How can you ensure your quality audits align with relevant standards and frameworks?

Adding SMART objectives into the quality audit process enhances the audit's effectiveness, increases its impact on improvement, adding a example: Specific: Conduct an audit of the manufacturing process to identify and document potential sources of contamination in the next 2 months. Measurable: Reduce the defect rate at X line by15% within 5 months following the audit. Achievable: Identify and implement process improvements based on audit findings that require no more than a 10% increase in allocated budget Relevant:Audit dispatch process to ensure compliance within the new standards introduced as part of QIP Time-bound:Complete a comprehensive audit of all procedures in the packaging department within 6 weeks from the audit initiation date

Rather than depending on Quality Audits thrust to be given on Quality Assurance and processes to be developed which ensures Quality Assurance rather than Audit, with advancement of Technology this is possible

You need to understand the SIPOC of a process and understand the CTQs and CTCs so that your audit standards meet the end goal of the service and also has compliance as a part of it.! Define a robust plan in sampling depending on the product, industry you support. At the end, the audit process should be aligned to the business goals.

Every auditor must be certified. Each improvement point should be agreed by auditee. No forceful agreement. Top leadership is must in opening and closing meeting. All observations to be shared at end of audit, no point to be pending.

Before conducting audit you should set your direction first, you should ask your self if you need to conduct audit as an improvement tool, customer requirements, complying with legislation and statutory or to ensure that you can mitigate different types of risks in your organization?. As well you must take into consideration that whatever the scheme that will be audited you should pay more focuse on the most important factors in the audit as you should ensure that you have a competent auditors, trained audittees, effective running system, will established communication chanels and first of all, top management commitments all those mentioned factors are cruisal factors to make your audit effective and value added.

There is a method to selecting your audit frameworks and standards. Start by performing a thorough analysis of your sector, legal requirements, and organizational objectives. Make use of resources like regulatory frameworks, industry-specific guidelines, and ISO standards as references. Prioritize those that are most in line with your organization's goals and how its operations are structured. You can choose the best standards and frameworks to effectively direct your quality audits by carefully weighing these factors.

To ensure that quality audits align with relevant standards and frameworks, we can follow a structured approach that involves the following steps: ? Familiarize yourself with Standards and Frameworks ? Define audit objectives and scope ? Create audit checklists ? Bring together a competent audit team ? Develop an audit plan ? Conduct the audit ? Document findings and observations ? Report and communicate findings ? Implement corrective actions ? Continuous improvement ? Stay updated ? If required seek external validation By following these steps, we can ensure that quality audits remain aligned with relevant standards and frameworks, contributing to the overall improvement of the organization's quality management system.

Site should have a competent person with respect to regulatory affairs in each department. This will help in conducting a robust internal audit framework within the organisation to achieve the relevant standard audit. Internal audit will play a key role to assess the compliance of the department.

Identify choose aligne and always close the loop ! Identify your audit objectifs, make sure they are aligned with your organisation’s strategy and then you can choose international standards and frameworks that meet your goals ( international means you can have an impact worldwide ) Now you can use these specific tools , they are recognized as effiscient ones in terms of continuous improvment( SMART PDCA …:) and finally make sure you close the loop.

Ensuring this aligns to the overall quality strategy for the business. When considering the potential regulatory standards make sure you consider ALL those which may be impacted in the foreseen business strategy. e.g. which markets are supplied, purchased from etc

Your audit team should not only be trained in auditing mechanisms and processes, but also have a good understanding of the systems and processes being audited. This is essential if the audit is to add value for all stakeholders.

Assure that those performing the auditing activities are trained and competent, or if this is part of training make sure this is acceptable to the auditees

Ensure that clear strategy is established to ensure that proper work products are chosen for the purpose of audit. The audit plan should be consistent with upcoming releases and customer expectations.

Audit Team: in case of internal quality audit, make sure there is no conflict of interest, any audit member/team not involved in auditing their own work or same department work. Good to have impartiality declaration record signed as document evidence by audit team in place before start of audit I have seen above issue usually in startup companies.

Trust your senses. Use all you senses where possible to collect and document your evidence. For example, listen to people or sounds, watch behaviours or work flows, pay attention to odors, touch surfaces where permissible to feel for anything that should or should not be present, and if in a food company ask to participate in taste test. Your senses can collect vast data than only listening and watching.

Do not forget 4 Cs of Documentation Review (Verification): as per ISO 19011:2018 1. Complete 2. Correct 3. Current 4. Consistent a) complete (all expected content is contained in the documented information); b) correct (the content conforms to other reliable sources such as standards and regulations); c) consistent (the documented information is consistent in itself and with related documents); d) current (the content is up to date). It should also be considered whether the information being verified provides sufficient objective evidence to demonstrate that requirements are being met

It is very important that the personnel responsible for the areas being audited are available. As a QA professional your job is to perform the audit (the necessary resource). It has been my experience that the appropriate personnel do not have the audit "in their schedule". There were several times where other personnel were sent to cover for a specific area and were unable to provide objective evidence resulting in a finding. I also found that had the appropriate person made themselves available, the finding would never had been issued. Try not to wait until the closing meeting to "Finish" the auditing process.

Compliance audit first, that is compare & make sure the procedures you created align with standards. Then continue with Implementation Audit to check wheter your implementations align with procedures and are effective to achieve the purpose of the standards.

Prior to commencing the audit, it is essential to request records from the auditee. These documents could include: Relevant management system documents and records Site master file Registers Standard Operating Procedures (SOPs) Previous audit reports Records of the company regarding complaints and recalls While reviewing the auditee's documentation, it is advisable to check our checklist and outline the key points to confirm during the inspection.

previous audit findings (if audit(s) were conducted before) are very crucial, there is no need to conduct several audits if the previous audit deficiencies or con-conformances were not completely addressed and closed. when making an audit plan to ensure that confirmation of closure of previously identified deficiencies is part of the plan.

The very simple answer is that implementing an effective internal audit program in the company by a properly trained & competent internal audit team according to the relevant standards.

Se você é um líder de auditoria, sempre anote pontos relevantes de todos os requisitos do plano (ainda os que outros auditores membros auditar?o), pois pode precisar de complemento para o relatório.

After conducting an audit and nonconformances were not observed that's a great thing, cool. However, if some nonconformances were observed, a (corrective and preventive action plan)CAPA plan should be established to ensure that all observed nonconformances are closed. this is important as it beefs up the continual improvement ideology.

Some lack of commitment in here. Many companies do the audit program in last minutes before audit by certification body, so the verification sometimes not deep enough, just mention "close" on the statement without verify the effectiveness of actions taken.

Establish a continuous improvement feedback loop post-audit. Gather insights from audit findings to refine processes continually. Prioritize root cause analysis for non-compliance. If a specific area consistently falls short of quality standards, conduct a thorough analysis to identify underlying issues. Ensure timely communication and reporting of audit results. If deviations from standards are identified, swift communication enables prompt corrective measures. Promote cross-functional collaboration for solutions. After an audit, convene a team comprising designers, manufacturing experts, and quality control personnel. Implement KPI's monitoring. Regularly track and analyze KPI's related to quality.

The real key for success of any quality audit starts with understanding first the type of business that you are going to audit so you understand the business challenges, key risks, opportunities. Then you can fine tune the audit agenda to really deep dive on the aspects that would support the audited business. Otherwise it will be to theoretical and not really adding any value

Update any risk score of the audited area / facility / entity with the outcomes and plan the next auditing date accordingly. This may be sooner if issues are found. Make sure any consequent decisions e.g. reduced testing strategies are documented

Use a qualified audit team.?The audit team should be composed of qualified and experienced auditors who are familiar with the relevant standards and frameworks. Be objective and independent.?The audit team should be objective and independent of the areas being audited. Be documented.?The audit process and findings should be well-documented. This will help to ensure that the audits are conducted consistently and that the findings are accurate and verifiable. Be continuous.?Quality audits should be conducted on a regular basis to ensure that the organization is maintaining compliance with the relevant standards and frameworks and that it is continually improving its quality performance.

In my experience the audit checklist can be used as an effective tool to ensure the scope of the audit is covered. For each question in the audit checklist, you should add the reference of the regulation or exposition that the requirement was derived from. This makes it very easy for the auditor to verify all the requirements have been covered in the checklist and to clearly demonstrate to the auditee, where the requirements are coming from. This helps to enhance the communication during an audit and maintain objectivity. Whenever the regulation is amended, updating the checklist becomes a simple and quick process.

In case of no co-operation of Auditte , stop auditing activities & inform auditee that you will not complete audit unless Auditte is cooperating & willing to answer questions & bring required audit objective evidence of records & forms etc. Believe me it worked with me.