Tel: Fax: Email: Postal: CK: Vat: 071 263 2963 086 658 0055 [email protected] P.O. Box 10765, Aston Manor, 1630 2007/211803/23 4060241330 How to develop your food safety management system Welcome to our series to assist you with the development of your food safety management system. We trust that this column will be beneficial and we look forward to your comments and questions. What to do about documentation? One of the most challenging aspects in the development of your food safety system is developing the required documentation. In most of the audits I have conducted I have found that companies do not struggle to do the right things, they struggle to write down what they are doing and keep records as evidence of this. 1. BENEFITS OF DOCUMENTATION The need for documentation within industry and commerce is a well-recognised fact. Primarily the need to document core financial activities is common. However, this element of control is extending to other organisational activities. The need for documentation is stressed by certification bodies in various published standards such as ISO 9001, SANS 10330, SANS 10049 and ISO 22000. As ISO 9001 represents a benchmark regarding documentation, it is useful to draw from the experience of quality management systems for food safety management systems. In fact, many food management systems such as BRC, SQF, ISO 22000 require the same documentation and controls to be in place. Some auditing companies make the claim that the effectiveness of the quality management system will, to a great extent, depend on how good the quality system documentation is. While this may be disputed in smaller organisations, which often do not have formal documentation but are still well controlled, having comprehensive quality system documentation demonstrates that quality related activities are planned and controlled. (The same can be adopted for food safety.) SANS 10049 states that the most effective way of ensuring food safety is by implementing documented procedures rather than relying only on product testing. Regardless of the accuracy of this claim, many organisations have derived great benefits from having documented management systems such as: TRAINING Most training conducted is on-the-job-training. This type of training is more successful and easier if the activity is documented. IMPROVEMENT Almost all activities can be carried out in different ways, not all of which are efficient or effective. A documented system can ensure a standard working practice is developed. © Von Holy Consulting | January 2009 | © The Food Safety Network| May 2010 REFERENCE Some complex tasks may require a reference. STATUTORY OBLIGATIONS There are several legal instruments that a company must comply with as previously discussed. Documented procedures and instructions assist in meeting these. This is particularly the case with the new Consumer Protection Act – when you go to court, what evidence will you be able to table? AUDIT A documented system is the basis for an audit to ensure that implementation is effective. 2. AUDIT REQUIREMENTS When an auditor approaches a food safety system, these are the basic requirements they need to look at: 1. Has the organisation’s food safety policy been defined? 2. Has this policy been translated into procedures and practices throughout the organisation? 3. Does the organisation cover all relevant activities within the system documentation? 4. Are there mechanisms in place to record the adherence and application of the policy and procedure such as records, checklists, forms? In other words, is there evidence the system is implemented and maintained? The audit company needs to ensure that the food safety management is an integrated part of the company’s management systems to be effective. At this point it is important to highlight that a documented management system may not necessarily be written in a text format. Any medium can be used to convey the message; in the form of diagrams, flowcharts, photographs, audio or video tapes. The documents may be on paper or electronic (software) format. The documentation must be meaningful and add value. It should always reflect the actual day to day activities. The ideal documented system should be simple, clear and efficiently controlled. Thus excessive paper and bureaucracy should be avoided at all costs. The documents should fit the organisation. The design and format must work for the company. Auditors should always bear this in mind. 3. SO WHAT SHOULD BE DOCUMENTED? There are various schools of thought on this issue. Some (food safety management) standards are very prescriptive regarding what should be documented, while others are vague. © Von Holy Consulting | January 2009 | © The Food Safety Network| May 2010 –2– The following would be considered good practice: POLICY OBJECTIVES COMMITMENT Regardless of what standard is being introduced, the responsibility for, and commitment to, a food safety policy belongs to the senior management. Food safety is an integral aspect of the management function of any food processor. Senior management of an organisation should develop and record its food safety policy and should take all necessary measures to ensure this policy is understood, implemented and maintained. The policy should be more than a document framed and hanging in reception. It should provide a clear message to all customers and employees regarding the commitment of the organisation to food safety. RESPONSIBILITY AUTHORITY INTERRELATIONS The responsibility, authority and interrelation of all personnel who manage, perform and verify work affecting food safety shall be defined(ISO 22000:2005). Responsibility and authority delegation for every activity contributing to food safety shall be established. Many companies use job descriptions for this, others use descriptions within procedures to define these aspects. The importance of this is to ensure there are no ‘overlaps’ - omissions or grey areas where the ambiguity around responsibility and/or authority could lead to a food safety issue. PROCEDURES SPECIFICATIONS RECORDS A food safety system is the organisational structure, responsibilities, procedures, processes and resources required to establish and implement food safety. This system should provide confidence that it is effective and shall supply a product or service that shall satisfy customer expectations and shall place the emphasis on problem/hazard prevention, rather than dependence on detection after occurrence. It is normally documented through several levels or tiers of documents: LEVEL 1 This level contains the food safety policy, a brief outline of the food safety management system and management’s intentions. Some companies develop policies for all their PRP’s. This would then references to procedures that describe how the intentions are implemented. LEVEL 2 Procedures describe what is being done, and why, by whom, where, when and how. LEVEL 3 Work instructions, which direct personnel to a single task. They are normally referenced in procedures. Work instructions may be operating manuals or recipes. This kind of document is also used for cleaning instructions LEVEL 4 Forms, specifications and documents of external origin are usually included in the system. Forms are special documents to prepare proper records. Specification must be in place for raw materials, final products and packaging as a minimum. External documents could be client specifications, codes of practice, regulations etc. © The Food Safety Network| May 2010 –3– 4. PROCEDURES TO CONTROL DOCUMENTS It may be obvious, but documentation is developed to define the controls within the food safety management system - yet the documentation also needs control. It should be noted that a procedure to control documents is a requirement of ALL international management system standards. In fact this should be the first procedure you write! To provide uniform and consistent instruction to all appropriate members of the organisation, it is essential that ‘the right document be available at the right time in the right place’. Most standards include document control requirements as it is a given, that with time, the organisation will change and thus the documentation will need to be revised. The following pointers should be considered in any PRP. 4.1 Who signs what Documents should be reviewed and approved prior to issue. Senior management should determine who signs what and record this. Evidence of the review and approval is required. This can be done by: • • • Signing on the document, usually the master copy Signing an attached approval slip, to the master copy Signing on the master list 4.2 Who has the latest version A distribution list should be in place to ensure that everyone who needs access to the documents has received their copy. Controlled distribution should discourage ‘uncontrolled’ photocopies that can become invalid, or obsolete. It should be noted that all individuals do not have to have their own copy, but should have access to the documents they need. When a document is changed, the distribution register will ensure all recipients get an updated copy. Obsolete or superceded documents should be withdrawn or identified, usually by a stamp. It is important that documents of external origin are also on a distribution register. Recipients should sign for these as well. 4.3 Controlled vs Uncontrolled Once something is printed on paper it can be photocopied and hence become outdated. Usually some colour distinction is applied to all ‘controlled documents’ (updated and issued by a custodian). The procedure for document control should detail this control. It should be noted that ‘paperless’ systems, that is where all documents are viewed electronically, still require the same controls to be in place. Software applications are available that ensure all document control requirements are followed. 4.4 A uniform style Many organisations develop a ‘house style’, a standard format for all documents within their system. This can greatly assist the users who become accustomed to the ‘look’ of the documents. It also represents a professional impression of your company at an audit. © The Food Safety Network| May 2010 The format of the documents will depend on the way the documents are to be controlled, but the following should always be included: • • • • • • Document name or title Document reference number (this is useful in subdividing document between areas/functions/types) Indication of issue and revision status and/or date of such Evidence of review and approval, either on the document or an attachment Page numbering Amendment history to identify changes 4.5 So what has changed? It is a strange phenomenon that as soon as something is written down, someone wants to change it. Documents should always be changed in order to improve the system. A record of the change should be kept. ISO 9001:2000 requires that the nature of the changes be identified and preferably on the document. Many companies include an amendment list in the document or as an attachment where the change can be identified, with background if necessary. Ideally (although a nightmare to control) changes could be highlighted in the list using a different font, underlining the change, or with a mark in the margin. 5 FINAL WORD … Records Records are the objective evidence of the operation of the food safety management system. Therefore they are needed to prove the effectiveness of the system. We are all familiar with the saying – “No job is finished until the paperwork is done” Make sure your procedures clearly reference all the forms in your system – otherwise they are standalone systems that won’t be addressed. Think creatively about developing checklists or forms – can you combine all daily tasks onto one checklist and so save paper? Remember the paper is a necessary evil but make it work for you, not the other way around. Document control will control the format of the records, but additional controls should be in place to control filing, indexing, accessing and disposition of records. It is suggested that all forms have a standard format such as company logo, version number, reference number for the form and effective date. All forms should be designed so details of corrective action can be recorded on the form. Always make sure there is a space for the signature of the person completing the record and then the person reviewing the record. A master file of forms should be kept so the company can keep control of the latest version of forms that should be in use. Completed forms should be filed in a controlled manner. Establish what must be filed, by whom, where it should be filed and for how long. There are no hard and fast rules for retention times for records. Some records are required to be kept for tax purposes and legislation defines these periods. It is always recommended that all records be kept for at least the shelfIife of the product. It should be noted that for retail and certification audits at least 12 months of records has to be available. Files should be labeled, indexed and records filed in a controlled way such as chronologically etc. Again filing systems tell an auditor a lot about how serious you are about food safety…. All records should be completed in pen, tippex should not be used and handwriting should be clear. Errors should be initialed. All forms should be countersigned by the supervisor and manager to take note of corrective action requirements. © Von Holy Consulting | January 2009 | © The Food Safety Network| May 2010 IN SUMMARY (As a loose guideline) REQUIREMENT PROCEDURE RECORD 1. When a requirement is identified, review it to define whether or not documentation is required. In some cases you are told a policy or procedure is required –if so write it down. Also consider your processes –how do you receive, how do you make your products, how are interfaces controlled. Use the flow diagram you developed last month for your hazard analysis as a guide for which operational procedures you should develop. 2. Create a policy/procedure/work instruction/form which accurately reflects the needs of the organisation in meeting the requirement. 3. Ensure sufficient records are created and maintained which will demonstrate the achievement of the requirement. © Von Holy Consulting | January 2009 | © The Food Safety Network| May 2010