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AS9100 Quality Record - 4.2.4 simply states Records, not Quality Records

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  Post Number #1  
Old 2nd December 2003, 05:44 PM
alrtorrro's Avatar

Total Posts: 2
Please Help! AS9100 Quality Record - 4.2.4 simply states Records, not Quality Records

There appears to be several schools of thought on the definition of quality records-
In our efforts to meet AS9100/A, we are trying to interpert the terminology in 4.2.4 which simply states "Records" not "Quality Records" as many of us have been accustomed to referencing.
Is there a diffrence between the two terms?

In my experience, a quality record was defined as a record that could be considered objective evidence that testing, verification, inspection, etc. was completed. It yielded "results" of an operation, typically one that involved meeting a cusotmer/specficiation requirement. "Records" were like training records, equipment maintence check sheets, etc.
How is this term typically defined in the AS9100 world?

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  Post Number #2  
Old 2nd December 2003, 09:11 PM

Total Posts: n/a
Yin Yang Yes, what you said

Have you tried a search under Quality Reocords? You will find this topic discussed many times, with varying opinions. Try it, you'll like it!
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  Post Number #3  
Old 2nd December 2003, 10:12 PM
Marc's Avatar

Total Posts: 25,679
I'm not sure there is a difference per se. Any AS experts out there?

If you look through you will find a listing of examples of 'quality' records there.


Q. What is a record?

A. The NASA definition of records: All documentary materials, regardless of physical form or characteristics, made or received by an agency of the United States Government under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the Government or because of the informational value of the data in them.

The ISO 9000 definition of records: Documents stating results achieved or providing evidence of activities performed.

Q. I sometimes hear the term, “quality records.” What are these?

A. Definition of quality records: A term sometimes used in the past for a subset of records to refer to specific documents cited in a procedure or work instruction which are maintained to demonstrate both MSFC conformance to specified requirements and the effective operation of the MSFC system.

Since quality records are just a subset of all records, we are moving away from using this term so that appropriate emphasis is placed on all records.

Q. What are the requirements for records?

A. Requirements for records: Records shall remain legible, readily identifiable and retrievable. Controls for identification, storage, protection, retrieval, retention time and disposition of records are contained in MPG 1440.2, “MSFC Records Management Program,” and NPG 1441.1, “NASA Records Retention Schedule.”

Q. What records do you generate? Where are the records kept? If you are the records custodian, what are the requirements for record retention and disposition?

A. Supervisors/Team leads should discuss this with employees on a routine basis. Your procedures and work instructions (MPGs, MWIs, and OIs) establish the way you do your work, and the quality records named in those instructions are the best evidence that you do your job in accordance with your instructions.

Each organization has a Records Liaison Officer and Records Custodians who should be aware of the records that the organization is responsible for and the Records Plans.

Here's a list of examples from a company - It does include controlled documents as well, but you should get the idea. If it says 'form' or 'log', the completed form or log would be a quality record:

Approved Supplier List
Archival Records: Admin/Document Control
Audit Checklist
Audit Summary Reports
Calibration Procedures
Calibration Record
Cleanroom Cleaning Checklist
Complaint Analysis Form
Complaint Log
Component Specifications
Contracts/ Modifications
Controlled Environment Monitor Log
Corrective Action Notice
Customer Complaint Form
Daily Receiving Log
Daily Shipping Log
Document Approval Record
Engineering Change Order
External Audit Records
Hepa Air Velocity Measurement Log
Incoming Inspection Report
Inprocess Inspection Log
Inspection Procedures
Internal Audit Records
Internal Auditor List (ISO)
Lab Notebooks
Management Review Reports
Manufacturing Procedures
Manufacturing Process Procedure/Specifications
Marketed Product Correction and Removal Form
Master Calibration List
Material Disposition Sheet
Material Review Report
MDR Event Report Log
MDR Reports
Medical Device Report Analysis Form
Medical Device Report Event Form
Mold, Fixture, Jig Certification Record
Non_Product Specific Work Instructions
Order Entry Form
Organizational Charts
Parts List/BOM
Preventive Maintenance Workorder
Process Specification
Process Validation Records
Product Release Verification
Product Description
Product Manuals/Labeling
Product Requirements Document(Functional Specs)
Product Travelers
Product Tree
Project Management Plans
Purchase Orders
Purchase Requisition
Quality Manual
Quality Trend Reports
Quotation Form
Returned Material Authorization Request
Returned Product Form
Scrap Report
Software Problem Report
Software Release
Source Code
Stock Purge Request
Supplier Evaluation
Technical Report
Temporary Calibration Extensions
Test Procedure
Test Specification
Training Exemption
Training Record
Vendor Authorization Request
Vendor History Form
Vendor Notification Report
Workmanship Standard
  Post Number #4  
Old 3rd December 2003, 09:18 AM
BadgerMan's Avatar

Total Posts: 699
With regard to your question, there is no difference between the language in AS9100A and ISO 9K2K. I believe the language changed from "Quality Records" to just plain "Records" with the 2000 revision of the ISO standard. We have not made any changes to our procedures/processes (related to control of records) and have not received any negative feedback from our registrar.

I'll bet you could get some really good advice if you did a search of the ISO 9000:2000 forum.


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