Archived - Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs
1.10.07 - Process Control Program

The objective of this program is to ensure the production of safe food. By having controls in place throughout the manufacturing process to monitor product formulation, labelling and preparation, shelf life and finished product analysis, the likeliness of having to recall product after it has left the establishment could be reduced.

This documented program as well as its effective implementation, will help control operational conditions within an establishment, allowing for environmental conditions that are favourable to the production of safe food. It serves as a prerequisite program or universal-type CCP for a HACPP based program.

1.10.07.01 General

Dairy establishments and importers (where applicable) must have a documented program in place to monitor and control all elements in this section, and maintain the appropriate records.

The process controls that must be covered in this program include product formulae, food additives, nutritional requirements, label accuracy, product preparation, shelf life studies, product and environmental monitoring (including Health Canada's (HC) Policy on Listeria monocytogenes in Ready-to-Eat Foods – HC Listeria monocytogenes (Lm) Policy) and laboratory facilities and practices.

Adherence to the criteria is verified by examining the establishment's written program that outlines the procedures that will be undertaken to ensure satisfactory conditions are maintained. The program must specify:

• assigned risk categories for ready-to-eat foods (HC Lm Policy),
• areas to be inspected (what is done),
• tasks to be performed (how it is done),
• person responsible (who does it),
• inspection frequencies (how often or when it is done),
• sampling procedures and lab methodologies,
• records to be kept,
• parameters of acceptability/unacceptability (tolerances),
• results of monitoring,
• verification procedures (both on-site and record review),
• action to be taken for deviant situations,
• trend analysis (HC Lm Policy)

The monitoring and verification procedures clearly define the preventative measures taken to prevent the re-occurrence of deviations. The person responsible for verifying the program must be different from the person performing the task. This program must be updated as required when changes occur.

The actual monitoring of this program will be done by assessing tasks 1.10.07.02 to 1.10.07.05.

1.10.07.02 Manufacturing /Allergen Controls and Records

This task assesses if the plant has good control over its product formulae, food additives, nutritional requirements and label accuracy. In order to rate this task as satisfactory the inspector must do an on-site observation to determine if product is being manufactured in accordance with written procedures for components listed in A - E.

A) Product Formulae: The manufacturer has written formulae available for each product processed that are current, permitted by the standard and provide a basis for assessment and control of food additives, nutritional requirements and food allergens (ingredients which may cause adverse reactions). 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 production worksheet identifies all ingredients (including re-runs and re-work) for each batch. Although it is not required, a double sign-off procedure is one way manufacturers can exhibit control over the ingredients being used. This is usually done at two separate stages of processing by two separate people, first when ingredients are measured out and secondly when added to the formulation or mix tank. The manufacturer has verified he has control over the ingredients and additives through calculations, ingredient inventory balance sheets and finished product testing.

B) Food Additives: Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations. Inadequate control of food additives could result in chemical or biological hazards. The manufacturer ensures that all food additives used are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations. The specifications for all food additives are on file. As part of the product formulations, the manufacturer can show with calculations and has verified that food additives are used within the maximum level specified in the Food and Drug Regulations. Certificates of Analysis from the ingredient suppliers stating all food additives used in an ingredient meet the requirements of the Food and Drug Regulations would be satisfactory for the sub-ingredients within an ingredient.

C) Nutritional Requirements: The addition of nutrients (with respect to vitamin and mineral fortification) to food products is controlled to meet the requirements of the Food and Drugs Act and Regulations. The manufacturer has control over the formulation to ensure that all nutritional requirements and claims are met. Formulation controls are necessary to prevent hazards which could result from excesses, inadequacies and omissions of nutrients, for example, infant formulae, fortified foods, foods for which there are nutritional claims (example calorie-reduced, low sodium). 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.

D) Label Accuracy: The manufacturer ensures that the label information accurately represents the composition of the products packaged at the facility. Controls are necessary to prevent the presence of undeclared allergens in the product. Accurate labels inform and protect segments of the population which may be allergic to certain foods. Procedures are in place to ensure that labels accurately represent product formulation and composition. The following are such procedures:

• new label review
• incoming label review for accuracy/correctness
• formulation changes/substitutions
• procedures are in place to prevent the product mis-labelling at time of packaging, example, effective separation of product types during changeovers, labels are visually checked prior to use, proper storage of labels
• weighed out ingredients used during the formulation process are properly labelled and segregated (where required)

It is recognized that it is common industry practice that the development of the label is completed at corporate office but it is expected that the checks for label accuracy, incoming label review, formulation changes and controls to prevent mis-labelling are all responsibilities of the processing establishment and thus require procedures to ensure accuracy.

E) Product Preparation: In order to avoid contamination with ingredients which may cause adverse reactions, for all products packaged in the facility, the establishment must provide proper training to ensure:

• that during product preparation no ingredient substitution occurs;
• that internally processed ingredients (re-runs and re-work material) do not contain ingredients that may result in adverse reactions unless the finished product label clearly indicates the presence of these ingredients;
• that controls are in place to ensure that when different flavours of dairy products are processed successively common equipment (such as mix transport lines, freezing machines, molds, novelty lines and hoppers) is free of undeclared ingredients which may result in adverse reactions that could be carried over into the next production;
• controls are in place to ensure that when milk/non-milk products are processed in the same establishment, there is no carry-over into the next production (no dead ends/pockets/cross connections allowing for the introduction of milk between dairy and non-dairy production runs, CIP systems are adequate);
• controls are in place for establishments that process both pasteurized and heat treated or raw milk cheese to ensure that all pasteurized product is processed first followed by the raw product with a complete wash with sanitizing prior to the processing of pasteurized product.
• controls are in place to ensure that raw milk cheese is labelled with the manufacturing date to ensure the 60 day period of maturation (Food and Drug Regulations B.08.042 - B.08.048).
• controls are in place to avoid mixing different ingredients during storage and handling;

It is recommended that manufacturers package in containers with tamper evident seals that will ensure the security and integrity of their products once they are produced, until they are purchased by the consumer.

1.10.07.03 Microbiological Control and Records

This task assesses if the plant has good microbiological control over its products and environment. Microbiological control programs are used to verify the production of safe food.

Product Shelf Life Studies:

Microbial growth is dependent upon many environmental conditions such as: ingredients, nutrients, water activity, pH, presence of preservatives (e.g. curing salts), competitive microorganisms, gas atmosphere, redox potential, storage temperature and time. Control of these conditions can therefore be used to limit microbial growth.

Product shelf life is an inherent control measure that, in many cases, is crucial for the safety and suitability of the product. There are a number of reasons for shelf life testing: to assure consumer acceptability, to test compliance with regulatory standards, to establish viability in the marketplace, to verify quality assurance procedures, to compare different processors' products and to determine effects of abuse on products.

Product shelf life is influenced by a number of factors, such as:

• Product formulation (might include decreased pH, decreased water activity)
• Scheduled heat or other preservation treatments,
• Applied hurdles (e.g. water activity, pH), including storage temperature,
• Cooling methods applied to product,
• Type of packaging (e.g. hermetically sealed or not, Modified Atmosphere Packaging),
• Level of post process contamination and type of contamination

Product shelf life studies must be determined and re-formulated for all products with a mandated best before date, for new products, when formulations change, when processing and equipment changes occur, when significant alterations have been made to the scheduled process and when the best before date is changed. If plant documentation and records show that changes made do not affect the already established shelf life study on a product there would be no need to conduct another shelf life study. For example, if a filling machine was replaced by another filling machine this would not necessarily constitute a shelf life study. However, if the type of packaging system changed for example to an extended shelf life system there would need to be a shelf life study done.

When establishing product shelf life, it is the responsibility of the manufacturer to assure and to demonstrate that the safety and suitability of the milk product can be retained throughout the maximum period specified, taking into consideration the potential for reasonably anticipated temperature abuse during manufacture, storage, distribution, sale and handling by the consumer. This means that any regulatory microbial limits must not be exceeded up to the last day of the product's shelf life.

Shelf life determination should be carried out at the establishment by testing products submitted to the storage conditions specified or by predicting microbial growth in the product under the specified storage conditions. Reasonable anticipated temperature abuse can be integrated into the study or be taken into account by applying an appropriate safety factor (e.g. by shortening the maximum durability specified in the labelling or by requiring lower storage temperatures). To determine shelf life potential, for example many establishments hold samples of processed milk in unopened consumer packages for seven, ten and/or fourteen days at 7.2°C (45°F) to the sell-by-date or beyond. This temperature is considered to simulate potential conditions under which milk is exposed during distribution and home storage prior to consumption. After a chosen holding period the milk is often evaluated for odour and taste. Bacterial tests may also be performed at this time. Ideally, coliform and Standard Plate Counts (SPC) should not increase significantly during storage when compared with fresh samples.

For longer shelf-life products, where shelf-life studies are commonly performed on unopened packages, it is recommended that the manufacturer applies a consume within … statement to the package to assist the consumer in making informed choices on the quality of the product once opened.

Product and Environmental Monitoring:

Food processing and environmental conditions are monitored to determine adherence to good manufacturing practices, conformance to standards, adherence to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods and for the detection of contaminants. It is the dairy establishment's responsibility to verify compliance to regulatory standards, to ensure the safety of the product and for verification that the HACPP based program is working.

The food establishment may perform analyses in house or use outside laboratory services. It is recommended that certified laboratories be used when possible. It is important when sampling to have a representative number of samples depending on the size of the lot and the type of analysis being conducted. Sample selection should be as random and representative as possible. When sampling for microbiological analysis aseptic sampling techniques (using sterile containers and equipment, clean clothing, sterilized gloves) need to be followed so as to not contaminate the samples. Procedures with respect to representative number of samples based on lot size, suitable sample size, random sampling, aseptic sampling procedures are outlined in the Dairy Sampling Procedures of the Dairy Product Inspection Procedures.

Acceptable test methodologies (methods which reliability, accuracy, reproducibility, lab variation have been statistically established) must be used when conducting the analysis so as to provide accurate and meaningful results, e.g., AOAC methods. The Standard Methods for the Examination of Dairy Products by the American Public Health can be consulted for methodologies. Preference should be given to methods which have been validated for the commodity concerned preferably in relation to reference methods elaborated by international organizations.

While methods should be the most sensitive and reproducible for the purpose, methods to be used for in-plant testing often sacrifice to some degree sensitivity and reproducibility in the interest of speed and simplicity. They should, however, have been proved to give a sufficiently reliable estimate of the information needed. The Health Canada website provides a reference of laboratory methods within the Compendium of Analytical Methods.

If an establishment is using a blend of both in-house indicator testing and validation/verification using the official testing procedures, this can be rated by the inspector as satisfactory. Whenever confirmation of a result is needed the official method of testing needs to be used as well as an acceptable method and lab.

For microbiological monitoring samples where the degree of non-compliance is minimal or non-existent it would be acceptable for the 5 sub-samples to be composited and still maintain the 3 class sampling plan. The document on how to evaluate composited results can be found in the Dairy Sampling Procedures of the Dairy Product Inspection Procedures. If results come back out of compliance on the composited sample, then the 5 sub-samples would have to be re-analyzed individually to ensure compliance to regulations.

It is most effective to test products in the condition the consumer purchases the product, for example after being packaged and cooled, not hot from the vat or churn. Products must be tested at a frequency sufficient to determine compliance to regulatory standards, adherence to good manufacturing practices, to ensure product safety (free from potential pathogens), as well as to meet the safety and suitability requirements at the end of the shelf life. It is up to the establishment to define the frequency of sampling and should be based on product history, risk of the product, type of process (batch vs. continuous), consumer complaints, volume of product produced, the intended use of the product, the category of consumers concerned. It will be up to the inspector to assess if the frequency is adequate based on the establishment's criteria. The Dairy Sampling Procedures of the Dairy Products Inspection Procedures can be used as a guide to determine what type of analysis could be performed on various types of products.

The following analyses should be considered:

I. Product testing:

1. As an indication of overall sanitation and shelf life:
   • total coliform and E. coli,
   • SPC,
   • yeast and mold
2. For compliance to regulatory standards and for product safety:
   • pathogens such as (but not limited to) Salmonella, Listeria, S. aureus or verotoxigenic strains of E. coli
3. To verify the suitability of incoming raw materials and ingredients and their compliance to supplier specifications.
4. Phosphatase Testing: For the manufacturers of dairy powders, where there is no HTST system, each lot is tested for alkaline phosphatase using a validated method such as Official Method (MFO)-3, Charm Paslite or Flurophos by in-house or accredited labs. Acceptable procedures are included in the manufacturer's product monitoring program. Product is labelled accordingly depending on the processing treatments received.

II. Environmental monitoring:

The establishment has a written program in place to monitor the environmental conditions and food contact surfaces within the establishment. Environmental monitoring is a tool to verify good manufacturing practices, effective sanitation and prerequisite programs within an establishment. Health Canada's policy on Listeria monocytogenes in Ready-to-Eat Foods (HC Lm Policy) clearly defines the roles of industry and government and can be found on Health Canada's website. Persistent contamination of product contact surfaces in the plant environment is an indication of inadequate good manufacturing practices and may lead to finished product contamination.

III. Application of Health Canada's Policy on Listeria monocytogenes Ready-to-Eat Foods

The HC Lm Policy describes Listeria verification activities for RTE foods in both the plant environment and in finished products. The verification activities assess the effectiveness of Good Manufacturing Practices (GMP) or the HACPP system to minimize potential sources of food contamination. Dairy processors producing RTE foods are responsible to test their environment for Listeria spp. and confirm whether any product is contaminated with Lm when environmental findings are unsatisfactory. With respect to this policy and the criteria listed under task 1.10.07.01, the establishment's written program specifically includes the following:

• assigned risk categories for RTE products,
• acceptable sampling procedures and methodologies of analysis,
• sampling sites, monitoring frequencies and rationale for these frequencies,
• trend analysis,
• notification to CFIA and submission of a corrective action plan for unsatisfactory situations

The establishment is responsible for determining the risk categories of their RTE foods and establishing sampling frequencies to monitor their environment and products throughout the year. Sampling frequency of environmental (Food Contact Surface (FCS) and non-FCS) and finished product should be based on an internal risk assessment that takes into consideration specific criteria such as product risk categories, volume produced, processing conditions, equipment design, history of compliance etc.

Environmental sampling (Listeria spp.) is to include FCS sites taken during production (including final packaging step) and non-FCS based on the complexity of the process as per the HC Lm Policy. The Dairy Sampling Procedures of the Dairy Product Inspection Procedures needs to consist of 5 sub-samples (at least 100 g each) and it is recommended these be taken at the same time as the FCS environmental sampling. Acceptable testing methods are to be used (see HC's Compendium of Analytical Methods)

It is also recommended for the establishment to hold product until results are received.

The establishment is to notify the CFIA of positive results for Lm or persistent L. spp. findings on a FCS (for all RTE foods). A corrective action plan is to be submitted by the establishment. Appropriate follow up actions (HC Lm Policy Figures 1, 2 and 3) are to be followed.

Industry is also responsible to perform trend analysis of environmental and product sampling results. This could include an on-going review and analysis of data for L. spp. from routine monitoring to detecting trends and improving controls before major issues develop. For example, the use of quality control methods and statistical methods, e.g. control charts, Pareto diagrams, etc. are recommended.

All records must indicate satisfactory frequency of monitoring and must be complete and available at the plant. Out of compliance results must trigger action that is documented in the records. Follow up investigations on any out-of-specification results must look for the root cause and be well documented.

1.10.07.04 Composition Control and Records

This task assesses if the plant adequately controls product composition.

Composition records must provide this assurance. Composition analyses can be performed in house or contracted out. It is important when sampling to have a representative number of samples depending on the size of the lot and the type of analysis being conducted. Sample selection should be as random and representative as possible. Procedures with respect to representative number of samples based on lot size, suitable sample size and random sampling procedures are outlined in the Dairy Sampling Procedures of the Dairy Products Inspection Procedures.

Acceptable test methodologies must be used when conducting the analysis so as to provide accurate and meaningful results. It is most effective to test products in the condition the consumer purchases the product, example after being packaged and cooled, not hot from the vat or churn.

It is the dairy establishment's responsibility to verify compliance to regulatory standards. Products must be tested at a frequency sufficient to determine compliance to regulatory standards. Records must be complete and available at the plant and indicate satisfactory frequency of monitoring and that appropriate action is taken for the products out of compliance. Follow up investigations on any out-of-specification results must be looking for the root cause and be well documented.

1.10.07.05 Laboratory Facilities and Practices

Lab facilities must not provide a contamination risk to food products. If the lab is conducting micro and pathogen testing the lab facilities must be well isolated from processing areas of the plant; if not isolated then the lab facilities must have negative pressure. Isolation and enumeration of pathogenic microorganisms must not pose a risk of contamination to the product or to the plant environment. Therefore, pathogenic testing should be done in a separate building.

Lab practices must be controlled to ensure that no contamination risk exists to food products. The techniques used to take samples in the processing line must not pose a contamination risk. Proper disposal of laboratory samples and materials is required.

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