Explanation

Relationship between System, Process and Product Audit

  • System, process and product audits represent a selection of the audit types available; however, this listing does not claim to be exhaustive. Comparison of the audit types : Audit Type / Subject / Purpose

    System Audit
    ---> Quality System
    ---> Assessment of the completeness and effectiveness of the basic requirements.
    Process Audit
    ---> Product development process / Serial production
    ---> Service development process / Providing the service
    ---> Assessment of the quality capability for specific products/product groups and their processes
    Product Audit
    ---> Products or services
    ---> Assessment of quality characteristics

    Process audits may be initiated, e.g., for the following reasons: decreasing process quality, customer complaints, and changes in the production sequence, - process insecurities, cost reductions, internal request.
    Process audits can be applied internally and externally across the full quality cycle in the following areas: Marketing, Development, Purchasing (Product/Service), Production/Service Provision, Sales/Commissioning, Customer Service/Services, Recycling

Individual Evaluation of the Questions and Process Elements

  • Each question is evaluated with regard to the respective requirements and their consistent achievement in the product development process (service process) and the serial production (service). The evaluation can result in 0, 4, 8, 10 points for each question, whereby the proven compliance with the requirements is the measure for awarding points. For a grading under 10 points corrective actions with deadlines have to be determined.

    Evaluation of compliance with individual requirements
    10 - Full compliance with requirements
    8 - Predominant compliance with requirements; minor nonconformities *
    6 - Partial compliance with requirements; more severe nonconformities
    4 - Unsatisfactory compliance with requirements, major nonconformities
    0 - No compliance with requirements

    (*) Predominant means, that more than ¾ of all requirements have proven to be effective and no special risk is given.

    The degree of conformity EE of a process element is calculated from:

    Sum of all points awarded for the respective questions
    EE [%] = ------------------------------------------------------------------- x 100%
    Sum of all possible points of the respective questions

Downgrading Rules

  • Downgrade from A to B despite an overall score of > 90%
    > Process elements P5 to P7, achievement level < 80%
    > At least one question assessed as 4 points
    > At least one question assessed as 0 points

    Downgrade from A or B to C despite an overall score of > 80%
    > Process elements P5 to P7, achievement level < 70%
    > At least one question assessed as 0 points

Serial Production

OVERALL GRADE

  • Grade. % Description of the grading
    A 90 to 100 Full compliance.
    B 70 to less than 90 Partial compliance
    C less than 70 No compliance

  • OVERALL GRADE DECISION

  • Downgrade

SUMMARY / RECOMMENDATIONS:

Overall degree of conformity in %

P 5 Supplier Management

  • 5.1* Are only approved/released and quality-capable suppliers selected?

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  • 5.2 Are the customer's requirements taken into account in the supply chain? Is the quality of purchased parts assured?

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  • 5.3 Have target agreements for delivery performance been agreed with suppliers and put into operation?

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  • 5.4* Are the necessary approvals/releases available for the out‐sourced products and services?

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  • 5.5* Is the quality of the out‐sourced products and services ensured?

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  • 5.6 Are incoming goods stored appropriately?

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  • 5.7 Are personnel qualified for the various tasks and are responsibilities defined?

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P 6 Process Analysis Serial Production

P 6-1 Process Input

  • 6.1.1* Has the project been transferred from development to serial production?

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  • 6.1.2 Are the necessary quantities / production batch sizes of incoming materials available at the right time and at the right place (stores; work‐station)?

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  • 6.1.3 Are incoming materials stored appropriately and are transport facilities / packing arrangements suitable for the special characteristics of the incoming materials?

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  • 6.1.4 Are the necessary identifications / records / approvals available and allocated appropriately to the incoming materials?

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  • 6.1.5 Are changes to the product or process in the course of serial production tracked and documented?

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P 6-2 Work Content / Process Sequences

  • 6.2.1* Are all the relevant details listed in the production and test/inspection documents, based on the production control plan?

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  • 6.2.2 Are production operations checked / approved and are setting data logged?

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  • 6.2.3* Can the customer's specific product requirements be satisfied with the production facilities used?

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  • 6.2.4* Are significant characteristics controlled in production?

  • 6.2.5 Are scrap, rework and setting parts kept separate and identified?

  • 6.2.6 Is the flow of materials and parts secured against mixing / wrong items?

P 6-3 Personnel Support

  • 6.3.1 Are operators given responsibility and authority to monitor the quality of product and process?

  • 6.3.2* Are the operators able to carry out their allotted tasks and are their qualifications kept up‐to‐date?

  • 6.3.3 Is there a personnel employment plan?

P 6-4 Material Resources

  • 6.4.1 How are the maintenance and overhaul of production facilities / tools controlled?

  • 6.4.2* Can the quality requirements be monitored effectively with the test, inspection and measurement facilities employed?

  • 6.4.3 Are the work‐stations and test/inspection areas suitable for requirements?

  • 6.4.4 Are tools, equipment and test/inspection facilities stored correctly?

P 6-5 Process Effectiveness Level

  • 6.5.1 Are target requirements set for product and process?

  • 6.5.2 Are quality and process data logged in such a way that they can be assessed?

  • 6.5.3* In the case of deviations from product and process requirements, are the causes analysed and the corrective actions checked for effectiveness?

  • 6.5.4* Are processes and products audited regularly?

P 6-6 Process Result / Output

  • 6.6.1* Are the customer's requirements met in terms of product and process?

  • 6.6.2 Are quantities / production batch sizes aligned with requirements and are they forwarded to the next process stage in a targeted manner?

  • 6.6.3 Are products / components stored in an appropriate manner and are transport facilities / packing arrangements suitable for the special characteristics of the products / components?

  • 6.6.4 Are the necessary records / releases carried out and stored appropriately?

P 7 Customer Support / Customer Satisfaction / Services

  • 7.1* Are the customer's requirements satisfied regarding QM system, product (on delivery) and process?

  • 7.2. Is customer support ensured?

  • 7.3* Is the supply of parts ensured?

  • 7.4 If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively?

  • 7.5 Is there a process which ensures that analysis of defective parts is carried out?

  • 7.6 Are personnel qualified for the various tasks and are responsibilities defined?

Action Deck

ACTION DECK:

  • P 5 Supplier Management

  • P5 #
  • Action:

  • By Whom:

  • By When:

  • P 6 Process Analysis Serial Production

  • P6 #
  • Action:

  • By Whom:

  • By When:

  • P 7 Customer Support / Customer Satisfaction / Services

  • P7 #
  • Action:

  • By Whom:

  • By When:

SIGNATURES

  • AUDITOR(S)

  • AUDITOR#
  • Add signature

  • AUDITEE(S)

  • AUDITEE#
  • Add signature

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