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 8 points corrective actions with deadlines may be required contingent on the number of question rated at 4 or 6. Business will not be awarded to any supplier with one or more questions answered with a 0.

    Evaluation of compliance with individual requirements
    10 - Full compliance with requirements
    8 - Predominant compliance with requirements; opportunities for improvement exist *
    6 - Partial compliance with requirements; minor nonconformities exist
    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 overall grade is determined as follows;

    A = max 7 questions Yellow or Amber and NO questions Red. This is cumulative (4 answers Yellow and 3 Amber maximum)
    B = max 14 questions Yellow or Amber and NO questions Red. This is cumulative (10 answers Yellow and 4 Amber maximum)
    **Action Plan or On Site PPAP review may be required for any B grade supplier**
    C = more than 14 questions Yellow (6) or Amber (4) and any questions Red (0). (No business will be awarded)

    Color Key:
    10 = Green
    8 = Blue
    6 = Yellow
    4 = Amber
    0 = Red

Serial Production

  • OVERALL GRADE DECISION

SUMMARY / RECOMMENDATIONS:

Overall degree of conformity in %

P 2 Project management

  • 2.1 Is there an established project organization (project management) and are tasks and authorities specified for the project management and team members?

  • 2.2* Are the necessary resources planned and available for the development of the project and are changes highlighted?

  • 2.3 Is there evidence that project plans have been agreed to with the customer?

  • 2.4 Is change management within the project ensured by the project manager?

  • 2.5* Are the responsible personnel within the organization and in the customer's company involved in the change control system?

  • 2.6 Is there a quality plan in the project? Is this implemented and regularly monitored for compliance?

  • 2.7 Is an escalation process established and is this controlled effectively?

P 4 Carrying out the product & process development

  • 4.1 Are the Design FMEA / Process FMEA drawn up in compliance with AIAG guidelines, up-dated in the course of the project and are corrective actions specified?

  • 4.6 Are the production control plans used for the various phases and are production, test and inspection documents derived from them, with the appropriate inspections recorded?

P 5 Supplier Management

  • 5.1 Is there a process to audit and qualify suppliers, and are only approved and quality-capable suppliers appointed?

  • 5.2 Are the customer's requirements including Change Management taken into account in the supply chain?

  • 5.4 Are the necessary approvals available for out-sourced products, services and raw materials including applicable performance testing and PPAP?

  • 5.5* Is the quality of the outsourced products and services ensured and are periodic requalifications of the products done?

  • 5.6 Is there an appropriate receiving inspection for outsourced materials and components? Are incoming goods stored in the appropriate manner?

P 6 Process Analysis Serial Production

P 6-1 Process Input

  • 6.1.3 Are upstream materials stored in the appropriate manner and do the transport methods / packing systems take account of the special characteristics of upstream materials?

  • 6.1.5 Are changes to the product or process in the course of serial production first approved by the customer and subsequently tracked and documented?

P 6-2 Work Content / Process Sequences

  • 6.2.1* Based on the production control plan, are all the relevant data fully listed in the production and test / inspection documentation?

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

  • 6.2.3* Can the customer's product-specific quality requirements be achieved with the production facilities?

  • 6.2.4* Are significant characteristics controlled in production?

  • 6.2.5 Are scrap, rework and Work in Process parts, as well as residual in-house quantities properly separated and identified?

  • 6.2.6 Is the flow of materials and components secured against mix-ups / incorrect identification? Is lot control and traceability maintained throughout the process?

P 6-3 Personnel Support

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

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

P 6-4 Material Resources

  • 6.4.1 Are the maintenance and overhaul of machines / facilities controlled on a preventive basis? Is there a posted schedule?

  • 6.4.2* Can quality requirements be monitored effectively with the measurement, checking and inspection equipment available?

  • 6.4.4 Are tools, equipment and test / inspection devices routinely calibrated and stored appropriately?

P 6-5 Process Effectiveness Level

  • 6.5.1 Are production and quality targets 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* If deviations from product and process requirements occur, are the causes analyzed and corrective actions checked for effectiveness?

  • 6.5.4* Are processes and products audited regularly?

P 7 Customer Support / Customer Satisfaction / Services

  • 7.1* Are the customer's requirements satisfied in terms of QM system, product (on delivery) and process? Are key measurables for quality and delivery posted in production areas?

  • 7.3* Is the supply of components secure?

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

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

General Manufacturing Questions (Not Scored)

  • Does the supplier use the latest technologies in manufacturing with automated/built in error proofing?

  • Does a visual labeling system identify and locate inventory, tools, processes, and flow?

  • Is the facility safe, clean, orderly, and well lit?

  • Do employees have the proper PPE based upon noise/head and eye hazards?

  • Does the plant layout minimize material travel and handling?

  • Is there an established 5S program within the facility?

  • Are regular lean manufacturing exercises conducted to improve plant conditions?

  • Did the supplier provide a comprehensive list of equipment to be used as reference to their capabilities?

  • Enter complete Equipment List:

Action Deck

ACTION DECK:

  • P 2 Project Management

  • P2 #
  • Action:

  • By Whom:

  • By When:

  • P 4 Carrying out the product & process development

  • P4 #
  • Action:

  • By Whom:

  • By When:

  • 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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