Title Page
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Audit date :
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Audit reference :
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Auditor :
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Auditee :
Mandatory Audit Questions
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Are procedures being audited meeting the requirements of the where applicable e.g., ISO 9001:2015 and customer-specific codes of practise?
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Are documents accessible and readily available on the master register?
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Are documents in use the correct revisions?
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Have the relevant staff been trained on these documents?
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Are training records up-to-date with the current documents?
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Previous Audit Reviewed?
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Any NC Raised in Previous Audit Closed?
Audit Specific Questions
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Does the organisation seek to continually improve & enhance customer requirements and customer satisfaction – how is this achieved
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Evidence :
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Does the organisation have a system in place to improve products and services to meet requirements – e.g investing in latest technology and innovation, improving reliability, improving yield, reducing cost, and improving on-time delivery
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Evidence :
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Improving the performance and effectiveness of the QMS by acting on process performance results,
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Evidence :
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Is there evidence that quality system documentation is revised & updated
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Evidence :
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Have any changes occurred in the production process since last audit & is there evidence that documentation has been updated & implemented
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Evidence :
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Is data used to develop improvement opportunities
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Evidence :
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Does the organisation monitor underperformance of the management system
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Evidence :
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Is data analysis and evaluation used to identify continuous improvement & improve the performance and effectiveness of the QMS
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Evidence :
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Are improvement systems planned
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Evidence :
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Does the organisation measure the effectiveness of processes / QMS improvements
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Evidence :
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Does it in turn improve the organization’s overall performance, efficiency, and effectiveness
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Evidence :
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Are changes documented properly according to the documentation requirements.
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Evidence :
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Where improvements are affected reactively through corrective actions is improvement realized
- Compliant
- Non-Compliant
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Evidence :
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Is root cause analysis used in correcting, preventing or reducing undesired effects
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Evidence :
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Is there evidence that the organisation acts on customer feedback and/or in service reports
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Evidence :
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Are audit findings reviewed & understood
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Evidence :
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Is there a document procedure for managing non-conforming products
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Evidence :
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Does the procedure include the requirement for staff to identify & report potentially non-conforming product
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Evidence :
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Is there clear identification of non-conforming product
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Evidence :
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Are defined responsibilities for making final decisions on use, reworking, use by concession etc at the appropriate level
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Evidence :
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Are records available showing decisions made
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Evidence :
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Is there a document procedure for the handling & correcting identified failures
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Evidence :
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Is there clear documentation of the non-conformity
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Evidence :
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Is immediate action [correction] taken to eliminate a detected nonconformity or defect taken
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Evidence :
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Does root-cause address the nonconformity
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Evidence :
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Is there evidence that the action relates to the address the identified root-cause
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Evidence :
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Has responsibility for the necessary action been identified
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Evidence :
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Is appropriate timescale for corrective action determined
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Evidence :
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Is there evidence that the proposed action was actually implemented
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Evidence :
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Is there evidence that the action was effective in preventing recurrence of the problem
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Evidence :
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Is there evidence that the necessary systems, policies, practices and procedures to prevent recurrence were updated & retraining completed
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Evidence :
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Does the organisation monitor effectiveness of corrective actions
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Evidence :
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Do management review meetings attended by senior management include review of incidents, corrective actions & non-conforming materials
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Evidence :
Opportunity For Improvement
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Number of OFI raised :
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Details
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Have the OFI details been added to HubSpot
Non-conformance
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Number of Non-conformances raised :
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Details
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Have the Non-conformance details been added to HubSpot