Title Page
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Audit ID
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Site
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Audit date
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Carried out by
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Department / Cell
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Process
Process Summary
Process description
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Provide details on the process being audited. If a process map is available, this should be attached
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Inputs:
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Outputs:
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People and responsbilities:
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Tasks / activities:
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Process controls:
Process performance
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How is the effectiveness of the process(es) measured?
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Detail process performance trends
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Is this process meeting performance targets
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What actions are being taken to address the process performance
Process assessment - Quotation, Order Entry & Contract Review
Quotation
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Observe the process and answer the following:
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What are the triggers for carrying out this process?
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Are these consistently understood/applied?
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Are there documented instructions for carrying out this process?
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Provide details
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Is the person carrying out the process aware of the documented instructions?
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Do they know how to access them?
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Do they refer to the instructions while carrying out this task?
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Is the process carried out in accordance with the documented instructions
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Are control points / checks carried out as part of this process?
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Are these checks controlled / standardised?
Order entry
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Observe the process and answer the following:
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What are the triggers for carrying out this process?
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Are these consistently understood/applied?
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Are there documented instructions for carrying out this process?
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Provide details
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Is the person carrying out the process aware of the documented instructions?
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Do they know how to access them?
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Do they refer to the instructions while carrying out this task?
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Is the process carried out in accordance with the documented instructions
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Are control points / checks carried out as part of this process?
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Are these checks controlled / standardised?
Contract review
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What does the person carrying out the process understand by 'Contract Review'
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Provide details on how/when the following are considered:
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a) Process capability
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b) Process capacity
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c) Availability of tooling and raw materials
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d) Product cost/price/margins
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e) Non-standard product requirements (eg. labelling, packaging, tolerances)
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f) Non-standard system requirements (eg. document retention, third party approval, supplier approval)
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How are non-standard requirements communicated?
ISO 9001:2015 Requirements: Requirements for products and services
Customer communication
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How is information relating to products / services communicated to customers?
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Provide examples
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How are enquiries, contracts or orders (including changes) handled?
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Is customer feedback relating to products / services obtained?
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Provide examples
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Is there communication with the customer regarding handling or controlling customer property?
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Provide details
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Is there communication with the customer regarding their requirements for contingency actions?
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Provide details
Determining product / service requirements
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Are requirements for products / services being offered defined?
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How are requirements defined?
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Provide examples
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Are applicable statutory and regulatory requirements included?
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Are requirements considered necessary by Tenmat included?
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Can the company meet the claims for products / services offered?
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How does the company ensure claims can be met
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Provide examples
Reviewing product / service requirements
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Is a review carried out to ensure the company has the ability to meet requirements for products / services before committing to supply?
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Does the review include:
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a) Requirements specified by the customer, including requirements for delivery and post-delivery activities
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b) Requirements not stated by the customer, but necessary for the specified or intended use
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c) Requirements specified by the organisation
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d) Statutory and regulatory requirements applicable to the product
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e) Contract or order requirements differing from those previously expressed
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Are contract or order requirements differing from those previously defined resolved?
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Provide details
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Are the customer requirements confirmed when the customer doesn't provide a documented statement of their requirements?
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Provide evidence on the results of the review
Changes to product / service requirements
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Is relevant documentation amended when requirements for products and services change
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Provide details
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Are relevane persons made aware of changes to requirements
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Provide details
ISO 9001:2015 Requirements: General
Competence
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What competencies are required by persons carrying out this process?
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Is the competency of these persons ensured
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How has competency been ensured?
- Education
- Training
- Experience
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Provide evidence of competence
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Was action taken to achieve the necessary competency?
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How was the effectiveness of the action evaluated?
Awareness
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Interview one or more persons carrying out tasks or activities as part of this process
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Are employees aware of the quality policy?
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Are employees aware of the quality objectives (for the site or their area)?
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Are employees aware of how they contribute to the effectiveness of the quality management system?
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Are employees aware of the benefits of improved performance?
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Are employees aware of the implications of not conforming with the quality management system?
Communication
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What internal or external communication is required as part of this process?
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Has the process owner considered:
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a) What information is communicated
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b) When it is communicated
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c) With whom it is communicated
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d) How it is communicated
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e) Who communicates
Documented information
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What documented information is required for this process?
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Provide examples
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Is the documented information:
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a) Appropriately identified
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b) In an appropriate format
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c) Reviewed and approved for suitability and adequacy
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d) Available and suitable for use, where and when it is needed
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e) Adequately protected
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What documented information is required to provide evidence of process status / results
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Provide examples
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Is this documented information suitably:
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a) Distributed
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b) Available (able to be retrieved as necessary)
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c) Stored and preserved
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d) Controlled to prevent change
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e) Retained for the required period of time
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If documented information of external origin is required, is this identified and controlled?