Questions for Auditing Utilizing a Process Approach
Whether facing a surveillance audit from a certification body or preparing for an internal quality audit – knowing what you face and being prepared puts you a step ahead. Review this checklist which covers the majority of the QMS requirements.
- Who or what are the:
- Process Owner
- Personnel Interviewed
- Documentation Reviewed
- Records Sighted
- What are the resources needed for the process?
- Are these resources appropriate?
- Are authorities and responsibilities for required resources defined, documented and known throughout the organization?
- Are these persons competent?
- Are competency criteria defined? What are these criteria? How is competency evaluated, approved and monitored, and by which method(s)?
- Are these methods effective? – refer to outputs
- Are the resources adequate? Which are they?
- Are records available and appropriately maintained?
- What are the inputs to this process?
- Are these inputs documented and reviewed by competent persons?
- Is a description of the processes available and documented?
- Are these descriptions controlled? – Verify the effectiveness of the organization’s documented information control procedure.
- Who are the “customers” (internal and external) of the processes? What are the requirements of these customers?
- What are the characteristics of the intended results of the process?
- What are the characteristics of the unintended results of the process?
- Are correction and corrective action applied as appropriate?
- What are the criteria for monitoring, measurement and analysis?
- How are these criteria incorporated into the planning of the processes?
- Are the business performance issues taken into proper account?
- What methods are used for data gathering?
- What records are kept and how these are maintained?
- What are the communication channels?
- How is external and internal information about the process provided? What are the outputs of the process? – Identify outputs.
- Do these outputs provide evidence of effective implementation of the process?
- How is process performance monitored?
- Are appropriate controls defined?
- What measurements are applied?
- How is the gathered information analyzed?
- How are the results of the analysis taken into account?
- How is feedback obtained?
- What data is collected?
- Is the issue of improvement of the processes properly addressed? How? What are the results?
Source: Eagle Certification Group – 2017 Annual Bootcamp/Conference
SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest internal quality auditing possible.
Links to Checklists:
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