Clause Interpretations related to AS9100 Implementation

O

Omkar S Rao

#1
Dear Forum members,

We are implementing AS9100 in our organisation. We need help with the following questions.

  1. Clause 7.1 a, Note. - Some of us feel this clause talks about design only and will be applicable only if we are involved in design - we do not have a design function in our org. The second view point is that the Std is mandating that product requirements and quality objectives are to be determined and process must be planned for product realisation.
  2. If 7.1 a, can be excluded ( if applicable as a design specific clause) then will a simple justification of " 7.1 a excluded as we do not have design " will suffice ?
  3. Does embedded software mean only software in the product itself ( like a radar screen) or does it also refer to CAM software used ( I am refering only to the application of and not design of CAM software) for product realisation ?
  4. Can 7.1(f) "maintenance of the product " also refer to packing of the product for despatch?
  5. If we exclude 7.3 , because we do not have product design, but we design fixtures and electrodes for spark erosion of profiles in Aerospace parts - how dow we address this in our QMS ?
  6. Can you site some examples of Statutory and Reguatory requirements for the aerospace industry.( to helps us understand difference between the two words).
  7. During manufacturing if we decide to change a resource and decide to mfg the parts on a more capable resource will we be required to do a First Article again?
  8. What is the difference between Measurement and Monitoring.
 
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S

Sorin

#4
Re: ISO 9001 vs. AS9100 Interpretations

Those interpretations are for ISO 9001 so it's probably not a good idea to entirely depend upon ISO 9001 interpretations for AS9100 interpretations.
I know that, but AS is like 80%ISO+20%SAE (and whatever the Primes considered as necessary).

From memory, I could be wrong, there are no differences between ISO and AS in regards to OP questions....


Edit: My bad...they are different...sorry for misleading

ISO

7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product
realization shall be consistent with the requirements of the other processes of the quality management system
(see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the
product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
(see 4.2.4).
The output of this planning shall be in a form suitable for the organization's method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realization
processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes.


AS

7.1 Planning of Product Realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4);
e) configuration management appropriate to the product;
1) resources to support the use and maintenance of the product.
 
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A

alspread

#5
  1. Clause 7.1 a, Note. - Some of us feel this clause talks about design only and will be applicable only if we are involved in design - we do not have a design function in our org. The second view point is that the Std is mandating that product requirements and quality objectives are to be determined and process must be planned for product realisation.
    This clause is NOT for design only and applies to your manufacturing/realization processes.
  2. If 7.1 a, can be excluded ( if applicable as a design specific clause) then will a simple justification of " 7.1 a excluded as we do not have design " will suffice ?
    No 7.1 a can't be excluded just because you exclude design. in fact, it is difficult to realize how any organization that produces something could possibly exclude 7.1. I know the standard says that elements of section 7 are excludable, but it is hard to imagine exclusion of 7.1
  3. Does embedded software mean only software in the product itself ( like a radar screen) or does it also refer to CAM software used ( I am refering only to the application of and not design of CAM software) for product realisation ?
    Embedded software is software included in or embedded in the product. Production software is typically controlled in section 7.5.1.3 and 7.6
  4. Can 7.1(f) "maintenance of the product " also refer to packing of the product for despatch?
    The list you reference includes the term "as appropriate" for each of the items a-f. I don't know anything about your product, but if you are a build to design firm (it sounds like you are) then "use and maintenance" may not apply, or may be "as appropriate" to your QMS.
  5. If we exclude 7.3 , because we do not have product design, but we design fixtures and electrodes for spark erosion of profiles in Aerospace parts - how dow we address this in our QMS ?
    Fixtures and electrodes are production equipment and are controlled by 7.5.1.3
  6. Can you site some examples of Statutory and Reguatory requirements for the aerospace industry.( to helps us understand difference between the two words).
    Statutory & regulatory requirements are things like: controls on governement contracts and contract reporting, complying with locals laws and regulations as they affect the QMS,, etc
  7. During manufacturing if we decide to change a resource and decide to mfg the parts on a more capable resource will we be required to do a First Article again?
    That all depends. Usually, yes, but the key term is "when changes occur that invalidate the original results". AS9102 has some better definitions on this, but you should check with your customer to be sure
  8. What is the difference between Measurement and Monitoring.
    Measurement is determining the value or result. Monitoring is comparing that result to a requirement, objective, or expectation.
[/QUOTE]

Good luck
 
O

Omkar S Rao

#6
Thank you Guys - for taking the time to post your replies. I appreciate it. I shall need your support for the numerous questions that i am sure i will have as we go ahead.

Regards,

Omkar Rao
 
#7
Please put one question at a time.This would help you to get better inputs.My friend has already helped you but I have question for you.Do you design those fixtures for your own process or for your customers?If you do it for your customers,you would not be able to exclude claus 7.3.
For statutory and regulatory requirements,don't get confused as all are now considered as legal requirements.Example of statutory requirement in aerospace industry for India-Indian Aircraft Act 1937.Regulatory requirements:All civil aviation requirements (CARs) by DGCA.
 
O

Omkar S Rao

#8
Thank you for giving such a useful input. Where can i get a copy of the CAR and the 1937 act.

Regards,

Omkar Rao
 
#9
CARs can be downloaded from DGCA web site and you need to purchase the bare act.It would be better if you can let us know about your product and customers,we would be able to assess if you fall under any legal requirements.
 

wooden nickle

Involved In Discussions
#10
How can a contract manufacturer that has nothing to do with the design function be responsible for 7.1a - quality objectives and requirements for the product? We have no control over any of the noted considerations listed in the standard. Believe me, we do make suggestions, but that is as far as we can go, AS YOU KNOW, THE CUSTOMER IS ALWAYS RIGHT.
 
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