AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled

M

Mario Alberto83

#1
Hello quality folks

I am leading the QMS development in the company I work for; I am doing some research and building the system following the standard sequence. Now I am at section 4 and i would like to know your comments.

4.2.3 says: "Documents required by the QMS shall be controlled":
I am developing documentation in order to meet this point but I would like to know if our drawings and specifications are considered documents "required by the QMS". I believe they are not, because I think those types of documents are not required by the QMS but an output/result of the QMS in product realization. I think this section limits to our qty manual, procedures, instructions, policies, formats, etc.

I think control guidelines for design documents are set in configuration control section.

Please let me know if I am in the correct direction in this challenge. Your guidance will be greatly appreciated.

Best Regards
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Re: 4.2.3 Documents required by the QMS shall be controlled

You'd be guessing incorrectly pardner...Control extends to any document necessary for effective planning and control....including your "drawings and specifications" especially if they relate to product realization
 
M

Mario Alberto83

#3
Re: 4.2.3 Documents required by the QMS shall be controlled

Thank you Sir.
I agree that they shall also be controlled, however design documents should go through a different kind of control per design stages during product realization in regards to "documents approval prior to use, review, update and re-approval". I want to bound my documents control procedure scope and know if they should include drawings and specs or I should handle them in different documents .

Regards
 

JaimeB

Starting to get Involved
#4
Re: 4.2.3 Documents required by the QMS shall be controlled

Think about it like this...


· Does the document guide the production of products (goods or services) provided by the organization?
· Does the document guide the verification, inspection, or testing of products provided by the organization?
· Does the document define customer and/or product requirements?
· Is the document used for controlling processes?
· Is the document used for decision making by production personnel?
· Is the document used for collecting data that could be used later for decision making within the scope of the management system (i.e., a form)?
· Is the information on the document so critical that failure to keep it updated would pose a risk to the organization or its customers?
· Does the document address or relate to a requirement from AS9100 (or whatever standard you're using)?

If the answer to any of these questions is yes, it should be controlled per your document control procedure.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: 4.2.3 Documents required by the QMS shall be controlled

...snip but I would like to know if our drawings and specifications are considered documents "required by the QMS". ...snip...but an output/result of the QMS in product realization. I think this section limits to our qty manual, procedures, instructions, policies, formats, etc.

I think control guidelines for design documents are set in configuration control section.
The key thing to remember is that you may have different document control processes, depending on the nature of the documents. So, for example, the process associated with control of procedures might be very different from the process developed for control of drawings and specifications. As long as your configuration control process describes how drawings and specifications are controlled, you don't need to reinvent the wheel. You are correct: drawings and specifications are, for the most part, design outputs, which are required to be approved in 7.3.3.
 
M

Mario Alberto83

#6
Re: AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Control

Thank you all for your guidance, I think my ideas are getting shaped and I know how to proceed as per my company needs and features.

I have another topic that I would like to know your input.

In some companies they incorporate policies whithin their QMS, and in other comapnies they exist, but they are not in the QMS scope.

In my company they have a bunch of policies, which are not related to QMS. As policies are basically principles and intentions, not methods or instructions, I believe they should not exist as documents in the documents pyramid, if they are required they must be contained in QMS documentation, as the quality policy which is contained in the Quality Manual and does not exist by itself.

If there are policies that are not related to QMS processes, I believe they should be included in the employee training plan for aknowledgement as they are usually for general personnel awareness like travel policies, confidentiality policies, etc.


I would like to keep my documentation the typical following way:
Quality Manual (including quality policy embedded)
Procedures
Work Instructions
Forms

How do you usually handle policies?

Thank you in advance for your valuable input.

Mario Durán
 
J

Jason PCSwitches

#7
Re: AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Control

It depends on the policy and what it's related to. If it correlates to any aspect of realization or control it should be included.

If it's pointing out where to take smoke breaks it does not.

However if you have these policies outlined in your employee training plan then they should already be under control as that plan itself should be included in your QMS.
 
M

Mario Alberto83

#8
Re: AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Control

That´s correct, If it correlates to realization or control, I would like to include them in the related QMS document maybe as an appendix, and not to exist by themselves.

Those not related ones...could they bring me troubles if I just ignore them? Deployment and control is responsibility of the department that issued them, can i just ignore them and construe them out of my QMS?
 
J

Jason PCSwitches

#9
Re: AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Control

That´s correct, If it correlates to realization or control, I would like to include them in the related QMS document maybe as an appendix, and not to exist by themselves.

Those not related ones...could they bring me troubles if I just ignore them? Deployment and control is responsibility of the department that issued them, can i just ignore them and construe them out of my QMS?
It depends on the relevance to that department. I wouldn't look at this as "your" QMS, look at it as the "organizations" QMS.

If the documents are an important part of your organization and in anyway are related to product realization and/or conformity, regardless of which department controls it, they should be included in the framework of the QMS.

How you control them is up to you. These control parameters should be specified in your company wide document control procedure. This is also where you should delegate authority for responsible department.
 
M

Mario Alberto83

#10
Re: AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Control

Thank you Jason
I am clear in regards the way to control and incorporate organization policies as long as they are related to the QMS in some way.

My question is... what am I going to do with those kind of policies that are important for the departments but are not related to the QMS? Should I just ignore them or there is something that triggers inlcusion in the QMS? Would it cause a gap if I just ignore them?.
 
Thread starter Similar threads Forum Replies Date
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Understanding AS9100 Clause 7.5.1.4 Post-Delivery Support Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
K AS9100 Clause 7.2.2 - Documenting "Special Requirements" and risks AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
G AS9100 Clause 7.5.1.1 Production Process Verification Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M Interpreting AS9100 Clause 8.2.2 Internal Audit Requirements Internal Auditing 28
B AS9100 Clause 8.2.3.C Monitoring and Measurement and 8.5.2 Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
B AS9100 Clause 7.3.3 - Design and Developement Requirements d and e AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
E Meeting AS9100 Clause 6.3 Infrastructure Requirements - Preventive Maintenance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
T Meeting AS9100 Clause 7.4.3 e) Delegation of Verification requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
Q Connecting AS9100 D Clause 4.2 to 9.3.2 b - Interested parties and relevant issues AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 24
A Definition of "Sensitive Products" Clause 8.5.4 (c) in AS9100 Rev. D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
C AS9100, Clause 8.5.1.3 - First Article Inspection Costs AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
I How to satisfy with AS9100 Clause 8.4.3 a, Information for external providers? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
oldqamanager How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
howste AS9100 Rev D Clause 10.2 - Is Cause always required? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 39
W AS9100 Clause 8.5.1.3 Production Run Verification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
A AS9100 Clause 7.1.1 Project Management - Process vs Project. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
W Checklist for AS9100 Clause 7.2.2 Review Of Requirememts Related to Product AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
W AS9100 Clause 8.2.3.C Monitoring and Measurement of Processes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
S Process Monitoring and Measurement - AS9100 Clause 8.2.3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
R Verification of Process Changes (AS9100 clause 7.5.1.2) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Z AS9100 Clause 7.4.2.d Revision Letter Flow Down to Suppliers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 12
M Management Review - AS9100 Clause 5.6.3 Review Output AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 12
V Application of AS9100 clause 7.5.1.1 - Tooling Supplier AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
G AS9100 clause for Repeat Orders AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
M Compliance with AS9100 clause 7.5.1.3 Ctrl of Equipment, Tools and SW Programs AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
M Changes Assessment as per AS9100 Clause 7.5.1.2 Control of Production Process Changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J AS9100 Clause 7.4.3 Verification of Purchased Product - OEM C of C required? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
C AS9100 C Clause 8.3 - Personnel Approval Process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
C AS9100 Rev C Clause 8.5.2 - CAR (Corrective Action Request) Format AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
J Production Process Verification - AS9100 Clause 7.5.1.1 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
Q AS9100 Clause 7.4.1 Purchasing Process and Approved Supplier List Records AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 37
R AS9100C Special Process Procedure - Work Instruction for AS9100 Clause 7.5.2 wanted AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
G AS9100 Clause 7.1.4 Control of Work Transfers clarification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 12
S AS9100 Clause 8.3 - Control of Nonconforming Product Q AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
quality1 AS9100 Clause 8.3 Control of Nonconforming Product - Clarification wanted AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
P Intercompany Work Transfer according to AS9100 Clause 7.1.4 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
O Clause Interpretations related to AS9100 Implementation AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
I Standard vs. Specification & AS9100 Clause 7.4.2 (d) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
H Planning of Product Realization - AS9100 Clause 7.1 - Can we exclude 7.1f? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
S Is Configuration Management Mandatory? AS9100 Clause 7.1.3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
S Problem Collecting In-Service Data (AS9100 Clause 7.5.1.4) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
A Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Service AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Q What is considered a Training Record? AS9100:2004 Clause 6.2.2 Records and Data - Quality, Legal and Other Evidence 8
B Question about the word "Design" in AS9100 Clause 8.3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
M New to AS9100 - Clause 7.5.3 - Do you have to identify each part produced AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
J Project Management Procedure - AS9100 Clause 7.1.1 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 15
C Definition Repair Schemes - Definition - AS9100 Clause 7.5.1.5 Control of Service Operations Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
Similar threads


















































Top Bottom