (brine volume, number of whole pickles, etc.)
  • equilibrium pH

Important Factors (Spoilage related)

• All important factors for each product are identified, tested and evaluated in the development of the process:
  • heat treatment

Note: The degree of testing and evaluation required is relative to the risk of the operation. Any changes to the process are assessed to ensure there is no impact on the safety or composition of the product.

• The pickle is designed as a low acid food; pH greater than 4.6 and water activity greater than 0.85,without requiring commercial sterilization at retort temperatures and is marketed without refrigeration.

• No process validation or process validation is incomplete, e.g. heat treatment process or equilibrium pH methodology is inferior to those found in literature and there is no documentation available to demonstrate the efficacy of the process being used.

• N/A

• PPR, 30.2(a) (i), the operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must keep a written description of scheduled process together with the name of the person responsible for the development of the scheduled process.
• PPR, 30.2(e) If requested by an inspector, produce written statement of all relevant data used in the development of the scheduled process

• For every product a written description of the process, including procedures, is available upon request.
• The process is established using accepted scientific methods and must respect sanitation Principles. Details of actual experimental methods are available.
• Any changes to the product formulation or the process are assessed to ensure there is no impact on the safety or composition of the product.

Fermentation - Safety Concern

• The process should be developed in order to use pH, Aw, preservatives, salt, refrigeration, etc. to obtain a safe fermented product. For the fermentation process the following factors should be considered:
  • Acidity and pH
    • The fermentation of vegetables or fruits is done under conditions of salinity that will help to the development of lactic bacteria. In some process, acid may be added in the initial brine to have conditions that will favor the lactic fermentation. Appropriate fermentation will result in acidification of the product. Where the fermentation is not adequately started, balancing the salt content or addition of vinegar to acidify the media would be a corrective measure that will help to contribute to a proper fermentation that will bring the acidification of the product.
  • Product/brine ratios
    • For cucumber fermentation (in tank), the general method of salting is to use a 30° to 40° salometer brine in the bottom of the tank. Once the cucumbers are added, the brine should decrease to 25° salometer. The brine shall cover all product completely.
  • Salt concentration
    • For cucumber fermentation (in tank), usually the brine strength is gradually raised by adding enough dry salt on the cover to give a holding strength of 16 to 18 percent at the end of four to six weeks.
    • For cucumber fermentation (in tank), Low Salt Brining consists to maintain 5-8 % of salt during fermentation. The addition of calcium ions in the form of calcium chloride has been found to allow fermentation at lower salt concentration. 0.20 to 0.35% (based on the tank contents) of calcium chloride is added.
    • In specific product and fermentation procedures, the salt content can be lower (e.g. 2.25-2.50% of salt for sauerkraut fermentation). The levels of salt and calcium chloride, if any, are to be specified in the process design.
    • Fermented foods should have a pH value of 4.6 or lower. Higher pH value would require a retort treatment in order to obtain commercial sterility, unless the product is kept refrigerated (if refrigerated, "keep refrigerated" shall be declared on the label) or preservatives are used to ensure preservation.

Salt stock storage - Safety Concern

• Process design should include the salt concentration, acidity and pH levels to be maintained during storing. Vegetables should be kept under the surface of the brine. When completely cured in a 60° salometer brine, pickles will keep satisfactory for a year or more.

Desalting of salt stock product - Quality Concern:

• The 15 to 18 percent of salt in the salted stock is reduced to about 4 percent.

Packing - Quality Concern

• Packing media is detailed:
  • pH of the packing brine.
  • Sweet pickles are packed with the proper quantity of sugar and are preserved adequately (pH of 4.6 or lower and use of preservatives).

Pasteurization and /or preservatives system - Quality Concern (avoid spoilage of the product)

• The pasteurization for fermented product is optional. Use of preservatives can be sufficient for proper conservation of the product. e.g.: peppers and relish.

Critical Factors

• All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process; for example:
  • pH of the product or equilibrium pH when packed in new brine.

Important Factors

• All important factors for each product are identified, tested and evaluated in development of the process:
  • integrity of containers and closures
  • vacuum (immediately after capper and after pasteurization)
  • pasteurization 145° F / 63°C at the cold point unless not applicable
  • preservative system for product packed in non hermetically sealed containers , e.g. pails

Note: The degree of testing and evaluation required is relative to the risk of the operation.

• N/A

• Fermentation process that does not specify the minimum salt content or that does not mention the necessity to have a good salt distribution.

• Process has been developed according to traditional procedures. The process is not documented in a way that all the critical parts are outlined (salt concentration, final pH, etc), but the product is safe.

• PPR 30.2 (a) The operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must keep a written description of the scheduled process together with the name of the person responsible of the development of the scheduled process
• PPR 30.2 (e) The operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must if requested by an inspector, produce written statement of all relevant data used in the development of the scheduled process
• PPR 31(oo) The words "keep refrigerated" if the product is sauerkraut with preservative
• F&DR B.01.007 Instructions for the proper storage

Fruit Products have a written description of the freezing process available.

• The manufacturer has a written description of the time and temperature for the blanching of vegetables.
  • During the blanching process, the product should attain the time/temperature outlined in the process design. Factors affecting the exposure times are:
    • particle size - the larger the particle the longer exposure necessary to attain the desired temperature throughout
    • temperature of blancher
    • depth of food on belt or in flume - thicker layers require more time for penetration of heat
    • blanching medium - steam has a slower penetration rate into product than water so longer exposure times are required

• Peroxidase testing should be done by the manufacturer to ensure vegetable products are properly blanched.
• Some vegetables are not usually blanched e.g. onions, celery. The products may be treated by other means to reduce the microbial load e.g. chemical treatment, chlorine. Any chemical used shall be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" or a letter of no objection from Health Canada.
• The manufacturer has a written description of the freezing process for both fruits and vegetables.
  • Freezing should occur quickly after blanching without delay. Freezing of fruits and vegetables should be carried out in a way that the range of maximum crystallization (-1 C to -5 C) is passed quickly. Freezing should not be considered complete until the product has reached -18 C at the thermal center after thermal stabilization.
  • The cooling and freezing media are controlled and free from pathogens and chemicals.
  • Bacteria count in frozen vegetables shall not exceed, 250,000 viable aerobic mesophiles per gram of product; and 100 aerobic thermophilic spores per gram of product if the frozen vegetable is intended for remanufacturing purposes.

• N/A

• N/A

• No written description exists but safety not compromised.
• The manufacturer does not have a system in place to ensure that the process used is that as described in the process design.

• PPR, Schedule I Table II
• PPR, Schedule II Specified Standards of Identity
• PPR, 2.1 (1) All components and ingredients of a food must be sound, wholesome and edible
• PPR, 14.(1)(i)
• PPR, 16(13) Product must be maintained at a correct temperature

• The manufacturer controls incoming ingredients, food additives and processing aids through one of the following programs or equivalent.
• The first three options apply to ingredients, food additives and processing aids that may be critical factors where further processing is not likely to eliminate a hazard.
• The fourth option applies to ingredients, food additives and processing aids that are not likely to impact on the safety of the food.

Note: Specifications for food additives and nutrients are assessed under Sections 5.1.1.3 (task 5103) and 5.1.1.4. (task 5104)

Option 1 - Periodic Evaluation of Incoming Ingredients, food additives and processing aids

• The manufacturer has written specifications for ingredients, food additives and processing aids.
• Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations and any other applicable regulations.
• The manufacturer maintains a documented history of adherence to specifications for each supplier, e.g., analytical results.
• The manufacturer obtains a certificate of analysis for each lot.
• A representative sample is taken to verify the accuracy of the certificates of analysis at a scheduled frequency, e.g., monthly.
• A new history of adherence to specifications is established when a firm changes suppliers, purchases ingredients, food additives and processing aids from a new supplier, purchases a new ingredient from an existing supplier or when spot checks do not agree with the certificate of analysis.

Option 2 - 100% Lots Inspected

• The manufacturer has written specifications for ingredients, food additives and processing aids.
• Each incoming lot is sampled according to a pre-determined sampling plan and analyzed for adherence to specifications.

Option 3 0 Vendor Certification

• When the manufacturer relies on vendor certification the following minimum requirements are in place:
  • The manufacturer has written specifications for ingredients, food additives and processing aids.
  • The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include, for example: process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
  • The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include process capability studies. Statistical process control charts for each critical control point shall be available upon request from each supplier.
  • Prior to implementation of a periodic monitoring program, the firm analyses an appropriate number of consecutive lots, to establish a historical data base and confirm adherence to specifications.
  • The manufacturer conducts periodic monitoring to verify adherence to specifications, e.g., annually.
  • The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

• Where incoming ingredients, food additives and processing aids are not likely to impact on the safety of the food:
  • The manufacturer has written specifications for these ingredients, food additives and processing aids.
  • Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations.

Non-Conforming Ingredients, food additives and processing aids (applies to all options)

• When ingredients, food additives and processing aids are found not to meet specifications the manufacturer investigates and identifies the root cause. If the ingredients, food additives and processing aids do not meet specifications but have not been used it is not considered a deviation. However, if it is possible that ingredients, food additives and processing aids not meeting specifications have been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13 (tasks 6301, 6302, and 6303), Deviations and Corrective Action.
• Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations or any other applicable regulations.
• Ingredients, food additives or processing aids arriving in dirty packaging are either rejected or packaging material cleaned before use. See section 5.1.5.5 (task 5505)

• No ingredient specifications, certification or monitoring for critical ingredients, food additives and processing aids.

• The manufacturer has specifications for critical ingredients, food additives and processing aids but cannot demonstrate adherence, e.g., no certification or monitoring program.
• Acceptance of non-conforming ingredients, food additives and processing aids contaminated with excessive amounts, non-hazardous avoidable material, e.g., insects.
• Acceptance of non-conforming ingredients, food additives and processing aids contaminated with hazardous foreign material, e.g., glass.

• No specifications for non-critical ingredients, food additives and processing aids e.g. Sugar, salt, calcium chloride.
• For critical ingredients, food additives and processing aids no certificates of analysis but the manufacturer has written specifications, maintains a documented history of adherence and verifies adherence to specifications.
• Acceptance of non-conforming ingredients, food additives and processing aids contaminated with non hazardous foreign material, e.g., dust, dirt.

• PPR 2.1(1) All ingredients, food additives and processing aids are not adulterated nor contaminated
• PPR, 16(13) Food must be kept at the correct temperature and humidity
• PPR, 16(16) Raw material are washed as needed to remove soil or contamination
• PPR, 16(17) Raw materials are inspected, sorted and culled

• Packaging material should be approved as food grade and listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" as published by the CFIA.
• Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.
• Packaging materials in use for foods shall comply with Division 23 - Food Packaging Materials of the Food and Drug Regulations.
• Packaging materials are properly protected on arrival.
• Packaging material evaluations are carried out under the control of a qualified person who has successfully completed a container evaluation course from a recognized institution.

Note: Qualifications are described under Section 4.4.1.2, Technical Training.

The manufacturer controls packaging materials through one of the following monitoring and/or certification programs or equivalent:

Option 1 - Periodic Evaluation of Incoming Packaging Material

• The manufacturer has written specifications for containers and ends:
  • physical dimensions
  • double seam dimensions
  • material specifications
  • performance specifications
• The manufacturer verifies the adherence to specifications by each supplier. A representative sample is taken to visually verify adherence to specifications at a scheduled frequency, e.g., monthly.
• The manufacturer has a documented history of adherence to specifications for each supplier.
• A new history of adherence to specifications is established when a manufacturer changes suppliers, packaging materials or when spot checks do not agree with specifications.

Option 2 - 100% Lot Inspection

• The manufacturer has written specifications for containers and ends.
• Each incoming lot is evaluated to ensure that specifications are met and containers are free from defects.
• The minimum sample size for visual evaluation of incoming containers is 200 containers/ends selected randomly from each lot.

Option 3 - Vendor Certification

• When the manufacturer relies on vendor certification the following minimum requirements are in place.
• The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include; process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
• The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include: statistical process control charts for each critical control point and process capability studies.
• Prior to implementation of a spot check program the manufacturer analyzes an appropriate number of consecutive lots to establish a historical data base and confirms adherence to specifications, e.g., annually.
• The manufacturer conducts periodic monitoring to verify adherence to specifications.
• The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

• Where packaging materials are not likely to impact on the safety of the food:
  • The manufacturer has written specifications for the packaging material.
  • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.

Non-Conforming Packaging Material - (applies to options 1 to 3)

• When packaging material is found not to meet specifications the manufacturer investigates and identifies the root cause. If the packaging material does not meet specifications but has not been used it is not considered a deviation. However, if it is possible that packaging material not meeting specifications has been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13 (tâches 6301, 6302, et 6303), Deviations and Corrective Action

• No inspection of empty containers where there is a contamination with hazardous extraneous material e.g. glass particles >2 mm and without any further inversion/cleaning and/or inspection steps before filling.

• Packaging material contains substances which may be injurious to consumers health and cannot be removed by subsequent steps of inspection or cleaning.
• The packaging material does not comply with Division 23 of the Food and Drugs Regulations.

• Periodic evaluation - monitoring is not done as scheduled to visually verify adherence to specifications.
• The manufacturer has specifications but cannot demonstrate adherence, e.g., no certification from the supplier or monitoring by the manufacturer is deficient.
• The manufacturer has no control over incoming packaging materials, e.g., no specifications, certification or monitoring.
• Containers not adequately protected. e.g. Protective coverings for packaging materials damaged/missing.

• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 30.3 (a), Container is suitable for use
• PPR, Schedule III, Tables I, II, III Prescribed container sizes for specified products
• Div 23, FDA&R No Package shall contaminate food

• Packaging material should be:
  • Accepted Construction, Packaging Materials and Non-Food Chemical Agents" as published by the CFIA.
  • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.
  • Packaging materials in use for foods shall comply with Division 23 - Food Packaging Materials of the Food and Drug Regulations.
  • Packaging materials are properly protected on arrival.
• Packaging material evaluations are carried out under the control of a qualified person who has successfully completed a container evaluation course from a recognized institution (only needed for Low Acid Foods (LAF) in Hermetically Sealed Containers and Acidified Low Acid Foods (ALAF) (fresh pack or fermented).

  Note: Qualifications are described under Section 4.4.1.2, Technical Training.

• The manufacturer controls packaging materials through one of the following monitoring and/or certification programs or equivalent.

Option 1 - Periodic Evaluation of Incoming Packaging Material

• The manufacturer has written specifications for containers and lids:
  • physical dimensions
  • material specifications
  • performance specifications
• The manufacturer verifies the adherence to specifications by each supplier. A representative sample is taken to visually verify adherence to specifications at a scheduled frequency, e.g., monthly.
• The manufacturer has a documented history of adherence to specifications for each supplier.
• A new history of adherence to specifications is established when a manufacturer changes suppliers, packaging materials or when spot checks do not agree with specifications.

Option 2 - 100% Lot Inspection

• The manufacturer has written specifications for containers and lids.
• Each incoming lot is evaluated to ensure that specifications are met and containers are free from defects.

Option 3 - Vendor Certification

• When the manufacturer relies on vendor certification the following minimum requirements are in place:
  • The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include; process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
  • The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include: statistical process control charts for each critical control point and process capability studies.
  • Prior to implementation of a spot check program the manufacturer analyzes an appropriate number of consecutive lots to establish a historical data base and confirms adherence to specifications, e.g., annually.
  • The manufacturer conducts periodic monitoring to verify adherence to specifications.
  • The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

• Where packaging materials are not likely to impact on the safety of the food:
  • The manufacturer has written specifications for the packaging materials and lids.
  • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations.

Non-Conforming Packaging Material - (applies to options 1 to 3)

• When packaging material is found not to meet specifications the manufacturer investigates and identifies the root cause. If the packaging material does not meet specifications but has not been used it is not considered a deviation. However, if it is possible that packaging material not meeting specifications has been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13(tasks 6301, 6302, and 6303), Deviations and Corrective Action.

• N/A

• Packaging material contains substances which may be injurious to consumers health. The packaging material does not comply with Division 23 of the Food and Drugs Regulations.
• Protective covering absent and evidence of hazardous extraneous material contamination found.

• Periodic evaluation - a representative sample is not taken to visually verify adherence to specifications.
• The manufacturer has specifications but cannot demonstrate adherence, e.g., no certification from the supplier or monitoring by the manufacturer is deficient.
• The manufacturer has no control over incoming packaging materials, e.g., no specifications, certification or monitoring.
• Containers not adequately protected. e.g. Protective coverings for packaging materials damaged/missing.

• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 30.3(a), Container is suitable for use
• PPR, Schedule III, Tables I, II, III Prescribed container sizes

Periodic Evaluations

• History of adherence to specifications, i.e., analytical results.
• Spot checks, i.e., analytical results.

100% Lot Inspection

• Analytical results for each incoming lot.

Vendor Certification

• Records which demonstrate knowledge of the vendor's process, e.g., process flow charts, critical control point identification, process specifications, critical limits, monitoring and verification reports, corrective action plans and reports, and on site evaluation reports.
• Records which demonstrate the capability of vendor's process, e.g., capability studies. Statistical process control charts are available upon request.
• Historical data base, e.g., analytical results on consecutive lots.
• Periodic monitoring, e.g., analytical results.
• Vendor audits, e.g., audit reports.

Specifications

• Records of incoming materials specifications

Non-Conforming Incoming Materials

• Identification of the material.
• Identification of the deficiency.
• Preventative and corrective action taken.

• N/A

• N/A

• Inaccurate, incomplete or absence of records which does not permit verification of incoming materials controls, e.g., the manufacturer relies on 100% inspection and analytical results of incoming lots are not kept for ingredients which could impact on the safety of the process.

• none

• The manufacturer has an effective system in place to prevent the use of:
  • contaminated, damaged or defective containers
  • contaminated, damaged or defective unformed packaging material e.g., roll stock
• Packaging is handled and transferred in a manner that minimize damage and contamination, e.g. forklifts, conveyors, transfer points, synchronization of line speed etc.
• Prior to use, packaging is examined for damage (cracks and fractures) and contamination (e.g., glass, rust, foreign material, old food particles etc).
• Packaging is used for its intended purposes only.

• N/A

• N/A

• The manufacturer does not have an effective system in place to prevent the use of: contaminated, damaged or defective containers.
• Inappropriate handling of packaging material in the establishment causing damage/contamination e.g. rough handling, in-plant storage without protection.
• Dirty field containers used to hold frozen berries etc.

• PPR, 30.3(a) Suitable for use
• PPR, 16(12), Product cannot be exposed to a source of contamination

Option 1 - Continuous Visual Monitoring

• Prior to depalletizing, containers are examined for damage, e.g., exterior pallet examination of 4 sides.
• Empty containers are visually examined to identify, remove and segregate defective containers during depalletizing or on-line.
• Adequate lighting is provided at inspection stations and an adequate system or method is in place to inspect containers, e.g., overhead mirrors are suspended at the depalletizer, line speeds are appropriate.
• Containers are handled and transferred in a manner that minimizes damage and contamination, e.g., conveyors, transfer points etc.
• Type and number of defects are recorded (4.6.1.3).

Option 2 - Container Handling Damage Control

• The manufacturer has controls in place to prevent container damage as follows:
  • Vendor Controls
    • The manufacturer verifies that the supplier has effective controls in place to minimize damage of containers. Verification may be accomplished through review of the supplier's internal audits and through vendor audits. Can handling controls include; careful handling, minimizing handling of pallets and optimizing pallet protection during loading, shipping and storage, e.g., size of pallet, condition of the pallet, condition of the slip sheets, shrouding, strapping pressure, corner protectors.
  • Manufacturer's Controls
    • The manufacturer has controls in place to minimize damage, and verifies the effectiveness of these controls through periodic audits:
      • receiving controls, e.g., driver handling, unloading, identification of damage problems and corrective action
      • storage controls, e.g., stacking restrictions, heights, spacing, protection from damage and contamination
      • depalletizing and conveying controls, e.g., careful loading, removal of damaged containers during de-shrouding, effectiveness of damage control, synchronization of line speeds, transfer points
      • identification of deficiencies in control and corrective action taken
    • Containers are used for their intended purpose only.

• N/A

• Cans with serious defects not removed from the line (LAF).
• In process can handling causes serious damage to cans (LAF).

• Pallets of cans are not examined prior to depalletizing,, however, other subsequent visual inspection is satisfactory.
• Can handling damage control - e.g., the manufacturer has controls in place but does not verify the supplier's controls (as outlined in Option 2).
• Continuous visual monitoring of cans is deficient preventing adequate inspection, e.g., no mirrors, insufficient lighting, excessive line speed, etc.
• In process can handling causes minor damage to cans.
• Cans used for other than intended purpose.

• PPR, 30.3(a), Suitable for use
• PPR, 16(12), Product cannot be exposed to a source of contamination

• Containers are handled and transferred in a manner that minimizes damage and contamination, e.g., conveyors, transfer points.
• Temperature differential between warehouse storage and cleaner/filler is monitored to avoid thermal shock breakage, or
• Tempering tunnel temperature is controlled to minimize thermal shock breakage.

The manufacturer must have an effective system in place to prevent the use of damaged, defective or contaminated containers. This can be accomplished either through:

Option 1 - Continuous Visual Monitoring

• Prior to depalletizing, glass containers are examined for damage, e.g., exterior pallet examination of four sides.
• Empty containers are visually or electronically examined to identify, remove and segregate defective, damaged or contaminated containers during depalletizing or on-line.
• Type and number of defects are recorded (4.6.1.3).
• Visual inspection system:
  • adequate lighting is provided at inspection stations and an adequate system or method is in place to inspect containers, e.g., overhead mirrors are suspended at the depalletizer, line speeds are appropriate
• Electronic inspection system:
  • defect standards are used to set up the system which reflects the defects expected and found on line
  • the electronic system is tested at a pre-determined frequency using the defect standards to ensure proper operation
  • there is a back-up system in place in case the electronic inspection system fails

Option 2 - Handling Damage Control

• The manufacturer has controls in place to prevent container damage as follows:
  • Vendor Controls
    • The manufacturer verifies that the supplier has effective controls in place to minimize damage of containers. Verification may be accomplished through review of the supplier's internal audits and through vendor audits. Container handling controls include; careful handling, minimizing handling of pallets and optimizing pallet protection during loading, shipping and storage, e.g., size of pallet, condition of the pallet, condition of the slip sheets, shrouding, strapping pressure, corner protectors.
  • Manufacturer's Controls
    • The manufacturer has controls in place to minimize damage, and verifies the effectiveness of these controls through periodic audits:
      • receiving controls, e.g., driver handling, unloading, identification of damage problems and corrective actions
      • storage controls, e.g., stacking restrictions, heights, spacing, protection from damage and contamination
      • depalletizing and conveying controls, e.g., careful loading, removal of damaged containers during de-shrouding, effectiveness of damage control synchronization of line speeds, transfer points
      • identification of deficiencies in control and corrective action taken
    • Containers are used for their intended purpose only.

• N/A

• Damaged and defective glass containers not removed.

• Pallets of bottles are not examined prior to depalletizing,, however, other subsequent visual inspection is satisfactory.
• Glass container handling damage control - e.g., the manufacturer has controls in place but does not verify the supplier's controls (as outlined in Option 2).
• The glass container handling damage control or visual monitoring program is absent or deficient such that defective containers may be used.
• Continuous visual monitoring - deficiencies which prevent adequate inspection, e.g., no mirrors, insufficient lighting, excessive line speed.
• Container handling damage control - e.g., deficiencies in the control program which may result in use of seriously damaged containers.
• Containers used for purposes other than intended use.
• Electronic inspection equipment is not functioning properly.
• Excessive temperature differential causing glass cracking.

• PPR, 30.3(a), Suitable for use
• PPR, 16(12), Product cannot be exposed to a source of contamination

• Containers that require cleaning are cleaned by:
  • Inversion in conjunction with pressured air, water, steam or suction to remove extraneous material. Where water or steam are used, the water or steam shall be potable. Where detergent or sanitizers are used , they are used in accordance with the manufacturer's instructions and should be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
• A container cleaning system that:
  • operates at all times that the line is in operation
  • is efficient to remove harmful extraneous material
  • is maintained, e.g., nozzles not plugged, free from accumulated debris
• For small operations, manual inversion and examination of every container to ensure they are clean could be sufficient.

• Containers that may not require cleaning:
  • new plastic containers received and stored in plastic bags and protected from further contamination
  • plastic pails received stacked and inverted to protect them from contamination
  • plastic film and unformed pouch material protected from contamination

• Hazardous extraneous material not removed e.g. glass > 2mm.

• Containers not inverted and evidence of contamination with harmful extraneous material.
• No container cleaning system and evidence of major contamination with objectionable material.

• Container cleaning system not fully operational, e.g., nozzles partially plugged.

• PPR, 14(o), Appropriate container cleaning equipment
• PPR, 16(10) Free from foreign material
• PPR, 16(9) Proper use of cleaners
• References listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents

• Only containers previously used to contain food products or reconditioned for use in the food industry are utilized. All suspect container are discarded.
• Drums/lids that are rusty or flaking varnish/paint are diverted from the food container pile or reconditioned.
• Severely dented drums are removed from food container pile
• Broken totes are repaired or discarded.
• Containers which may have held other than food products or packaging material are removed from the premises.

The manufacturer has a system in place to thoroughly clean bulk containers before use.

• In place an effective cleaning system, e.g. High pressure washer, steam, etc.
• Where water or steam are used, the water or steam is potable and the containers are inverted; where detergent or sanitizers are used , they are used in accordance with the manufacturer's instructions and should be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
• The container cleaning system operates at all times that the line is in operation.
• The cleaning system is maintained, e.g., nozzles not plugged, free from accumulated debris.

• Hazardous extraneous material not removed e.g. glass > 2mm.
• Non reconditioned drums which had previously held container toxic chemicals are used to pack food.

• Containers not inverted/cleaned and evidence of contamination with harmful extraneous material (glass, wooden part, grease and oils).
• No container cleaning system and evidence of major contamination with objectionable material (food residues, soil, insects).
• No container inspection system and containers previously used to contain non food chemicals are used as food containers.
• History of containers is unknown.

• Container cleaning system not fully operational, e.g., nozzles partially plugged.
• No container inspection system and barrels with excess rust/flaking paint are used to pack food.

• PPR, 14(o), Appropriate cleaning system
• PPR, 16(10), Free from foreign material
• PPR, 16(9), Proper use of cleaners
• PPR, 16(12), Product cannot be exposed to a source of contamination

Written records of control of can handling damage and/or visual monitoring of empty containers are maintained and are available on request.

• The manufacturer records the date and can lot number or retains the pallet tag to permit lot traceability.

Can Damage

• Continuous Visual Monitoring.
• Records are kept of the defects identified at the depalletizer or on-line inspection; and/or

Container Handling Damage Control

• The manufacturer retains records of internal and vendor audit reports.
• The manufacturer maintains records of major activities related to can handling damage. For example, investigation reports including identification and scope of problems and the corrective action taken to minimize the possibility of recurrence.

• N/A

• N/A

• Records are incomplete or absent, e.g., no lot traceability.

• none

• no containers are left on the line between the cleaner and the filler at breaks, during clean-up or extended downtime unless adequate measures are in place to prevent contamination
• line stoppage procedures
• clean up methods
• disposal methods for removing damaged or contaminated containers
• glass breakage procedure is followed see section 5408
• minimum distance exists between filler and cleaner

• Containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination to clean or cleaned contain with hazardous extraneous material e.g. glass particles >2 mm.
• High risk of contamination to clean or cleaned containers with hazardous extraneous material e.g. glass particles >2 mm.
• Hazardous extraneous material >2 mm found in cleaned containers.

• Containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination e.g. wash up water, condensate.
• High risk of contamination to clean or cleaned containers with hazardous extraneous material e.g. glass particles
• Glass breakage procedure is not being followed.

• Containers left unprotected on the line at breaks and downtime where there is a low to moderate risk of contamination.
• Distance between cleaner and filler is too great, cleaned containers are not protected and there is a low possibility of contamination.

• PPR, 16(3), Strict sanitary control
• PPR, 16(10), Free from foreign material
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 16(14), Product cannot contact anything that may affect quality or color

• The manufacturer has a written procedure developed for each line where glass is used (related to the speed of the line, the jar size).
• The glass breakage procedure specifies:
  • who is responsible
  • the line where it applies
  • the immediate action to initiate when a glass breakage occur (e.g., stop the line);
  • the number of jars (or length of conveyor) to reject from the line (empty jars, filled jars, closed jars) depending of where the breakage occurs
  • the cleaning procedure of the piece of equipment or conveyor and surrounding area where the breakage occurred (e.g., cleaning material to use)
  • evaluation of the cause of breakage
  • disposal of the glass/jars and affected product
• The glass breakage procedure has to be available to the production employees.
• If product is recycled, any glass particle is effectively removed.
• Any other glass breakage occurrences (e.g. from glass bulbs, thermometers, etc.) are to be covered by this procedure.

Note: The application of the glass breakage procedure is evaluated within the process step ( filling, closure etc.).

• N/A

• No written glass breakage procedure.

• Glass breakage procedure not available to production employees.
• Incomplete glass breakage procedure.

• PPR, 16(10), Free from foreign material

• Records are available and demonstrate control of broken glass and affected product.
• Glass breakage records has to include:
  • the date/time, where it occurred, corrective action taken, responsible person initials or signature

• N/A

• N/A

• Insufficient information on records. which do not permit confirmation of the adequacy of glass clean up.

• none

Allergens (See Appendix IX)

• The manufacturer has controls in place to prevent the presence of undeclared allergens and other ingredients which may cause sensitivity reactions. Allergens are those ingredients that will elicit an allergic response in sensitive individuals.
• Areas that may require control include:
  • misdirection of ingredients
  • use of rework
  • contamination by undeclared ingredients
  • ingredient carryover
  • ingredient substitutions
  • contamination due to residues from previous run, e.g., product changeovers

Food Additives (e.g., colors, preservatives, firming agents, antifoaming agents, processing aids).

• The manufacturer has controls in place to ensure that food additives are permitted and are used within allowable levels. These include:
  • clear identification of additives
  • accurate measurement
  • adequate blending for homogeneity

Nutrient Enrichment

• The manufacturer has controls in place to ensure that nutrient levels comply with regulatory and label requirements including:
  • clear identification of nutrient
  • proper storage and handling to maintain nutrient potency
  • accurate measurement
  • adequate blending for homogeneity

• Inadequate or no control of rework, substitutions and use of the allergens with a known history of producing anaphylactic reaction in sensitive individuals (see Appendix IX ).
• Inadequate control and evidence of the above allergens in the food e.g. sulphiting agents in glazed fruit.

• Use of rework or ingredient substitutions is not adequately controlled and the sensitive ingredients (e.g., lactose, MSG) are used in the plant.
• Amount of additives or nutrients being blended does not meet formula requirements and safety may be affected.

• Lack of control resulting in significant variation in the levels of food additives and nutrients outside formula requirements but not affecting food safety.
• Ingredient substitutions and use of rework is not adequately controlled but no listed allergens used in the plant (See Appendix IX) (e.g., lactose, MSG).

• PPR 2.1(1)(f) Meets the requirements of the Food and Drug Regulations
• F&DR, B.01.008(3) Ingredients must be shown in descending order of proportion on the label

Thermal Processing

• The manufacturer has controls for critical factors identified in the validated process. Examples of critical factors are:
  • size control, e.g., dicing, grinding, slicing
  • temperature treatment control, e.g., heating, blanching (textural changes), defrosting, cooling
  • moisture control, e.g., rehydration, concentration (viscosity, Brix)
  • proportioning control, e.g., weighing, volumetric control (metering)
  • pH/Acidity control, e.g., pH measurement, titratable acidity for pectinization
  • preservatives, e.g., as allowed by the Food and Drug Regulations and PPR
  • firming agents e.g. calcium chloride

Preparation/Blending Microbial Control

• The manufacturer controls time and temperature during preparation, blending and holding of in-process materials to prevent conditions that could result in excessive microbial growth or in the production of enterotoxin by Staphylococcus aureus.

• Inadequate control of critical factors specified in the scheduled process, e.g., inaccurate preparation, blending or measurement of critical ingredients.

• Inadequate control of pre-process holding conditions that may result in the growth of Staphylococcus aureus.

• N/A

• PPR 30.3(f), Thermal process meets or exceeds schedule process
• PPR Schedules I and II
• Food and Drug Regulations, B11

Acidification/Brine Preparation

• The manufacturer has controls for critical factors identified in the process design which will contribute to obtain the equilibrium pH of less than 4.6, such as:
  • appropriate acid: type and concentration, e.g. percent of acid or grains vinegar (United States or Canada)
  • amounts of acid required
  • pH measurement and/or titratable acidity of the brine
• Where a food has come into contact with a strong base such as lime (Olives) and there may actually be undissolved particles present, these particles can result in an occasional final container having a pH greater than 4.6.

Microbial Controls

• The manufacturers monitors periodically the pH/titratable acidity of the product and brine during the fermentation process.
• The fermentation conditions [e.g. time, % salt, (salt additions)] are controlled in order to obtain the acidification of the product and brine to prevent undesirable microbial growth or the production of metabolic byproducts of microbial growth.
• Low-acid ingredients (i.e. cucumbers) destined to become acidified foods shall not be held for extended periods under conditions which allow the growth of pathogens.

• Inadequate control of critical factors specified in the process design, e.g. inaccurate preparation, blending or measurement of critical ingredients which may have an impact on the equilibrium pH of the finished product.
• Lack of control of sulfite addition.

• Amount of additives being blended does not meet formula requirements and preservation of the product may be affected.

• N/A

• PPR 30.3 (f), Thermal process meets or exceeds scheduled process
• CFIA Pickle Manual

• Records to demonstrate adherence to critical limits specified in the formula
• records for critical factors specified in the validated thermal process
• for nutrients in foods that are a sole source of nutrition
• records for critical factors specified in the acidification process:
  • pH or titratable acidity measurements of the brine
  • solid/liquid ratio (drained weight)

• N/A

• Record entries for critical factors are not complete, e.g., results not recorded at time of activity, activity conducted but not consistently recorded.
• Records absent, inaccurate or incomplete for critical factors.

• Deficiencies in record keeping which do not affect verification of the adequacy of critical factor controls.

• PPR, 30.2(f) Records that set out the low acid food product history

Biological hazards

• Visual inspection controls, e.g., removal of decomposed product.
• Washing using potable water e.g., reduction of the microbial load.
• Washing using disinfection agent in water e.g. reduction of the microbial load.

Chemical hazards

• Control by washing raw material to remove/reduce chemical/pesticides residue applied by the grower.
• Control of natural toxins by sorting, e.g., color (glycoalkaloids in potatoes).
• Disinfectant water is used as per manufacturer's instructions. Disinfectants are listed in the "Reference Listing of Accepted Consutruction Materials, Packaging Materials and Non-Food Chemical Products" published by CFIA or the manufacturer has a "letter of no objection" from Health Canada. The concentration of disinfectant is to be controlled and the product is rinsed with potable water when necessary.

Physical hazards

• Metal contamination controls, e.g., magnets, metal detectors.
• Other extraneous matter controls, e.g., sorting/cleaning by gravity, air or water, inspection.
• Pit portion control e.g., peach or cherry.

The manufacturer removes the non hazardous extraneous materials and defective products e.g., vegetative material, insects, plastic, culls etc. by sorting/cleaning by gravity, air, water, or inspection.

• Inadequate cleaning, sorting, and/or preparation of raw material where there is a contamination with hazardous extraneous material e.g. glass particles > 2 mm and without any further control before filling.

• Inadequate control of pit material > 2 mm.
• Deficiencies in the removal of hazardous contaminants - decayed apples not sufficiently removed to prevent patulin contamination.
• Contamination concern - e.g., high risk of contamination with avoidable filth.
• Health risk concern - e.g., absence of control in removal of hazardous contaminants such as glass, metal.
• Disinfectant material not used as per manufacturers instructions.
• Dirty ingredient containers not cleaned before ingredient is used.

• Inadequate control of pit material < 2 mm.
• Deficiencies in the removal of non-hazardous contaminants, e.g., washing of raw materials is ineffective.
• Product not rinsed after disinfectant.

• PPR, 2.1(1), Is not contaminated
• PPR, 2.1(d), Prepared in a sanitary manner
• PPR, 16(13), Food must be kept at the correct temperature and humidity
• PPR, 16(16), Raw material are washed as needed to remove soil or contamination
• PPR, 16(17), Raw materials are inspected, sorted and culled

• Preparation, peeling, coring, de-stemming.
• Size control, e.g., dicing, grinding, slicing.
• Time/temperature control, e.g., heating, cooking, blanching, frying (textural changes), defrosting, cooling.
• Moisture control, e.g., reconstitution, drying, rehydration, concentration, (viscosity, Brix).
• Ingredient proportion control, e.g., sugar, salt, starch, weighing, volumetric control (metering).
• Ingredient authenticity (Economic Fraud)
• pH/Acidity control, pH measurement, titratable acidity (e.g., for pectinization).
• blending/mixing e.g., concentrate and water.
• Chemically preserved fruit/vegetables is thoroughly washed prior to processing to ensure it meets the requirements of B11 of the food and Drugs e.g., SO₂ preserved fruit.

• N/A

• N/A

• Product not manufactured according to quality specifications/formulation.
• Inadequate control of soluble solids could lead to growth of yeasts and molds.
• Inadequate control of the slicing/dicing of fruits and vegetables.
• Manufacturer is not meeting the time/temperature requirements as outlined in the process design with no safety impact.
• Inadequate control of firming agents resulting in poor quality product.

• PPR, 2.1 (1) (c) All components and ingredients of a food must be sound, wholesome and edible
• PPR Section 6, Schedule II Standards for Fruit and Vegetable products are prescribed
• PPR Section 31 (e) Product shall be labeled with the true and correct grade name
• PPR Schedules I and II
• PPR: Table XI, Part I, II, III and IV Grades and identity standards
• PPR: 2.1.1 References to F&DR

• fill temperature
• ingredient distribution, e.g., meat, gravy, vegetables
• orientation of products in the containers and handling, e.g., wieners, asparagus
• volume/weight control, e.g., proportion weights, fill weights, head space
• correct container is being used e.g., can-enamel, coatings, tin plate, bottle, pouch, etc.
• proper packing medium used
• product is protected from contamination during filling

Please refer to relative sections for filling criteria for specific types of containers.

• 5.1.6.4, task 5604 - cans
• 5.1.6.5, task 5605 - jars
• 5.1.6.6, task 5606 - pouches

• Inadequate or absent control for critical filling factors specified in the scheduled process, e.g., drained weight exceeds process requirements, product orientation incorrect, incorrect can size.

• Inadequate control of filling factors, however; other controls reduce the likelihood of a health risk occurring, e.g., inadequate control of filling temperature but other controls, such as monitoring of IT at retorts, reduces the risk of under processing.

• Incorrect can type (enamel) is used.

• PPR 30.3(b), Filling is in compliance with schedule process
• PPR, 30.3(a), Containers suitable for use
• PPR, 20 - 22, Prescribed container sizes are used to pack fruit & vegetable products

• correct container type
• drained weight
• fill temperature, e.g., frozen product not allowed to thaw, minimum temperature for hot filled product
• net quantity
• liquid/solid ratio
• head space
• vacuum
• proper packing medium used
• product is protected from contamination during filling

Please refer to relative sections for filling criteria for specific types of containers.

• 5.1.6.4, task 5604 - cans
• 5.1.6.5, task 5605 - jars
• 5.1.6.6, task 5606 - pouches

• Inadequate or absent control for critical filling factors specified in the process design , e.g., liquid/solid ratio (fresh pack pickles only).

• Inadequate control of filling factors, however; other controls reduce the likelihood of a health risk occurring, e.g., inadequate control of filling temperature but other controls, such as monitoring of IT at pasteurizer, reduces the risk of under processing.
• Inadequate control of hot fill temperature for juices - no other controls to reduce the likelihood of a health risk.
• Incorrect container type is used (glass vs metal) where product is pasteurized in the container.
• Inadequate brine used for filling of pickles (fresh pack or fermented), but Equilibrium pH and final pH are not at risk.

• Incorrect container type is used (container lining).
• No vacuum in containers where specified in the process design.
• Product temperature not maintained (frozen or refrigerated).

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 20 - 23, Prescribed container sizes are used to pack fruit & vegetable products
• PPR, 26(3), Minimum fill for frozen product is 90% of container capacity
• PPR, 30.3 (a) Container suitable for use (ALAF)
• PPR, 30.3(b) Filling is in compliance with schedule process (ALAF)
• PPR, Schedule I Table II Micro specifications for Frozen Vegetables

• Meet the prescribed container sizes and dimensions as outlined in the PPR if applicable (unless for export).
• Are filled to meet volume/weight requirements of the PPR and the CPLR.

• N/A

• N/A

• Manufacturer uses containers not prescribed in the PPR
• Fill weight is not controlled to meet the declared net quantity (fraud only).

• PPR, 20 - 27 Containers must be prescribed sizes. Container sizes smaller than the smallest prescribed sizes (specified containers) must have registered labels. Fill weight must meet prescribed amount.
• PPR, 57, Standard containers sizes and fill weights exempted for export

• continuous monitoring of containers and/or caps to eliminate sealing area interference, e.g., visual or electronic examination
• verification of the effectiveness of continuous monitoring, e.g., quality assurance checks prior to sealing

• N/A

• Sealing area interference control is absent or ineffective resulting in serious double seam defects, e.g.., droops LAF and Acidified Foods.

• Sealing area interference control is absent or ineffective resulting in minor sealing defects.
• Sealing area interference control is absent or ineffective resulting in serious double seam defects, e.g., droops Acid Foods in HSC, Frozen Foods.

• PPR, 30.3(l) Containers handled to avoid damage

• Evaluating areas that may contaminate the product with glass.
• Checking of alignment and timing.
• Inspecting filling area regularly for broken glass.
• Monitoring/gap detecting for a possible broken container. The gap detector will shut down a piece of equipment when a major container break occurs. The unit counts the number of containers entering and exiting the equipment. Any discrepancies in the counts indicates a container failure.
• For products filled on a carbonated beverage filler i.e., juices, water, refer to inspectional method 302.2 (6) in the Food Inspection References Manual.
• Removal of broken glass.
• Tearing down of equipment to the extent necessary to remove the potential for glass contamination i.e., seal, rubbers, valve blow outs, valve dismantling.
• Continuous monitoring of containers and/or caps to eliminate sealing area interference, e.g., visual or electronic examination.
• Verification of the effectiveness of continuous monitoring, e.g., quality assurance checks prior to sealing.

• Broken glass found on food contact surfaces or in jars.

• Filling area not inspected regularly for broken glass.
• Sealing area interference control is absent or ineffective resulting in serious sealing defects, (Low Acid Foods and Acidified Foods).

• Gap detector not tested.
• Sealing area interference control is absent or ineffective resulting in minor sealing defects.
• Sealing area interference control is absent or ineffective resulting in serious sealing defects, e.g., closure defects droops (Acid Foods in HSC, Frozen Foods).

• PPR 2.1 (1) Is not contaminated, adulterated, etc.

• filler drip does not contaminate seal area of empty pouches
• product or liquids not drawn onto seal area by high vacuum
• product not overfilled onto the sealing area
• seal not stressed by insufficient air evacuation or excess back flush

• N/A

• Sealing area interference control is absent or ineffective resulting in serious sealing defects (LAF).
• Seals stressed by improper air evacuation (LAF).

• Sealing area interference control is absent or ineffective resulting in minor sealing defects
• Sealing area interference control is absent or ineffective resulting in serious seam defects, e.g., blister Acid Foods in HSC, Frozen Canned Foods.

• PPR, 2.1 All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed
• PPR, 16(12), Product cannot be exposed to a source of contamination
• Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)

• Temperature control records, e.g., filler bowl temperature recorder charts and/or manual records.
• Ingredient distribution control records, e.g., visual checks for product orientation.
• Weight/volume control records, e.g., portion weights from multi-phase fillers, total weights, head space.

• N/A

• Absent or inadequate records for critical factors, e.g., temperature recorder controller, temperature recorder (where it is the only means of monitoring temperature), statistical process control charts used to control ingredient distribution or weight/volume.

• Deficiencies which do not affect verification of the adequacy of critical factors in filling, e.g., date missing, date missing for one time period, not signed by operator.

• PPR 30.2(f) Records set out the low acid food product history

Unsealed containers are conveyed from filler to sealer/seamer in a manner to prevent breakage/damage and hazardous contamination.

The processor has the following controls in place:

• no containers are left on the line between the filler and the sealer/seamer at breaks, during clean-up or extended downtime e.g. line stoppage procedures,clean-up procedures
• disposal methods for removing damaged or contaminated containers
• equipment and surfaces contacting the container shall not result in damage or abrasion
• pouch breakage procedure is followed
• glass breakage procedure is followed

• Unprotected filled containers left on line, containing hazardous extraneous material >2mm.

• Filled containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination e.g. wash up water, condensate, spoilage or conditions affecting the process.
• Filled containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination with hazardous extraneous material.
• Clips to hold pouches, damage the sealing area causing serious seal defects (LAF Products).

• Filled containers left unprotected on the line at breaks and downtime where there is a low to moderate risk of contamination, spoilage or change in conditions affecting the process.
• Clips to hold pouches, damage the sealing area causing minor seal defects (LAF Products).
• Clips to hold pouches, damage the sealing area causing serious seal defects (Acid Foods in HSC).

• PPR, 16(12), Product cannot be exposed to a source of contamination

• During operations, the manufacturer monitors equipment (metal detectors, magnets, etc) to ensure it detects and removes extraneous metal.
• If a metal detector is used, shall be tested on a regular frequency to ensure it is operating in accordance with detector manufacturer specifications.
• If equipment other than a metal detector is being used, it shall be shown that it is operating in accordance with specifications.

• N/A

• Metal detector in operation, but hazardous metal fragments found in product.

• Metal detector not operating in accordance with manufacturer=s specifications (if installed).
• Insufficient exposed surface area on magnet.

• PPR, 2.1 All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR, 16(12), Product cannot be exposed to a source of contamination

• protecting the cap/lid hopper from glass contamination
• adjusting closing equipment to avoid chipping either the finish or glass edge and forming a hermetic seal
• broken glass is removed from capping equipment and surroundings
• closure heads are adjusted based on the results of the destructive examination to ensure hermetic seal

• Broken glass found in capper hopper or on capper machinery.

• Capper area not inspected regularly for broken glass.
• Closure heads not adjusted to ensure hermetic seal.

• N/A

• PPR, 2.1 All ingredients, food additives and processing aids are not adulterated
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed

• properly formed & undamaged pouches are used
• the proper placement of the pouches within the jaws of the sealing machine - equipment & pouch alignment
• sealing material compatibility
• flat, smooth & parallel sealing surfaces
• sealing pressure by the sealing tool holding the pieces together
• sealing time of the sealing tool holding the pieces together
• correct temperature of fusion
• condition of the sealing surface

• N/A

• Improper pouches are used, causing serious seal defects (LAF).

• Pouch not properly placed in the sealing jaws causing minor seal defects (LAF).
• Pouch not properly placed in the sealing jaws causing minor or serious seal defects (Acid Foods in HSC).

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated
• PPR 2.4, Food product container is not defective
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed
• Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)

• The manufacturer has specifications and controls for container vacuum as follows:
  • all factors affecting vacuum are controlled, e.g., temperature, air exhaustion by steam or mechanical vacuum, fill weight/volume and head space to prevent permanent seam distortion during processing
  • where appropriate, container vacuum is monitored and controlled to ensure adherence to the requirements of the scheduled process

• Insufficient control of vacuum where vacuum is a critical factor in the scheduled process.

• Consistently packing product with no or low vacuum which does not permit verification of a hermetic seal (LAF).
• Insufficient control of vacuum causing (LAF) permanent seam distortion.

• Deficiencies in vacuum control which occasionally results in no or low vacuum.

• PPR, (LAF) 30.3(C), Operations at each closing head is evaluated
• PPR 2.4, Food product container is not defective

• all factors affecting vacuum are controlled, e.g., temperature, air exhaustion by steam or mechanical vacuum, fill weight/volume and head space to prevent permanent seam distortion during processing
• where appropriate, container vacuum is monitored and controlled to ensure adherence to the requirements of the process design

• N/A

• N/A

• Deficiencies in vacuum control which occasionally results in no or low vacuum.
• Consistently packing product with no or low vacuum which does not permit verification of a hermetic seal.
• Insufficient control of vacuum causing permanent seam distortion.

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR 2.4, Food product container is not defective

• Visual examinations are in accordance with the Government of Canada "Metal Can Defect Identification and Classification Manual".
• The manufacturer visually monitors ends for damage prior to use.
• The manufacturer visually examines sealed containers for defects, as follows: a minimum of at least 1 can from each seaming head at intervals not exceeding 30 minutes.

Jars: External Inspections at Capper

• The manufacturer visually monitors caps for damage prior to use
• The manufacturer visually examines sealed containers for defects, as follows:
  • Straight line cappers a minimum of 6 consecutive jars every 30 minutes.
  • Rotary cappers - 1 jar from each head every 30 minutes.

Pouches:

• Visual examinations are in accordance with the Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
• All samples are inspected visually for defects.

All other types:

• examinations are conducted at start-up, after major jams or after adjustments.

• N/A

• Less than 1 can/bottle/pouch per head examined.
• Sealed containers are visually inspected at time intervals significantly exceeding 30 minutes on a consistent basis, e.g., two, three or four hour intervals.
• Absence of visual examinations of sealed containers after startup, major jams, etc.

• Ends/caps are not visually checked prior to use.
• Sealed containers are visually inspected at time intervals occasionally exceeding 30 minutes.

• PPR 2.4, Food product container is not defective
• PPR (LAF) 30.3(C), Operations at each closing head is evaluated

The manufacturer conducts destructive examinations to ensure conformance to specifications as follows:

Frequency

• intervals do not exceed four hours
• a minimum of one container from each seaming, sealing, turret feed or closure head is examined
• tear downs are conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing /sealing machine

Cans:

• Destructive or tear down examinations are conducted in accordance with the "Government of Canada Metal Can Defect Identification and Classification Manual".
• Seam Measurements
  • The manufacturer conducts double seam tear downs and internal and external measurements as follows:
    • external - thickness and height
    • internal - body hook, cover hook, optical overlap or equivalent
    • visual inspection - tightness Rating

Jars:

• Container Closure Examination:(The manufacturer also verifies closure after cooling by physical measurements: see 5.1.1.8, task 6108).
• Destructive exam: Different types of inspections are available for the closure control of jars, their applicability depends on the type of closure and the type of capper. These measurement should be taken by authorized personnel.
  • straight Line Machines 3 jars taken consecutively every 4 hours
  • rotary capper 1 jar per head every 4 hours
• The usual controls are:
  • Security Value
  • Removal Torque (optional)
    • Measured with a Torque-meter
  • Gasket:
    • The gasket should have a uniform 360° impression in it, resulting from contact with the glass finish.

Pouches:

• Destructive or tear down examinations are conducted in accordance with the Flexible Retort Pouch Defects, Identification and Classification Manual, Draft Version (April 1, 1998)
• empty containers are tested for bond strength
• Tests include:
  • burst test
  • in-process after pouch formation - Air Burst bottom and side seal
  • in-process-after closure seal - Air Burst Top Seal visual for defects
  • tensile test
  • seam examination for evidence of product in seal area and seal width

• N/A

• Intervals significantly or consistently exceed four hours.
• Absence of destructive examinations.
• Teardowns not conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.

• Intervals occasionally exceed four hours.

• PPR 2.4, Food product container is not defective
• PPR (LAF) 30.3(C), Operations at each closing head is evaluated

• Visual examinations are in accordance with the Government of Canada "Metal Can Defect Identification and Classification Manual" and Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft).
• The manufacturer visually monitors ends for damage prior to use.
• The manufacturer visually examines sealed containers for defects. e.g., a minimum of one container from each seaming, sealing, turret feed or closure head is examined.

• N/A

• N/A

• Visual checks on ends/lids not conducted.
• Visual checks on bottles, cans and pouches not conducted.

• PPR 2.4, Food product container is not defective
• PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner contaminated

The manufacturer conducts destructive examinations to ensure conformance to specifications as follows:

• Destructive or tear down examinations are conducted in accordance with the "Government of Canada Metal Can Defect Identification and Classification Manual" and Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
• Security value - This measurement should be taken at intervals during every production period. After processing and cooling, the gasket should have a uniform 360 degree impression resulting from contact with the glass finish.

Frequency

• Tear downs are conducted at an appropriate frequency.
• Tear downs are conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.
• Inspection of closure of jars shall be made both at the closing machine and after cooling of the finished product.

• N/A

• N/A

• Destructive examinations not conducted at regular intervals.
• Teardowns not conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.

• PPR 2.4, Food product container is not defective
• PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner contaminated

Container exteriors are effectively cleaned prior to processing, where necessary.

• The manufacturer has a program in place to identify and eliminate points where container damage could occur. Particular attention is given to container transfer points, areas where containers abruptly change speed or direction, controls to stop conveyors when containers are stationary and synchronization of container handling systems.
• Where necessary, the manufacturer cleans containers and monitors the effectiveness of cleaning, e.g., removal of extraneous material from can exteriors.
• Pouches are handled in a manner to prevent puncturing by sharp objects or abrasion from equipment.
• Pouches are minimally handled.
• Excessive flexing, folding, movement and vibration of pouches is avoided.

• N/A

• Cable cut where the outer layer of metal is torn or cut through (LAF).
• Deficiencies in control resulting in severe damage of double seam (LAF).
• Deficiencies in control resulting in serious container handling defects to pouches (LAF).

• Deficiencies in control resulting in minor abrasion of double seam.
• Containers not effectively cleaned.
• Deficiencies in control resulting in minor handling defects to pouches.
• Deficiencies in control resulting in serious container handling defects to pouches (Acid Foods).
• Deficiencies in control resulting in serious can handling defects (Acid Foods).

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, contaminated
• PPR 2.4, Food product container is not defective
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 16(14), Product cannot contact anything that may affect quality or color

The manufacturer visually examines sealed packages for defects.

• Heat Application - pure pac and plastic bags- Continuous seals.
• Metal Ends are properly mechanically seamed to body of the cans.
• Mechanical Press On Lids- pails and tubs or totes.
• Klick Lock - seams heat sealed/glued as required.
• Cardboard Box with poly liner - poly lined folded over, taped or tied, The boxes are glued, taped or stapled.
• Totes with poly liner - liner properly folded over.
• Barrels (open head) - metal and plastic - liner is tied and lid applied.
• Barrels (closed head) - metal and plastic - no liner - bung is plugged.

• N/A

• N/A

• Visual checks on containers not conducted.
• Packages are not properly closed.

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, contaminated
• PPR 2.4, Food product container is not defective
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 16(14), Product cannot contact anything that may affect quality or color

Visual Examination Records

• code lot
• date and time of evaluation
• examination results
• corrective actions taken

Destructive Examination Records

• code lot
• date and time of closure evaluation
• container closure specifications (cans, jars, pouches, bricks etc)
• container closure measurements
• corrective actions taken

• N/A

• Deficiencies which do not permit verification of the adequacy of container integrity examinations, e.g., no record of tightness, overlap, etc. (LAF).
• Absence of records which are part of the control mechanism, e.g., destructive examination records.

• Deficiencies which do not affect verification of the adequacy of container integrity examinations, e.g., minor variations in frequency.

• PPR, 30.2(f) Records set out the low acid food product history (LAF)

• The manufacturer has a system of control in place to prevent damage by coding, e.g., letters and code blocks that are damaged or worn, misaligned or improperly matched letters and pressure applied, etc.
• The manufacturer conducts visual monitoring for enamel damage, metal fracture or perforation at regular intervals and after adjustments or changes to the coder.
• Mechanical coding equipment is maintained to prevent damage to containers.

• N/A

• Use of excessively worn letters or code blocks resulting in fractured enamel or metal in products subject to accelerated corrosion. No leakers identified but likelihood of leakage occurring within normal shelf life. Coding can compromise the integrity of containers.
• Perforated metal and leakage identified.
• Lack of maintenance of code blocks and letters resulting in fractured codes caused by worn code blocks and letters.

• Inadequate monitoring but controls are effective, i.e., no defective containers identified.

• PPR 16(12), Product cannot be exposed to a source of contamination
• PPR 30.3(c), Closing heads are evaluated to ensure container is properly sealed
• F&DR B.27.003, No person must sell a low-acid food packaged in a hermetically sealed container where the container is swollen, is not properly sealed, or has any defect that may adversely affect its hermetic seal

• The manufacturer has a system of control in place to prevent damage by coding, e.g., letters and code blocks that are damaged or worn, misaligned or improperly matched letters and pressure applied, etc.
• The manufacturer conducts visual monitoring for enamel damage, metal fracture or perforation at regular intervals and after adjustments or changes to the coder.
• Mechanical coding equipment is maintained to prevent damage to containers.

• N/A

• N/A

• Inadequate monitoring but controls are effective, i.e., no defective containers identified.
• Use of excessively worn letters or code blocks resulting in fractured enamel or metal in products subject to accelerated corrosion. No leakers identified but likelihood of leakage occurring within normal shelf life.
• Perforated metal and leakage identified.
• Lack of maintenance of code blocks and letters resulting in fractured codes caused by worn code blocks and letters.

• PPR, 16(12), Product cannot be exposed to a source of contamination

• The manufacturer has a system of coding which ensures that each hermetically sealed container of:
  • low acid foods and acidified low acid foods has a legible and permanent code
  • graded fruits has a legible code
• Code marks used and the exact meaning of the code are available to the inspector.
• Where applicable, the code accurately reflects the "best before" date, expiration date, or shelf life of the food.

• N/A

• N/A

• No coding or illegible codes identified.

• PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR 30.3(d), Container is marked in a legible and permanent manner to identify the establishment, the food product and the date on which the food product is thermally processed and, where any part of this information is coded, the meaning of the code used is made available to an inspector on request
• PPR 31(aa), Code marks indicate establishment where product was packed and date of pack for graded canned fruits & vegetables
• PPR 33, Product packed for first dealer shall have be coded with establishment registration number or establishment identification code

• The manufacturer can demonstrate that the product is commercially sterile and is free from toxins under the most extreme time, temperature and product conditions.
• Sealed product is held at temperatures that will not permit the growth of microorganisms that could impact on the safety of the process (less than 4°C [39°F] or greater than 65°C [149°F]).
• The heat transfer characteristics of the product are not affected.
• The manufacturer has control over the time lapse between sealing and retorting, e.g., reporting of line breakdowns or interruptions that may result in excessive lapse times.
• If the time lapse exceeds that demonstrated by the manufacturer to be safe, the product is treated as a process deviation and is held for safety evaluation.
• If there are line breakdowns or interruptions, the manufacturer processes product in partially filled retorts to ensure that the maximum lapse time is not exceeded.

• N/A

• The time lapse exceeds that determined to be safe by the process authority.

• Lapse times occasionally slightly exceed one hour, e.g., time lapse 75 minutes, product temperature 62°C (144°F) and no assessment by a processing authority.

• PPR 30.1(1), Product must be processed until it is commercially sterile
• PPR, 30.3(f), Requirements of the schedule process shall be met

Loading Procedures

• The manufacturer adheres to the loading requirements specified in the temperature distribution studies and process schedule, e.g., layering of dividers, types of dividers, hole configuration of the dividers (e.g., size, pattern, area), product orientation, number of layers per basket, pouch placement, etc.
• The manufacturer does not permit nesting of cans or touching of pouches unless it has been included in the temperature distribution studies and scheduled process.

Damage Control

• The manufacturer has adequate controls in place to minimize impact damage during loading (e.g., use of damaged baskets, rough handling of full baskets) and inadequate cushioning of containers during scrambled/jumble loading is prevented.
• Pouch racks are kept free of rust, scale etc that may cause pin holing.

• Baskets not loaded to meet requirements of the temperature distribution or heat penetration studies (use of double dividers, can orientation - asparagus) (LAF).
• Pouches touching resulting in under processing.

• Inadequate control of basket loading practices such that damage affecting the hermetic seal could occur.
• Container damage and leakage.
• Rust or scale on pouch racks which could cause pinholing.

• Use of damaged baskets that may cause minor defects on cans.

• PPR 30.3(f), Thermal process meets the schedule process
• PPR 30.3(l), Containers are handled to avoid damage
• PPR 16(12), Product cannot be exposed to a source of contamination
• Flexible Retort Pouch Defects, Identification and Classification Manual (1998 Draft)

• Control systems are in place to prevent co-mingling of processed and unprocessed products, e.g., physical separation between closing and retorting, mess guards around crateless retorts.
• Containers of unknown process status are immediately destroyed, e.g., cans found lying under or beside retorts are punctured.
• Where there are multiple retorts and products requiring different processes, there is a system of identification to verify that each basket has been directed to the correct retort, e.g., a tag system.
• All baskets or containers are clearly marked with a heat sensitive indicator(s) that undergoes changes only after exposure to processing temperatures, e.g., thermotropic ink, tape, tags.
• Indicators are stored and handled according to manufacturer's recommendations to ensure adequate performance.
• After retorting, the manufacturer monitors the indicator to verify that each retort basket was subjected to a heat process (indicators do not verify that the correct temperature or time was achieved during the process).

• Incomplete control of unprocessed product, e.g., tags are not functioning as required due to improper storage and handling, the indicator on each basket is not checked after processing.
• Absence of controls to prevent misdirected baskets; mixing of products requiring different processes; products by-passing the retort.
• Containers of unknown status left in retort area and not destroyed.

• N/A

• N/A

• PPR 30.3(j), Use of heat sensitive indicators

• The manufacturer monitors the temperature to ensure that the product does not drop below the specified initial temperature, e.g., temperature of the coldest can for each retort load.
• The manufacturer's procedure for determining the initial temperature reflects the procedure used to determine the minimum IT during the heat penetration studies, e.g., the product is stirred or shaken, the temperature is taken at the center or in several locations for multi-phase products.

• The initial temperature is below that required by the scheduled process.

• Procedures for determining initial temperature are not the same as those used in the heat penetration tests.
• Monitoring frequency is not sufficient to verify that initial temperature requirements are met.

• N/A

• PPR 30.3(f), Thermal process meets the schedule process

• The manufacturer ensures that correct vent and process schedules for each product and container size being processed are accessible to the operator, i.e., posted at the retort or available at the retort operator's station.

• N/A

• N/A

• Process or vent schedules are not readily accessible or available to the operator.

• PPR 30.3(g), Located near the unit of thermal processing

The manufacturer controls retort operations as follows:

• Written Retort operating Procedures
• Retort operating procedures include venting, processing and cooling procedures and instructions for handling deviations, e.g., the operator has clear instructions to either extend the process, reprocess and/or isolate affected product for safety evaluation.
• The procedures are based on critical factors identified in the temperature distribution studies and in the validated process, and provide clear instructions to the operator.

• N/A

• Written retort operating procedures are deficient resulting in a possible processing error.

• Written retort operating procedures are deficient but safety is not affected.

• PPR 30.3(e), Certificate of competence for thermal processing
• PPR 30.3(f), Thermal process meets schedule process
• PPR 30.3(g), Location of schedule process

• The vent schedule meets both the minimum time and temperature requirements established in the temperature distribution tests.
• The vent procedure is carried out in adherence to specifications resulting from the temperature distribution studies, e.g., loading configuration, steam manifold pressure, number of retorts being vented at one time.
• The manufacturer controls venting to ensure adherence to the procedures.

• Vent does not meet the minimum time or temperature requirements and the operating process is equal to the scheduled process.
• No vent.

• Vent does not meet the minimum time or temperature requirements but the operating process is greater than the scheduled process, i.e., process has a safety margin.

• N/A

• PPR 30.1(1), Product processed to meet commercial sterility
• PPR 30.3(f), Thermal process meets schedule process

• The process time meets the minimum requirements of the scheduled process.
• The operator monitors and controls process time using an official timing device, e.g., clock.
• Process time is verified by the operator with a written log and a recording chart.
• The timing of the process does not begin until the retort has been properly vented and the scheduled process temperature has been achieved.
• For systems using automatic time control, the accuracy of the timer is verified by the operator at an appropriate frequency, e.g., the operator compares the timer against the official timing device.
• The retort processing time is confirmed by the operator using the official timing device and logged prior to termination of the thermal process.
• When more than one official timing device is used they are synchronized.
• The time on the recorder chart agrees with the actual time of day on the official timing device.
• Process time is controlled to ensure that the full time specified in the scheduled process is achieved, e.g., where an official timing device does not indicate seconds a one minute safety factor is added to the vent and to the process.

Process deviation controls are to be evaluated under section 5.1.13.1 (task 6301).

• Actual process time is less than the scheduled process time and no deviation control is initiated.

• Official timing devices not synchronized and more than one clock can be used for the same retort.

• The actual process time is less than the operating process requirements, but still meets the scheduled process requirements.
• The time on the recorder varies significantly with the actual time on the official timing device.
• Official timing devices used are not synchronized, but only one clock can be used for each retort.

• PPR 30.1(1), Product processed to meet commercial sterility
• PPR 30.3(f), Thermal process meets schedule process

• The minimum temperature requirements for the scheduled process are met.
• The operator monitors the indicating thermometer temperature at the start of the process and at least once during the process to verify that the minimum temperature is achieved and maintained.
• The operator compares the indicating thermometer temperature with the recorder temperature at least once during the process after temperature equilibrium has been achieved.
• The recording thermometer does not vary by more than 0.5° C (1° F) from the indicating thermometer and at no time reads higher than the indicating thermometer.
• The operator ensures that the recording chart produces a continuous record of the temperature. In the absence of the continuous record (ink skips), the operator adequately documents that the temperature was maintained.
• The correct chart is used for the recorder, e.g., the numbers on the chart match those on the panel of the recorder specified by the instrument manufacturer.

Process deviation controls are to be evaluated under Task 5.1.13.1 (task 6301).

• The recorder reads higher than the indicating thermometer and the indicating temperature is less than the scheduled process and no deviation control is initiated.
• Actual process temperature is less than the scheduled process temperature and no deviation control is initiated.

• Consistent ink skips and the manufacturer has not taken corrective action.
• The recording thermometer varies by more than 0.5° C (1° F) from the indicating thermometer.

• The manufacturer uses both Fahrenheit and Celsius temperature scales.
• Wrong chart used, but operator's log is complete.
• The recorder reads higher than the indicating thermometer, but the indicating temperature is above the scheduled process temperature.
• Occasional ink skips.

• PPR 30.1(1), Product processed to meet commercial sterility
• PPR 30.3(f), Thermal process meets schedule process

Retort Operator's Log

The following minimum information is recorded on the retort operator's log:

• process schedule requirements
• product/style of pack
• retort number
• number of baskets in the retort
• cook number
• container size
• container code
• initial temperature
• time steam on (vent open)
• temperature prior to closing the vent
• time vent closed
• time temperature up (process starts)
• time steam off (process ends)
• indicating temperature near start of process
• chart temperature near start of process
• indicating thermometer temperature during processing
• date

Note: Minimum information required on records may vary depending on the degree of system automation.

Recording Chart

The following minimum information is recorded on the recording chart:

• retort number
• date
• product
• container size
• code
• retort operator's initials

Deviations

• Deviations are noted on the records by the operator.

Note: Qualifications are described under sub item 4.4.1.2, Technical Training.

• N/A

• Key information missing from the operator's log that is required to verify the process, e.g., vent time, temperature, product, size where multiple product sizes are processed in the same day.
• No permanent record of process time or temperature.
• Deviations not noted on the records and no process adjustment made.

• Records not kept for not less than 3 years after the date of processing.
• Missing information on the recording chart.
• Missing information on the operator's log, e.g., retort number, number of baskets, code, process schedule requirements, etc.

• PPR 30.2(f), Records set out the low-acid food product history

• The process time meets the minimum requirements of the process design.
• The minimum temperature requirements of the process design are met.
  • The retort vent schedule should be met.
  • Heating tunnels i.e. water or steam, are heated prior to commencement of production.
  • Hot filled cans are inverted for the time prescribed in the process design to sterilize lids.

• N/A

• Actual process time is less than the process design time.
• Actual process temperature is less than the process design temperature.
• Hot filled cans are not inverted.

• The actual process time is less than the operating process requirements, but still meets the process design requirements.
• The actual process temperature is less than the operating process requirements, but still meets the process design requirements.

• PPR 16(12), Not exposed to a source of contamination

• Pasteurization
  • Pasteurizer should be in good operating condition, food should be properly packed, sealed and at the correct temperature when entering the pasteurizer. The correct temperatures are achieved during the pasteurization process.
    • incoming steam line (pressure gauge functional, valves)
    • conveying belt speed
    • pasteurizer temperature in sections
    • jars evenly distributed across full width of pasteurizer
    • temperature of product at cold spot (center of a large pickle located just below the center of the container)

• N/A

• Pasteurization parameters have not been fully followed but Equilibrium pH is satisfactory.

• An important factor not fully controlled which may result in a spoilage problem.

• PPR 30.3(f), No low-acid food product packed in a hermetically sealed container must be thermally processed in a registered establishment unless the thermal process meets or exceeds the requirements of the scheduled process
• F&DR B.27.002, Commercial sterility
• FDR B.27.003, No person must sell a low-acid food packaged in a hermetically sealed container where the container is swollen, is not properly sealed, or has any defect that may adversely affect its hermetic seal

Written records that adequately reflect the control of the acid or acidified low acid thermal process should be available upon request.

For acid product, the manufacturer should have records available to demonstrate that the process was complete.

Operator's Records

The following information should be recorded on the operator's records:

• product/style of pack
• process design requirements
• container size
• container code
• initial temperature
• chart temperature near start of process (when a chart is used)
• process temperature e.g., retort, pasteurizer
• indicating thermometer temperature during process
• belt/reel speed (related to time of processing)
• date of processing
• time of processing (batch process)
• fill temperature (hot filled product)
• operator's initials

Note: Minimum information required on records may vary depending on the degree of system automation.

Recording Chart

The following minimum information should be recorded on the recording chart:

• date
• product
• container size
• code
• operator's initials

Deviations

• Deviations are noted on the records by the operator.

Note: Qualifications are described under sub item 4.4.1.2, Technical Training.

• N/A

• N/A

• Missing information on the recording chart.
• Missing information on the operator's log, e.g., code, process schedule requirements, etc.

• PPR 16(12), Not exposed to a source of contamination
• PPR 30.2(f), Records set out the low acid food product history

Manufacturer controls blanching and freezing conditions to meet the requirements of the process design.

Blanching:

• The time and temperature is controlled to ensure enzyme deactivation and reduction of microbial load.
• Blanched product is cooled and promptly conveyed to the freezer under sanitary conditions to prevent contamination and bacterial growth.

Freezing: (IQF)

• Product is in a frozen state at the freezing tunnel exit. Product temperature or state is monitored as product leaves the freezing tunnel.

Prepackaged (bulk or consumer size):

• Product temperature is quickly brought down through the range of maximum crystallization (-1 C to -5 C). Freezer temperature is monitored to ensure maximum freezing capacity. Freezing should not be considered complete until the product has reached -18 C at the thermal center.
• Product is stacked to allow air flow and circulation.

• N/A

• Product held too long between blanching and freezing resulting in the growth of pathogens.

• Freezer capacity is inadequate to freeze product in specified time frames.
• Freezing coils not defrosted frequently enough in freezing tunnel resulting in inadequately frozen material.
• Freezer temperature not monitored.
• Peroxidase test indicates inadequate blanching (Frozen Vegetables excluding Fried).

• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR Schedule I and II

• The operator controls pressure in the retort to prevent excessive pressure differentials between the interior and exterior of the container that may result in paneling, buckling, seam distortion and bursting.
• Where thermophilic bacterial growth is a concern (LAF and product with pH from 4.0 to 4.6 ), containers are cooled as rapidly as possible to prevent spoilage.
• Can/jars cooling temperature is controlled to retain enough residual heat to rapidly evaporate water for corrosion prevention (105 - 110°F).
• Cooling rate of glass jars is controlled to prevent thermal shock.
• Pouches are cooled to an internal temperature of 110 - 140°F.

• N/A

• Improper cooling and storage conditions that maintain elevated product temperature, possibly resulting in thermophilic growth.
• Paneled or buckled containers with possible leakage.

• Lack of control of container cooling, thermophilic growth not a concern, e.g., minor corrosion due to over cooling.
• Minor container damage with a low likelihood of leakage.

• PPR 30.3(f), Thermal process meets the schedule process
• PPR 30.3(l), Containers are handled to avoid damage

Note: Treatment with a bactericide is not required when single use potable water is used for cooling processed containers in a retort/pasteurizer.

• Recycled cooling water is treated with a bactericide prior to use.
• Bactericide is applied in a manner to ensure that an effective residual level is maintained throughout the cooling system (e.g., 0.5 to 2.0 ppm for free available chlorine).
• Bactericide levels are monitored at a frequency adequate to ensure that specified limits are consistently achieved.
• Test reagents are suitable and effective.
• Monitoring is conducted at the location(s) in the cooling system where the bactericide level is the lowest.
• Cooling systems are maintained to prevent buildup of organic and inorganic materials which may reduce the effectiveness of the bactericide.

For the verification of the microbiological quality of the cooling water refer to 5.1.14.1 (task 6401) - Verification of product quality and safety

• N/A

• Recirculated water is not treated by the manufacturer.
• Bactericide monitoring not conducted, taken at wrong location or tested at insufficient frequency.
• Inadequate treatment, measurable residual not consistently maintained.
• Untreated water from other than municipal source used for cooling.

• Excessive buildup of organic material which could affect the residual bactericide level.

• none

Note: Records not required where single use potable water is used.

Water Treatment Records

• date and time of analysis
• concentration of residual bactericide and pH
• method of analysis
• code
• product
• analyst
• retort system/sample site.

• N/A

• N/A

• Missing information on water treatment records.
• No records of water treatment.

• PPR 30.2(f), Records set out the low-acid canned food history

Cans and Glass:

• Containers are tilted to remove excess water.
• Until the container vacuum is achieved and the compound has established proper sealing integrity.
  • containers are handled in a manner to prevent contact with unsanitary surfaces, e.g., employee contact, water splash from floors, sprays, aerosols, condensation and unsanitary equipment
  • containers are handled in a manner to minimize impact damage and damage caused by equipment, e.g., cable burns/cuts, abrasion, dents, seam damage
  • Containers are dried as soon as possible after processing.

Pouches are:

• Minimally handled.
• Excess flexing, folding, movement and vibration are avoided.
• Handled in a manner to prevent puncturing, etc.
• Rigid packaging may be used to minimize container damage. If final protective packaging is done outside primary processing plant extreme care should taken to transport pouches to their packaging location.

• N/A

• Cable cut where the outer layer of metal is torn or cut resulting in a high risk of leakage (LAF).
• Hot, distended containers in contact with unsanitary surfaces (LAF).
• Deficiencies in control resulting in serious container handling defects (LAF).

• Wet containers with partial vacuum in contact with can handling equipment.
• Dirty recycled cardboard used to separate slightly wet cans.
• Deficiencies in control resulting in minor container handling defects.

• PPR 30.3(1), Containers are handled to avoid damage
• PPR 16.(12), Product cannot be exposed to a source of contamination

The manufacturer monitors container integrity through at least one of the following options or equivalent:

Option 1 - Low Vacuum Detection Equipment (immediately or after 10 days)

Note: Option 1 pertains only to the operation of equipment including monitoring and verification testing. Functioning of low vacuum detection equipment is assessed at Section 4.3.4.2.

• The manufacturer routinely monitors container integrity by passing product through low vacuum detection equipment.
• Qualified personnel monitor the type and number of ejects.

Option 2 - Visual Inspection Program

• Containers from each lot are examined by qualified personnel, using the Visual Inspection Protocol.
• Qualified personnel monitor the type and number of defects.

Option 3 - Incubation Program

• A representative sample of containers from each lot is incubated and examined by qualified personnel.
• Qualified personnel monitor the type and number of defects.
• Time/temperature conditions selected by the manufacturer are adequate to detect leakage and subsequent microbial growth.

When deficiencies in monitoring can integrity are identified in this sub item, the follow-up is assessed in Section 5.1.13.1, Deviation Control.

• N/A

• Ineffective or no monitoring of low vacuum detection equipment, e.g., no testing with defective containers to verify equipment is operating, swell or leaking cans in evidence.
• Ejects are not evaluated.

• Effective low vacuum removal but inconsistent monitoring of ejects in regular production.

• PPR 2.4, Food product container is not defective
• PPR 30.2(f)(vi), Records of incubation results

• N/A

• N/A

• Handling product such that containers are damaged e.g., forklift damage, sharp edges on equipment.
• Delay between packaging and movement to freezer storage.

• PPR, 16(3), Strict sanitary control
• PPR, 16(12), Product cannot be exposed to a source of contamination
• PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner

Equilibrium pH

• Equilibrium pH shall be 4.6 or below. The pH shall be tested after the product has reached equilibrium, which is generally achieved within 24 hours after heat treatment.
• The equilibrium pH can also be measured by blending the product and brine after processing to a uniform consistency and taking the pH of the puree.

Filled container (Fresh Pack)

• Solid/liquid ratio is verified.

• pH of the product is greater than 4.6, the product is not heat processed at sterilization temperatures and the product will be marketed without refrigeration or preservative system.

• Equilibrium pH (critical factor) has not been checked prior to the shipping of the product.
• Equilibrium pH of product close to but lower than 4.6 is not verified at a sufficient frequency to ensure product safety.

• N/A

• PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR 2.4, Food product container is not defective
• 30.3(b), Containers filled in compliance with scheduled process
• 30.3(f), Thermal process meets or exceeds scheduled process

Jars:

• The manufacturer verifies closure after cooling by physical measurements (closure application measurements are also taken at capper: see sections 5.1.7.3 (task 5703) and 5.1.7.5(task 5705).
• Visual exam
  • On a minimum of 6 random jars or as specified by the jar manufacturer, at intervals not exceeding 30 minutes.
• Destructive exam
  • Different types of inspections are available for the closure control of jars, their applicability depends on the type of closure and the type of capper. Theses measurement should be taken by authorized personnel every 4 hours after cooling. The usual controls are:
  • Vacuum
    • Jars shall have measurable vacuum.
  • Security Value
    • Removal Torque (optional)
    • Measured with a Torque-meter.
  • Gasket
    • After processing and cooling, the gasket should have a uniform 360° impression in it resulting from contact with the glass finish.

Pouches:

• Final Package after retorting Air Burst 13 random samples 6 burst randomly (6 bottom and side, 7 for top seal).
• Tear downs are conducted after twenty-four hours or more storage period:
• REF: Chapter 4, p.20 of the Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
  • Seal strength and width are evaluated on 4 pouches per retort load.
  • Residual Gas Test is conducted on one pouch per retort load.
• The manufacturer must also visually examine all the samples for defaults

• N/A

• Less than 6 bottles or 4 pouches per retort load are examined.
• Time intervals significantly exceed 30 minutes on a consistent basis, e.g., two, three or four hour intervals.
• Absence of visual examinations (jars).

• No control of hermeticity for fermented or non-fermented pickles.

• PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
• PPR 2.4, Food product container is not defective
• PPR - 30.3(b), Containers filled in compliance with scheduled process

• Equilibrium pH records for each lot of production (product, date and container size).
• Solid/liquid ratio records (Fresh Pack).

• N/A

• Incomplete records related to the Equilibrium pH (critical factor).

• N/A

• PPR 30.2(f), Records that set out the low acid food product history

Visual Examination Records:

• code lot
• date and time of evaluation
• examination results of complete inspection for visual defects
• corrective actions taken

Destructive Examination Records:

• code lot
• date and time of closure evaluation
• container closure specifications
• closure measurements
• corrective actions taken

• N/A

• Deficiencies which do not permit verification of the adequacy of container integrity examinations, e.g., no record of pouch seal width or strength, cap removal (glass jars), etc., (LAF).
• Absence of records, e.g., destructive examination (LAF).