Review workplace documents – content guide Table of contents Overview 2 Understanding products and processes 2 Understanding what goes into a food safety program 4 Setting up audit trails 5 Choosing the documents to review 6 Documentation related non-conformances 11 Summary 13 Further references 14 Food Safety Auditing Toolbox Review workplace documents – content guide 1 Overview Reviewing workplace documents is an essential part of conducting an audit. The purpose of reviewing workplace documents is to ensure that the company has a documented food safety program that is appropriate to the activities of the food business and meets the requirements of the legislation. Understanding products and processes Before reviewing the workplace documents, an auditor needs an understanding of the likely hazards, risks and control measures associated with the food product and processing method used. A good knowledge of food safety systems within food manufacturing businesses, together with specific knowledge about the actual process being audited, is essential. The business’s food safety plan and HACCP documentation are the key elements that require auditing when reviewing workplace documentation. It is the food safety auditor’s responsibility to ensure that a food safety plan and any HACCP documentation cover all the risks associated with the process. If you are unsure as to some technical aspects of the process you are auditing it is a good idea to research the risks. Often, this begins with researching the types of hazards associated with given products, which is directly related to the specific microbiological hazards associated with certain food types. Pathogen/food associations or combinations are well documented in government, scientific and industry literature, as are known control measures applied by industry within their processes in order to eliminate or reduce these risks to acceptable levels. Often, contacting the peak industry body associated with a given food processing sector or visiting the industry or associated websites can lead you in the right direction with respect to finding this information. When assessing the risks associated with products and processes, an auditor needs to consider the following: 2 Is there any epidemiological evidence with respect to known food poisoning outbreaks associated with the food? Are there any known pathogens associated with the food? Food Safety Auditing Toolbox Review workplace documents – content guide What industry knowledge and historical evidence of food safety is required? What scientific knowledge of the process and food type do I need? How is the food packaged? Some forms of packaging (eg vacuum packing of sliced meats) extend shelf life but may also favour growth and survival of specific pathogens. So the business needs to take measures to completely eliminate the presence of such pathogens to produce a safe product. What is the intended use of the food? Will it be sold to vulnerable populations? What known allergens are associated with the food or ingredients in the food? What supply chain risks are associated with raw materials? For example, what chemical contamination risks are associated with the primary production process of the food (the growing of the food) as well as further processing? These may include risks associated with residues from agricultural pesticides, antibiotics or hormones, as well as residues left by cleaning chemicals, lubricants, etc. What are the foreign object contamination aspects of the primary production process, and are there any further processing of food products that need to be considered? Foreign objects such as sticks, stones, etc may be present, or in the case of fresh fruit or vegetables, dirt, insects and snails may be present. All the risks associated with food products and their production are far too extensive to cover in this Content guide, and there are too many for an individual to know them all. Indeed, newly emerging food safety risks are being discovered all the time as scientific methods and technological applications improve. Governments and industry continually strive for new and innovative ways to process, package and sell food in an increasingly globalised economy, so the food safety auditor will always be challenged with a growing knowledge bank that needs continual research in order to stay abreast of developments. Through experience and research, a solid foundation of the most common risks associated with contemporary food products and associated processes is paramount to becoming a competent food safety auditor. Some instances where an auditor applies this knowledge include: checking that all process steps have been documented confirming that all hazards have been identified and risks appropriately assessed checking that the control measures in place are appropriate for the hazard checking that relevant support programs are established and effective. Food Safety Auditing Toolbox Review workplace documents – content guide 3 A well developed HACCP plan often references scientific literature as part of its validation and the risks that need to be controlled are clearly set out. How critical limits are derived, types of pathogens and preventative measures to control growth or stop contamination at various stages of the production process should be well documented in the hazard analysis and hazard audit tables. Understanding what goes into a food safety program According to the Australian Food Safety Standard 3.2.1 Food Safety Programs, a food safety program must: 1. Systematically identify the potential hazards that may be reasonably expected to occur in all food handling operations of the food business. 2. Identify where, in a food handling operation, each hazard identified under point 1 can be controlled and the means of control. 3. Provide for the systematic monitoring of those controls. 4. Provide for appropriate corrective action when that hazard, or each of those hazards, is found not to be under control. 5. Provide for the regular review of the program by the food business to ensure its adequacy; and 6. Provide for appropriate records to be made and kept by the food business demonstrating action taken in relation to, or in compliance with, the food safety program. Other requirements of food businesses relate to registration. These requirements may differ according to State. For example, in Victoria: The food safety plan must be submitted as part of food business registration—failure to submit, or failure to comply with requirements may lead to loss of registration. The registration authority must be given a copy of any revisions to the program within 14 days of the revision being made. Each business must nominate a food safety supervisor who: – knows how to recognise, prevent and alleviate the hazards associated with the handling of food – knows which food safety competency standards apply, and how they apply – has the ability to train other people to safely handle food. 4 An independently prepared food safety plan must be audited by an approved third party auditor at least annually (this will depend on the type of business—high-risk operations may require more frequent third party audits). Food Safety Auditing Toolbox Review workplace documents – content guide Setting up audit trails Reviewing the documentation before you conduct the ‘hands on’ part of the audit should give you an indication of how the business is operating and what aspects of their activities you might want to take a closer look at. As you review documents, you should start noting down any gaps or issues that warrant closer attention. This is known as setting up audit trails. The audit trails will guide you in making decisions about what activities or practices you need to observe more closely when walking around the business and reviewing workplace practices. Audit trails help focus your attention on areas of greatest concern. So, for example, you are likely to be using an audit checklist as a prompt to cover all aspects of the audit but once you have established the audit trails you want to investigate, you might revise the order in which you want to tackle the activities so you devote time and attention to areas that are most likely to be of concern. Closed loop and open loop audit trails Audit trails can be ‘closed loop’ or ‘open loop’. Where you identify closed loop audit trails, you will need to review the procedures and documentation through to a conclusion within a defined work area. However, where you identify open loop audit trails, you may need to further investigate evidence in other functional areas of the business in order to be satisfied a system is working. An example of an open loop audit trail may be the investigation of how the business handles customer complaints with respect to foreign objects. If the complaint has been completed or ‘closed out’ by the business, an auditor may review the documentation and be satisfied that the customer complaint procedure has been followed correctly. The auditor would need to see that: 1. the date and all relevant details of the customer complaint, including when it was received, have been logged 2. the foreign object has been returned (where possible) to aid in the investigation 3. the foreign object has been identified 4. the origin of the object can be explained 5. the root cause of how the foreign object ended up in the product has been investigated by the company 6. investigations have ruled out any other products being affected 7. corrective action has been taken that will prevent a recurrence of the complaint. This may take the form of : – – staff counselling changes to procedures in the HACCP plan Food Safety Auditing Toolbox Review workplace documents – content guide 5 – – increased checking or new checks banning certain equipment (eg replacing loose bristled brushes used for cleaning with a more robust variety that won’t leave bristles behind that end up in the product) 8. follow up audits in the work area where the foreign object originated confirm the corrective action has taken place and is effective 9. appropriate feedback has been given to the customer. The above is a single, open loop audit trail, as all that the auditor needs to verify is that the corrective action taken by the company is in place. In the case of replacing certain types of cleaning equipment (see point 7) the auditor needs to check that the types of brushes that caused the complaint have been replaced as indicated in the complaint records. Choosing the documents to review There are different types of documents an auditor will be interested in reviewing. Systems documentation is the key set of documents that detail the food safety plan. Some State legislation mandates that certain businesses develop a HACCP-based, food safety plan in order to operate. In Victoria, the proprietors of declared food premises (under section 19C of the Food Act) must operate under a food safety plan. State legislation establishes the minimum requirements that reflect HACCP principles but are not strictly the same as a full HACCP program. Some businesses may voluntarily develop their own HACCP food safety programs in order to access certain markets, so the terminology used may differ. In this Content guide, the term HACCP is used to encompass all food safety programs. There are a range of documents that support food safety in the workplace. These documents include: 6 HACCP documentation: this includes the food safety policy, the HACCP plan, which includes a process flowchart, HACCP analysis tables, HACCP audit tables, a description of the product and intended use tables. Process documentation: for example, HACCP team minutes and training records. Validation documentation: these documents outline the basis upon which controls are determined, for example, codes of practice, industry standards, lab reports, etc. Programs and procedures: examples of support programs include change management, personal hygiene, pest control, calibration, cleaning/sanitation, approved supplier, sampling/testing and product recall. Previous audit reports, the Corrective action request (CAR) register and related documentation. Food Safety Auditing Toolbox Review workplace documents – content guide Records: for example, production logs, test results, etc. HACCP is a tool or technique developed specifically to deal with potential hazards within a process. It identifies specific hazards, and establishes preventative measures to control the hazards. The desired result is maximum assurance of food safety. HACCP on its own is not a total quality management system. It is only one of the tools required to effectively and efficiently establish quality objectives. Some companies combine food safety with related policies and programs such as quality. There are various quality systems, each with a different approach, and with different emphases. Some examples of quality systems used in the food industry are shown in the table below. Table 1: Quality systems used in the food industry Quality system Key points Total quality control (TQC) Total quality management (TQM) AS3900 ISO9000 BS5750 Food Safety Auditing Toolbox Review workplace documents – content guide assumes that the operator has the most knowledge about the product, has greatest effect on the quality and, as such, is the most important in quality control employees are encouraged to contribute ideas in improving quality and reducing costs uses statistical measuring and charting of processes and outputs the process is divided into stages and each stage is viewed as a customer of the previous stage. encompasses all aspects of the business requires commitment by top management, demonstrated by the authorisation of a quality policy concentrates on prevention of problems by improving processes and introducing control mechanisms ensures effective communication by eliminating barriers through the company hierarchy places effort on training of employees and on improvement of plant and equipment measures results in all aspects of the business. requires commitment by top management formation of a steering team selection of a registrar training in the quality system requirements formation of a quality manual containing policies, systems and detailed procedures of all related activities commencement of internal audits assessment and amendment, registration with an accreditation body (eg 7 Standards Association of Australia). Approved quality assurance (AQA) a quality assurance program developed by the Commonwealth government in accordance with AS and ISO, and in response to developments in industry recognises the inadequacy of the traditional methods of inspection uses audit procedures to determine whether quality, safety and conformity to regulation is assured has a fee for an audit and at least two audits are conducted per year more comprehensive than AS and ISO as the legislation pertaining to the particular commodity is also included in the program differs from TQM, only in that it does not include emphasis on improvement in order to apply for AQA, a manual describing the quality system must be produced. The extent of document review will depend on the purpose of the audit— that is, whether it is specific to food safety or whether it is a combined food safety and quality audit. This Content guide focuses specifically on food safety issues. Table 2: HACCP documents HACCP documents Content to be covered (as appropriate to the product) Company information Current certificate of food business registration Organisational chart Product description & intended use Detailed description of products manufactured by the business Process flow chart Hazard analysis HACCP audit tables For each CCP establish: critical limits method and frequency of inspection identification of personnel responsible record keeping requirements corrective action procedures required if process is out of control. Process documents The process of designing and monitoring the HACCP plan is as important as its content. An auditor should check to see who was involved in putting the plan together, what processes are used to communicate information about roles and responsibilities and what training is provided to support implementation. 8 Food Safety Auditing Toolbox Review workplace documents – content guide In small workplaces, the plan might be developed by the production or quality manager. In medium and larger workplaces, you would expect the business to convene a team of people from different work areas to provide input to the plan development. There should also be a clear procedure to upgrade operating documents, such as Standard operating procedures (SOPs), to reflect any changes to the food safety plan. It is a requirement that food businesses have a system in place to regularly review and update their food safety plan. In Victoria, for example, this review needs to be undertaken every 12 months (or as required where there is a change in process). The auditor should confirm that there is a process for regular review and that the frequency of review meets legislative requirements. By legislation, food businesses are responsible for ensuring that employees have the competencies (skills and knowledge) required to support their role in producing safe food. Some businesses choose to do this by requiring employees to participate in formal training programs. Others may provide instruction in-house. Unless State-based legislation mandates minimum qualifications for food handlers this choice is up to the business. The auditor needs to be satisfied that the business has an effective way of ensuring its employees understand and can carry out their food handling responsibilities safely. In medium and larger workplaces, this would usually be supported by a record keeping system to keep track of the food handling competencies of each employee. Validation documents The HACCP-based approach to managing food safety uses risk management rather than prescriptive standards to support production of safe food. This means that it is up to each food business to determine and justify appropriate and safe production methods. In most cases, businesses will follow recognised industry standards. For example, pasteurised products must be heated to a temperature of not less than 72°C for not less than 15 seconds and immediately shock-cooled to a temperature of 4.5°C or less (Export Control Milk and Milk Products) Orders 2005. However, a business may opt to use different processing methods provided they can produce credible scientific evidence to support their practices. This information is sometimes referred to as validation evidence and it should be provided to support processing methods and corrective action procedures. An auditor should cite evidence, particularly for non-standard processes, and determine whether the evidence presented is adequate and credible. Examples of the types of evidence that is acceptable for validation purposes include: existing (Australian) legislative requirements challenge tests Food Safety Auditing Toolbox Review workplace documents – content guide 9 peer reviewed scientific papers targeted scientific reports validation already carried out in other jurisdictions and recognised by the responsible authority mathematical modelling (eg predictive microbiology models) industry codes of practice (where implementation by the food business is verified during audits). Programs Support programs will depend on the nature of the products and processes, but there are some common programs that apply to any food business. These include: personal hygiene pest control calibration cleaning/sanitation approved supplier list, procedures and test results sampling/testing (eg end product testing, work in progress product testing, environmental swabbing or cleaning) product recall. Procedures Each program will usually be supported by a procedure. The content to be included in the procedures will vary depending on their purpose. Some common information includes: 10 What purpose, procedure and standards are to be met? What are the method(s) to be used? What outcomes are required? In some cases this can include critical limits (eg in designing a cleaning procedure). Where information on critical limits is provided, advice on what to do if these limits are not met should also be included. What are the record keeping requirements? This includes the frequency of inspection, the information to be recorded and who is responsible for recording it. Food Safety Auditing Toolbox Review workplace documents – content guide Recording: check sheets, log sheets and records For each Critical control point (CCP), records should be available to show how a process is performing and whether it is within the limits or standards set. Increasingly, these records are logged electronically but many businesses still use paper-based recording systems. These data collection instruments need to be appropriately designed and should include: the date and time the information was recorded advice on how information is to be recorded (eg, is it adequate to tick off an item, or do the actual parameters such as time/temperature need to be recorded?) how often the information needs to be recorded directions on action to take in the event HACCP measurements show a process is not conforming to requirements who recorded the information who needs to sign off the record sheet (if appropriate). Check sheets are also commonly used to record results and the efficacy of support program activities. Hygiene check sheets or cleaning records indicating that the work has been carried out and that it is satisfactory are a common example of this type of record. Other relevant records include internal audit documentation. Document design and management Apart from including relevant content and designing documents to fit their purpose, it is important that the business has a way of managing and controlling documents. At a minimum this requires a system for keeping track of the current version of documents such as specifications and SOPs. This is usually done by ‘controlling’ documents. This is a system for managing documents according to status (draft, version, current, etc) and records effective date, number/date of review and sign off from a document manager. Where documents are in draft, it records who needs to/has reviewed and signed off the draft document. These systems are designed to make sure that everyone is following the same procedures. Documentation related to nonconformances The main purpose of reviewing documents is to get a better understanding of the business and its food safety program as well as to establish audit trails to be followed up when conducting the workplace inspection. In some cases, shortcomings or gaps in the documentation could constitute a non-conformance. Food Safety Auditing Toolbox Review workplace documents – content guide 11 Examples of non-conformances related to documentation could include: 12 the business being unable to locate HACCP documentation documentation is out of date there are no records of cleaning and sanitation there is no system for controlling and managing food safety documents samples of documented records indicate the process is out of control with no record of corrective action being taken activities that should be described as part of the food safety program but for which there is no supporting documentation (eg no cleaning schedule) record sheets inadequately designed—examples could include records that do not cover all the process parameters as indicated by the HACCP plan or do not show adequate accountability (ie there are no sections for operator sign off or date of recording, etc). Food Safety Auditing Toolbox Review workplace documents – content guide Summary Reviewing workplace documents is critical in the process of conducting the audit. The process of reviewing workplace documents is sometimes referred to as a ‘desk audit’. In itself, this step cannot be considered an ‘audit’ but it is an essential part of the evidence gathering process within an audit. Businesses vary in their approach to documentation. Some will have the bare minimum while others will be drowning in detail. As an auditor, you won’t have time to read everything so it is important to make informed decisions about which documents you need to look at. Food Safety Auditing Toolbox Review workplace documents – content guide 13 Further references CSIRO Publishing (1997), A guide to the implementing and auditing of HACCP, SCARM report 60, CSIRO publishing, Collingwood. Foley K (2000) The quality auditor, Quality Assurance Services Pty Limited, Consensus Books, Sydney. Sutherland, P. S. and R. J. Porritt (1997) ‘Listeria monocytogenes’, In A. D. Hocking, G. Arnold, I. Jenson, K. Newton and P. Sutherland (eds), Foodborne microorganisms of public health significance, 5th ed, AIFST (NSW Branch), Sydney, Australia. 14 Food Safety Auditing Toolbox Review workplace documents – content guide