Imported and Manufactured Food Program Inspection Manual
Chapter 7: Sampling

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7.0 Scope

Product sampling and testing are part of CFIA's routine activities and are performed to identify potential hazards that may affect the quality and safety of food products that are available to consumers. Sampling may be conducted to assess human exposure to food-related risks, to monitor trends, and to support creation of standards and guidelines. Sampling is a means to validate compliance with the regulations, and can be used to support enforcement actions.

In the Imported and Manufactured Food Program, inspection-driven sampling, as described in the Work Specifications, is undertaken to support inspection findings. This means that samples may be taken at the inspector's discretion to verify inspection observations. Inspectors should follow the sampling instructions in the Work Specification with regards to sample size and number and samples should be submitted to the lab under the appropriate sample plan (FS Code). These sampling plans have been negotiated with the labs so it is important for inspectors to follow the directions for the number and timing of the sampling, if specified.

An inspector may also decide to sample a product to validate inspection findings related to the effectiveness of a company's food safety controls (outside the scope of the Work Specification) or to follow up on a specific food safety issue. Before taking an unplanned sample, an inspector should ask themselves 'what is the purpose for taking the sample?'. Is it to verify that an issue exists? Is it to link the product to an issue? Inspectors should consult with their Supervisor, the Area Program Specialist or the Laboratory to determine the necessity of analysis, and laboratory capability and capacity

7.1 Authority to Take Samples

An inspector's regulatory authority to carry out sampling functions is provided in the Food and Drugs Act (section 23(1)(a.1)). Prior to collecting a sample, the inspector should provide appropriate identification (e.g. badge, identification card, business card) to establish his/her authority to collect samples.

7.2 Protective Equipment

Protective items, when worn, serve to protect the inspector as well as minimize the potential for contamination of the sample, the product being sampled and the environment. Prior to entering an establishment, ensure that the protective items are clean and in suitable condition. The analysis, the type of sample collected and the environment in which the sample will be collected, will determine the protective items that will be required. Prior to collecting samples, the inspector should consult with his/her supervisor for the specific occupational health and safety (OSH) requirements. When collecting a sample, the following protective items (see table below) should be used as appropriate.

Protective Equipment

  • Protective footwear
  • Hard hat
  • Ear protection
  • Safety glasses
  • Lab coats/disposable coveralls
  • Sterile gloves
  • Hair/Beard restraints
  • Dust mask

Inspectors are expected to follow principles of good personal hygiene. This includes keeping hands, fingernails, hair, beard, clothing, and shoes/boots thoroughly clean. Prior to collecting a sample, personal effects and jewellery should be removed. Those that cannot be removed should be well secured (under clothes or gloves).

7.3 Sampling Equipment/Materials

Table 2 below outlines sampling equipment/materials that may be necessary for the collection, preparation, storage and transportation of a sample. Inspectors should ensure that these tools are part of their inspection kit and that they carry these tools with them to all inspections.

Sampling equipment/material

  • Sample Containers
    Sampling containers should be sterile, clean, dry and leak-proof. The capacity of the container should be adequate for the desired sample unit. (e.g., Whirl-Pak® bags, sterile cups, etc.)
  • Instruments for Opening Food Containers
    Instruments should be clean, dry and sterile. (e.g. Scissors, knives, box cutters, etc.)
  • Sampling Devices
    Sampling devices should be clean, dry and sterile. (e.g., Scoops, triers, forks, etc.) Pre-moistened sterile swabs, RODAC plates and/or Petrifilm™ plates may be required for environmental sampling.
  • Disposable Gloves
    Pre-packaged, non-latex sterile disposable gloves. Gloves with talcum powder should not be used since it may interfere with laboratory testing.
  • Shipping Containers
    Insulated container (e.g. Styrofoam cooler) of sufficient capacity should be used, when appropriate. Samples of foods normally stored at ambient temperature may be shipped in cardboard boxes
  • Packing Material
    • Suitable material should be used to secure samples within the shipping container.
      (e.g., crumpled newspaper, shredded paper, styrofoam nuggets, bubble wrap, etc.)
  • Coolants
    Plastic containers filled with refrigerant or well-frozen ice packs in re-sealable airtight plastic bags should be used. Dry ice may be used to keep frozen samples in a frozen state.

    Note:

    • 1. Exercise caution when handling dry ice
    • 2. Do not use ice as melting ice can result in sample contamination
  • Other equipment
    Document holders, notebooks, pencils/pens, sanitized thermometers, sanitizing agents (e.g. alcohol swabs), flashlights, markers, labels/tags, rubber bands and sealing tape, etc..

7.4 Aseptic Sampling

Accurate and defendable analytical results depend on proper sampling. If the samples are not obtained in a manner that ensures and protects the integrity of the sample, the results may become irrelevant.

It is always preferable to take intact, pre-packaged samples. However, if this is not possible, it is essential to use aseptic techniques, especially for microbiological and allergen analysis. This means using sterile tools and techniques and clean disposable gloves. If the units to be sampled are in an unclean area of the establishment, it may be necessary to take the units and move to a cleaner area to obtain the samples.

For aseptic sampling, use pre-sterilized plastic or metal tools. If pre-sterilized plastic or metal tools are unavailable, metal tools can be sterilized immediately before use with a propane torch. The metal tool should be cooled inside a sterile container before being used to collect samples. Soaking the metal tool with 70% alcohol and flaming off is also an acceptable method of sterilization.

If it is necessary to drill, saw, or cut the item being sampled (such as large frozen fish, cheese wheels, frozen fruit, etc.), use pre-sterilized stainless steel bits, blades, knives, etc. Sampling instruments with wooden handles are particularly susceptible to bacterial contamination and are difficult to sterilize. These types of instruments should be avoided.

7.5 Finished Product Sample Collection

7.5.1 Choosing the Sample Unit

When sampling finished product, choose consumer-ready packages whenever possible. In general, the sample should represent the product as it is purchased by the consumer. Take random samples, representative of the lot, from various locations (e.g., top, middle and bottom of pallet). Do not sample open, broken or damaged containers.

Do not sample products that are past the "use by" date or the "best before" date and collect samples so that they can be tested before the "use by" or "best before" date. This ensures that the samples collected represent an accurate profile of the product, as product should not be sold past the "best before" or "use by" date.

7.5.2 Number and Size of Sample Unit

The number and minimum size of each sample unit is indicated in the specification for each sampling plan and depends on the laboratory tests to be performed. Collect the sufficient number and size of each sample unit to enable the Laboratory to perform all analytical tests required. Consult the appropriate work specification for the required sample number and size. For samples taken due to a consumer complaint or investigation, consult the appropriate Area Program Specialist to determine the size and number of units to be taken.

7.5.3 General Principles of End Product Sample Collection

  • Wash and dry hands prior to sampling.
  • Conduct sampling aseptically for microbiological or allergen testing (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves, when necessary.
  • Take samples randomly, i.e., top, middle and bottom.
  • When sampling from master containers, choose the master containers at random; and from these, choose sample units at random.
  • Whenever practical, sample product in the original unopened container. Submit pre-packaged product as one, intact, sample unit.
  • When sampling containers are used, choose the appropriate size and avoid damage to the integrity of the sampling container.
  • Securely seal sample containers after filling so that they cannot leak or become contaminated during further handling.
  • Immediately label each sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.6 In-line Sample Collection

7.6.1 Choosing the In-line Sample

The purpose of in-line product sampling is to determine the characteristics of the product at a specific point in the production process (e.g. a Critical Control Point). Collect in-line samples randomly by using a random number system (e.g., Random Number Table) to develop a selection system for the product that will be sampled. Choose each unit based on this predetermined frequency until the required number of sample units are collected. Do not intentionally sample a product that has been observed to have unsatisfactory characteristics.

7.6.2 Number and Size of In-Line Sample Unit

The number and minimum size of each in-line sample unit are indicated in the specification for each sampling plan and depend on the laboratory test to be performed. Collect a sufficient number and size of in-line sample units to enable the Laboratory to perform all analytical tests required. For samples taken due to a consumer complaint or investigation, consult the appropriate Area Program Specialist to determine the size and number of units to be taken.

7.6.3 General Principles of In-line Sample Collection

  • Wash and dry hands prior to sampling.
  • Conduct sampling aseptically (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves.
  • Sample randomly.
  • Whenever possible, have an assistant prepare the sterile container and /or bag to receive the in-line sample unit.
  • Securely seal in-line sampling containers after filling so that they cannot leak or become contaminated during further handling.
  • Immediately label each in-line sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.7 Environmental Sampling

Environmental sampling is conducted to ensure that food products are not exposed to harmful environmental hazards during processing. A product can be contaminated by physical, chemical or biological hazards in its surrounding environment, which in turn may pose a health and safety risk to consumers.

Environmental sampling for the detection of microorganism(s) is employed to determine the presence of pathogens or other organisms on equipment and food contact surfaces. Depending on the microorganism(s) identified, its presence may indicate poor sanitation or microbial growth niches in a food establishment. Results of environmental sampling are important as they can be used by inspectors to identify potential deviations from good manufacturing practices for enforcement purposes and as an educational tool to inform establishment management where corrective measures are neededFootnote 6.

This section outlines techniques used to collect environmental surface samples for microbiological analysis. Similar techniques may also be used to determine the presence of allergens, chemical or physical hazards on surfaces. Other types of environmental sampling (e.g. water, air) may be useful under some circumstances. Specialized equipment may be required (e.g. air sampler). Consult with your Inspection Supervisor/Inspection Manager (IS/IM), Area Program Specialist, and laboratory personnel to determine the feasibility of these types of samples.

7.7.1 Preparation Prior to Taking the Sample

Take the following steps prior to sampling (where possible):

  • Draw a process flow chart, including the employee and product traffic patterns, and identify the location of the critical control point(s) (CPPs)
  • Identify sampling sites and target microorganisms or hazards and supplies needed for sampling. Sampling sites may include walls, floors, drains, equipment, food contact surfaces, etc.
  • Define the purpose for sampling, and plan sampling times accordingly; if information is needed regarding cleaning and sanitation conditions in the facility, it is recommended that samples be taken immediately after cleaning and sanitation, but before production. If information is needed regarding the microbiological conditions during production, then samples should be taken during production.
  • Arrange to have all necessary sterile equipment, supplies, clothing, etc., ready before going to sample.

7.7.2 General Principles of Environmental Sample Collection

  • Wash and dry hands prior to sampling.
  • Begin the sampling sequence in the finished product area first (least contaminated) and proceed through the potentially contaminated areas, finishing at the raw materials and receiving areas.
  • Conduct environmental sample collection aseptically (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves during environmental sample collection.
  • Label each environmental sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.7.3 Environmental Sampling Techniques

The type of environmental sample will determine which method to use.

7.7.3.1 Surface Contact Sampling: Swab Method

  • Used to sample any surface up to 1 metre squared (m2).
  • Swab walls and floors (1 m2) using cloths.
  • Swab small food contact surfaces (100 cm2) using fabric-tipped swabs or sponges.
  • Wash and dry hands.
  • Aseptically open the container (Nalgene jar or Whirl-Pak® bag) containing the pre-moistened sterile swab. (Note: Each container should only have one sterile pre-moistened swab, cloth or sponge.)
  • Aseptically remove the pre-moistened sterile swab from the container using sterile gloves or tongs
  • Rub the swab firmly and thoroughly over the surface to be sampled.
  • For surfaces that are easy to swab (i.e., flat surface), rub five times (5x) from top to bottom and five times (5x) from left to right.
  • For surfaces that are difficult to swab (i.e., contour surfaces), rub as thoroughly as possible.
  • When collecting environmental samples from inside large equipment (e.g., milk drier), dress entirely in sterile clothing (e.g., head cover, facial hair cover, disposable overalls and overshoes).
  • Change sterile forceps and/or gloves after each environmental sample is collected.
  • Aseptically remove the sample and place it into a sterile Whirl-Pak® bag or sterilized bottle/container. Avoid touching the outside of the container with the swab.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • Place the sample into your carry bag/cooler.

7.7.3.2 Dried Material Sampling

  • The sample size will be determined by the analysis required and/or the amount of sample available (e.g. dried material on food contact surface).
  • Select the environmental site for sampling.
  • Determine what sterile materials/tools will be needed to collect the sample, e.g., scraper, sweeper, tongs, forceps, spoons, etc.
  • Wash and dry hands.
  • Put on sterile gloves.
  • Aseptically remove the sample using sterile tools and place it into a sterile Whirl-Pak® bag or sterilized bottle/container.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • When collecting environmental samples from inside large equipment (e.g., milk drier), dress entirely in sterile clothing (e.g., head cover, facial hair cover, disposable overalls and overshoes, etc.).
  • Change sterile tools (e.g. forceps, etc.) and gloves after each environmental sample is collected.
  • Place the sample into your carry bag/cooler.

7.7.3.3 Surface Contact Sampling: Replicate Organism Direct Agar Contact (RODAC) Plate method (for flat impervious surfaces)

  • Wash and dry hands.
  • While wearing sterile gloves, open the bag containing the RODAC plates and only remove the plate that will be used.
  • Remove the plastic cover and carefully press the agar surface to the surface being sampled.
  • Apply uniform pressure on the back of the plate so that the entire agar surface contacts the area being sampled.
  • Remove the RODAC plate from the surface being sampled and replace the cover onto the RODAC plate.
  • Using a new RODAC plate each time, repeat the above procedure until all environmental surfaces are sampled.
  • Immediately label each RODAC plate with adequate information so that the plate can be matched to the sampling submission form. The markings must be legible and permanent.
  • Stack the plates (e.g., 5 - 10) on top of each other and secure them with masking tape.
  • Put the piled RODAC plates in Whirl-Pak® bags or other suitable containers.
  • Seal bag tightly.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • Place the sample into your carry bag/cooler.
  • Before going to the next sampling site, wipe off the surface that was sampled with a sterile wet cloth or sanitizer (e.g., Rocal, 70% ethanol).

7.7.3.4 Surface Contact Sampling: Petrifilm™ method (used for sampling irregular surfaces)

  • Wash and dry hands.
  • While wearing sterile gloves, open the bag containing the Petrifilm™ plates.
  • Remove as many plates as required, and hydrate them following the manufacturer's instructions.
  • Peel back the top film of the Petrifilm™ (gel will adhere to top film). Note: On occasion the gel may split (adhering to both the top and bottom of the Petrifilm™ when the top film is lifted). This splitting of the gel will not affect the performance of the product.
  • Contact the top film of the gel, not the bottom, to the surface being tested.
    Note: Avoid touching the growth area and bottom cardboard of the Petrifilm™ plate with any surface, including your hands, that is not being sampled.
  • Firmly rub fingers over the entire film side of the gelled area of the Petrifilm™ to ensure good contact with surface.
  • Lift the film from surface and rejoin the top and bottom sheets of the Petrifilm™.
  • Before going to the next sampling site, wipe off the surface that was sampled with a sterile wet cloth or sanitizer (e.g., Rocal, 70% ethanol)
  • Label each Petrifilm™ plate with adequate information so that the plate can be matched to the sampling submission form. The markings must be legible and permanent.
  • Put the Petrifilm™ plates in a Whirl-Pak® bag and handle with care.
  • Place the sample into your carry bag/cooler.

7.8 Post-sampling Procedures

7.8.1 Disposal of Garbage

Place used gloves and sampling material in a large plastic bag and dispose of them at the facility or take them with you. Collect multiple used tools (spoons, tongs, etc.) in a plastic bag and return them to the office or laboratory.

7.8.2 Transportation and Storage

Samples should be transported back to the office or laboratory as soon as possible after sampling. Transport samples in clean, dry containers. Refrigerated or frozen samples should be transported in coolers with a sufficient quantity of ice packs or dry ice to maintain sample integrity. If samples are not shipped immediately, store them in a secure location in the office. Refrigerated or frozen samples should be stored in either a refrigerator or freezer, as appropriate. Whenever possible, plan sampling activities so that samples are not stored or shipped over the weekend. In some cases, the laboratory will accept samples for analysis on the weekend. Contact the laboratory in advance to determine availability.

7.8.3 Completion of the Sample Submission Form (LSTS)

Inspectors should contact the laboratory in advance before submitting samples. Laboratory personnel will need to determine whether the requested testing is available, and which lab can accept the sample(s). The correct laboratory information is required to complete the sample submission form (LSTS).

It is critical that the information entered into the LSTS Sample Submission Form is accurate and complete. Directions for completing the sample submission form can be found at RDIMS 1857345 or in Section 8.3 of this Manual.

Refer to the work specifications for the appropriate LSTS sampling plan codes. For unscheduled or ad hoc samples, please contact your Area Program Specialist for sample plan codes.

7.8.4 Shipping

7.8.4.1 General shipping guidelines

  • Use clean, sturdy materials and containers for each sample or group of samples being shipped.
  • Choose transport coolers and containers that are appropriate for your sample size, the number of samples being sent (do not squeeze too many samples into one container) and are dry, leak-proof and sealable.
  • Do not ship different analytical product/sample types in the same transport cooler/container.
  • If more than one shipping container is required (due to sample size/weight), clearly indicate the container number and total number of containers on each box/cooler, courier waybill, and LSTS form. A copy of the LSTS form should be placed in each container.
  • Pack samples tightly to prevent shifting within the shipping container but not so tight that the samples may be compromised during transport. To achieve properly secured samples, use shredded paper, styrofoam nuggets, bubble wrap, or other suitable packaging material.
  • Before sealing the transport container, be sure that all completed submission documents are included. Pack LSTS submission forms in a plastic bag to protect them from moisture.
  • Tightly close and secure the transport coolers/containers.
  • After the samples have been picked up by the shipper, contact the lab to advise them that the samples are now in transit. Request that the lab contact you if the samples should not arrive within a specified period of time.

7.8.4.2 Temperature Control

Temperature abuse of samples is a serious problem that can result in sample rejection before testing. Refer to the following guidelines for refrigerated and frozen samples:

  • Transport frozen or refrigerated samples in insulated shipping containers of rigid construction.
  • Prior to packaging the sample units into the shipping container, measure the temperature of the sample and record it on the sample submission form.
  • For refrigerated samples, pack the shipping container with suitable coolant material to maintain the samples at a temperature between 0 - 7°C.
  • Do not allow coolant material, e.g. ice packs, to directly touch the samples. Use a layer of packaging material to avoid direct contact between the samples and the coolant material in order to prevent freezing.
  • For very large coolers, ice packs around the sides of the cooler or in between samples may be necessary to ensure consistent and adequate temperature.
  • During warmer months, prior to use, place shipping containers in a freezer long enough to chill them thoroughly. Include more ice packs in hot weather.
  • When dry ice is used to ship frozen samples, avoid direct contact with the samples. Use sufficient dry ice to keep the product frozen.
  • Dry ice should be handled subject to the Transportation of Dangerous Goods Act.

7.9 Official or Legal Sampling

7.9.1 What is Official Sampling?

An inspector may perform legal or official sampling when legal action is the anticipated follow-up action. It demands more complex procedures for sample collection, submission and laboratory testing compared to regular product sampling.

In order to ensure that testing results are admissible in court, official sampling procedures, as directed in subsection A.01.050 of the Food and Drug Regulations, must be strictly followed. Inspectors should seek legal advice prior to initiating official sampling.

7.9.2 Sample Number and Size

Consult with the Area Program Specialist prior to taking official samples. Generally, for extraneous material testing, select 24 individual containers with a minimum of 250 g or mL per container. For all other analyses, select 5 sub-samples with a minimum of 250 g or mL per sub-sample.

7.9.3 Obtaining the Sample

Refer to Subsection A.01.050 of the Food and Drug Regulations for complete details.

Where, in the opinion of the inspector, division of the product to be sampled would not interfere with analysis or examination, obtain a sufficient quantity of product for a triplicate sample and

  1. divide the quantity into three parts,
  2. identify the three parts as the owner's portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample,
  3. seal each part in such a manner that it cannot be opened without breaking the seal, and
  4. deliver the part identified as the owner's portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination.

Where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination

  1. identify the entire quantity as the sample,
  2. seal the sample in such a manner that it cannot be opened without breaking the seal, and
  3. forward the sample to an analyst for analysis or examination.

Always choose sub-samples randomly from the same lot. At no time should the inspector allow a company representative to choose the samples.

7.9.4 Sample Identification

Write the sample number on all containers/packages of samples submitted to the laboratory. Avoid obscuring portions of the labels that are significant, such as the list of ingredients, label claim statements, product and brand name, lot code, etc.

7.9.5 Shipping

  • Use a courier service that guarantees next-day delivery.
  • Ship samples at the beginning of the week.
  • Do not ship official samples with planned or ad hoc samples or other official samples.
  • Pack shipments in such a way as to minimize the potential for damage occurring in transit

7.9.6 Security

  • Between the time the sample is taken and the time it is shipped to the laboratory, take all the necessary precautions to ensure that the sample is kept in a controlled environment under lock and key.
  • Seal the sample with yellow CFIA Official Seal tape in a manner that it cannot be opened without breaking the seal.
  • Clearly write "Official Samples" on the box to ensure that receiving laboratory staff take proper precautions to protect the samples and ensure validity in court.

7.9.7 Documentation

Complete the sample submission form and include a signed copy of the form in the shipping box.

7.9.8 Laboratory Contact Information

Consult the appropriate laboratory contact prior to taking official samples, to ensure that the laboratory is able to handle the samples. It is important to let the laboratory contact know when the samples will arrive, the number of samples that will be shipped, and the analyses to be performed.

7.10 Analysis and Interpretation of Results

When testing is completed, the laboratory analyst enters the final results with comments into LSTS. Once authorization is complete, a notification of the report of analyses is automatically sent via e-mail to the inspector who sent the sample.

Table 1 below outlines the four possible sample test result outcomes: Satisfactory (S), Unsatisfactory (U), Investigative (I) and No Decision (ND). It is important to remember that the sample assessment is not directly related to compliance.

Table 1: Sample Assessments
AssessmentCommentsFollow-up Action
Satisfactory N
Investigative Determine if there is a potential health and safety issue and/or a violation Y/N
Unsatisfactory Determine if there is a potential health and safety issue and/or a violation Y
No Decision Can be a result of the sample being unfit for analysis, no assessment criteria, pre-determined decision Y/N

In most cases, consultation with the Area Program Specialist can assist the inspector in determining the most appropriate follow-up action. See Chapter 6, Section 6.8 for further instructions.

7.11 Instructions for Tracking Sample Follow-up in IMS

7.11.1 Creating an Issue

The following fields are mandatory:

  • Subject Line: Enter the "Year-Project Code-Sample" with no spaces (e.g."2012 WS_CONF-Sample"). Note: Correct coding is very important to enable tracking of non-compliance.
  • Area of Concern: There can be multiple areas of concern. Select all that apply.
  • Illness/Allergic Reaction/Injury Reported: Select "Yes" or "No"
  • Priority: Usually "urgent" would be selected.
  • Trigger Type: MCAP Inspection
  • Occurred On: Enter the date that the sample result was received.
  • Area/Region/District: Enter the Area/Region/District in which the manufacturer/importer is located.

7.11.2 Product Screen

The following fields are mandatory to be able to save a product: Commodity Group/Class, Commodity Subclass, Product, Brand Name, Common Name, Source, Country of Origin, Size, UPC, Code on Product. Enter complete and accurate information.

If information such as the UPC is not available, enter N/A in the field.

7.11.3 Client Screen

  • Enter the name of the establishment/facility that manufactured/imported the sample.
  • If the establishment is not in the client data base, add the establishment.
  • If the client data base is incorrect, update the information.
    • Note: do not make any changes to registered establishments in the database.
  • Select the product associated with the client.

7.11.4 Samples Screen

  • Use this screen to link the LSTS report for the sample to the IMS.
  • Go to the 'Samples' tab and click 'Add'.
  • Under 'Type' choose 'CFIA'.
  • Click on 'Search LSTS' on the left side of the screen.
  • Enter the LSTS number under 'System ID'. For other query types, see the IMS User Manual.
  • Click on 'Search'. Select the LSTS report from the table and click 'OK'.
  • Click on 'Save' to link the LSTS to the IMS.

7.11.5 Task Activity Log Screen

  • Enter all activities taken to address the issue.
  • This is to be a summary of the actions taken and should offer the reader a complete picture of the issue.
  • After a Task/Activity record is added to the issue it cannot be modified or deleted, therefore, it is important to carefully consider the information being captured.
  • Do not cut and paste the LSTS report into a Task Activity. Use the Samples screen as directed above.

7.11.6 Corrective Actions Screen

  • Document all compliance actions taken with a facility and/or product on this screen.
  • If the investigation results in a recall, use the same issue to record actions taken regarding the recall.
  • Note: This section must be completed even if no corrective action was required.

7.11.7 Completing the Issue

  • Prior to closing your assignment and completing the issue, review the information to ensure that it is complete and accurate.
  • Enter a deviation and a conclusion on the main screen. The conclusion should be brief, accurate and complete.
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