AS9100 Rev D - List of Required Procedures

[amitrajkapoor]

Dear All,

Can any provide me list of procedures which are compulsory for AS9100D.

Can organisation exclude the procedure of AS9100 D related to Clause No. 4 i.e. Context of The Organisation and Risk based Thinking. if yes kindly share the valid reason.

Our organisation does not have regular production for Defence & Aerospace. we have very low orders for Aerospace & Defence.

Also we have conducted the Internal Audit based on AS9100C in the month of April 2017. Now our Auditor asked us to conduct the audit again as per AS9100D. Also I request you to share Internal Audit check list.

Please share your valuable reply ASAP.

Thanks & Regards
Amit Kapoor

 

[Marc]

You might want to read this: AS9100:2016 (Rev. D) Required Procedures as a starter, and see the Tags for some discussions of Context of The Organization and Risk based Thinking.

Checklist discussion: AS9100D Internal Audit Process Checklists

 

[amitrajkapoor]

Sir,

Thanks for your replay & suggestion.

Kindly advice if we have very less order from Aerospace and Defence companies in this case Can organisation exclude the procedure of AS9100 D related to Clause No. 4 i.e. Context of The Organisation and Risk based Thinking. if yes kindly share that what reason I can right in the Quality Manual.

Regards

Amit Kapoor

 

[Marc]

To know about exclusions, we would have to know a lot more of the specifics of your specific scenario.

You might want to read: AS9100 - What QMS Exclusions are allowed? - It's to rev C but I have bumped it to see if there were/are any changes.

 

[ljreimer]

The AS9100 Rev D identify two areas where it is required to maintain documented information. (new term for procedures). Section 8.7 for nonconforming outputs, and section 10.1 for corrective actions.
Under section 4.4.2 requires organization to establish and maintain documented information that addressed the bullets lines for identification of interested parties, Scope of AQMS, descriptions of processes needed for the AQMS, interactions of these processes and the assignment and authorities for the processes identified. Within the notes of this section references to Quality manual can be used to compile the information under section 4.4.2. Typically this can be communicated in a document with 6-12 pages if it contains only the requirements of 4.4.2.
As a minimum, Quality manual, Nonconforming outputs and corrective actions require procedures. Weather this is address separately or singularly is defined by the company.
Under the A.6 Appendix provides clarification on documented information.

As to the question of exclusion to section 4.1 for context of organization and requirements for risk based thinking. The AS1900 Rev D does not limit exclusions to production processes and requires any area of the standard that is not relevant, to be identified and justification for any area that is not applicable. Since risk based thinking is foundation for any effective management system as identified under section 0.3.3 of the standard, and as a business, you need know what internal or outside issues could affect the sustainability of the business. Justification for exclusion of these requirements would be difficult.

Being a third party auditor I agree with the premise that should any auditor convey specific requirement that is not being met, that should be supported with objective evidence and traceability to requirement. That being said, with the reduction of procedural requirements more focus will be on interview process and retained documents (Records) to support that management system is controlled for the desired outputs.

 

[Kirby]

The AS9100 Rev D identify two areas where it is required to maintain documented information. (new term for procedures). Section 8.7 for nonconforming outputs, and section 10.1 for corrective actions.
Under section 4.4.2 requires organization to establish and maintain documented information that addressed the bullets lines for identification of interested parties, Scope of AQMS, descriptions of processes needed for the AQMS, interactions of these processes and the assignment and authorities for the processes identified. Within the notes of this section references to Quality manual can be used to compile the information under section 4.4.2. Typically this can be communicated in a document with 6-12 pages if it contains only the requirements of 4.4.2.
As a minimum, Quality manual, Nonconforming outputs and corrective actions require procedures. Weather this is address separately or singularly is defined by the company.
Under the A.6 Appendix provides clarification on documented information.

As to the question of exclusion to section 4.1 for context of organization and requirements for risk based thinking. The AS1900 Rev D does not limit exclusions to production processes and requires any area of the standard that is not relevant, to be identified and justification for any area that is not applicable. Since risk based thinking is foundation for any effective management system as identified under section 0.3.3 of the standard, and as a business, you need know what internal or outside issues could affect the sustainability of the business. Justification for exclusion of these requirements would be difficult.

Being a third party auditor I agree with the premise that should any auditor convey specific requirement that is not being met, that should be supported with objective evidence and traceability to requirement. That being said, with the reduction of procedural requirements more focus will be on interview process and retained documents (Records) to support that management system is controlled for the desired outputs.

I was actually looking for something else and came across your 2 1/2 year old response regarding required documented info. I've been in the Quality community for a while but I'm always ready to learn and what better source that a 3rd party auditor?

I have been under the impression that the following documentation was required ;
- Scope of the QMS (clause 4.3)
- General description of relevant interested parties, QMS scope including boundaries and applicability, description of QMS processes and applications, sequence and interaction of QMS processes, assignment of responsibilities and authorities for QMS processes (clause 4.4.2)
- Quality policy (clause 5.2)
- Quality objectives and plans to achieve them (clause 6.2)
- Procedures for control of externally provided processes, products and services (clause 8.4.1)
- Process for control of non-conforming products and services (clause 8.7.1)
- Process for nonconformity and corrective action management (clause 10.2.1)

Along with 18 (?) records. I work with the AS standard regularly but I did not compile this info, I actually took it from an on-line "SME"., could you offer insight?