Managing Non-conformance Categories Page 1 Safefood 360° is the provider of food safety management software for industry leading businesses. WHITEPAPER Managing Non-conformance Categories CONTENTS SUMMARY 1. Introduction 2. What is a non-conformance? 3. How are non-conformances Identified? 4. Why record non-conformances? Food companies collect 5. Corrective and preventive action data on non-conformances within their operations but 6. Cause and effect analysis this valuable data is often lost in paper piles and poorly designed systems. In this 7. The true nature of whitepaper we will take a non-conformances closer look at what exactly is a non-conformance, why we 8. Developing a robust need to record them in the non-conformance structure first place and how to design the systems that facilitate effective analysis and im- 9. Organising folders and categories provement in your business. in Safefood 360º Safefood 360, Inc. 2014 Part of Our Professional Whitepapers Series Managing Non-conformance Categories Page 2 1 Introduction There are many types of requirements. Some of these include food safety re- Every day, food companies collect data quirements, quality requirements, pro- on non-conformances within their oper- cess requirements, product requirements, ations but this valuable information can customer requirements, management often be lost in paper piles and poorly systems requirements, and legal require- designed systems that have been devised ments. for analysing the data. In this whitepaper we will take a closer look at what exactly Whenever your organization fails to is a non-conformance, why we need to meet one of these requirements, a non- record them in the first place and how to conformity occurs. For example, the design the systems that will facilitate ef- ISO 22000 standard defines food safety fective analysis and improvement in your management system requirements. When business. Finally, we will provide tips on your organization deviates from these how to set up your non-conformance requirements, a non-conformance or categories in Safefood 360º. nonconformity occurs. Requirements by type include food safety, quality, process, product, material, supplier, systems and legal. 2 What is a non-conformance? The variation in how companies manage 3 How are non-conformances in their food safety non-conformances system is vast, and the design of these identified? systems can either support or hinder the effectiveness of the continuous Within a typical food safety management improvement policy. Good design and system non-conformances are identified management of non-conformance data through a number of channels. These and specifically non-conformance cate- include customer complaints, internal gories is crucial to making improvement audits, product recalls / withdrawals, a real part of the company’s activities external audits, regulatory notifications, and not just a documented policy. incoming as well as in-process and final product inspection, testing and casual Non-conformance relates to a failure to observation. A food business with a comply with requirements. A require- food safety management system certified ment is a need, expectation, or obliga- to a specific standard will have in place tion. It can be stated or implied by an a system for recording these non-con- organization, its customers, or other formances. These standards will include interested parties. the ISO 22000, GFSI and other industry standards. Safefood 360, Inc. 2014 Part of Our Professional Whitepapers Series Managing Non-conformance Categories Page 3 4 Why record formances and Corrective and Preven- non-conformances? tive Actions which will define the char- acter of the management system and There are two reasons why a food busi- some key processes. ness will record non-conformances. Figure 1 (below) illustrates the relation- • Compliance Requirements – to ship between a non-conformance and meet the specific requirements of a cus- actions. tomer, standard or regulatory obligation. As we have already covered, a non-con- • Process Improvement – record- formance is a failure to meet a require- ing non-conformance data can facilitate ment. When this occurs, the company analysis leading to incremental and con- should take action. There are two main tinuous improvement in business and types of action. Preventive action is operational processes. an action taken to eliminate a potential non-conformance. Corrective action is an action taken to eliminate the cause of 5 Corrective and a non-conformance. We can see we have preventive action two main elements at play: non-con- formance and actions. To fully under- Like most entities in a food safety man- stand these elements and their relation- agement system, a non-conformance ship we need to introduce the concepts does not exist in an insulated bubble. It of Cause and Effect. maintains a close relationship with cor- rective and preventive actions which of- ten occur together with the identification 6 Cause and Effect of non-conformances. For example, the Analysis ISO 22000 requires a business to have a non-conformance procedure in place In recent years, food safety standards with data capture as a prerequisite to tak- have introduced the requirement of ing specific actions. Root Cause Analysis (RCA). In times past, companies only needed to record It is this relationship between Non-con- Safefood 360, Inc. 2014 Part of Our Professional Whitepapers Series Managing Non-conformance Categories Page 4 the non-conformance and then imple- Cause and Effect Analysis is typically ment corrective action. The requirement used to identify the root cause of the to explain the basis for the action was non-conformance. The technique em- not specifically asked for and as a result ploys a structured brain storming and actions were taken on an ad hoc basis the use of diagrams to drive you towards with little concern for their effectiveness. the possible causes of the issue. Pio- The powers that be recognised that a neered by Professor Kaoru Ishikawa the more robust approach was needed. approach is now widely used in manu- facturing as a quality management tool When a non-conformance is identified, and is gaining increasing acceptability in addition to recording the details, the within the food sector. The tool is better company must examine all possible rea- known as the Fishbone Diagram. sons that may have caused it. Only then can the company consider taking the When using the tool, the first step is appropriate actions. This approach has to clearly identify the problem or non- many benefits including finding timely conformance e.g. the poor shelf life of a and permanent solutions. We can now product. Supporting information should develop our model a little further: also be recorded as much as possible, including which products were affected, Figure 2 (above) illustrates the relation- times and dates, quantities, trends and ship between non-conformance and so on. Taking the fishbone diagram, the actions with root cause analysis. non-conformance is written into a box on the left-hand side. A line is drawn horizontally across the page from the box, as is illustrated by the figure below. Safefood 360, Inc. 2014 Part of Our Professional Whitepapers Series Managing Non-conformance Categories Page 5 The important point here is to define Once these are developed, the team the issue or non-conformance clearly. should brainstorm around these areas to Einstein once said that if he only had determine the possible causes. These can one hour to come up with a solution, he be drawn as shorter lines coming off the would spend 50 minutes thinking about ‘bones’ in the diagram. The approach the problem and 10 minutes about the can be broken down in as much detail as solution itself. This is simply a reflec- is required. For example, if the problem tion of the fact that if you do not know is a short product shelf life we might what it is you are trying to solve it is very identify ‘heat treatment’ under the Fac- unlikely you will solve it. tor that’s called ‘Process’. The next step is to identify the various For each of the factors, the brain storm- factors that may contribute to the prob- ing should continue for the possible lem. In the case of a food manufactur- causes. For example, ‘heat treatment in- ing business these can include systems, adequate’. This may lead to the question equipment, materials, objective factors, why? The team may suggest: human resources and so on. You should draw out these factors from the main ‘No calibration of the ‘temperature spine of the diagram and label each as probe’ indicated in the above illustration. ‘Auto divert is not working’ ‘Set temperature was too low’ Safefood 360, Inc. 2014 Part of Our Professional Whitepapers Series Managing Non-conformance Categories Page 6 Now we are beginning to unravel the to record the Effect and not the Cause. true Cause and not just the Effect This is understandable since the cause (which is the non-conformance). is seldom immediately obvious. On the other hand, the effect is clear and can be Once the diagram has been fully devel- factually recorded for analysis later on. oped the team should analyse it to iden- tify the most likely causes. Further inves- To ensure this system is effective, it is tigation may be required but only now critical that the recording of the effect can the team implement effective actions (non-conformance) is well organised and based on an understanding of the root managed. This requires the following to cause. be in place: Actions may include ‘inclusion of the 1. A well designed system of catego- probe in a calibration program’, ‘increas- rising and recording of non-conform- ing the set temperature point’, ‘imple- ances menting a flow divert check at the begin- ning and end of each shift’. 2. A well designed management pro- cess covering root cause analysis, correc- tive and preventive actions 7 The True Nature of A typical issue is that we don’t record the Non-conformances non-conformances in a clear and organ- ised fashion and we are losing this very Based on the cause and effect analysis valuable information which could be we can now see that most non-conform- used for further analysis.