AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk

rickpaul01

Involved in HankyPanky
#1
The last sentence in this section says: "When a customer or organization has identified raw material as a significant operational risk (e.g., critical items), the organization shall implement a process to validate the accuracy of test reports."

It would appear to me that the first use of the word "organization" would apply to any organization in the universe, and the second use of the word "organization" would apply only to the AS9100 certified organization providing product of service to the customer.

Anyone out there have insight?

Thanks
 
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BoardGuy

Quite Involved in Discussions
#2
The organization referenced here would be your company primarily but this requirement could and should also be flowed down to your material supplier. Your material supplier should verify the test reports it receives from its suppliers prior to shipping them to your company. You are then also required to verify the test reports (usually to the material standard) upon receipt.

[FONT=&quot]When contractually required by your customer, it does not matter if the QMS is AS9100, ISO 9001, ISO 13485 or some other QMS Standard. It is a requirement of the product.[/FONT]
 
#4
Organization is defined by ISO 9000:2015 - Quality Management Systems - Fundamentals and vocabulary as:
ORGANIZATION: person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives.

Note 1: The concept of organization includes, but is not limited to, sole-traders, company, corporations, firm, enterprise, authority, partnership, association, charity or institution, or part or combination thereof, whether incorporated or not, public or private.

Note 2: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by modifying Note 1 to entry.


In layman's terms is the company.
 

BoardGuy

Quite Involved in Discussions
#5
[FONT=&quot]MichelleQA it’s even easier than that. On Page 5 of AS9100D, “Intended Application” section, it states “[/FONT][FONT=&quot]This standard is intended for use by organizations that design, develop, or provide aviation, space, and defense products and services”.[/FONT]

Also most organizations error when trying to implement AS9100 because by jumping right to Section 4 of the Standard. All the sections before Section 4 are important and in case of Risk-Base Thinking, Clause 0.3.3 is important as are Annex A thru C.

Did you know that in 0.1 it clearly states that it is not the intent of the standard to imply the need for uniformity of structure, alignment of documentation to its clauses or event to use the specific terminology found within the Standard. Good reference to known when explaining you system to the registrar auditor.
 
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