Before conducting an audit or inspection, you need to define the scope and objectives of the activity. The scope should specify the areas, processes, documents, and records that will be covered by the audit or inspection. The objectives should state the purpose, criteria, and expected outcomes of the audit or inspection. For example, the objective could be to verify compliance with a specific standard, regulation, or policy, or to assess the performance and effectiveness of the FSMS.
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As apart of the "process," specifying the methods for documentation should be explicit. For example, going paperless with all documents, records, and reports that are apart of an audit to ensure 100% error free documentation and digital signatures to show proof of reviews. By paperless, I don't mean using excel but instead a robust document creation and management tool. This tool will allow heads of FSQA teams to easily add automation, to these documents, which will cross reference standards, SOPs, and any rules to ensure accuracy when QA team members are filling them out.
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Good food safety audits need careful planning and smart execution. Use experienced auditors who know about food safety, and focus on areas with higher risks. Have a thorough checklist that matches industry rules and do interviews, watch things in real-time, and check documents. Sort out problems by how serious they are, and work together on plans to fix them with practical timelines. Encourage the team to always make things better, and listen to what everyone has to say. Check back later to make sure things got better and follow the rules. Keep things private, act professionally, and talk openly. Use helpful tools on computers and keep learning about safety.
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From my understanding, it is necessary that before defining the scope, the team, senior management and everyone involved are aware that not only conformities but also non-conformities will be identified and these need to be dealt with in sequence so that the audits have validity and are not a waste of time, people and financial resources. Therefore, in my experience, before scoping, everyone needs to understand and commit to a broader and strategic planning of why the audits will be carried out at that moment, in what scope and with what objective.
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Define the Scope and Objectives: The foundational step in any food safety audit or inspection is to clearly delineate the scope and establish specific objectives. This involves identifying the particular areas, processes, or products to be evaluated, and setting clear goals for what the audit or inspection aims to achieve. These objectives should align with regulatory compliance requirements, industry standards, and internal quality benchmarks to ensure that all critical aspects of food safety are thoroughly assessed.
The audit or inspection team should consist of qualified and competent personnel who have the relevant knowledge, skills, and experience in food safety and auditing or inspecting. The team should also be independent and impartial, meaning that they should not have any conflict of interest or bias towards the auditee or the inspected entity. The team should also have good communication and interpersonal skills, as well as the ability to collect and analyze evidence, report findings, and provide recommendations.
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A cross-functional team trained in auditing makes for the best audit team. For example, having operations, quality, regulatory, purchasing, industrial health and safety, and even accounting and HR take part in walking the production floor for regular inspections. You don't need everyone, every time, but the benefit is that different people will observe different things and therefore you will get more value of the time spent on the audit or inspection.
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??Selecting a food safety audit team includes several steps: 1?? Determine the qualifications and experiences required for team members based on the scope of the audit. 2?? Look for individuals with relevant backgrounds in food safety and auditing. 3?? Review resumes, certifications (such as HACCP, ISO 22000, etc.), training records, and past audit experiences to evaluate candidates. 4?? Interview chosen candidates to assess their understanding of food safety principles, auditing approaches, communication skills, and ability to work effectively in a team. 5?? Aim for a diverse team with varied experiences to cover different aspects of food safety. 6?? Continuously monitor the team's performance during and after the audit process.
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Its very important to select people that have excellent background and well training in audit. taking in account their experience in Auditing, food safety, GMP, HACCP and ISO.
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A cross-functional audit team, adept in various domains, is paramount for conducting comprehensive inspections. This team should include members from operations, quality, regulatory, purchasing, industrial health and safety, and even accounting and HR. Their diverse perspectives will enhance the audit's efficacy. Selecting this team involves several meticulous steps: identifying necessary qualifications, seeking individuals with pertinent food safety backgrounds, scrutinizing resumes , interviewing candidates to gauge their comprehension of food safety principles , and ensuring a heterogeneous team to address all aspects of food safety. Continuous performance monitoring during and post-audit is essential for sustained efficacy.
The audit or inspection plan is a document that outlines the details of the audit or inspection process, such as the schedule, duration, methodology, checklist, sampling plan, and reporting format. The plan should be based on the scope and objectives of the audit or inspection, as well as the available resources and information. The plan should also be communicated and agreed upon with the auditee or the inspected entity in advance, to ensure their cooperation and readiness.
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In addition to what has already been described, the plan must have clear and simple communication so that everyone involved has an understanding of how the stages of the plan will occur. It cannot interfere with the company's routine processes so that everything can be verified with the guarantee of the veracity of execution of the audited processes.
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One thing I find on how to make audit easier for your team is when the checklists are separated into departments and the clauses involved for each are indicated
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Prepare the Audit or Inspection Plan: Prior to the actual site visit, develop a detailed audit or inspection plan. This plan should outline the logistics of the audit, including the schedule, the specific areas and processes to be examined, the criteria against which they will be assessed, and the tools and methods that will be used. Effective planning is essential for ensuring that the audit is conducted efficiently and comprehensively.
The audit or inspection should be conducted according to the plan, following the relevant standards, guidelines, and procedures. The audit or inspection team should collect and evaluate evidence from various sources, such as observations, interviews, documents, records, and tests. The team should also document their findings, noting any strengths, weaknesses, opportunities, or threats in the FSMS. The team should also provide feedback and clarification to the auditee or the inspected entity throughout the audit or inspection process.
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??To conduct the audit: ??Conduct a complete inspection of the facility, including processing areas, production areas, and storage facilities. ??Use audit checklists to collect the data & your observations. ??Verify compliance with food safety regulations, sanitation protocols, pest control measures, and allergen management procedures. ??Interview staff to evaluate their knowledge of food safety practices & their role in maintaining a safe food environment. ??Review documentation and records to ensure accuracy, completeness, and adherence to established protocols. ??Identify non-conformities or areas for improvement based on the audit findings. ??Suggest recommendations for corrective actions to address identified non-conformities.
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Conducting a food safety audit demands meticulous planning. Start by defining audit objectives and scope. Develop a checklist aligned with relevant standards. During the audit, engage with personnel, observe processes, and review documentation. Maintain transparency, allowing open communication with auditees. Utilize technology for efficiency, ensuring a comprehensive evaluation. Post-audit, provide constructive feedback, emphasizing compliance and improvement opportunities.
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Conduct the Audit or Inspection: During the actual execution of the audit or inspection, team members should systematically collect data, observe operations, interview staff, and review relevant documentation to assess compliance with food safety standards. It is important for auditors to remain impartial and focused, methodically gathering evidence without disrupting the normal operations of the facility.
The audit or inspection results should be reported in a clear, concise, and accurate manner, using the agreed upon format and criteria. The report should include the scope, objectives, methodology, findings, conclusions, and recommendations of the audit or inspection. The report should also highlight any non-conformities, deviations, or corrective actions that need to be addressed by the auditee or the inspected entity. The report should also be reviewed and approved by the appropriate authorities before being distributed to the relevant stakeholders.
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It is important that all parties understand the report so that the results of the audits can be treated appropriately and not provisionally, resulting in an improvement in processes, making them robust, consistent and suitable for product safety.
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Reporting audit results is a critical aspect of ensuring food safety. Craft a detailed report outlining findings, observations, and compliance levels. Clearly communicate strengths and areas for improvement. Prioritize clarity and transparency in language, facilitating understanding across diverse stakeholders. Include actionable recommendations and timelines for corrective actions. Encourage collaboration between auditors and auditees to foster continuous improvement in food safety practices.
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Report the Audit or Inspection Results: Following the completion of the audit, compile a detailed report that summarizes the findings, highlights any non-compliances or areas of concern, and provides actionable recommendations for improvement. The report should be clear, objective, and constructive, facilitating understanding and action by the management of the audited entity.
The audit or inspection actions are the steps that need to be taken by the auditee or the inspected entity to resolve any non-conformities, deviations, or corrective actions identified by the audit or inspection team. The actions should be implemented in a timely and effective manner, following the agreed upon deadlines and responsibilities. The actions should also be monitored and verified by the audit or inspection team, to ensure that they are completed and effective. The audit or inspection cycle should be closed once all the actions are satisfactorily implemented and verified.
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This is a step that defines the real objective of an audit or inspection, which are the actions that need to be taken by the auditee to resolve/address the non-conformities, deviations or corrective actions identified, these are the actions that validate the audit process/ inspection.
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Follow up on the Audit or Inspection Actions: Post-audit follow-up is crucial to ensure that the necessary corrective actions are implemented. Set a timeline for these actions and monitor compliance to ensure that all issues are addressed. Further evaluations may be needed to verify that the implemented changes have effectively resolved the issues identified during the audit.
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Lots of insights are shared already. I would add that a refresher to self on the standards/criteria to be audited against is essential and I would definitely consider that weeks ahead of my planning if I will be part of the audit team. This gives guidance and boost that confidence when executing the audit.
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Whether you are performing internal audits, supplier audits, or third party audits it can be useful to have software to manage and organize audits. Software can help keep records digital while managing schedules, auditors, and compliance. Audit software can also help you generate and automatically follow-up on Corrective Actions Reporting. Using a digital solution for audit management can also bring trend analysis and risk management capabilities to your audit team.
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From a food safety quality expert's perspective, thorough preparation and leveraging technology are vital for effective audits. Refreshing knowledge of standards and criteria well in advance enhances confidence during the audit. Utilizing digital checklists and audit management software improves data accuracy and efficiency. Cultivating a culture of continuous improvement and providing regular training on food safety regulations ensure proactive compliance and audit readiness. This comprehensive approach guarantees meticulous and effective audits, reinforcing the organization's commitment to food safety.
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