- Language: English
- 1500 Pages
- Published: July 2014
Configuration Management Guidelines and Kit
- Published: January 2011
- Quality Control Systems & Services
The new AS 9100C-2009 Aerospace Quality Management System Standard requires a process that describes methods and procedures to comply with Configuration Management requirements under clause 7.1.3-Configuration Management. A similar configuration management concept may be applied to ISO 13485, clause 7.1, 7.3 and 7.5.
The organization shall establish, implement and maintain a process for configuration management that includes as appropriate to the product:
a) Configuration management planning
b) Configuration identification
c) Change control
d) Configuration status accounting, and
e) 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
1. Assign and document personnel authorized and responsible to carry out and control configuration management activities. (Organization Chart)
2. Review and identify (determine) product configuration requirement based on customer order or contract and similar input requirements. When applicable include product design requirements. (Drawings, Specs, D & D input, etc.)
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 risk criteria (ref. Risk Management standard clause 7.1.2). (Process Feasibility and Risk Evaluation Checklist)
4. Develop a documented Configuration Management Plan, addressing the appropriate configuration management and control processes. (Configuration Plan)
5. Develop and 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
The process requirements stated in the AS 9100C standard under clause 7.2.1- Determination of Product requirements. Clause 7.2.2 Review of Product requirements, clause 7.3-Design and Development, clause 7.4.3-Verification of Purchased Product- clause 7.5.1-Production and Service Provisions, and clause 8.2.4-Monitoring and Measurement of Product are all part of meeting clause 7.1.3-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-Risk Management, the standard requirements as stated above and under clause 7.1.3-Configuration Management are utilized to control and manage the product and its configuration output. Variation Management Control will be part of this concept. SHOW LESS READ MORE >
- Introduction to Configuration Management Requirements.
Policies and Procedures:
1. Policies and Procedures for clause 7.1.3-Configuraton Management
2. Work Instruction: How to apply and implement Configuration Management Processes
1. Configuration Management Plan
2. Flow Chart for Interaction of Key Processes in Sequence, covering the key Standard clauses within a MFG environment (this chart also meets AS 9100C clause 4.1b interaction in sequence of key processes requirements)
3. Organization Chart
4. Inspection and Test Report for First Article, In Process and Final Inspection
5. Process Feasibility Review of Critical and Special Product Characteristics
1. Audit Checklists addressing respective Standard requirements,
1. Documentation is saved on CD ROM for customization and for reference purpose
A practical straightforward approach to meeting Configuration Management requirements. This ready to use documentation will save you many hours of research and eliminates a trial and error approach. It is relatively easy to implement and to comply with.
This concept was developed by QCSS under the auspices of Gunther B. Gumpp, Senior Consultant and President of QCSS.
(Copyright © 2011 Gunther Gumpp/ QCSS/ ISBN 1-881006-84-0)