AS9100D, Clause 8.1 - Operational Planning and Control

CanadianQA

Starting to get Involved
#1
Hi All,

I am in the process of implementing AS9100D and am wondering what other companies are doing to meet the requirements of 8.1 - Operational Planning and Control?

My company has been ISO 9001:2015 certified since Feb 2016. We are a manufacturer of aftermarket aircraft accessories and a maintenance provider for several rotary wing platforms.

We currently have policy / procedures manuals that define how our processes are controlled, established criteria and acceptance of our products and services as well as the other ISO related parts of this clause, but I'm not sure how to incorporate the AS requirements.

How are other companies meeting the requirements of this clause?

I appreciate any guidance that is offered.
 
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dsanabria

Quite Involved in Discussions
#2
Hi All,

I am in the process of implementing AS9100D and am wondering what other companies are doing to meet the requirements of 8.1 - Operational Planning and Control?

My company has been ISO 9001:2015 certified since Feb 2016. We are a manufacturer of aftermarket aircraft accessories and a maintenance provider for several rotary wing platforms.

We currently have policy / procedures manuals that define how our processes are controlled, established criteria and acceptance of our products and services as well as the other ISO related parts of this clause, but I'm not sure how to incorporate the AS requirements.

How are other companies meeting the requirements of this standard?

I appreciate any guidance that is offered.
What is your concern or fear?
 

CanadianQA

Starting to get Involved
#3
I guess I am unclear where things like:
  • personal and product safety;
  • producibility and inspectability;
  • reliability, availability, and maintainability;
  • suitability of parts and materials used in the product;
  • selection and development of embedded software;
  • product obsolescence;
  • prevention, detection, and removal of foreign objects;
  • handling, packaging, and preservation;
  • recycling or final disposal of the product at the end of its life.
need to be shown where they are considered. Is this supposed to be in the design stage? If so, why is this requirement here and not in 8.3?

As well, at what stage do the requirements of 8.1 (b)(2)(f-j) come in? Is this determined at a high level or on a job by job basis?

The AS requirements are relatively new to me and I don't have a consultant working with me, so sorry if the question is unclear or seems uninformed.
 

dsanabria

Quite Involved in Discussions
#4
I guess I am unclear where things like:
  • personal and product safety;
  • producibility and inspectability;
  • reliability, availability, and maintainability;
  • suitability of parts and materials used in the product;
  • selection and development of embedded software;
  • product obsolescence;
  • prevention, detection, and removal of foreign objects;
  • handling, packaging, and preservation;
  • recycling or final disposal of the product at the end of its life.
need to be shown where they are considered. Is this supposed to be in the design stage? If so, why is this requirement here and not in 8.3?

As well, at what stage do the requirements of 8.1 (b)(2)(f-j) come in? Is this determined at a high level or on a job by job basis?

The AS requirements are relatively new to me and I don't have a consultant working with me, so sorry if the question is unclear or seems uninformed.
You need to breath and let's take one item at a time

Remember - the way to eat an elephant - is one bite at a time.

so - what is your first concern.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
I guess I am unclear where things like:
  • personal and product safety;
  • producibility and inspectability;
  • reliability, availability, and maintainability;
  • suitability of parts and materials used in the product;
  • selection and development of embedded software;
  • product obsolescence;
  • prevention, detection, and removal of foreign objects;
  • handling, packaging, and preservation;
  • recycling or final disposal of the product at the end of its life.
need to be shown where they are considered. Is this supposed to be in the design stage? If so, why is this requirement here and not in 8.3?
Don't make this too hard. Where does YOUR company do these things? Don't reinvent a wheel to satisfy some perceived need to make things fit into tight little boxes with AS9100 labels.

I must assume, for example, for every product you consider requirements for how you produce it. When and where do you determine how you will produce it? Keep FOD out of it? Package it?

If there is something that you don't currently do -- say you have no consideration regarding FOD prevention, then you and your team can figure out when/where/how to handle this requirement.

But I'll bet you already do most of these things -- so be prepared to show someone objective evidence of such.
 

CanadianQA

Starting to get Involved
#6
Yes, Ok, thanks both for the responses. (Breathing a little easier...) After having the evening to think about this, I guess my question was really related to if this all had to be done in one procedure or can it be done in many stages.

Mile S. is correct that many of the items listed in 8.1 are addressed at different stages during our design and build process, I just wasn't sure if it that met requirements.

Sorry, I feel a bit in the dark on some of the clauses of the AS standard. Since I'm not working with a consultant, you all will be getting to hear my questions!
 

dsanabria

Quite Involved in Discussions
#7
Yes, Ok, thanks both for the responses. (Breathing a little easier...) After having the evening to think about this, I guess my question was really related to if this all had to be done in one procedure or can it be done in many stages.

Mile S. is correct that many of the items listed in 8.1 are addressed at different stages during our design and build process, I just wasn't sure if it that met requirements.

Sorry, I feel a bit in the dark on some of the clauses of the AS standard. Since I'm not working with a consultant, you all will be getting to hear my questions!
So - do you have a question?
 

CanadianQA

Starting to get Involved
#8
Yes, as noted above, the question boiled down to if this all had to be done in one procedure or can it be done in many stages.

I'm guessing after reading Mike S. post, that as long as we can demonstrate that each of the requirements of 8.1 have been accounted for at some point, that would be Ok. Do you concur?
 
#10
This can be done across many procedures. the problem we found in this clause is the first statement stating that you should plan, implement and control processes (4.4 QMS) to meet the requirements of product and service provision and those requirements of 6 (planning). Which kind of pins pretty much the whole standard!
So we set up an NPI process that considers the life cycle and ensuring stage gate sign offs have the right competencies to determine the risks and opportunities of product and process conformity, considering all aspects of potential failure modes.

So basically NPI contains
DFMEA, risk assessments, control plans, key characteristic considerations (AS9103), inspection plans and validation verification analysis (AS9102), lessons learnt logs, Design reviews, production readiness reviews, supplier approval analysis..
I doubt I have remembered it all here but my point is that everything has been considered.
Hope that helps..
 
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