Information
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Document No.
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Audit Title
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Client / Site
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Key Processes: (1..2..3..)
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Conducted on
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Prepared by
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Location
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Personnel
Explanation
Relationship between System, Process and Product Audit
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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
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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
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OVERALL GRADE DECISION
SUMMARY / RECOMMENDATIONS:
Overall degree of conformity in %
P 2 Project management
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2.1 Is there an established project organization (project management) and are tasks and authorities specified for the project management and team members?
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2.2* Are the necessary resources planned and available for the development of the project and are changes highlighted?
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2.3 Is there evidence that project plans have been agreed to with the customer?
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2.4 Is change management within the project ensured by the project manager?
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2.5* Are the responsible personnel within the organization and in the customer's company involved in the change control system?
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2.6 Is there a quality plan in the project? Is this implemented and regularly monitored for compliance?
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2.7 Is an escalation process established and is this controlled effectively?
P 3 Planning the product & process development
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3.1 Are the product-specific and process-specific requirements set out?
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3.2 Is manufacturing feasibility assessed on the basis of the requirements established for the product and process, on a cross-functional level?
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3.4 Have the necessary resources been taken into account for the product and process development?
P 4 Carrying out the product & process development
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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?
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4.2 Are the necessary demonstrations of suitability and releases available for the relevant phases of the project, based on the requirements?
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4.3 Is the transfer of the project to full production secure in terms of the product launch?
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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
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5.4 Are the necessary approvals available for out-sourced products, services and raw materials including applicable performance testing and PPAP?
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5.5* Is the quality of the outsourced products and services ensured and are periodic requalifications of the products done?
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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
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6.1.1 Has the transfer of the project from development to full production been completed?
P 6-2 Work Content / Process Sequences
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6.2.1* Based on the production control plan, are all the relevant data fully listed in the production and test / inspection documentation?
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6.2.2. Are production operations checked/approved and are settings data logged?
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6.2.4* Are significant characteristics controlled in production?
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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 6-4 Material Resources
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6.4.2* Can quality requirements be monitored effectively with the measurement, checking and inspection equipment available?
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6.4.3 Are the work-areas and test / inspection stations suitable for requirements?
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6.4.4 Are tools, equipment and test / inspection devices routinely calibrated and stored appropriately?
P 6-5 Process Effectiveness Level
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6.5.1 Are production and quality targets set for product and process?
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6.5.2 Are quality and process data logged in such a way that they can be assessed?
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6.5.3* If deviations from product and process requirements occur, are the causes analyzed and corrective actions checked for effectiveness?
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6.5.4* Are processes and products audited regularly?
P 6-6 What should the process produce ? (process result / output)
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6.6.1 Are the customer's requirements satisfied in terms of product and process?
P 7 Customer Support / Customer Satisfaction / Services
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7.3* Is the supply of components secure?
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7.4 If there are deviations from quality requirements, are failure analysis carried out and corrective actions implemented effectively?
Action Deck
ACTION DECK:
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P 2 Project Management
P2 #
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Action:
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By Whom:
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By When:
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P 3 Planning the product & process development
P3 #
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Action:
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By Whom:
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By When:
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P 4 Carrying out the product & process development
P4 #
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Action:
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By Whom:
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By When:
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P 5 Supplier Management
P5 #
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Action:
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By Whom:
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By When:
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P 6 Process Analysis Serial Production
P6 #
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Action:
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By Whom:
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By When:
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P 7 Customer Support / Customer Satisfaction / Services
P7 #
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Action:
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By Whom:
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By When:
SIGNATURES
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AUDITOR(S)
AUDITOR#
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AUDITEE(S)
AUDITEE#
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