Selection and Use of Acceptance Criteria
4.7 Auditing Food Operations for Supplier Acceptance
In the context of food production, auditing is a systematic process of objectively obtaining and evalu-ating evidence as a means of verifying compliance against a pre- determined scheme. Schemes can be international standards like ISO 22000, GFSI benchmarked schemes, quality assurance schemes issued by trade bodies or proprietary supplier specifications. As discussed earlier, supplier audits
Table 4.3 Factors that can influence the decision whether to sample and test a lot of food
Factor influencing decision to sample and test
Condition that would increase the likelihood of sampling the lot
What is the expected outcome if the food is not sampled and is accepted?
Illness among consumers is probable Has the food commonly been involved in foodborne
illness?
The food has a recent history of causing illness What is the severity of the hazard(s)? The expected hazard is of high severity Is there reason to suspect the food will not meet
established criteria?
Certain lots occasionally fail established criteria Is the food intended primarily for a vulnerable population The food is designed and intended for high risk
populations Is the food from a country or region with endemic disease
of importance to food safety.
Recent reports indicate that endemic disease has resulted in foodborne illness among consumers of an importing country.
Is the country or supplier known to exercise control over the production of the food?
The exporting country’s inspection program is considered inadequate for the expected hazard(s) in the food.
Can a sampling plan be used to detect unacceptable lots, particularly when a small number of defective units are expected?
When defective lots occur the number of defective units is sufficiently high to be detected.
Can the sampling plan detect a low prevalence of a pathogen of concern?
When present, the pathogen occurs in sufficiently high numbers that it can be detected by the method employed.
What is the expected complexity, accuracy, sensitivity and time for the result?
The laboratory method is easily performed, accurate, sensitive and the time to obtain a result will not lead to a decrease in the quality of the product.
Does the laboratory have the equipment and expertise to analyze the samples?
Yes
Where is the food located; can the lot be easily sampled? The lot is located nearby and can be easily sampled.
Ease of transporting the samples to the laboratory The laboratory is situated locally.
What is the cost of the product that will be sampled, The product samples need not be purchased.
Are there sufficient funds, personnel and laboratory support to collect and analyze the samples.
These resources are available.
Are there any outside influences to consider (e.g.
regulatory standards, supplier specifications)
There are no outside influences.
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typically cover more than just food safety management systems and often extend into quality systems, general management systems and commercial systems. Food companies engaged in supplier accep-tance audit activities should ensure the integrity of their activities by following internationally accepted standards for the conduct of audits.
Standardization of audit activities has developed considerably over the last decade. There are now two key international standards that provide an audit framework and establish consistent standards for bodies involved in audit. ISO 19011:2012 (ISO 2011a) provides guidelines for auditing management systems. It is aimed at companies engaged in audits, including smaller food businesses, and outlines how management system audits should be conducted. The standard concentrates on internal audits (termed first party audits) and supplier audits (termed second party audits) whilst third party audits by external certification bodies against standards for certification purposes are further elaborated in a complementary standard called ISO/IEC 17021:2011 (ISO 2011b). The details included in this latter standard will not be elaborated in this chapter.
In brief overview, ISO 19011 establishes a set of principles designed to ensure that an audit is reli-able and effective and can be used by the audited company as a basis for improvement. The principles are as follows:
• Integrity of the auditors (professionalism and competency)
• Fair presentation (truthful and accurate reporting)
• Due professional care (reasoned judgement)
• Confidentiality (security of information)
• Independence (impartiality and objectivity)
• Evidence-based approach (verifiable audit evidence)
The audit program itself, consisting of one or more audits, is broken down into a cyclical activity involving four main components called Plan-Do-Check-Act. The planning stage involves establishing objectives for the audit program and developing the details of the audit program which in turn includes the personnel and audit procedures. The implementation stage details the activities involved in actual audit(s) undertaken as part of the audit program. The monitoring stage is where an overview of prog-ress is maintained including issues such as performance of the audit team members and stakeholder feedback. Finally, these stages are followed by a review of the audit program and any adjustments necessary to improve the process prior to starting a further program cycle.
Food companies that use standardized audit procedures as a basis for supplier audits are more likely to ensure consistency, transparency and fairness in their audit activities which provides a sound basis for good supplier relations and development of the supplier base.
4.7.1 Further Considerations for Auditing a Supplier When a FSO/PO Has Been Established
If a food business is producing or selling a food that is subject to a FSO or a PO it may need to estab-lish a PO of its own as an acceptance criteria for raw materials produced by a supplier. For example, a producer of dried milk used as an ingredient in a dry mixed infant formula will have to assure that the level of Salmonella is below a certain level. If a PO for infant formula was established as <1 Salmonella /108 g of product, then the PO for the milk powder ingredient could be set ten times lower, for example, < 1 Salmonella /109 g of product. If the initial concentration of Salmonella in milk was 1 colony forming unit (cfu)/10 ml (−1.0 log cfu/ml) meeting such a PO would require treatment of the milk to achieve an 8 log reduction in Salmonella. The 8-log reduction is an example of a PC that could be set by the supplier in order to meet the buyer’s PO. The PC could be achieved by pasteurization at a temperature of 75 °C for 8 s as a minimum before spray drying or by another means (see Chap. 15).
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This process criterion would be documented as a critical limit for the thermal process CCP in the supplier’s HACCP plan. Recontamination should also be prevented through the application of GHP. For some GHPs (e.g., air filtration) a process criterion could be set, but for others (e.g., dry cleaning practices) criteria cannot easily be established and monitored.
Chapter 3 contains information on how control measures should be set to meet FSOs. Auditors should take account of this information when developing their auditing procedures as the basis for evaluating whether the operation being audited has established effective risk-based controls that can be justified. For example, will the system meet established PC? Can the critical limits at CCPs (i.e., process criteria and product criteria) be expected to prevent, eliminate, or reduce the hazard(s) to acceptable levels? If default criteria are selected as a basis for control, are they being correctly applied?
During a supplier audit when a PO for a product has been established by the buyer or a regulator it is essential that there is an objective evaluation of evidence regarding the validation of any risk management metrics established by the supplier and designed to meet the PO such as PC, process or product criteria. This can be done during the pre-audit assessment process by examination of any relevant validation records and supporting documents. This should be carried out by a member of the audit team who has the appropriate microbiological skills. Verification that these critical criteria are met consistently can commence in the pre-audit phase by examination of monitoring records, but would need to be completed during the physical audit.
References
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(CAC/GL 21-1997). Supplement to Volume 1B-1997. Joint FAO/WHO Food Standards Program, FAO, Rome.
Codex Alimentarius. (2003). Guidelines on the judgment of equivalence of sanitary measures associated with food inspection and certification systems. (CAC/GL 53-2003). Joint FAO/WHO Food Standards Program, FAO, Rome.
Codex Alimentarius. (2007a). Principles and guidelines for the conduct of microbiological risk management (MRM).
(CAC/GL 63-2007). Joint FAO/WHO Food Standards Program, FAO, Rome.
Codex Alimentarius. (2013). Principles and guidelines for the establishment and application of microbiological criteria related to foods (CAC/GL 21-1997). Rome: Joint FAO/WHO Food Standards Program, FAO.
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Health Canada. (2011). Policy on Listeria monocytogenes in Ready-to-Eat Foods. http://www.hc-sc.gc.ca/fn-an/legisla-tion/pol/policy_listeria_monocytogenes_2011-eng.php. Accessed 21 Nov 2015.
ISO (International Standards Organization). (2011a). Guidelines for auditing management systems. ISO 19011:2011 (2nd ed.). Switzerland.
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WFP (United Nations World Food Programme). (2009). Food specifications. http://foodqualityandsafety.wfp.org/speci-fications. Accessed 21 Nov 2015.
WTO (World Trade Organization). (1995). The WTO agreement on the application of sanitary and phytosanitary mea-sures (SPS Agreement) http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm. Accessed 21 Nov 2015.
References
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International Commission on Microbiological Specifications for Foods (ICMSF), Microorganisms in Foods 7, https://doi.org/10.1007/978-3-319-68460-4_5
