in Vol. 17 - May Issue - Year 2016
AS EN 9100 rev D
Details are emerging of the latest revision "D" to the aerospace Quality Assurance Standard AS 9100. This standard uses ISO 9001 as a baseline and a previous Standards Forum article outlined the important changes made in the ISO 9001:2015 revision. The topic of this article is the additional requirements contained in AS EN 9100 revision D.
Reasons for the change to revision D
The revision to AS 9100 is needed to:
1. Incorporate changes made to the ISO 9001 baseline standard in 2015.
2. Take account of Aviation, Space and Defence industry needs identified since the last revision.
3. Include requested clarifications to the last revision of AS EN 9100.
Some of the key changes particular to AS 9100 D are:
• Greater emphasis on product safety, with defined requirements.
• Counterfeit parts prevention included as a separate clause and in other appropriate areas.
• The merging of current 9100 requirements for Risk Management with the new ISO requirements and emphasis on risks in operational processes
• Configuration management clarified and improved to address stakeholder needs
• Reinforced requirements for awareness of individuals' contribution to quality
• Human factors included as a consideration in nonconformity / corrective action
The structure, common to all ISO management standards, has 10 clauses and these include the particular aerospace requirements as shown:
Clause 1 Scope: includes addition of risk-based thinking and defining the Quality Management System (QMS) and context of the organization. No actual requirements defined.
Clause 2 Normative References: as ISO 9000: 2015.
Clause 3 Terms and Definitions: Counterfeit parts and product safety added to ISO 9000: 2015 definitions
Clause 4 Context of the organisation: ISO 9001: 2015 discontinued the requirement for an identified Quality Assurance Manual. AS 9100 D requires that documented information is maintained with content defined, which in effect, is a quality manual. Organizations can exclude some requirements if this can be shown to be justified. These justified exclusions from the requirements of the standard are no longer limited to activities in "Operations" (previously "Product realization").
Also, the processes within the QMS must have indicators which are monitored to gauge performance.
Clause 5 Leadership: ISO 9001:2015 removed the requirement for "management representative" but AS 9100 D includes this position as a focal point for Quality Management issues. It also requires that the QMS requirements to be integrated into the general business processes and a common strategic direction.
Clause 6 Planning: When planning the QMS, the organization must determine the actions needed to address opportunities and risks. This addresses business improvement and preventive action against potential non-conformance. There are increased requirements for planning of changes, including work transfer.
Clause 7 Support: AS 9100 D requires staff to be aware of product conformity, product safety, and ethical behaviour. It also adds the requirement to define data protection processes for documented information managed electronically.
Clause 8 Operation: This was previously identified as "Product Realization" and contains the majority of specific aerospace requirements and clarifications. These include:
• Planning for product obsolescence
• Plan activities needed to assure product safety throughout the product life-cycle
• Prevention of counterfeit parts
• Process to validate test reports for raw material based on risks
• Release of products and services
• Controlling risk in operational processes and work transfer
• Review of requirements (contract review) coordinated with applicable functions of the organization
• Actions in case of not meeting some customer requirements
• Emphasis on On-Quality and On-Time delivery of products or services
Clause 9 Performance evaluation: AS 9100 D requires the establishment of performance indicators for the QMS which can be monitored and reviewed in internal audits. Also, on-time delivery performance to be reported for management review.
Clause 10 Improvement: There is the added requirement in AS 9100 D to evaluate the need for action based on human factors to ensure nonconformities do not recur.
Expectations for the new standard
When correctly implemented and managed, the new standard shall provide the following benefits:
• Safe and reliable products which continually improve
• Customer and regulatory requirements that are met or exceeded
• Processes that are well-defined and managed
• Documentation accurately reflecting the work and actions to be performed
• Focus on the complete supply chain and stakeholders
• Fewer customer unique documents
• Recognition by Regulatory Authorities
For questions contact email@example.com
by Paul Huyton,
MFN Course Director World Wide
more information at www.mfn.li/trainers