Internal Auditing Requirements of Statutory and Regulatory Requirements for AS9100

[Julius]

I am preparing the AS9100, Rev C Internal Auditor Course. The course will not be offered until the AS9101 is published, anticipated in July 2009.
AS9100, Rev C states in 4.1, 7.2.1, 7.3.1, 7.3.2, and 7.5.5: "..applicable statutory and regulatory requirements."
If anybody knows the answers to the following questions, please post them:
1. What Statutory and Regulatory requirements are applicable to the aerospace industry?
2. Does an AS Auditor have to know the applicable Regulations?
3. If a Lead Auditor for a Registrar is auditing an organization for registration and he finds that the client is not in compliance with the Statutory and Regulatory requirements, can he write a Nonconformance?
4. If he can write a Correction Action Report would the classification be: Major, Minor or OFI?

Julius

 

[Randy]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

I am preparing the AS9100, Rev C Internal Auditor Course. The course will not be offered until the AS9101 is published, anticipated in July 2009.
AS9100, Rev C states in 4.1, 7.2.1, 7.3.1, 7.3.2, and 7.5.5: "..applicable statutory and regulatory requirements."
If anybody knows the answers to the following questions, please post them:

1. What Statutory and Regulatory requirements are applicable to the aerospace industry?

Depends upon the country, in the US primarily 14CFR - FAA, but you should know that already if you are going to teach AS9100

2. Does an AS Auditor have to know the applicable Regulations?

Know them? Not really memorize them, but be familiar with them...But then again if you are going to teach auditing you should know that as well.

3. If a Lead Auditor for a Registrar is auditing an organization for registration and he finds that the client is not in compliance with the Statutory and Regulatory requirements, can he write a Nonconformance?

Yes, but not for violating the law, mainly for either not identifying an applicable requirement or not meeting the control (procedure) to comply with it

4. If he can write a Correction Action Report would the classification be: Major, Minor or OFI?

Registration auditors don't write CAR's they issue nonconformances...Could be major, could be minor depends upon the requirement, evidence and all that other auditing stuff you should be familiar with if you are going to teach auditing

Julius

What is your background Julius?

 

[Julius]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Randy, I am a retired Professor and Dean. I participated in introducing AS9100 in the USA and Globally. I have been in the QMS business since 1984 and have completed 398 Audits as a Lead Auditor. I have retired from auditing and teach ISO and AS courses, which I design and get approved by RABQSA and RMC. Julius

 

[Jeff Frost]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

I would add to Randy’ information a sometimes over looked item related to this requirement. You may also be required to meet the regulatory and statuary requirements of the country you will be selling to.

Example. Your product in the US is required to meet FAA regulatory requirements but if sold, in lets say in Canada, that same product may also need to meet the regulatory requirements of Transport Canada (Canada's version of FAA).

 

[Julius]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Jeff, Thank you very much. Good point. I will cover it in the course. Julius

 

[Sidney Vianna]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

1. What Statutory and Regulatory requirements are applicable to the aerospace industry?

In the USA, all the FAR's, including requirements associated with PMA's, type certification, Airworthiness Directives, etc...
REACH, from Europe, is another example.

2. Does an AS Auditor have to know the applicable Regulations?

One of the reasons for audit teams to be required to be competent in the type of business they are auditing is for them to be "somewhat" familiar with the type of regulatory regime the organization operates under. CB auditors do not perform regulatory compliance audits, but they should be aware of the applicable regulations. Obviously, due to the sheer volume of regulatory requirements, no CB auditor could be fully knowledgeable in all legal requirements.

3. If a Lead Auditor for a Registrar is auditing an organization for registration and he finds that the client is not in compliance with the Statutory and Regulatory requirements, can he write a Nonconformance?

S/he should. But, what s/he should really do is to investigate why the non-compliance happened in the first place. Does the organization have a robust SYSTEM to assure regulatory compliance? Was this a totally isolated lapse? Was this non-compliance already identified by the organization? Were they working on resolving it? There are many things to be considered. Nevertheless, if a CB auditor found the nonconformity, s/he MUST write it up, as discussed in another thread, since this is the DIRECTIVE coming from the IAQG; at least from the RMC.

4. If he can write a Correction Action Report would the classification be: Major, Minor or OFI?

Categorization would depend on the result of the assessment I referred above, when answering question # 3.

 

[Randy]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Randy, I am a retired Professor and Dean. I participated in introducing AS9100 in the USA and Globally. I have been in the QMS business since 1984 and have completed 398 Audits as a Lead Auditor. I have retired from auditing and teach ISO and AS courses, which I design and get approved by RABQSA and RMC. Julius

You're initial questions indicated a big gap in your level of expertise and the task you are undertaking, it's not uncommon for some poor soul with absolutely no experience to ask questions of the nature that you did...My mistake.

But if you have all that experience why are you asking such basic questions? Clarification?

Oh yeah...Sidney is more eloquant than me...I used to rush headlong into firefights and barroom brawls so finesse isn't one of my strengths

 

[Julius]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Randy, I agree with Blanchard. Whenever I prepare a course, I search the field of experts to see if any new ideas have advaced or were published. I like for my students to receive as much information as they can comfortably absorb, understand, and pass on to others. Julius

 

[Randy]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Gotcha and agree, I was as I said, confused...I like Blanchard myself...Simple, common sense, usable, adaptable

 

[koalatee]

Re: Statutory and Regulatory Requirements for AS9100, Rev C

Anyone know how far an AS9100 auditor can go with the 'Statutory & Regulatory' requirements statement. The way I interpret the standard, Statutory & Regulatory requirements only apply to the product. So, would a nonconformance be valid if they identified a piece of equipment that was not inspected per OSHA requirements or a safety violation in the operation of equipment (such as air monitoring, etc..)? In fact, clause 6.3 Infrastructure, and 6.4 Work Environment specifically state "the organization SHALL determine...", not Regulatory agencies.