y nye = Free Resource ISO 22000:2018 Food Safety Management System Course Section 7: Performance Evaluation & Continual Improvement Performance evaluation (Clause - 9) This Clause - offers requirements on assessing the performance of the food safety management system. This Clause - encompasses main areas of evaluation which are as under: + Monitoring, measurement, analysis and evaluation + Internal audit + Management reviewsy myles = Free Resource Overview of Clause - 9 In Clause — 9, evaluation of the system performance is addressed. It is divided in 3 sub-clauses: Monitoring, measurement, analysis and evaluation is new and forces the food organization to define what and when monitoring and measurement should take place and how, when and who must analyze and evaluate their results Within Internal audits the importance of taking in consideration changes in the FSMS and the results of monitoring and measurement when defining the audits program has been introduced. It also states that there is a duty to report the audit results to the food safety team and relevant management, and that internal audit should check compliance of the FSMS against food safety objectives and policy Management review has undergone some changes, especially in the inputs. Internal and external issues, business context, risk and opportunities must also to be considered as inputs. Regarding the outputs the main thing is the inclusion of any decisions regarding changes in the system.y The Free Resource Monitoring, measurement, analysis and evaluation (Clause - 9.1) The organization must develop, apply and carry on different processes needed for monitoring, measurement, analysis and evaluation of its FSMS. Measurement is the allocating numbers to performance events or objects. It is related with performance evaluation and can be extracted from use of verified or calibrated equipment for example measured temperature of a chicken during roasting process. Monitoring is done to confirm the status of the process if it is compliant or non-compliant, it can be based on testing results related to food safety (for instance checking frying temperature against the acceptable range); assessment of documented information for example records, and can involve identifying the alarming status so that deviation from performance level can be recognized. Analysis is covered with consideration of data to discover patterns, relationship and trend. It is related with measurement events. It is also defined as the “A systematic examination and evaluation of data or information, by breaking it into its component parts to uncover their interrelationships. Opposite of synthesis. (Source: Business Dictionary Read more: http://www. businessdictionary.com/definition/analysis.html) Evaluation is defined as “Rigorous analysis of completed or ongoing activities that determine or support management accountability, effectiveness, and efficiency. (Source: Business Dictionary Read more: http://www. businessdictionary.com/definition/evaluation.html) Evaluation is also defined as “the process of checking an inspection or process output measurements against given established criteria to identify the performance of the process or conformity of a process output”.y Tighe Free Resource General (Clause - 9.1.1) The management must identify: A) What requirements to be monitored and measurement. Following issues can be taken care under this cause 1. The extent to which legal and other requirements are complied 2. Activities and processes concerned with recognized food safety hazards, associated risks and opportunities 3. Improvement towards attainment of the management's food safety objectives 4. Impact and efficiency of operational and other controls B) Methods for measurement, monitoring, analysis and evaluation of performance, as relevant, to make sure valid results. Measurement: It is the activity of delivering data to a method so as to state impartially a quantitative or qualitative measure. It is actually a performance capturing tool without any criterion of acceptability on its own. There can be different be different ways employed to measure, monitor, analyze and evaluate. Depending on the processes, food organizations utilize various measuring devices like pressure gauges, thermocouple, and humidity meter to measure the values of critical controls. Whereas for management system processes, food organizations use different subjective measuring tools for instance to measure the level of customer satisfaction, employee satisfaction different survey forms are used., nye = Free Resource Monitoring: Measurement alone is not enough, organization has to monitor the measured values and check if the values are coming in acceptable range. Monitoring means measurement has to be done at specified interval or there is a rational for measurement frequency on samples of a lot. If the values are not within the acceptable range they have to apply control of non-conformance and corrective action procedures to address the nonfulfillment of a process or management system requirement. Control charts are used to monitor process values. Analysis: It helps organizations to study relationships, trends and tendencies of a measured output. Monitoring alone is not enough, once food organization has monitored the measured values, analysis is done to study why the process is yielding such values and what are the input variables that change the output. Analysis is also done on any nonconformance to address the causes. So as to take corrective action as discussed in Clause - 10.1. There are different tools for analysis, for example fish bone analysis tool and the scatter diagram tool. Evaluation: It is the process of checking the process or product performance against established criterion. It is due to evaluation that a deviation from acceptable range is identified and then changes are made into the process, equipment or system in order to produce acceptable outputs, nye = Free Resource C) When the monitoring and measuring must be performed All those processes, product checkpoints or quality gates must also be identified with a defined frequency of interval. For instance an organization who sells fried chips can define that temperature of frying for every lot of chips being fried in the ovens will be measured and monitored. Temperature of frying is the measurement, and repetition of measurement in every lot is monitoring. D) When the results from monitoring and measurement must be analyzed and evaluated The data collected from measurement and monitoring should be analyzed and evaluated at defined interval. So for instance organization can define analysis and evaluation will be done after frying of each lot. For example the inspection monitors the control chart which shows the temperature of frying oven is shifting its process mean towards the lower zone of acceptable level, analysis should be done what has gone wrong. Evaluation is the results of measurement and monitoring is acceptable or not. E) Who must analyze and evaluate the results from monitoring and measurement. After the food organization has defined the frequency or interval of analysis and evaluation, it also important that this responsibility of analyzing and evaluation should be assigned to specific qualified personals in organization for example QA officer. The food organization must retain suitable documented information as evidence of the results of monitoring, measurement, analysis and evaluation. The organization must also evaluate the performance and the effectiveness of the FSMS., nye = Free Resource Analysis and evaluation (Clause - 9.1.2) The food organization must analyze and evaluate appropriate data and information arising from following: 1. Monitoring and measurement 2, Results of verification activities related to PRPs and the hazard control plan 3. Internal audits 4. External audits Methods to analyze data can also include statistical techniques. The analysis must be carried out to achieve following: a) Confirm that the overall performance of the system meets the planned arrangements and the FSMS requirements established by the organization b) Identify the need for updating or improving the FSMS c) Identify trends which indicate a higher incidence of potentially unsafe products or process failures d) Establish information for planning of the internal audit programme related to the status and importance of areas to be audited e) Provide evidence that corrections and corrective actions are effective.Crles Free Resource The results of the analysis and the subsequent activities must be kept as documented information. The results must be stated to top management and utilized as input to the management review (Clause - 9.3) and the updating of the FSMS (Clause - 10.3).y nye = Free Resource Internal Audits (9.2) ISO 22000 mandates the standard’s prospects of management to execute internal audits with in their food organization. The standard expects that the internal audit must meet the designed arrangements of the food safety management system, and the outputs must be made presentable to top management and related personals. The internal audit plan must be well scheduled and developed with thorough understanding of the system scope. The plan should be developed on the outcomes of both aspect impact analysis and former audit reporting. While most of this seems workable, resembling numerous clauses in ISO 22000, the internal audit should be opted more vigilantly than its comparable standard of ISO 9001 (quality management system). The justification of serious internal audits is simple: Nonproductive internal audits in food safety system can threaten the organization’s reputation and can lead to a ban by regulatory bodies. Quest for professionals: Thus, in this situation, how can we make sure that the internal audit function is as effective as it can be, and that the resultant actions safeguard the food safety of the workforce? Learn how to carry out management system audits by another detailed free online course based on ISO 19011: hitps://alison.com/course/iso- management-system-audit-techniques-and-best-practicesy nye = Free Resource Internal audit Program The top management or delegated personals must: a) Plan, develop, apply and carry on an audit programme together with the rate of occurrence, techniques, responsibilities, consultation, planning needs and reporting, which must take into account the significance of the related processes and the results of former audits b) Outline the criteria of audit and its scope c) Choose auditors and perform audits to make sure objectivity and the non-biasness of the audit process d) Make sure that the results of the audits are informed to concerned managers; make sure that concerned audit results are reported to relevant employees, and food safety team ) Take measures to remove nonconformities and continually improve food safety performance £) Keep documentation as proof of the application of the audit program and the results g) Confirm if the system meets the intent of FSMS policy and objectives The management should have designed internal audits at consistent intervals when conducting the management review. The outcomes of hazard analysis and critical control point, customer input and complaints, risk and opportunities, verification activities can and should be utilized to plan an internal audit. The internal audit should be performed at “scheduled intervals,” or when additionally seems mandatory or helpful to ISO 22000 system., nye = Free Resource Who: The standard says that the choice of the auditor must make sure “impartiality and neutrality.” The delegation of the auditor is serious. Noticeably, the auditor must have knowledge, work experience and a recognized training, and be extremely conscious of the food safety policy, objectives, and related performance. Many organizations consider external advice from proficient personals for internal audits. This shows internal audit is the critical process. How: the internal auditor must have all applicable info in hand, as “input” to the audit process. Hazard analysis and critical control points, prerequisite programs, food safety performance results, stakeholder inputs, and food safety objectives will all be needed by the auditor. The internal auditor should also have access to the elements of evidences within scope of the audit. Numerous different audit documents can be sought before commencement of audit. Management should choose the type and depth of internal audit that fulfills organization’s requirements best., nye = Free Resource Why Internal Audits? Along with being a standard requirement under ISO 22000, the internal audit should be considered as a key power in the continual improvement process and an immensely significant pre-emptive measure for avoiding food safety outbreaks. So, those involved in communication with the auditor should endeavor to render correct and honest information during the progression of the audit. “Objectivity and neutrality,” along with truthful assessment should equate the prospect for candid evaluation and recommendations for enhancement, founded on historic and present data.y myles = Free Resource Reporting of Internal Audit Results The ISO 22000 standard says that the results of any internal audits should be presented to concerned management, food safety team and leadership. As such, choices of improvement can be opted by the top management on measures that should come as outputs from the internal audits. On the other hand, it is also helpful in terms of continual improvement if the auditor makes recommendations on the base of the audit itself; given that auditor have had more direct communication and involvement with the process and ways throughout the audit. In this manner, the management will have more comprehensive view of the efficiency of the audit and the legitimacy of its results, causing ina better prospect of continual improvement and output that avoids possible emergency situations Documenting this audit process, together with the outcomes, results, and measures, is clearly a requirement of ISO 22000., LCE Free Resource Auditable Requirements of the Standard Remember, the internal audit will check capability of food organization to fulfill the needs of the standard. Except Clause - 1 to Clause - 3, all clauses of the standard are auditable. Make sure your organization have encountered all requirements of the standards, together with management review, hazard analysis and critical control, pre-requisite programs, operation controls, control of nonconformities and emergency planning and response. Consider that Non-conformity will be communicated and corrective action process will be used to correct some recognized non- conformities.y nye = Free Resource Management reviews (Clause - 9.3) Standard necessitates reviews of the food safety management system’s appropriateness, suitability and usefulness of the FSMS to be carried out by top management at premeditated interims. Management reviews are the prospect for esteem management to analytically and systematically gauge the performance of the food safety management system to determine if it continues to be: Appropriate: Does the management system suitable with the food organization, its process, its values and business systems Satisfactory: Is the management system applied properly? Usefulness: Has the management system attained its planned results?y The Free Resource The management review should review the following: + The status of actions from preceding management reviews + Variations in internal and external issues that can influence on the food safety management system for example risks and opportunities, the requirements and expectations of appropriate interested parties, legal and other requirements + The sufficiency of resources for carrying on an effective food safety management system + Applicable dialogue with internal and external interested parties + Prospects for continual improvement, myles = Free Resource The reviews should also involve information on the food organization's food safety performance including developments in: 1. The fulfillment of food safety objectives 2. Incidents, nonconformities and corrective actions 3. Measurement and monitoring 4. The assessment of compliance with legal and other requirements a . Internal and external audits 2 . Risks and prospects for opportunities n . Results of system upgrading activities (Clause - 10.3) 8. Analysis of the results of verification activities related to PRPs and the hazard control plan 9. Customer and regulatory inspections 10. Performance of external providers and suppliers 11. Any emergency situation, incident, or withdrawal/recall that occurred, myles = Free Resource The management reviews should be done on a consistent basis such as: 1. Quarterly 2. Semi-annually 3, Annually Fractional management reviews of the performance of the food safety can be done at more regular intervals, if needed. The management review procedure should not just assess historical trends but should want to improve the food safety performance of the food organization through the commencement of enhancement actions.y nye = Free Resource Decisions that should be taken at the end of the management review course relate to: 1. The effectiveness of the food safety management system in having its planned results 2. Areas for continual improvement 3. Any requirement for modifications to the food safety management system 4, More resources required 8. Other actions required 6. Opportunities to advance the integration of the food safety management system with different business processes for instance quality, health and safety and business continuity. 7. Any impacts on the strategic direction of the food organization.y nye = Free Resource Improvement (Clause - 10) The first thing that is noticeable when comparing Clause - 10 i.e. Improvement (2018 version) versus Clause - 8.5 i.e. Improvement (2005 version) is that there is a new sub-Clause - which addresses nonconformity and corrective action. There is now clear guidance for the steps to take when nonconformity occurs. The management must identify opportunities for improvement and apply mandatory actions to attain the planned results of its food safety management system., nye = Free Resource Nonconformity and corrective action (Clause - - 10.1) Product non-conformities with their correction, disposal, handling and recall/withdrawal are already discussed in the course as per Clause - 8.9 of the standard. This Clause - 10.1 focuses on management system related nonconformities in particular and has generic requirements for nonconformity and corrective action just like other standards for example Quality Management System ie. ISO 9001. The management must develop, apply and carry on processes, together with investigation, report preparation, and taking measure, to identify and manage incidents and nonconformities. When an incident or a nonconformity exists, the management must: Respond ina time oriented way to the incident or nonconformity and, as relevant: o Take measure to manage and correct it © Cope up with consequences, The Free Resource Assess, with the involvement of employees and the participation of other appropriate interested parties, the requirement for corrective action to eradicate the root causes of the nonconformity, so as to it does not happen or exist elsewhere, by: 1. analyzing the incident or assessing the nonconformity 2. identifying the reason of the nonconformity or incident 3. identifying if same incidents have reported, if nonconformities is present, or if it can happen potentially The food organization is required to take actions to address nonconformities if needed. If required the organization can make changes in the food safety management system to prevent nonconformity occurring again., myles = Free Resource The management must retain documented information as proof of: 1. The status of the nonconformities any following measures taken 2. The outcomes of any measures and corrective action, with measured effectiveness. Level of Investigation The extent of investigation for nonconformity is proportional to the extent of its impact on food safety performance or on management system. The nonconformity should be documented and presented internally and reported externally were appropriate to regulatory bodies. Who will investigate? Where applicable, the investigation should be performed by an individual not dependent on the activities being analyzed., nye = Free Resource Continual improvement (Clause - 10.2) The management must continually improve the relevancy, sufficiency and effectiveness of the food safety management system. 16.jpg Top management must make sure that the food organization continually improves the effectiveness of the FSMS through the use of following: © Communication (Clause - 7.4) o Management Review (Clause - 9.3) o Internal Audit (Clause - 9.2) o Analysis Of Results Of Verification Activities (Clause - 8.8.2) © Validation Of Control Measures (Clause - 8.5.3) o Combinations Of Control Measures (Clause - 8.5.3) © Corrective Actions (Clause - 8.9.3) o FSMS Updating (Clause - 10.3), nye = Free Resource Some of continual improvement prospects involve, but are not restricted to following : 1. Incorporation of latest technology 2. Good work practices that may rise internally in the food organization or externally to the organization 3. Proposals and advise from interested parties 4. Acquiring latest knowledge and comprehension of food safety issues 5. Better supplies or better use of materials 6. Working on workers’ competence Attaining better performance with minimized resources, nye = Free Resource Idea of Continual Improvement The idea of continual improvement is referenced in all management systems founded on Annex SL for example ISO 9001 (https://alison.com/course/iso-90012015-fundamental-concepts) and of course ISO 45001 (https://alison.com/course/iso-45001-2018-principles- of-occupational-health-and-safety-management-systems ). Measures which an organization might take with a perspective to gain continual improvement in the appropriateness, relevancy and effectiveness of its food safety management system involve: 1. Improving food safety performance 2. Enhancing a culture that renders support to the FSMS 3. Encouraging the participation of employees in the recognition and application of measures for continual improvement of the FSMS 4. The appropriate results of continual improvement 5, Maintain and keep documented evidence as proof of continual improvement, myles = Free Resource Update of the food safety management system (Clause - 10.3) Top management must make sure that the FSMS is continually updated. Top management must assign food safety team to evaluate the FSMS at planned intervals. The team must consider whether it is vital to review following: o Hazard Analysis (Clause - 8.8.2) o Established Hazard Control Plan (Clause - 8.5.4) o Established PRPs (Clause - 8.2) The management system updating activities must be based on: a) Input from communication, external as well as internal (Clause - 7.4) b) Input from other information concerning the suitability, adequacy and effectiveness of the FSMS c) Output from the analysis of results of verification activities (Clause - 9.1.2) a) Output from management review (Clause - 9.3)y myles = Free Resource System updating activities must be retained as documented information and reported as input to the management review (Clause - 9.3). Some of the examples modifications to the food safety management system are listed below: . Updating food safety policy 2. Updating a process flow map 3. Revising a procedure to add additional controls 4 . Updating Hazard analysis and critical control point = Modifying the critical control limit based on severity and occurrence ey . Modifying the OPRPs nN . Reengineering or changing machinery or tools 8. Establishing and applying procedures or enhancing processes 9. Increasing inspection sampling plan for a critical process 10. Modifying the maintenance frequency of equipment