Title Page
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Site conducted:
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Conducted on:
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Prepared by:
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Interviewed:
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Signed off by:
Internal Audit questions
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Interviewed
7.0 Support
7.1.3 Infrastructure
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How do you determine, provide, and maintain the infrastructure for the operation of process to achieve products and service conformity?
7.1.4 Environment for the operation of process
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Working areas - do personnel have the required working documents and process guidance documents to carry out their duties effectively?
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When or if staff have grievances, do they know whom they can turn to for further assistance?
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is there a 6s process present and followed?
7.1.5 Monitoring and measuring resources
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Is the approved asset list up to date, which Identifies the status of all plant and Equipment?
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Is equipment up to date with calibration (view few measuring instruments and certificates)
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Is there a clear responsibility for calibration process?
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How is calibration organised?
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How do you determine the validity of previous measurements if you find an instrument to be defective during verification or calibration? What appropriate actions can you take?
7.2 Competence
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Are the skills matrixes / records maintained and up to date (including new personnel?)
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Are training records for temporary staff maintained and up to date?
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Are the external contractor permits retained?
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Is there a clear process for keeping and maintaining training records?
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Are there any forms / training records for new starters?
7.3 Awareness
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Do members of staff on the shopfloor have a basic understanding of ISO9001 and how it effects the business?
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Is there a copy of the policy available for staff?
7.4 Communication
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How is the organisation's policy communicated with staff?
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Is staff aware of the policy?
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How does facility communicate any changes that would affect staff and other stakeholders?
7.5.1 Documented information - General
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How documents are stored and controlled?
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Is there a retention time for specific documentation? - HR records?
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IS the retention time being followed?
7.5.2 Documented information - Creating and updating
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IS there a procedure for updating and creating new documents?
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How are the upates communicated?
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7.5.3. Documented information - Control of documented information
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How documents are controlled?
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Who is responsible for the the controlled of the documents
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Are there revisions in place?
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How documents are protected from any unapproved changes?
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How do you identify appropriate and how do you control documented information of external origin, which the facility determined as necessary?
Any other comments - additional NCR or OFI (if more than 1 raised for a section)
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Please add NCR details to notes
8.0 Operation
8.1 Operation planning and control
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How are requirements for products and services determined?
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How does the production plan production effectively, and how is efficiency verified with the facility?
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how facility ensures that orders are made on time?
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what if the orders changes? What impact has this on the day-to-day plan?
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How facility prevents delays due to stock shortages?
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Are there any contingencies in place in case goods are not available on time?
8.2.1 Determination of requirements for products and services - Customer communication
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What are your processes for communicating with customers?
8.4.1. Control of externally provided products and services - General
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How do you ensure externally provided products conform to specified requirements?
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Is there a defined process that would deal with any nonconforming products (ask about RTV)
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Show me how you apply specified requirements for the control of externally provided products and services when:
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a) Products and services are provided by external providers for incorporation into your own products and services;
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b) A process or part-process is provided by an external provider as a result of a decision to outsource a process or function.
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8.4.2 Type and extent of control of external provision
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How do you determine the controls applied to the external provision of processes, products and services and take into consideration:
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a) The potential impact of the externally provided processes, products and services on the ability to consistently meet customer and applicable statutory and regulatory requirements?
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b) The perceived effectiveness of the controls applied by the external provider?
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When processes or functions have been outsourced to external providers, how do you consider a) and b) in 8.4.2 and how do you define the controls intended to be applied to the external provider and to the resulting process output?
8.5.1 Control of production and service provision
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How does the facility plan to prevent undesirable outcomes to processes?
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Can you show me controlled conditions for
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a) the availability of documented information defining the characteristics of the products and services;
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b) the availability of documented information defining the activities to be performed and the results to be achieved;
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c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met.
8.5.2 Identification and Traceability
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How facility ensures correct traceability of the internal and externally provided goods?
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Is there a defined process / procedure to ensure correct traceability?
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Is the process followed? - Documented evidence required.
8.5.3 Property belonging to customers or external providers
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Does the Facility contain any items or products that are the property of external providers?
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What care do you provide for customer or external provider’s property while under your control?
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How do you identify, verify, protect and safeguard that property which is provided for use or incorporation into your products or services?
8.5.4 Preservation
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How do you ensure preservation of process outputs during production and service provision to maintain conformity to product requirements? (handling, packing, storage)
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Who is responsible for the machine maintenance?
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Are the records available?
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Is there a schedule?
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Who maintaines the schedule?
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View permits for contractors
8.5.5 Post-delivery activities
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How do you meet requirements for post-delivery activities associated with products and services?
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is there any process for receiving customer feedback and complaints?
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How are customer complaints resolved?
8.5.6 Control of Changes (internal ECR)
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Is there a process / procedure for change control?
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How the changes are controlled and communicated to stakeholders?
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Who and how determines change implementation processes are completed?
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How do you review and control unplanned changes to ensure continuing conformity with specified requirements?
8.6 Release of products and services
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How facility ensures that correct goods are sent out to the customer?
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How facility determines what packaging is required for the goods?
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Who is responsible for the despatch of the goods and how customer is notified about the ready order?
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If the products must be verified & approved by the customer is there a process for communicating and obtaining a go ahead? ( e.g. concession etc.)
8.7 Control of nonconforming outputs
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How are the nonconforming products determined?
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How are the nonconforming products controlled?
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Is there designed area to keep nonconforming product away from the production
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Who decides what to do with the product
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How do you verify conformance where process outputs, products and services are corrected following nonconformance?
Any other comments - additional NCR or OFI (if more than 1 raised for a section)
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Please add NCR details to notes
9.0 Performance evaluation
9.1.1 Monitoring, Measurement, Analysis and Evaluation - General
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Show me how you determine:
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a) What needs to be monitored and measured?
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b) Methods for monitoring, measurement, analysis and evaluation to ensure valid results?
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c) When to perform monitoring and measuring?
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d) When results shall be analysed and evaluated?
9.1.3 Monitoring, Measurement, Analysis and Evaluation - Analysis and evaluation
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How the data gathered is reviewed and analysed?
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Is the data used to demonstrate conformity of products requirements, Assess process performance, demonstrate planning was successfully implemented?
9.2 Internal audit
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Can you demonstrate that necessary correction and corrective actions are taken without undue delay?
Any other comments - additional NCR or OFI (if more than 1 raised for a section)
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Please add NCR details to notes
10.0 Improvement
10.2 Nonconformity and corrective action
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View NCR - and explain:
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How the NCR are maintained?
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How NCR process works?
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Who is responsible for NCR closure?
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How CAPA are implemented and determined?
10.3 Continual improvement
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Are there any processes / products that are part of continual improvement?
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How facility determines which process / product to improve
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How facility controls the process?
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Who is responsible for giving a green light for the improvement?
Any other comments - additional NCR or OFI (if more than 1 raised for a section)
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Please add NCR details to notes
