Programs

Many PRPs are systems in their own right and require many of the elements of a Quality Management system in order to operate them efficiently and effectively. We’ll take a brief look at those that are usually included as HACCP PRPs. (a) Supplier Quality Assurance

One of the key areas for initial focus alongside HACCP development is raw material safety. We must understand the hazards associated with our raw materials if we are going to make a safe product. It is particularly important to know that the supplier is controlling hazards if these cannot be controlled in our process or by consumer action. For these reasons, an effective Supplier Quality Assurance (SQA) system is one of the most important PRPs. Many industry failures (Chap.1) are the result of a single supplier failure that carried through into many other companies’ finished products.

There are a number of different elements to an effective SQA program, including having agreed specifications, auditing suppliers, and certificates of analysis. Sup- plier approval will depend on having confidence in the supplier’s operation; that the supplier is competent at identifying and managing the hazards. It is therefore vital to develop good customer/supplier relationships—partners in the management of safe raw materials and products.

1. Raw material risk evaluation

Most companies will be purchasing a large number of raw materials and might also have some of their products produced by a contract manufacturer. It is important to be able to prioritize where to spend your time and a risk evaluation of the raw materials is an excellent use of the HACCP approach. Later (in Chap.6) we will see an example of a raw material decision tree that can be used to help with this activity. It requires that you consider whether the raw material will undergo a hazard reduction step during your process or whether it needs to be safe when it enters your facility.

Suppliers should be asked for a description of how the raw material is processed, a Process Flow Diagram, and a site (GMP) plan. If they are also willing to supply a copy of their hazard analysis and HACCP plan it will be a real benefit but not all companies will do that. Any such information will be really helpful to the HACCP team in ensuring that they have fully identified all hazards of concern in the raw material and can determine which of the raw materials are the highest priority for on site assessment. These documents can be used to draw up a checklist of questions before the supplier audit. If your supplier is unwilling to provide detailed processing information, perhaps for reasons of confidentiality, then you must be able to assure yourself that the raw material is safe by some other means. This may be through an understanding of the raw material’s critical intrinsic factors, research of past failures in the industry, good reference materials, e.g.,Microorganisms in Foods 8: Use of Data for assuring Process Control and Product Acceptance (ICMSF, 2010), along with the structured audit of the supplier’s operation.

2. Specifications

It is important that all raw materials are purchased from approved suppliers and to an accurate and up-to-date agreed specification. The specification is the corner- stone of your SQA system, detailing all the accepted criteria against which raw material quality and safety are measured. It should define clearly all the factors that you consider important to the raw material and should include limits or tolerance of acceptability/unacceptability. The document can be as lengthy or as concise as you wish, but should always include your minimum acceptance criteria.

A typical raw material specification would include the following (these issues will also need to be addressed if you are buying in a finished product):

• Details of supplier and manufacturing/supply location, i.e., not simply the head office or broker that the order is placed with. This detail may not be included if you are buying against your own specification on the open commodity market. • A description of the raw material and its functionality.

• An ingredients list (to enable allergen assessment).

• Details of all intrinsic factors with tolerance limits, e.g., aw, pH, salt, preservatives.

• Microbiological, chemical, or physical acceptance criteria, e.g., absence of identified hazard organisms in a specified sample size.

• Analytical and microbiological sampling plans. • Labeling requirements.

• Storage and distribution conditions. • Safe handling and use instructions.

• Description of pack type, size, and quantity. 3. Supplier auditing

Supplier auditing is one of the key functions in any SQA system, as it is only through on site audits that real confidence can be gained in the supplier’s operation. Before auditing a supplier there are a number of questions you will want to ask.

Table4.2provides an example of the type of pre-audit survey that might be sent to suppliers, but this list is by no means exhaustive. This information will also be important for low-risk raw materials when you do not intend to audit the supplier. When you have constructed a program of auditing requirements, it is important to think about how audits will be carried out (Fig.4.6). Do you, for example, have personnel who can carry out audits and are they trained and authorized appropri- ately? The SQA audit is critical to the safety and quality of your products and ultimately your brand reputation, so it is vital that it is carried out by competent personnel who can evaluate food safety controls and build a trusting relationship Table 4.2 Supplier quality assurance pre-audit survey example

Iced-Delights: Supplier pre-audit survey Company Name:

Address:

Key contacts and ownership details, number of employees, and annual turnover:

1. Production location: (for product/raw material to be purchased) 2. History: how long has the business been in operation? 3. Describe the organizational structure and where Quality fits in.

4. Building and Facilities: When was it built? Was it designed for food manufacture? 5. What other products are manufactured at the facility?

6. What allergens are used on site?

7. Is the manufacturing site certified to a formal food safety and quality system (e.g., a GFSI recognized scheme, ISO22000, ISO 9000)?

8. Does the company operate a formal HACCP system?

9. Is microbiological testing carried out on site, and does this include pathogen testing? 10. Is a third-party contract laboratory used and is it certified?

11. Does the manufacturing site use a pest control contractor? If not, what control procedures are in place?

12. Does the site operate a captive uniform policy and how are the uniforms laundered? 13. Are all raw materials and finished products stored on site or are off-site warehouses used? 14. Are complete, accurate specifications available for all ingredients, packaging, and finished

products?

15. How is supplier quality assured? 16. Are written work procedures available?

17. Is there a training (hygiene related) program in place? 18. How are distribution vehicles monitored for food suitability?

19. What food regulations are considered applicable to the company’s operations? 20. Have there been any product recalls from this site or any other owned by the company?

Date completed : – – – – – – – – – – – – – – – – – – Signature: – – – – – – – – – – – – – – – – – – – – – –

with your suppliers. To approve a supplier is a big responsibility which is often not fully recognized or appreciated within food companies.

We will discuss auditing in much more detail in Chap. 7, where we will be looking at auditing the HACCP system. The elements are the same for successful supplier auditing, except for supplier audits we are looking more broadly at the supplier’s entire operation with HACCP as a key element.

4. Certificates of analysis

Certificates of analysis can be obtained for individual lots of raw materials to verify that these have been sampled and tested for specified criteria. You will need to check that results comply with specifications for these criteria, that the test laboratory is competent, and that the methodology and sample size is appropriate. These certificates can form a useful part of the SQA system, but the limitations of end- product inspection and testing should be remembered (Chap.1), and they should not be the only way of verifying that the finished product is free from the hazard(s). 5. Third-party auditors and certification

If you do not have sufficient resources in terms of trained and experienced staff available to carry out your planned program of audits, then you may wish to use third-party audits as part of the program. In choosing third-party auditors, you will also need to consider the expertise and experience of the auditors. It is vital that the auditors have sufficient experience both in the technology concerned and in auditing practices. You must be confident that they will highlight any potential food safety problems and help you to maintain good relationships with your suppliers. This can be achieved by working closely with auditing providers and, for example, by going out and accompanying your third-party auditors to confirm that you are happy with their performance.

It is important to select a reputable auditing organization, and you should check whether their services have been accredited by a higher-level board, e.g., against the requirements of BS EN45011 (General requirements for bodies operating product certification systems (BSI, 1998)) and whether they are an accredited certification body for an external standard. GFSI benchmarked audits now provide some assurance of a competent and consistent approach but for high-risk raw materials we would advise that in addition to buying from third-party certified suppliers you go and see for yourself. If they are already certified then spend the time focusing on the food safety controls that you think are needed for your product.

6. Buying from agents and brokers

When you buy raw materials through agents or brokers, you lose out on direct contact with the supplier. This can have drawbacks when the agent has little or no technical knowledge of the raw material, but it can work if you manage the situation effectively.

You must know how your raw materials have been processed and handled at every stage, in order to establish whether the likely hazards are present. It is important that you can obtain the appropriate assurances and ideally copies of third-party certification from the agent. If it is a high-risk raw material, most com- panies will visit the manufacturing location to ensure that appropriate control is built into suppliers manufacturing operation.

Even with the best-planned SQA system it is impossible to be absolutely sure that your raw materials always meet the required standards for safety and quality. In order to do this more effectively it is advisable to pass on to your suppliers the requirement to be certified to a GFSI scheme or ISO22000 so that you know they have a HACCP system for food safety hazards control. This requirement can be passed right up the supply chain, so that at each stage—growers, processors, distri- butors, agents—there is some level of confidence in the material at that stage in the chain. Auditor competency however remains a challenge as the audits are only as good as the auditor.

Acceptance testing can be helpful. This may be visual (the material is free from foreign material) or organoleptic (does it look and smell right?). Specific tests may be done, e.g., Aflatoxin for certain feed ingredients, or microbiological testing for food ingredients which can be verification of the supplier HACCP program. (b) Cleaning and Disinfection (Sanitation)

Hygienic operating conditions must be maintained and that will require documented programs, appropriate chemicals and tools, and adequate space in which to carry out required cleaning. Cleaning and disinfection programs are known as “sanitation” in a number of countries so for simplification, we will use that term throughout. A formalized sanitation program is one which is based on a risk assessment, is documented, and is validated as being effective and routinely

verified. What might each of these elements look like when properly implemented? The key elements that you should have in your program are as follows:

1. A sanitation risk evaluation

This is an evaluation of the type of residues that will need to be cleaned, together with consideration of the equipment, and process environment, including shift patterns and available down time. Considerations will include:

• Potential microbiological risks

• Pathogenic and spoilage microorganisms • Potential chemical risks

• Allergens

• Additives and drug residues (particularly in the feed industry where variability in species intolerance is a major hazard

• Pesticides

• Cleaning chemicals (e.g., cyanuric acid in chlorine-based manual cleaners) • The operating environment

• Wet or dry

A documented evaluation should be done for each area of the plant and each piece of equipment in the process.

2. Determination of cleaning methods

Determination of the cleaning method is usually done together with the external sanitation services provider. Wet cleaning using chemical cleaners and sanitizers are usual for microbiological and allergen hazards. However dry cleaning has considerable benefits in terms of reducing the amount of water available to microorganisms and is nowadays regarded as a better option for plants that process dry products. It is generally easier to prevent environmental microbiological growth in dry rather than wet conditions. If dry cleaning is used, a sanitizer could follow (in countries where it is permitted) but it is not always necessary. This should be evaluated and appropriate data gathered to validate the method selected and to make adjustments as needed when setting up the program.

3. Sanitation schedules/cleaning procedures

Procedures and work instructions, sometimes known as Sanitary Standard Operating Procedures (SSOPs), must be properly documented for all the required daily cleaning activities as determined above. In addition, a Master Sanitation Schedule (MSS) must be established for all areas outside the regular equipment and process area cleaning. It should include overheads and light fixtures, walls and ceilings, coolers and freezers, and the external yard and perimeter, This could also be incorporated into a Master Cleaning Schedule designated to

indicate tasks which are daily, weekly, monthly, quarterly, or annual. You need to include:

• The details of equipment/area to be cleaned • How it is to be cleaned (method)

– This should be documented in detailed work instructions or “one point lesson” plans which could include:

• The time (duration) allowed for the task. • Materials to be used, e.g.,

• Chemicals • Tools

• Chemical concentration and contact times.

• Including any routine strength testing, e.g., with titration. • Health and safety requirements, e.g.:

– Safety glasses and protective clothing will be needed. Consideration should be given to how these will be kept clean such that they do not become a source of (microbiological) contamination.

• Expected outcome, e.g.:

– Visual standards of cleanliness

– Environmental microbiological monitoring requirements • Corrective and preventative action in the event of a problem, e.g.:

– Actions required (e.g., re-clean, investigate root cause, and verify that the issue was resolved).

– Who to notify (in the event of a problem). It is beneficial to think this through ahead of time and to document requirements.

• Record keeping requirements

– Operator sign off—as having completed the task in accordance with the work instructions

– Reviewer sign off—to confirm (verify) that this was satisfactorily achieved • Routine verification/pre-operations inspections

– The person responsible should be clearly identified

– The required method for verification should be established and documented

4. Drain and janitorial cleaning

A separate program should be in place for these activities with similar procedures to those described above. You need to include requirements for an up-to-date

schematic of the drains (with an indication of flow direction) and ensure that you have dedicated (color coded) equipment. The plant will recognize that contamina- tion tends to accumulate around drains and that this is potentially a major cross- contamination risk if not properly controlled.

5. Cleaning in Place (CIP) Programs

If you are a plant that is operating a CIP system you will usually have a separate documented program. It will typically include the following:

• Diagrams of CIP systems and circuits • Descriptions of each circuit

• List of parts that are cleaned manually together with work instructions

• Validation of hygienic design, e.g., separate circuits for raw and processed product and no dead ends

6. Sanitation equipment and chemicals • Tools and equipment

You should have a program in place to ensure the integrity of the cleaning tools such that they themselves are not a source of contamination.

– Stored clean and dry

– Be on a regular cleaning schedule – Have designated containers

– Sanitation equipment must never be used for process operations (e.g., sanita- tion sinks for produce washing).

• The design of the sanitation tools is important. Avoid anything made from absorbent material, also designs that could be foreign material hazards such as: – Reusable cloths

– Reusable mops

– Wire bristle brushes (unless unavoidable and then should be controlled) – Tools with wooden handles

– Abrasive scrub pads (if used, these should be single use and issued on a controlled basis)

– Any tools with crevices that could become harborage sites • Chemicals:

– All chemicals used must be suitable for food use and approved by the appropriate authorities.

– A Material Safety Data Sheet (MSDS), sometimes called a hazard data sheet, must be retained on file along with a supplier continuing guarantee. All chemicals must be properly labeled and never decanted and stored in old or new food containers.

– Chemicals must be stored securely and in accordance with the manufacturer’s recommendations. This is best done by having a locked area within the facility.

7. Validation

Validation of PRP programs such as Sanitation is the same as for HACCP, and third-party certification schemes such as those benchmarked by GFSI include this requirement. It is essential to establish that the programs will be effective. In a formal program evidence of this will be documented. Many companies work with their sanitation provider on this area. Validation data will include:

• Evidence that the chemicals are suitable for the tasks being carried out and are approved for use in the food industry.

• Evidence that the chemicals will be effective against hazards of concern. 8. Monitoring and Verification of the program

A number of routine activities will be carried out. This might include: • Wet Cleaning:

– Cleaner/Sanitizer concentrations checks – Adenosine Tri Phosphate (ATP) swabs

– Visual pre-operations inspections (also post-cleaning if there is a time delay) – Microbiological and/or allergen residue checks of rinse water or of first

production off the line. • Dry Cleaning:

– Usually entails pre-operations visual inspections • CIP Cleaning:

– Cleaner/Sanitizer concentration – Wash temperature

– Wash contact time

For COP (out of place cleaning), the above might be appropriate plus post- cleaning ATP and visual inspection followed by a pre-op inspection.

• Environment (Microbiological) Surveillance

Microbiological surveillance programs are an essential verification activity and all but very low-risk operations will have them. Your program should include a risk-based sampling plan which takes account of the facility history, plant layout, product risk, and includes identified sampling sites, targeted microorganisms (usually Salmonella and Listeria species), or indicator organisms such as Enterobacteriacea, plus the frequency and method of testing. As indicated

above, microbiological surveillance testing of first product off the line after cleaning is sometimes carried out but where this is practiced (and pathogen rather than indicator organism testing is done), all production must be placed on HOLD until the results are known. If pathogen surveillance testing is being done on food-contact equipment, a positive result would implicate anything made on the equipment following the test sample—through to the next clean and back to the

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