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Configuration Management Kit

Procedures, Work Instructions, Audit Checklists, Control Forms, Charts & Tables For: AS 9100, AS 9120, ISO 9001-2015, ISO/TS 1649, ISO 13485 and related Quality Management Systems Standard Requirements

The AS 9100 - 2009 and the new 2016 Aerospace Quality Management System Standards requires a process that describes methods and procedures to comply with Configuration Management requirements under clause 7.1.3 for 2009 and clause 8.1.2 for 2016 version Configuration Management, stating the following:
The organization shall establish, implement and maintain a process for configuration management that includes as appropriate to the product .

  1. ) Configuration management planning
  2. ) Configuration identification
  3. ) Change control
  4. ) Configuration status accounting
  5. ) Configuration audit

The following illustration shows a simple step by step configuration management process based on Configuration Methods, Procedures and Control Forms designed by QCSS:

  1. QMS Standard and Customer order and/or product requirements
  2. Product design requirements (applicable if you have your own designed product)
  3. Drawings. Standards, Specifications, Design baseline Metrics, Product Samples, etc.
  4. Special Product and Process requirements, including critical product requirements determined by customer or organization
  5. Regulatory or Statutory requirements, when applicable
Action taken:
  1. Assign and document personnel authorized and responsible to carry out and control configuration management activities
  2. Review and identify (determine) product configuration requirement based on customer order or contract and similar input requirements. When applicable include product design requirements
  3. Review and identify (determine) configuration risk level, e.g. nominal, critical and/or key product characteristics, affecting Form, Fit, Function, Safety and/or other criteria (ref. Risk Management standard clause 7.1.2 for 2009 and clause 8.1.1 for 2016)
  4. Develop a documented Configuration Management Plan, addressing the appropriate configuration management and control processes
  5. Implement Configuration Management Procedures and Control Processes
  1. Configuration Management Plan
  2. Functional Organization Chart
  3. Documented Policies and Procedures
  4. A documented Work Instruction outlining in simple steps the operations to be taken to meet the configuration management plan and requirements
  5. Control Forms that enable the management team to record and control product configurations including control of product variations
  6. Have available procedures, methods and documentation to meet configuration management standard requirement and analyze for effectiveness
  7. Meeting standard and configuration management system requirements, based on effective policies and procedures and control documentation as follows:
    Process requirements stated in the AS 9100-2009 and for AS 9100-2016 under clause 7.2.1-for 2009 and clause 8.2.2 for 2016 version addressing Determination of Product requirement; clause 7.2.2 for 2009 and clause 8.2.3 for 2016 version - Review of Product requirements; clause 7.3 for 2009 and clause 8.3 for 2016 version - Design and Development; clause 7.4.3-2009 and clause 8.4.2 for 2016 version - Verification of Purchased Product; clause 7.5.1-2009 and clause 8.5.1 - Production and Service Provisions, and finally clause 8.2.4-2009 and clause 8.2 and 8.6-2016 version Monitoring and Measurement of Product. Stated clauses are all part of meeting clause 7.1.3 -2009 and clause 8.1.2 Configuration Management requirements.
    Once it is determined to go ahead with product realization, e.g. risks have been determined to be acceptable or are mitigated to an acceptable level as required under clause 7.1.2-2009 and clause 8.1.1 and 6.1- 2016 version and under clause 7.1.3-2009 and 8.1.2-2016 version findings are utilized under configuration output. Variation Management Control will be part of this concept.

(Copyright 2011/2016 Gunther Gumpp, ISBN 1-881006-84-0)

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