Processed Products Establishment Inspection Manual

Chapter 2 - Establishment Inspection Methods and Procedures

2.1 Introduction

• 2.1.1 Chapter 4: General Inspection Criteria
• 2.1.2 Chapter 5: Manufacturing Controls
  • Table 2-1: Layout of the inspection criteria in Chapters 4 and 5
• 2.1.3 Compliance Ratings

2.2 Preparation for an Inspection

• 2.2.1 Determining the Inspection Type
• 2.2.2 Establishing the Inspection Frequency
  • Table 2-2: Annual In-Depth Inspection Frequencies
• 2.2.3 Determining the Inspection Scope
• 2.2.4 Non-PPR Product Lines
• 2.2.5 Creating the Inspection Team
• 2.2.6 Notifying the Establishment
• 2.2.7 Reviewing the Establishment File and Other Documentation
  • 2.2.7.1 Establishment File
  • 2.2.7.2 Legislation and Manuals
• 2.2.8 Inspection Material and Equipment Frequencies

2.3 Conducting the Inspection

• 2.3.1 Professionalism
• 2.3.2 Opening Meeting
• 2.3.3 Scheduling and Inspection Order
• 2.3.4 Inspection Techniques
• 2.3.5 Writing Inspection Observations
  • Table 2-3: Observation guidelines
• 2.3.6 Assessing Compliance and Assigning Compliance Ratings
• 2.3.7 Observations with Health and Safety Implications
• 2.3.8 Preliminary Closing Meeting with Management

2.4 Final Report and Exit Meeting

• 2.4.1 Determining the Inspection Type
  • Figure 2-1: MCAP screen shot to show the location of the "Comments" section
  • Figure 2-2: MCAP screen shot to show how to capture two or more ratings on a single task
• 2.4.2 Minimum Compliance and Corrective Action Deadlines
  • Table 2-4: Minimum Compliance, Action Plan Submission and Corrective Action Deadline
• 2.4.3 Final Report and Cover Letter
• 2.4.4 Final Exit Meeting or Delivery of Final Report
• 2.4.5 Amending Inspection Results

2.5 Inspection Follow-Up

• 2.5.1 Written Corrective Action Plan
• 2.5.2 Evaluating the Corrective Action Plan
• 2.5.3 Directed Inspections

2.6 The Establishment File

Appendix 2-1 Template Cover Letter
Appendix 2-2 Template Action Plan Acceptance Letter
Appendix 2-3 Template Action Plan Rejection Letter
Appendix 2-4 Corrective Action Plan Template
Appendix 2-5 Corrective Action Plan Assessment Form

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2.1 Introduction

This Chapter describes the processes and procedures involved in the inspection of establishments registered under the Processed Products Regulations. As such, this Chapter begins with a general description of the set-up and content of Chapters 4 and 5, which contain the inspection criteria that will be applied during establishment inspections

2.1.1 Chapter 4: General Inspection Criteria

Chapter 4 sets out the general inspection criteria which apply to all establishments. The chapter is divided into seven major sections:

• 4.1. Premises
• 4.2. Transportation and Storage
• 4.3. Equipment
• 4.4. Personnel
• 4.5. Sanitation and Pest Control
• 4.6. Complaints and Recalls
• 4.7. Records

2.1.2 Chapter 5: Manufacturing Controls

Chapter 5 sets out the inspection criteria for the major steps involved in controlling processed products manufacturing. The chapter is divided into fourteen major sections:

• 5.1.1 Product Formulation
• 5.1.2 Process Design
• 5.1.3 Incoming Material Control
• 5.1.4 In-Process Package Control
• 5.1.5 Product Preparation/Blending
• 5.1.6 Filling
• 5.1.7 Container Closure Control
• 5.1.8 Product Coding Control
• 5.1.9 Pre-Process Control
• 5.1.10 Process Control
• 5.1.11 Post-Process Control
• 5.1.12 Labelling Control
• 5.1.13 Deviations and Corrective Actions
• 5.1.14 Verification of Product Safety and Quality

Table 2-1: Annual In-Depth Inspection Frequencies

Section 4.1	Premises
Subsection 4.1.2	Building Interior
Task 4.1.2.3	Ventilation
MCAP Task and Revision Date	Task 103 - April 2, 2001
Principle Statement	Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, and to remove contaminated air.
Assessment Criteria	Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust, excessive heat or contaminated air. Ventilation openings are equipped with close-fitting screens or filters as appropriate to prevent the intake of pests or contaminated air. Filters are cleaned or repaired as necessary.
Rating Guide	Examples
Rating I	N/A
Rating II	Inadequate ventilation and high risk of contamination, i.e. infestation, microorganisms, condensation, etc. Condensation dripping on product which will have no further kill step
Rating III	Inadequate ventilation, condensation/mould evident, contamination not likely Screens, filters not tight fitting
Legal Authority	PPR 14(1) (c) Protected against entry of pests, birds, etc. (e) Adequate ventilation system (h) (iii) Dressing rooms, lunch rooms and lavatories well ventilated

Section: Major divisions of Chapters 4 and 5, as described in sections 2.1.1 and 2.1.2 above.

Subsection: Subdivisions of the sections of Chapters 4 and 5.

Task: A specific element within the Subsection.

MCAP Task & Revision Date: Corresponding MCAP task number and the latest revision date.

Principle Statement: Principle statements are generic, broad, outcome based statements which are similar in style to CFIA Code of Practice - General Principles of Food Hygiene, Composition and Labelling, April 2006 (RDIMS 577408), the Codex Alimentarius Commission General Principles of Food Hygiene and the International Standards Organization (ISO) standards. Under each task number, principle statements express the intent of the applicable legal authority (see below) and are written to permit flexibility with respect to the type of process and the possible introduction of new technologies. Each principle statement can only be assessed once per inspection.

Assessment Criteria: The assessment criteria section lists the factors that will be evaluated by an inspector to determine if a manufacturer is in compliance with the principle statement of each task. Where appropriate, examples are used to clarify assessment criteria. Assessment criteria help provide transparency to the food industry with respect to the specific factors required and assessed by the CFIA. As new technologies and/or commodities become available, evaluation of additional criteria may become necessary. For this reason, assessment criteria given in this manual should not be regarded as exhaustive.

Rating Guide Examples: The rating guide examples are intended to be a source of guidance for inspectors when assessing the risk associated with a deficiency. Rating guide examples provide benchmarks to inspectors and promote uniformity and transparency in the assessment of conditions and operations in the processed products industry. The examples illustrate a range within which most deficiencies can be classified but do not cover all possible deficiencies or concerns. Unusual circumstances which are not addressed in the manual or circumstances where similar examples cannot be found in the rating guide can be addressed by the supervisor or the Area/Regional Program Specialist.

Legal Authority: A reference to the applicable sections of the regulations accompanies each task. The following abbreviations are used:

• PPR: Processed Products Regulations
• CAPA: Canada Agricultural Products Act
• FDA&R: Food and Drugs Act and Regulations

2.1.3 Compliance Ratings

For each task assessed, one of the following compliance ratings will be assigned. See section 2.3.6 for details on assigning a compliance rating.

• Category I: Deficiencies entailing a risk with a high likelihood of occurrence and serious health consequences.
• Category II: Deficiencies entailing a moderate health risk, a direct source of contamination or adulteration (e.g. sensitive ingredients, foreign materials), or repetitive regulatory infractions.
• Category III: Deficiencies entailing regulatory violations, a low health risk or an indirect source of contamination or adulteration.
• Satisfactory (S): No deficiencies, no health risks and no risks of contamination or adulteration were observed.
• Not Applicable (N/A): The specific task is not applicable to the establishment. Tasks assessed N/A will have no impact on the overall establishment rating.
• Not Inspected (N/I): The task cannot be assessed because the equipment is not available for inspection or because the task to be assessed is related to a part of the establishment that is not operational. Tasks assessed N/I will have no impact on the overall establishment rating.

2.2 Preparing for an Inspection

The importance of proper and adequate preparation can not be overemphasized. As with almost any task or project, good preparation will not only make the job easier and the inspector more confident but it will ensure better results.

2.2.1 Determining the Inspection Type

There are two types of inspections conducted:

1. In-Depth Inspection
2. Directed Inspection (formerly known as a "Follow-up" Inspection)

During an In-Depth Inspection all applicable generic inspection criteria from Chapter Four, as well as all criteria for the selected scope (process type) from Chapter Five are assessed. One scope (see section 2.2.3) and equipment system (e.g. retort type) and all associated processing lines feeding that equipment system should be inspected. In addition, all items on the Outstanding Tasks Report from MCAP must be reviewed. An In-Depth Inspection is also an excellent opportunity to collect product samples, if time permits.

Directed Inspections are performed as a follow-up to an In-Depth Inspection and/or to collect product samples. For details on Directed Inspections see section 2.5.3.

2.2.2 Establishing the Inspection Frequency

Table 2-2 outlines the minimum frequencies of In-Depth Inspections per Registered Establishment per year. The levels of inspection service and types of establishments are defined in Chapter 1, section 1.3.2 of this manual.

Table 2-2: Annual In-Depth Inspection Frequencies

Level of Inspection Service	Low-Acid and Acidified Low-Acid Food Products	Other than Low-Acid Food Products
Full	2	1
Reduced	1	1

2.2.3 Determining the Inspection Scope

The tasks in Chapter 4 apply to all establishments and should be assessed during each In-Depth Inspection, regardless of the scope selected for Chapter 5. Depending on the type of establishment and the products being produced, certain tasks in Chapter 4 may not apply.

Chapter 5 is divided into 6 scopes, based on processes and types of products:

1. Low Acid Foods (LAF) in Hermetically Sealed Containers (HSC)
2. Acidified Low Acid Foods (ALAF) Fresh Pack, Fermented Pack
3. Acid Foods
4. Frozen Foods
5. Low Water Activity Foods (Low A_w)
6. Low and High Acid Aseptic Foods (under development)

To assist in selecting the appropriate scope(s) for an establishment inspection, the following additional information is presented:

1. Low Acid Foods (LAF) in Hermetically Sealed Containers (HSC)
   • Method of preservation: thermal treatment to achieve commercial sterility (12D process)
   • Products with a pH above 4.6 and a water activity (A_w) value above 0.85
   • Traditionally, the product is packaged hermetically, then processed for sterility.
   • Alternately, the product can be sterilized and then aseptically packed in hermetically sealed containers.
   • Examples: canned vegetables, vegetable broth in a Tetra-Brik™ or Combibloc™, retortable pouched entrées, most vegetable juices
2. Acidified Low Acid Foods (ALAF)
   • Fresh Pack
     • Method of preservation: acidification + some heat treatment (to discourage spoilage)
     • Fresh vegetables are combined with brine (vinegar, salt, sugar, spices, seasonings, etc.) then heat-treated and left to reach an equilibrium pH of less than 4.6.
     • Final acidification occurs as the product sits in the finished package.
     • Examples: most relishes and chutneys, pickled cucumbers, pickled mushrooms, pickled beets, pickled onions
   • Fermented pack
     • Method of preservation: acidification + some heat treatment, preservatives and/or refrigeration (to discourage spoilage)
     • Low-acid products are left to acidify by natural fermentation in bulk (barrels, totes, silos, etc.).
     • The acidified vegetables are then packed in either the original brine or a new brine. Examples: "traditional" dill pickles, sauerkraut, olives (could include relishes and chutneys)
3. Acid Foods
   • Method of preservation: inherent acidity + some heat treatment (to discourage spoilage)
   • Foods which naturally have a pH of less than 4.6 and 4.9 for tomato products naturally and a high water activity (above roughly 0.85)
   • Examples: canned fruits, canned tomato products, fruit juices and nectars
4. Frozen Foods
   • Method of preservation: freezing and held below -18 °C
   • Fruits and vegetables that have been frozen, regardless of pH or A_w
   • Fresh produce is prepared (peeled, cut, blanched, etc.) and then subjected to sub-zero temperatures to solidify the water within.
   • Examples: frozen vegetables (peas, broccoli, etc.), frozen fruit (berries, apples, etc.) and frozen fruit juices (concentrated orange and apple)
5. Low Water Activity Foods (Low A_w)
   • Method of preservation: a lack of available moisture + low pH (incidental)
   • By removing water and adding sweeteners (or other humectants), the water activity is reduced to below 0.85.
   • These products may also have some natural acidity, but this is not the main method of preservation.
   • Examples: fruit jams, jellies, marmalades, maraschino cherries, glace fruit
6. Low and High Acid Aseptic Foods (under development)
   • Method of preservation: inherent acidity + heat treatment and proper packaging (to inhibit spoilage)
   • Examples: "Tetra pak™" or "Combibloc™" juices, bag in box juices

When determining the inspection scope, keep in mind that more than one scope could apply to a single establishment (e.g., an establishment could produce pickles, jams, and juices). During a registration inspection for a new establishment all available scopes (process types) must be inspected (see Chapter 1 for more details). For regular inspections, only one scope should be selected per In-Depth Inspection. For the first regular In-Depth Inspection (newly registered establishment), select the scope with the highest risk.

The order of relative risk, from highest to lowest is:

1. Low Acid Foods in Hermetically Sealed Containers and Low Acid Aseptic Foods
2. Acidified Low Acid Foods (fresh pack or fermented)
3. Frozen Foods
4. All others (Acid Foods, Low Water Activity Foods, High Acid Aseptic Foods)

A different scope should be selected for each subsequent In-Depth Inspection until all relevant scopes have been used, then the cycle begins again. In establishments with a low acid component, this scope must be inspected at least once per year. However, in order to inspect other scopes, establishments on a reduced level of inspection service (see Table 2-2) must have all available scopes assessed. Usually these establishments are seasonal and should have other scopes assessed at the same time as the inspection of the low acid component. Alternatively, even though they are on reduced schedule, these establishments could be visited more than once in a year to inspect an other-than-low-acid scope to ensure every scope in the establishment will be assessed over a number of years.

Once the appropriate scope has been identified it should be selected in MCAP. MCAP automatically generates the appropriate worksheet for printing. In general, inspectors should not modify the worksheet as generated by MCAP. If certain tasks do not apply, they must be rated N/A or N/I (see sections 2.1.3 and 2.3.6), not deleted from the MCAP worksheet because it is important to indicate why the task was not assessed. However, since only one scope can be selected in MCAP, when assessing more than one scope, inspectors may add any necessary tasks to the MCAP worksheet. See the Table of Contents in Chapters 4 and 5 to help identify which tasks apply to each scope.

2.2.4 Non-PPR Product Lines

When an establishment is registered under other programs (Meat, Fish, Dairy, Honey, Maple) in addition to Processed Products, management at the responsible CFIA office, through consultations with Programs, must decide how to apply the various establishment inspection programs.

If a Processed Products establishment also produces products that are covered solely under the Food and Drug Regulations (FDR), the Processed Products inspector is responsible for inspecting these production lines as well. Most tasks in Chapter 4 of this manual apply to lines that produce products solely under the FDR. Some of the common tasks from Chapter 5 apply as well, such as Product Formulae (5.1.1.1), Food Additives and Processing Aids (5.1.1.3) and Label Registration/Accuracy (5.1.1.5). It is up to the inspector to determine which tasks from the Chapter 5 apply to each of the non-PPR lines.

2.2.5 Creating the Inspection Team

The team concept is useful for the inspection of food processing operations. The size of the inspection team is a decision made by the management at the responsible CFIA office, and should be based on:

• The complexity and risk of the manufacturing process(es), for example low acid processes
• The size of the establishment
• The type of inspection (In-Depth or Directed)
• The time frame in which the inspection is to be conducted
• The experience of inspector(s)

The team approach is used for the following reasons:

• Inspectors may exchange places during the inspection in order to provide a fresh perspective on a particular activity.
• Inspectors with different experience and backgrounds have a broader experience base.
• It greatly improves inspection uniformity, as long as the same inspectors do not always work together. Each inspector learns something from the other inspector, making the Region more consistent when identifying and scoring of infractions.

Often, the inspection team may consist of only one inspector. In these cases, another inspector or the supervisor must be available (via phone, etc.) in case the responsible inspector requires assistance.

2.2.6 Notifying the Establishment

Under normal circumstances, the inspector should not notify the establishment's management of upcoming inspection date(s). However, if production is irregular the inspector may wish to verify that the establishment will be operating during the time of the planned inspection. Seasonal operations should communicate with the inspector regarding when they will be operating.

2.2.7 Reviewing the Establishment File and Other Documentation

In order to be properly prepared, the inspection team should review the Establishment File, the relevant legislation and manuals, and any other relevant documentation prior to the actual inspection.

2.2.7.1 Establishment File

For a list of the items that should be included in a complete establishment file, see section 2.6. The inspection team must take the time to read through the establishment file (at a minimum, the previous year's documents) in order to:

• identify the establishment manager and key personnel by name;
• review previous In-Depth Inspection reports;
• review Directed Inspection and Product Inspection results;
• identify outstanding deficiencies;
• review any consumer complaints;
• be aware of the size and complexity of the establishment;
• note any unique features of establishment (e.g. equipment, technology, and product lines);
• decide where the inspection will begin, identify when a major clean up will be observed and find out when a second shift (if applicable) can be observed; and,
• familiarize themselves with the product(s) being processed (including ingredients, additives and processing aids) and the processes and equipment in use.

2.2.7.2 Legislation and Manuals

The inspection team must review the relevant sections of the:

• Canada Agricultural Products Act
• Processed Products Regulations
• Food and Drugs Act and Regulations
• Processed Products Product Inspection Manual
• Processed Products Establishment Inspection Manual
• Processed Products MCAP Manual (under development)

This will ensure familiarity with:

• grades and/or standards for the product(s) being processed, including permitted ingredients and additives;
• general and product-specific labelling requirements and standard container sizes;
• the process(es) being inspected, and;
• inspection procedures.

2.2.8 Inspection Material and Equipment

Each inspector must have the following items and use or wear them in the appropriate situations:

• Identification
  • inspector's identification card (must always be carried)
  • business cards
• Attire
  • a clean, CSA-approved safety hat (white)
  • hair and (if applicable) beard covers without holes (not mesh/net types) in good condition
  • CSA-approved ear and eye protection
  • nuisance dust mask (if necessary)
  • a clean, white lab coat or coveralls with snap or Velcro fasteners, having no pockets above the waist (re-useable or disposable)
  • "freezer coat" and insulated gloves (if necessary)
  • safety reflector vest (if necessary)
  • sanitary gloves to cover plain, non-removable wedding bands (if necessary)
  • sanitized rubber safety boots (if necessary) or clean, CSA-approved safety footwear
• Equipment
  • a case or bag
  • a pen without a cap
  • a clean, non-porous clipboard that can be easily sanitized
  • a flashlight in good working order
  • a calibrated light meter
  • a calibrated thermometer with steel shaft
  • sampling supplies (cups, sterilized bags, spoons, etc.)
  • coolers and ice packs for transporting temperature-sensitive samples
  • additional equipment as required during Directed Inspection
• Forms and References
  • MCAP inspection worksheet (with appropriate scope, see section 2.2.3)
  • Inspection Report (CFIA/ACIA 0992)
  • Notice of Detention (CFIA/ACIA 3256) and Notice of Release (CFIA/ACIA 3257) forms
  • supplementary tags and CFIA seal tape
  • receipts:
    • Sample Portion (Official Sample) (CFIA/ACIA 0072)
    • Receipt for Sample(s) Taken (CFIA/ACIA 4168)
  • a copy of the applicable regulations and the inspection manuals

All forms are available to CFIA staff only and can be found in the internal forms catalogue or Desktop eForms

2.3 Conducting the Inspection

2.3.1 Professionalism

The inspector is an official representative of the Agency and must exhibit a professional image when dealing with establishment officials. All information discussed and obtained from a specific company must remain confidential. However, this does not preclude government inspection reports being made available under the provisions of the Access to Information Act.

The inspection team should park in a suitable area and ensure that their clothing (see section 2.2.8) and behaviour is appropriate (no jewellery, watch, gum chewing, etc.). Plain wedding bands and MedicAlert™ bracelets/necklaces are acceptable, as long as they are properly secured and covered (i.e., with a rubber glove or beneath the clothing). Establishment policies must be respected at all times.

2.3.2 Opening Meeting

Upon arrival at the establishment, the inspection team should conduct an opening meeting to:

• introduce themselves to the establishment manager or person in charge;
• present their identification or business cards;
• explain the objective of the inspection
• determine the establishment's work schedule and discuss the inspection plan/order (see section 2.3.3);
• invite an establishment representative(s) to accompany the inspection team (see below);
• ask about any special protective equipment requirements, safety measures or policies specific for that particular plant, and;
• make arrangements for a Preliminary Closing Meeting (see section 2.3.8) and/or a Final Exit Meeting (see section 2.4.4 to discuss the inspection findings.

The establishment management should be encouraged to provide a knowledgeable representative (management, foreman, quality control) to accompany the inspection team throughout the inspection. This allows for questions to be asked on the spot and serious infractions to be addressed immediately. Any infraction that is identified during an inspection and corrected immediately must still be documented and rated appropriately on the inspection report (see section 2.4.3). Inspectors must be careful not to allow the accompanying plant personnel to rush the inspection or lead them away from infractions.

Establishment personnel are encouraged to carry out their own inspections along with the inspection team and/or independently as required by their establishment.

2.3.3 Scheduling and Inspection Order

During the opening meeting, the inspection team should have determined the establishment's working schedule, which will help when planning the inspection. Every effort should be made to assess equipment prior to start-up, in an operational condition and during disassembly, washing and sanitizing. If applicable, the inspection team should be present for shift changes (morning to afternoon, afternoon to evening, etc.) to observe the change-over routine (finishing and starting employee habits, traffic patterns, equipment cleaning, etc.) and note any deficiencies.

When possible, inspectors should be as efficient as possible in arranging the inspection order.

The inspection team should complete all tasks that require walking through the plant, observing the physical conditions of premises, personnel, equipment, etc., before proceeding with records and written programs.

The inspection should begin with the critical processing steps (e.g. retort room for low-acid establishments) and areas where major problems were revealed during previous inspections. In general, to reduce the risk of cross-contamination, the inspection team should work from the microbiologically cleanest areas to the least microbiologically clean areas (e.g., start in the packaging area and work towards raw receiving or establishment exterior).

2.3.4 Inspection Techniques

Every effort must be made by the inspection team to minimize cross-contamination. Utilize hand washing/sanitizing facilities as frequently as possible.

In general, inspectors should direct questions to management rather than to employees or non-plant personnel (e.g. truck drivers). However, questioning establishment employees can help determine if personnel are adequately trained and whether or not establishment procedures (regular production procedures, sanitation procedures, deviation procedures) are being followed properly.

In storage, mixing and blending areas, take note of ingredients, additives, and processing aids in use (especially those which you suspect could be non-permitted) so that they can be verified for compliance with the Processed Products Regulations and the Food and Drug Regulations.

In the labelling area(s), obtain a sample label of the product(s) currently being processed and packed. Briefly check the label for obvious infractions while in the establishment. Attach the label to a worksheet so it can be reviewed more closely back at the office.

In the boiler room, note the boiler additives being used, especially if steam is being used in any product or on any product contact surfaces in the establishment.

In other non-food chemical storage areas and the boiler room, note the chemical names, trade names and manufacturers of the sanitation and water/steam treatment products. Compare the list of products in use with the establishment's sanitation program and the CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products (http://www.inspection.gc.ca//english/fssa/reference/refere.shtml). These chemicals should be stored away from the main traffic stream and away from ingredients and packaging materials. Other poisonous chemicals, such as pesticides, must be stored in a separate area (preferably restricted) away from all cleaning chemicals and food products.

2.3.5 Writing Inspection Observations

The observations made on the MCAP worksheet are a record of the conditions at the time of the In-Depth Inspection and the objective evidence used to determine category ratings. Great care must be taken to ensure that inspection observations are clear and concise, accurate, unbiased, relevant and sufficient to assign an accurate rating. Each team member should complete his/her own worksheet observations. Record which products are produced each day of the inspection. Table 2-3 outlines guidelines can be used to help write inspection observations.

Table 2-3: Observation Guidelines

Observation Criteria	Example of poor description	Example of high quality observations
Fully describe the non-conformity. Include the location of the infraction and details such as the severity of the problem (amount, proximity to product, how product is affected, etc.).	Rust on equipment.	Moderate rust on 3 of 4 pickle slicer frame legs on Line 1.
Fully describe the non-conformity. Include the location of the infraction and details such as the severity of the problem (amount, proximity to product, how product is affected, etc.).	Build-up of weeds outside.	Vegetation, approximately 2 feet high, growing close to wall on west side of building.
Do not draw conclusions	Equipment stored in and unacceptable manner.	Hand tools at filling station left on floor, not in their designated storage spot.
Do not make recommendations for correction.	Kettles 1 and 2 need cleaning.	Build-up of fruit residue on outside of kettles 1 and 2.
Do not make recommendations for correction.	Housekeeping needs improvement.	Hoses and aprons left on floor behind filler 3.
Avoid FSEP and other program requirements or terminology (References to Corrective Action Requests (CARs), Prerequisite Programs, verification frequencies, regulatory audits, etc.).	Coving where walls meet floor is filthy (Meat requirement)	Build-up of dirt where east-facing wall meets floor.
State only objective facts. Personal opinions, conjecture and speculation do not belong in the Observations.	Pest control program out of date appears that the representative isn't doing his job.	2 rodent traps added in warehouse, changes not reflected on Trap Location Map.
State only objective facts. Personal opinions, conjecture and speculation do not belong in the Observations.	The apple receiving area is disgusting.	Build-up of dirt and filth in tote dumping area (apple reception).
Tasks rated N/I or N/A should either have a brief comment describing why that task is not applicable or not inspected.	N/A	This task does not apply because the equipment is not in use in the establishment.
Tasks rated N/I or N/A should either have a brief comment describing why that task is not applicable or not inspected.	N/I	This task was not inspected because the equipment is not in use at this time (no production)
Do not include names of individuals, instead, use positions or titles	John Smith did not initial log.	Retort operator (4-8pm shift) did not initial retort log at the 6pm retort process on May 15th.

Ensure that you review your comments, correct spelling mistakes and that the comments are with the correct task and that each non-satisfactory task has adequate comments.

2.3.6 Assessing Compliance and Assigning Compliance Ratings

Prior to discussing inspection results with the establishment, the inspection team should meet in private to discuss the inspection results among themselves to ensure agreement and consistency.

The inspection team must review all recorded observations and assign a compliance rating (see section 2.1.3) for each task.

Since only one compliance rating is possible for each task, when there are two or more non-compliances found for a task, the most serious category rating must be assigned to the task (see figure 2-2). However, within the task, the observations should be clearly grouped and each group may be assigned a different category rating even though the overall task is assigned only one rating (the most severe). The overall task rating is what counts towards calculation of the overall establishment compliance ratings. Grouping observations by category rating helps to make determining corrective action timeframes easier. This grouping does not necessarily have to be done on the worksheet used during the inspection, but should be done when entering observations into MCAP for the final report (see section 2.4.1).

Rating guide examples given for each inspection task in Chapters 4 and 5 provide benchmarks to inspectors. The examples illustrate a range within which most deficiencies can be classified, but do not cover all possible deficiencies or concerns. Unusual circumstances not addressed in the manual or circumstances where similar examples cannot be found in the rating guide can be addressed by the supervisor or Area/Regional Program Specialist.

2.3.7 Observations with Health and Safety Implications

When observations warrant Category I or Category II infractions and identify a direct source of contamination or adulteration, or multiple regulatory violations, the following guidelines are used to evaluate the potential food safety risk and identify necessary product action.

The inspection team must evaluate product safety, notify the establishment management and require the establishment to implement corrective action immediately or as soon as possible, depending on the circumstances. The inspectors must contact the appropriate CFIA supervisor as soon as possible to inform him/her of the situation. Any infraction that is identified during an inspection and corrected immediately by the establishment's staff must still be documented and rated appropriately on the inspection report (see section 2.4.3).

A full evaluation must be initiated while the inspection is still in progress, following the steps below:

1. Determine the potential cause(s) of the infraction to evaluate product safety.
2. Determine when the deficiency first occurred.
3. Detain all potentially unsafe products and contact the Regional/Area Recall Coordinator if the products are on the retail market.
4. If the cause of the deficiency cannot be determined immediately or if product safety cannot be evaluated, place all product under detention until satisfactory corrective action is implemented.
5. Draw samples for evaluation (e.g. lab analysis), if necessary.
6. Evaluate the establishment's proposed corrective action and ensure it is implemented immediately, if required.
7. Copy documents, obtain records and make note that may later be required for compliance actions.
8. Refer to Chapter 3 if the establishment is not cooperative.

If additional corrective action is not required immediately, ensure that the company submits an Action Plan in writing and implements corrective action within 24 hours.

Refer to section 2.5.2 for details on evaluating corrective action plans.

2.3.8 Preliminary Closing Meeting with Management

At the conclusion of the inspection activities, the inspection team may meet with the appropriate member(s) of the establishment management team to:

• review the inspection findings;
• highlight the key observations, and;
• establish a date and time for the final exit meeting or arrange for delivery of the final report (see section 2.4.4).

If it is determined that the final report will be delivered in lieu of a Final Exit Meeting, the inspection team must be sure to fully explain the inspection findings during the Preliminary Closing Meeting. It is important that the establishment management understands the inspection findings and the reasons why certain items are unsatisfactory and require correction or improvement.

2.4 Final Report and Exit Meeting

2.4.1 Entering Observations into MCAP

Once back at the office, the inspection team must enter the inspection findings into the Multi-Commodity Activities Program (MCAP) database. Transfer all hand-written inspection observations into MCAP. In the "comments" section on the MCAP report, record which products are produced each day of the In-Depth Inspection (see figure 2-1 for the location of the comments section in the MCAP system).

Click on image for larger view

Figure 2-1: MCAP screen shot to show the location of the "Comments" section

If more than one observation applies to a single task, be sure the comments are clear and well organized. Bullet points or numbering can help keep different observations separate. In cases where the observations show that more than one rating is possible for one task, the observations should be clearly grouped by category rating to make determining corrective action timeframes easier. Only one overall rating is assigned for each task (see section 2.3.6), as illustrated in figure 2-2, below.

Click on image for larger view

Figure 2-2: MCAP screen shot to show how to capture two or more ratings on a single task (Category II and Category III ratings on inspection task 101, 4.1.2.1)

MCAP can generate the following documents:

• The Inspection Worksheet: a complete list of all tasks rated during the inspection;
• The Non-Compliance Report: a list of Category I, II, and III deficiencies;
• The Category Rating: a list of overall compliance percentage rating per category. This may need to be verified by manual calculations;
• The Outstanding Task Report: a list of all infractions that have not been closed in MCAP.

2.4.2 Minimum Compliance and Corrective Action Deadlines

The establishment must submit a Written Corrective Action Plan (see section 2.5.1 for more details) within the time frames outlined in Table 2-4. The time frames begin the day after the exit meeting or delivery of the final report (see section 2.4.4).

The Category Rating report from MCAP is used to state the overall compliance percentages for each category (these may have to be verified by manual calculations).

The Minimum Compliance percentages (see Table 2-4) are based on health risk and compliance with the applicable regulations. Since the deadlines in Table 2-4 are maximum time frames, the inspection team may request action plan submission and/or corrective action within a shorter time frame. When establishments are found to be below minimum compliance, the inspection team should work in consultation with the establishment's management to determine which infractions should be given priority for correction in order to achieve minimum compliance. These infractions should be given a completion date that is reasonably achievable, but helps the establishment to achieve minimum compliance quickly. The remainder of the outstanding infractions must be addressed within the time frames outlined in Table 2-4.

Table 2-4: Observation Guidelines

Category	Minimum compliance	Action Plan Submission	Corrective Action
I	100%	Immediate*	Immediate*
II	75%	less than 2 weeks	less than 1 month
III	65%	less than 1 month	less than 1 year

* For all Category I infractions, corrective actions, even if they are just temporary measures, must be completed immediately (before the conclusion of the In-Depth Inspection). If the establishment requires extra time for long-term corrective actions or preventative measures, they must discuss this with the inspection team during the inspection and submit an action plan within 24 hours of the identification of the infraction.

2.4.3 Final Report and Cover Letter

A complete In-Depth Inspection Report package includes:

• a Cover Letter (see Appendix 2-1) requesting the Written Corrective Action Plan(s) within the time frames outlined in Table 2-4;
• the Category Rating report from MCAP;
• the Non-Compliance Report from MCAP; and,
• the printed MCAP Worksheet (if requested by the regulated party).

Once the In-Depth Inspection Report package is completed, the inspection team (and the supervisor, if required), should review it for accuracy:

• Compare the total number of tasks required for the selected scope with the sum of the ratings (Satisfacatory + Non-Compliant + N/I + N/A) to ensure they match.
• Compare the cover letter with the Category Rating report to ensure the category ratings match; and,
• Proofread the reports and cover letter to eliminate spelling and grammatical errors.

2.4.4 Final Exit Meeting or Delivery of Final Report

The inspection team should conduct a Final Exit Meeting with the establishment's management at the time previously arranged during the Preliminary Closing Meeting (see section 2.3.8). During the Final Exit Meeting the inspection team will:

• provide company management with the complete In-Depth Inspection Report package
• begin with general remarks pointing out positive observations as appropriate
• summarize the non-conformities by severity i.e. Category I, Category II and Category III
• request that a Written Corrective Action Plan be submitted within appropriate timeframe (see Table 2-4).

In some situations, due to seasonality or travel time, the final report may be faxed or mailed to the company in place of an exit meeting. In such cases, the inspection team must ensure the establishment management understands the findings of the inspection and what is expected of them in regards to corrective action. This can be done either through the Preliminary Closing Meeting (see section 2.3.8) or by the inspectors making themselves available for questions or discussion over the phone or email.

2.4.5 Amending Inspection Results

If a deficiency was improperly categorized and the Inspection Report Package has already been delivered to the establishment, the inspector(s), supervisor and program officer/specialist should discuss the situation and decide if the inspection results should be amended. If an amendment is deemed appropriate the inspector should:

• contact the establishment to inform them that an amended package will be sent and request that the first package is returned to the issuing office for disposition;
• make the necessary changes to the MCAP Worksheet;
• indicate "TASK(S) (numbers) AMENDED (date)" in the Comments section in MCAP (see Figure 2-1);
• reprint the MCAP Worksheet, Non-Compliance Report, and Category Rating Report
• hand-write "TASK(S) (numbers) AMENDED (date)" on both copies of the Non-Compliance and Category Rating Reports; and,
• print a new Cover Letter, modified to indicate that the report was amended and to specify the changes.

2.5 Inspection Follow-Up

2.5.1 Written Corrective Action Plan

The establishment must submit a Written Corrective Action Plan within the time frames outlined in Table 2-4. The time frames begin the day after the exit meeting.

For each infraction in the Non-Compliance Report, the establishment must provide:

• action to be taken;
• time frame for corrective action to be completed;
• person responsible for correcting the problem; and,
• measures to prevent reoccurrence.

If more than one infraction is noted for a single task, each of the infractions must be addressed separately by the Corrective Action Plan. Once completed, the action plan must be signed and dated by an establishment official. To ensure all the necessary information is addressed in the Written Corrective Action Plan, the establishment may use the Corrective Action Plan Template included in Appendix 2-4 (also found in RDIMS 1568449).

If an Action Plan is not received by the due date, the responsible inspector will send a registered letter to the company requesting a Corrective Action Plan within 5 working days of receipt of the letter. If the action plan is not received after the 5 days, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3).

2.5.2 Evaluating the Corrective Action Plan

The Written Corrective Action Plan submitted by the company must be evaluated by the inspection team. To help with the evaluation of the corrective action plan, the inspectors may use the Corrective Action Plan Assessment Form found in Appendix 2-5 (also found in RDIMS 1568506).

The action plan will be rejected if:

• any of the information listed in section 2.5.1 above is missing;
• any infractions are not addressed;
• the time frames for corrective action exceed those in Table 2-4, or those requested by the inspector;
• the action to be taken will not correct the infraction.

In a timely manner, the inspector will notify the company in writing whether the action plan is accepted or rejected. See Appendix 2-2 for the template letter for action plan acceptance and Appendix 2-3 for the template letter for action plan rejection.

If the action plan is accepted, the inspector will plan the Directed Inspections according to the proposed dates of completion for the corrective actions (see Table 2-4).

If the action plan is rejected, the company will be requested to submit a revised action plan within 5 working days of receiving the Rejection Letter.

If a revised action plan is not received within the 5 days, or if the revised action plan is rejected, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3).

If only simple clarifications are needed on the action plan, the inspector may request these from the establishment via email. All email correspondence regarding action plans must be kept in the establishment's file.

2.5.3 Directed Inspections

A Directed Inspection is a partial inspection of an establishment. Directed Inspections are used for one or both of the following:

1. To assess the corrective actions implemented by the establishment according to their Written Corrective Action Plan.
2. To collect samples for product inspection or laboratory sample submission.

Frequencies for Directed Inspections conducted for the purpose of collecting samples should be determined in consultation with supervisors and based on Operational Workplans, the Processed Products Program - Product Inspection Frequencies and/or the Processed Products Program - Product Sampling Plans.

Frequencies for Directed Inspections conducted to assess corrective actions will vary according to the number and severity of non compliant inspection tasks. These Directed Inspections must be completed in a timely manner to ensure that the establishment has implemented their corrective actions as outlined in their Written Corrective Action Plan.

Category I Infractions

Due to the severity of these deficiencies, corrective action for most Category I infractions should have been implemented and assessed immediately (i.e., before the conclusion of In-Depth Inspection). In some cases, the establishment may have implemented corrective actions that are just temporary and submitted an action plan detailing long-term corrective actions. If so, a Directed Inspection must be completed within 24 hours of the proposed correction date. Enforcement action should be taken if the corrective actions are not implemented or are not effective (see Chapter 3).

Category II and III infractions

Assessment of Category II corrective actions should be a priority over Category III infractions. If there are multiple completion dates within a category, the inspector and supervisor must plan at least one inspection to verify all the corrective actions. Further inspections may be necessary and can be planned at the inspector's discretion, in consultation with their supervisor. In some cases, when only Category III infractions have been identified, a Directed Inspection may not be necessary and instead, assessment of the corrective actions can take place during the next In-Depth Inspection.

Establishments below minimum compliance

At the discretion of the inspection team, establishments that are found to be below minimum compliance may be given shorter time periods to submit action plans and implement corrective actions (see section 2.4.2 for more details). To ensure the establishment achieves minimum compliance as quickly as possible, a Directed Inspection should be planned immediately after the corrective action completion dates agreed upon by the establishment's management and the inspection team. During this Directed Inspection, the inspector must verify that the establishment has implemented effective corrective actions on at least enough of the outstanding infractions to bring the establishment into compliance. Further Directed Inspections may be planned to assess the remainder of the outstanding infractions.

Once the inspector verifies, through a Directed Inspection, that the corrective actions were implemented as per the accepted Action Plan, the Directed Inspection findings and the date of the Directed Inspection will be entered in the "Resolved Comments" and "Resolved Date" columns in MCAP, respectively. See the MCAP manual for more details. If the establishment requests a record of the Directed Inspection, the inspector can summarize the findings on an Inspection Report (CFIA/ACIA 0992) and distribute as necessary. This form is also provides a record of the Directed Inspection for the establishment file.

In general, Directed Inspections do not involve the identification of new infractions. However, sometimes during Directed Inspections the inspector may observe infractions that require attention. In such cases, the inspector should record these findings on an Inspection Report (CFIA/ACIA 0992) and request that corrective action be taken within a time frame that is appropriate for the type of infraction.

If a Directed Inspection reveals that a corrective action was not implemented within the timeframe given on the Corrective Action Plan, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3). If several Directed Inspections do not indicate satisfactory corrective action and it is felt that compliance will not be forthcoming, procedures to cancel or suspend registration should be initiated (refer to Chapter 3 for more details).

2.6 The Establishment File

A complete Establishment File should contain a minimum 3 years of all of the following items:

1. A current Outstanding Tasks Report
   • Previous In-Depth Inspection Report packages (as presented to the establishment)
   • Cover letter (see Appendix 2-1)
   • Non-Compliance Report from MCAP
   • Category Rating from MCAP
   • Completed MCAP Worksheet (if requested by the establishment)
2. Follow-up documentation resulting from each In-Depth Inspection:
   • Written Corrective Action Plan as submitted by the establishment
   • any correspondence requesting changes to the Action Plan and any modified Corrective Action Plans
   • Letters of Acceptance (see Appendix 2-2) and/or Rejection (see Appendix 2-3) of Written Corrective Action Plan
   • results of Directed Inspections
3. Product-related reports:
   • Grading and Inspection Report (CFIA/ACIA 0989)
   • Inspection Reports (CFIA/ACIA 0992) for product inspections
   • Laboratory Reports of Analysis (LSTS)
   • IMS reports and consumer complaint documentation
4. Other establishment documentation:
   • copy of the Certificate of Registration and renewal documentation
   • blueprints and product flowcharts (if available)
   • plant management contact list (names, phone numbers, email addresses)
   • product lists and lot code definitions
5. Compliance and Enforcement documents:
   • warning letters
   • Notice of Detention (CFIA/ACIA 3256) and Notice of Release (CFIA/ACIA 3257) forms
   • Inspector Non-Compliance Reports (CFIA/ACIA 5393)
   • other enforcement correspondence and related records
   • General correspondence (email, etc.)

All documents listed above should be kept in an orderly manner and easily accessible for any inspector or supervisor who wishes to review the establishment file.

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Appendix 2-1 Template Cover Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
<Establishment address>

Subject: In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Please find enclosed the Establishment Inspection Report, generated from the In-Depth Inspection of <Establishment name and registration ##> on <Dates>. The Processed Products Establishment Inspection Manual was used to assess the establishment during this inspection. The inspection was completed by <Inspection team members>. During the exit meeting all deficiencies were discussed with you <or name of other representative(s)>.

The Risk Category Ratings below have resulted in an <Acceptable or Unacceptable> Overall Establishment Rating.

Risk Category/Compliance Level

I / __%
II / __%
III / __%

A complete list of infractions can be found in the attached Non-Compliance Report.

You are reminded that you may be in contravention of Sections 15 to 17 <and/or Sections 30.1 to 30.3 if the plant produces low acid food products packed in hermetically sealed containers> of the Processed Products Regulations under the Canada Agricultural Products Act.

Please forward your signed Written Corrective Action Plan(s), addressing all items in the Non-Compliance Report, to this office no later than:

Category I Infractions / <Date>
Category II Infractions / <Date>
Category III Infractions / <Date>

<We or I> would like to thank you and your staff for your cooperation during this inspection. Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-2 Template Action Plan Acceptance Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
Establishment address>

Subject: Acceptance of Action Plan from In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors> has reviewed the action plan and accepted your proposed corrective actions. Shortly after your stated dates of completion, we will verify through Directed Inspection(s) that your corrective actions were implemented as written.

Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-3 Template Action Plan Rejection Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
Establishment address>

Subject: Rejection of Action Plan from In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors>, has reviewed the action plan and must reject it for the following reasons:

<List reasons for the rejection - see section 2.5.2, do not make recommendations.>

Please submit a revised Written Corrective Action Plan by <Date>. Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-4 Corrective Action Plan Template

Contact your Area and Regional Office.

Appendix 2-5 Corrective Action Plan Assessment Form

Contact your Area and Regional Office.

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