View Full Version : AS9100B - 4.3 Configuration Management - What do I do?
Cari Spears 28th March 2005, 10:12 AM Split from ISO 10007 - Configuration Management Requirements (http://elsmar.com/Forums/showthread.php?t=6095) by request.
We manufacture products in accordance with someone else's configuration management plan - we're not design responsible. So I think our procedures need to address cmp's as they pertain to us - like change control/contract review and document control, etc. In the same manner that we control and use technical orders and repair manuals given to us by some of our customers (customer specific requirements).
I'm also not sure about configuration audits - who does them? The design responsible function who created the CMP? Or is it our final product inspection? 10007 says "A CA may be required for the formal acceptance of a configuration item."
Well, I'm glad I did a search. I forgot I posted this last year - I almost started a new thread asking exactly the same thing. Anyway - Here's what I think:
ISO10007 gives guidelines to ensure that a complex product continues to function when components are changed individually. Since we are not a design responsible organization, our procedures will address configuration management only as pertains to us - such as change control and document control.
But the standard specifically requires:
AS9100 - 4.3 Configuration Management: The organizatioin shall establish, document and maintain a configuration management process appropriate to the product.
What do I do? Can I just put a couple of sentences in our policy manual that direct the reader to the various procedures that address configuration management stuff?
Or - because of the requirement to clearly show the relationship between our documented procedures and requirements in the standard, I've added a column to my list of Level II procedures where I've x-referenced the AS elements - I've already got 4.3 noted next to our procedures for Advanced Product Quality Planning, Contract Review, Control of Engineering Drawings, Control of Customer Specific Requirements and Preservation of Product. Think I could just leave it like that?
I do not want to write a procedure specifically for Configuration Management - it's not really its own process here. It's a part of many processes.
waterdog 30th March 2005, 06:55 PM Cari,
Hi, I am a bit of a rookie in the AS9100 world, but I can tell you what our registrar auditor told me. He said that if you don't design, don't bother to read ISO10007 as it will just confuse you. In our case we added a couple of sentences to our manual referencing Inspection Records, Document Control, etc and this was satisfactory. It sounds like you are on the right track. Hope this helps!
Raptorwild 31st March 2005, 06:10 PM But the standard specifically requires:
AS9100 - 4.3 Configuration Management: The organizatioin shall establish, document and maintain a configuration management process appropriate to the product.
What do I do? Can I just put a couple of sentences in our policy manual that direct the reader to the various procedures that address configuration management stuff?
Cari,
I know you are a busy woman and I would hate to see you create more work for yourself. IMO your first instinct is the best...let the Auditor do the work. If you state in your policy manual that various procedures address configuration management throughout your company, then that is good enough. The Auditor will be able to trace that statement to plenty of objective evidence to prove you have established, documented and maintain a configuration management system appropriate to your products!
You do it anyway, don't make it harder than you have to. I have had a similar statement in our Quality System Manual since the begining of our ISO/AS relationship and have had 3 different Auditors, and not one has had a problem with it.
Good Luck! :bigwave:
Paula
lrsiyer 9th January 2007, 06:30 AM Cari,
I think if you are not responsible for design forget about ISO 10007 and 4.3. Just address in your manual about the way the design changes are being handled in your company. that is it!!!!!!!!!!!
Shankar
Cari Spears 9th January 2007, 08:50 AM Thanks, lrsiyer.:bigwave: That is what we did and all is well.
Welcome to the cove!!
AS_QualityEngineer 21st March 2007, 04:35 AM Cari,
I think if you are not responsible for design forget about ISO 10007 and 4.3. Just address in your manual about the way the design changes are being handled in your company. that is it!!!!!!!!!!!
Shankar
Hello Mr.Shankar ,
I have one question.
We are an aerospace engineering services company and we do design activities based on customer requirements and specifications using software’s like CATIA, Nastran etc. But We do not hold any pattern rights for the design.So we exclude clause 7.3 and also we are not manufacture any parts or components.
so company like us using COTS for development work, should develop configuration management process or we should get it from our customer ?
Thanks in advance.
kiwisfly 21st March 2007, 06:53 AM Hi All
Just a quick note from an auditor. 4.3 is an additional clause from ISO 9001 for a very good reason so I wouldn't be so quick to exclude your way out of it or minimise it in any way. The clause specifically states "the organizatioin shall establish, document and maintain a configuration management process appropriate to the product." In the aerospace industry, configuration management is an essential part of being in the sector and it's importance is recognised by its inclusion in the standard. Note, that it is not in Section 7 so it can not be excluded.
I encourage the companies I audit to demonstrate their understanding of Configuration Management and how it applies to them through the documentation of their policies and procedures to meet the requirement of 4.3. If the company can not tell me what the configuration items are they have some control over and how the controls are applied then I am unlikely to be convinced they actually know what configuration management means.
Far too many aircraft accidents have been caused by organisations not maintaining the correct configuration of products they design, make, repair or sell. I believe the writers of the AS 9100 family of standards recognise this as well and have included this specific requirement to ensure that all companies achieving AS 9100 / AS9110 / AS9120 certification/registration understand their responsibilities with respect to configuration management and have the necessary controls in place.
Evidence from this thread suggests that this might not be the case, and even worse from some approved AS9100 auditors! I encourage you to impress your auditors with your implicit understanding of configuration management, what the configuration items are you deal with, examples of configuration documentation you control and what happens when you find configuration problems and how they're dealt with. I believe this is the intent of the clause.
Just my 2 cents worth. I'll get off my high horse now!!
lrsiyer 21st March 2007, 10:33 AM Dear AS Quality Engineer,
One side you are telling you are in to design activities. Other side you are telling your activities are as per customer specifications and you are excluding 7.3 also. Not very clear about the processes of your organisation. I may need some more information.
Any how, since the organisation is into desging of product,4.3 the configuration management and 7.3 design and development is applicable.
AS_QualityEngineer 22nd March 2007, 02:39 AM Dear AS Quality Engineer,
One side you are telling you are in to design activities. Other side you are telling your activities are as per customer specifications and you are excluding 7.3 also. Not very clear about the processes of your organisation. I may need some more information.
Any how, since the organisation is into desging of product,4.3 the configuration management and 7.3 design and development is applicable.
Thanks Mr.Shankar,
We are the company offering engineering services to Tier 2 suppliers. So are not having any rights to hold the pattern rights for the design. That’s the reason we excluded 7.3 and we should address 7.5 (Service provision).
Our nature of business is getting the work package from our customers (Time and Material based Programs).Doing the design work based on their specification and requirements and sent it back to the customers.
so company like us using COTS for development work( ie Services to our customer), should develop configuration management process or customer will advice about CMP?
lrsiyer 26th March 2007, 04:35 AM Hi Kiwisfly,
1oo% agreed. dilution and dilution led us to think like this. design applicable or not actually we need to think about CM. we should have CA also.
thanks.
Iyer
k_srinivasan66 15th June 2007, 05:45 AM ACTUALLY cm IS NECESSARY FROM THE POINT OF RAW MATERIAL TO DISPATCH STAGE, WHEN YOU ARE NOT DESIGN RESPONSIBLE. i WOULD LIKE TO ADD IT IN THE PROCEDURE AND MAINTAIN RECORDS
lrsiyer 16th June 2007, 09:35 AM Mr.Srinivasan,
the CM is not about the traceability, that is what I believe. For traceability we have to have a sound procedure as per 7.5.3. b.
As far as records maintenance concerned everybody shall appreciate that.
Regards,
Iyer.
k_srinivasan66 17th June 2007, 12:05 PM Mr.Iyer,
Of course CM is about a means of identification and traceability and you can refer ISO 10007 where in more requirements are for software, but the CM item in a manufacturing sector will be the part number which will be configured thro the revision status and it is nothing but a means of traceability
QCALPINE 19th June 2007, 11:37 AM I am also new to ISO9000 and AS9100 and have a similiar question.
I am in the process of revising our quality manual. Looking at ISO9000 and AS9100B there are many "shall" statements.
Example" Where traceablity is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
In our current quality manual this is recorded as:
"Where traceability is a requirement, the organization controls and records the unique identification of the product ( 4.2.4).
There are no shalls in the Quality manual only that things are done.I am used to having shalls in my quality manual and in the implementing procedures as required by NQA-1. What is the common practice in the ISO- and AS-industry? My gut feel is that they should be there but don't wont to commit to shalls unless required. Will run advice by management before I make such a drastic change. In the DOE world anything that is a shall you have to do, or the potential exists for an audit finding.
Based on my past experience I would say if it is a shall it is not an option but something that must be done. But this is a new world to me so I could be looking through the wrong set of glasses.
Looking for answers and opinions.
k_srinivasan66 19th June 2007, 12:23 PM Actually shall is a mandatory requirement whihc tells that you have to do. In the manual we generally transform this shall to is implemented or will be implemented.
lrsiyer 20th June 2007, 09:29 AM Example" Where traceablity is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
the above example says that one has to have controls like what is the unique methodology to be followed for identification and traceabililty.
So, wherever there is a shall the content become mandatory for the organisation to exhibit the controls and records thereof.
regards,
Iyer.
speck 10th July 2007, 12:11 PM For our heat treat organization we are 7.3 exempt. I made a FAI and CM procedure as they are closely knit for us. I Called out what Items are part of the CM and now from the time the customer parts enter our building and the job router travels through the processes, all document and records are collected in the routing folder. At the end of a satisfactory final inspection all documents, prints, data cards, inspection records, po's etc. are stapled together and filed by job number.
Configuration management is a black hole and I realized that as I was implementing AS9100 here. Everyone has a different view but it was explained to me here on the cove at one time, that it is just a collection of EVERYTHING that went into the product and most importantly being able to find those records. (For recalls, product defects, failures and so the right company gets sued for them.)
Someone with more experience please correct me if I am wrong. If I am wrong I have a procedure to revise.:cfingers:
Jeff Frost 10th July 2007, 06:12 PM The additional requirement added by AS9100B in Clause 4.3 is very specific to this specific business sector. In summary the clause is requiring that all documents that pertain to the product, including such items as part drawings, material specifications, field service manuals, installation instructions must be managed. The key to the aerospace sector is interchangeability of components.
Design Control now known Design and Development, clause 7.3, can be excluded per Clause 1.2 Application but if you are already are certified to ISO 9001:2000 without taking exclusion to Clause 7.3 why try to run two separate systems. AS9100 contains all the requirements of ISO with additional aerospace sector requirements.
kiwisfly 11th July 2007, 05:25 PM Hello Speck
You are partly right but a little background on design certification may assist you to further understand how you can ensure that CM is maintained within your organisation.
When an aircraft is designed and built, it receives a Type Certificate from the FAA (or another regulator) agreeing that the design and manufacture is safe and the general pubic will be safe to fly on the aircraft. The safe design information is detailed on drawings and specifications etc...; we call these configuration documents.
When you have a process that is involved in that safe design and manufacture (in your case heat treatment) then you must ensure that your processes are completed in accordance with all the specified design documents. These will be specifications etc.. that the customer has called out in their purchase order. Any related document that you develop (eg router) then must carry the correct configuration information to ensure that the safe design is maintained throughout the manufacture process.
Configuration management, is the control of the design data within your organisation that ensures that products are made to the approved design data. When approved changes to the design are made, you in turn may need to change your configuration documents (router, temperature settings, soak times, inspection etc..) so that the change is correctly incorporated into your manufacturing process. You should always check the specification revision you have been asked to heat treat to and ensure that your process meets the same revision as being asked for. The customer may not tell you the specification has changed. When changes occur, how are these introduced into your documents? When a change is made, will a FAI be required?
I hope this helps, if you have any more questions, just ask away.
Cheers :D
Chelsea 27th September 2007, 12:29 PM My company designs and manufactures gyroscopes, our customers buy either by pre-manufactured parts, pre-designed, as is, or if it's a worth our while, we contract with companies and design based on their requirements, we do not exclude any part of section 7. So I guess my question is do we need a separate CMP or can our processes etc. for section 7, product realization, be referenced in place of a CMP? :confused:
ktlasers 22nd October 2007, 08:34 PM He said that if you don't design, don't bother to read ISO10007 as it will just confuse you.
We don't do design, but our auditor looked into the CM of our programs (we do Electrical Discharge Machining (EDM) and our machines run programs we generate). Not doing design doesn't necessarily mean you don't have any CM issues. That said, we didn't fuss with ISO10007, but we still had to address that section of the checklist.
kiwisfly 26th October 2007, 02:08 AM My company designs and manufactures gyroscopes, our customers buy either by pre-manufactured parts, pre-designed, as is, or if it's a worth our while, we contract with companies and design based on their requirements, we do not exclude any part of section 7. So I guess my question is do we need a separate CMP or can our processes etc. for section 7, product realization, be referenced in place of a CMP? :confused:
Hi Chelsea
In my view the answer is yes, you need a CMP. As the designer you take responsibility for the drawings, parts lists, operations and maintenance manuals. Each of these will have a correct configuration that ensures that the gyrosopes operate safely when they are fitted to aircraft. Your CMP should ensure that each configuration item (a gyro in this case) is able to be fitted and maintained as you designed it. A regulator probably confirmed that your design meets the required standards through the Part 21 Certification process. You may possibly sell approved parts or be the approved repair facility. You might also authorise others to repair or sell your parts. These other organisations need to have the correct configuration documents to ensure that only the correct configuration item is ever fitted to an aircraft. Failure to do this could affect your company if incorrect configuration documents are used. As the designer, it is your responsibility to ensure that the correct configuration documents are available and your CMP should describe how you do it.
I hope this helps.
Cheers
Oldrice 15th November 2007, 12:31 PM Hi Kiwisfly,
Thank you btw for clearing so much of this up for us (me specifically!).:thanx:
We're implementing AS9100B and I'm struggling with this CM issue too. We don't make the parts on the aircraft - we make the check fixtures that the parts are checked on. And 9 times out of 10, once the customer receives our check fixture, they modify it even more. Usually because they purchase it just after the idea has hit prototype stage - changes are dealt with during our production of the fixture but as you can guess, it's changed many more times after the customer receives it and by the time it's used for a production run.
So, since we're not actually making an aircraft part, some of this becomes really cloudy at best to me. Do I think we should implement a CM procedure? No. But I do think we should implement CM into areas of our existing system where change control and control of docuentation and design development is considered.
Your thoughts?
Oldrice-
Sterling Heights, Mi
Oldrice 28th November 2007, 01:52 PM Hi Kiwisfly,
Thank you btw for clearing so much of this up for us (me specifically!).:thanx:
We're implementing AS9100B and I'm struggling with this CM issue too. We don't make the parts on the aircraft - we make the check fixtures that the parts are checked on. And 9 times out of 10, once the customer receives our check fixture, they modify it even more. Usually because they purchase it just after the idea has hit prototype stage - changes are dealt with during our production of the fixture but as you can guess, it's changed many more times after the customer receives it and by the time it's used for a production run.
So, since we're not actually making an aircraft part, some of this becomes really cloudy at best to me. Do I think we should implement a CM procedure? No. But I do think we should implement CM into areas of our existing system where change control and control of docuentation and design development is considered.
Your thoughts?
Oldrice-
Sterling Heights, Mi
Am I missing something here? We've secured a registrar and time is running out - honestly, I think from what I've read it's not necessary for us to have a procedure for Config Mgmt - since we do not mass produce a "part". Again, am I missing something here?:notme:
Oldrice-
kiwisfly 1st December 2007, 12:25 AM Hi Oldrice
Sorry I didn't respond to your question earlier, it's busy time in the registration business and we're all flat out running in to Christmas.
Yes, I believe you still need a CM procedure but it should be very simple. It should refer to the technical data that you receive from the customer that you manufacture the tooling to. You may have your own processes, tools or programs related to the customers technical data (such as a NC program) so this needs to be controlled in line with the customer's data. Just make sure you control the technical data the customer gives you and ensure all of your items related to it are well controlled.
You might note that AS9100:2008 moves the CM requirement into Section 7. This means it can be excluded with justification.
I hope this helps.
Cheers
Wes Bucey 1st December 2007, 10:21 AM Am I missing something here? We've secured a registrar and time is running out - honestly, I think from what I've read it's not necessary for us to have a procedure for Config Mgmt - since we do not mass produce a "part". Again, am I missing something here?:notme:
Oldrice-You might benefit from reading through the comments added to this thread Configuration Management - Please review my procedure (http://elsmar.com/Forums/showthread.php?t=24706) - especially post #6.
Kiwisfly is on the mark when he writes
Yes, I believe you still need a CM procedure but it should be very simple.As I see it, once you deliver a check fixture, any change to it, and thus the configuration management after the point of delivery is beyond your control and therefore beyond the scope of your system.
If the customer later comes back to you with a reorder (but including the modifications they have made in-house), then, and only then, are you, in fact, creating a revised product, a change to an existing one, and then you will also have to assure the preceding and succeeding steps in your process of bringing the product from order to delivery are in accord and do not conflict. You will consider such steps as material selection and purchase, inspection procedure and instrumentation, operator training, stamping or marking the product with unique identification to assure it does not get confused with similar products at the customer's end, etc. etc.
Oldrice 3rd December 2007, 09:02 AM Good points. Really. Thank you very much! I was concerned the CNC had to be controlled properly and the math data from the customers as well. The CNC doesn't usually change as it's created once, maybe revised during set-up but once it's made it's part, it's just stored and 99% of the time it's never used again. But the math data, the drawings that come from the customers have been revised a couple times before we get it, then while we have it the details have changed many times revising the end item number several times before it hits production where sometimes late changes are implemented too. But once it's shipped, we probably won't ever see another one. If it comes back (they often do years later) it's a new job with a referral note to the original job.
Glad to hear you both agree. I haven't reviewed the post #6 yet but I will right now.
Thanks again!
Oldrice- :thanx:
Anne Johnson 4th April 2008, 05:53 PM Does anyone know of place where we could get Configuration management training?
In looking at this thread - there seems to be many definitions of what Configuration Management is and I would prefer to do it right.
:2cents:
Stijloor 4th April 2008, 06:19 PM Does anyone know of place where we could get Configuration management training?
In looking at this thread - there seems to be many definitions of what Configuration Management is and I would prefer to do it right.
:2cents:
Anne,
Have you looked here (http://www.google.com/search?hl=en&q=Configuration+management+training+aerospace&btnG=Search)?
Stijloor.
lrsiyer 7th April 2008, 03:52 AM Dear Kiwisfly,
I saw that you are quoting the AS 9100:2008 and the CM may have the exclusionable exclusion. can I have some explanation on this. It would be very useful.
Thanks,
Shankar.
kiwisfly 14th April 2008, 05:40 AM Hi Irsiyer
Only clauses in Section 7 of the standard can be excluded from the certification process. All exclusions must be justified. For example, a number of companies who do not have design responsibility exclude clause 7.3 as it is not applicable to them.
The AS9100:2008 standard has moved the Configuration Management clause from 4.3 to 7.1.3. This means, in theory, the CM clause can be excluded with justification.
I'm one of those who believe that CM is one of the main clauses in the AS9100 standard, important enough to remain at 4.3 as it forces all companies seeking AS9100/9110/9120 registration to consider how the configuration of the items they make, repair or sell is maintained. It is a very important part of the entire aerospace sector.
Perhaps someone on the RMC can assist to provide information about what the thinking was behind the decision to move the clause into Section 7. The only reason I can see is to allow companies to exclude it if they justify it. A very strange move, in my view, and one that will diminish the effectiveness of the AS9100 standard.
Cheers
lrsiyer 17th April 2008, 04:29 AM Dear Sir,
I am in full agreement with you. By taking clause 4.3 to clause 7.1 and enabling it as a possiible exclusion, is going to dilute the essence of the AS standard. The essence lies in the CM as it integrate the supplier inline with the customer.
One should always think of positive even though the path is bit difficult:(
thanks,
Shankar Iyer
Big Jim 17th April 2008, 11:00 AM The more complex the design, the greater the need for Configuration Management.
Where I think it may be appropriate to ask for an exclusion is for suppliers that are low in the chain where they have no involvement in design. They build to print, a print that is and should be tightly controlled by the customer. In such cases, where the supplier has no control of the configuration, an exclusion would be appropriate. In such cases, a full blown Configuration Management procedure is an unnecessary burden.
Wes Bucey 17th April 2008, 12:43 PM The more complex the design, the greater the need for Configuration Management.
Where I think it may be appropriate to ask for an exclusion is for suppliers that are low in the chain where they have no involvement in design. They build to print, a print that is and should be tightly controlled by the customer. In such cases, where the supplier has no control of the configuration, an exclusion would be appropriate. In such cases, a full blown Configuration Management procedure is an unnecessary burden. "unnecessary burden" is what you propose laying on the organizations further up the food chain in the supply chain. What you propose is the buyers take responsibility for assuring no supplier retains ANY copies of prints or engineering drawings or other documents delineating the revision level of a product after an order is shipped and to assure those same suppliers won't make an assumption when a reorder is issued and will therefore go through the entire set of plans each time to set up a process for making the product (even if there is no revision change) since they won't have any retained documents to use as comparison.
It seems to me the lack of Configuration Management would create more cost and hassle for the supplier without the continuity of processes which any well-kept Configuration Management system provides.
Big Jim 17th April 2008, 11:33 PM Obviously this is a sensitive topic. I only ment to point out that I can see that in some cases it would be valid to claim an exclusion. Please note my new emphasis. "In such cases, a full blown Configuration Management system is an unnecessary burden."
Wes Bucey 18th April 2008, 12:28 AM Obviously this is a sensitive topic. I only ment to point out that I can see that in some cases it would be valid to claim an exclusion. Please note my new emphasis. "In such cases, a full blown Configuration Management system is an unnecessary burden."What's the definition you put on full-blown? Either an organization has Configuration Management for documents subject to revision or it doesn't. You can't (in my opinion and that of most folks dealing in aerospace) pick and choose WHICH revisions are important enough for CM. What do you do about Associated Documents? Who decides? I fail to see how "half fast" [spelling?] Configuration Management would do anything but confuse the situation. Please explain.
Big Jim 18th April 2008, 01:29 AM ISO 10007.
Do you really see the need or benefit for implementing the entire guidance from ISO 10007 in a six man machine shop?
ValleyGirl 19th May 2008, 01:07 PM Our company went through an AS9100B registartion audit for. We are currently registered for ISO9101..and have been for ten years. (The same company that we are registered with for ISO did our AS9100 audit.)
I'll admit that we were not prepared for the audit and receivied quite a number of nonconformances. Some of which were nit-picky (we have since hired a consultant)
Our delima is this...we feel our auditor is not a good fit for our company. We don't think he understood our business very well. There was definately a personality clash. He was extremely condesending and rude.
Our CAR's are due this Friday to our original auditor...I feel we have a good handle on these. A revisit is schedcule for July 2&3. Our President has requested of change of auditors.
He is also having me look into a change of Registrars.
At this point do we - just go on with this audit...or should we switch registrar's <and if we do this can they use the results of the first Audit as the initial audit??
I am new to QA although I have been a part of this company for some time.
Thanks!
Coury Ferguson 19th May 2008, 01:16 PM Our delima is this...we feel our auditor is not a good fit for our company. We don't think he understood our business very well. There was definately a personality clash. He was extremely condesending and rude.
Request the change of the auditor or better yet change Registrars.
Our CAR's are due this Friday to our original auditor...I feel we have a good handle on these. A revisit is schedcule for July 2&3. Our President has requested of change of auditors.
He is also having me look into a change of Registrars.
That is the best action that the President can do.
At this point do we - just go on with this audit...or should we switch registrar's <and if we do this can they use the results of the first Audit as the initial audit??
Does your ISO9001:200X Certificate expire now or later? I would suggest if it expires later drop the need register your system to AS9100X at least for now. I know that this has been discussed before and I know Boeing is driving the Registration to AS9100X on/or before June 30, 2008, but just let Boeing know about the issues your are having with your "current" Registrar.
Big Jim 20th May 2008, 01:33 AM This is a little hard to answer from so little information from one side of the problem. Have you tried talking to the registration company? There should be a mechanism in place to apeal any findings that you disagree with. There is with the registration company I work with. I have the impression that it is an acreditation body driven requirement for registration companies.
Keep in mind that AS9100B is more nit-picky than ISO 9001:2000 by nature. You will be under greater scrutney.
Wes Bucey 20th May 2008, 01:35 AM 4.3 Configuration Management
4.3.1 COMPANY shall establish, document and maintain a configuration management process appropriate to the product. In most cases, customer procedures will be implemented to ensure configuration control for processes and product are properly implemented. [At a minimum, COMPANY has established a process to track the item configuration received for processing from the point received to the point when the delivery is made to the customer. All required documentation with regards to traceability will be maintained in house for any verification.]
At COMPANY, the basis of Configuration Management (as required) is to do the following, more or less simultaneously:
1. Go through a formal process of revision and approval when you change any aspect of the part or document
2. Make a determination about the compatibility of the changed part or document with all the other Allied Documents
3. Determine if any of the Allied Documents must be revised to be compatible in form, fit, or function with the original changed document
4. Notify all parties who may be concerned about the change and get acknowledgement that change is implemented and obsolete documents or processes are withdrawn
5. Monitor the process to ensure all the changes work together.
Regards
Karthi.TGee! That sounds like something I would say. Oh, wait! I DID say that
http://elsmar.com/Forums/showpost.php?p=241861&postcount=6
:lmao::lmao::lmao::lmao::lmao:
Randy 20th May 2008, 08:38 AM Plagarism,the greatest form of compliment;)
You may have a Groupie as well Wes.:lol:
Wes Bucey 20th May 2008, 01:44 PM Plagarism,the greatest form of compliment;)
You may have a Groupie as well Wes.:lol:Does this mean there might be a market for my REAL autograph (versus the photocopied or 'clip & paste' one?):lmao::lmao:
AS9100 Lady 3rd September 2009, 05:12 PM Ok I have been reading a lot of this configuration management. I feel as if my brains are on overdrive. I am reading into Rev C of AS9100. From what I have been reading it seems as if this Configuration Management is a review of contract review but reviewing ALL PERTINENT DOCUMENTS. Is this correct? We make flight safety parts as well as regular aerospace assembly. We do not design nothing. All of our requirements are flowed down to us. When I receive a purchase order, I review the following:
1) I verify that Traveler Package (traveler, op/sht, b/p, CNC machine revisions) are same as customer requirements.
2) I make up an inspection report that reflects the order
3) I verify that all process revisions are current to customer requirements
4) If there are any changes, I make notation and change all pertinent documents to reflect such change.
5) If there is a question on requirements, I request a tech hep from the customer prior to releasing package.
Is this configuration management? :cool:
speck 3rd September 2009, 05:52 PM Now take all the documents that involve everything that you listed and put them into a pile and that is your configuration management. As far as I have been taught, teached:o, showed and been audited to, configuration management is simply everything and I mean everything, thing that went into the final product or service from the customer order form to the bill of laiding to ship it to him. (If you are in that line of work).
For your application and your part of the configuration management:
make sure that you have evidence of the verifications you are doing (not just looking and verbally saying they match)
make sure the completed inspection reports meet customer requirements and have records that show this
have evidence that process revisions are current to customer requirements and that you documented they are - again not just visually saw rev A matched Rev A
Document any changes on this order and make sure it flows down to all parts thereafter - notify departments effected and determine if effected product needs to be recalled because of the changes. (Safety issues)
and have some type of log or documentation from any tech service that you get.
Keep these records for the specified amount of time traceable to those parts and that is configuration management as I understand it.
We do not design anything either we just heat treat customers parts to specification and send them back to them with certificates of heat treat. Our configuration management is everything that went into that heat treat job stapled together and then filed for 7 years from the receiving po to when the customer approved carrier picked them up.
:2cents:
AS9100 Lady 3rd September 2009, 06:00 PM That is funny, because that is our completed job folder. We keep everything that has to do with the job in a folder and prior to job being shipped every requirement is again reviewed to ensure all is met. We call this our job folder. :)
speck 3rd September 2009, 06:11 PM I drove myself crazy for months trying to grasp the "Configuration management mystery" and then I realized our "Control Plan Packet" WAS the configuration management.:bonk:
As I see it also, this is a self leveling / self checking way to look at it, because the the more complicated your product or service is, the more complicated your configuration management needs to be. (IE. we have no shelf life products anywhere in the building so I have no procedure or checks for it. If we painted things or decorated cakes, somewhere in the configuration management there must be a verification to make sure that the product shelf life has not expired.)
Our companies configuration management is relatively simple. Just make sure that your configuration management procedure simply details all the documents and records (where applicable) that make up your "configuration packets". If you don't have a procedure for configuration management, make up a short one and be done with it.
AS9100 Lady 4th September 2009, 08:48 AM A procedure? I record everything in a form that I made up that requires me to enter all this data and print it out from our customers portal so that i can verify everything against requirements. A procedure? :confused: A procedure that says what? To verify everything at beginning of production and before shipping? How would I go about it when it is basically checks and balances?
speck 4th September 2009, 11:45 AM Firstly - it is not a required procedure, you only have to establish, "..document and maintain a configuration management process appropriate to the product." (AS9100 rev B section 4.3) I chose to make a procedure for my own sanity. I combined FAIR (when required) and Configuration management into one procedure. Again my opinion is that they are very similar and you can't have one without the other. FAIR is more pre production/customer focused and is everything that went into the product to satisfy all customer requirements before production was approved. Configuration management is the combined FAIR and everything that went into making the actual parts that are on airplanes right now. (Maybe this more true for my industry than others).
My configuration management procedure just says something like:
Our companies configuration management process provides complete traceability and post delivery recall provisions should the end user require such activity......
XYZ companies configuration management process contains:
(List all the document names and numbers that are stapled together in our control plan packet)
Customer purchase order
F-004 Control plan
F-003 control plan summary
F-040 serial number form for load XXXXX
Records of final results documented on F-040 (If necessary)
Sublet labor purchase order F-054 (If necessary)
Verification of sublet labor test reports(Our test results of our sub tier labor reports)
Etc
Etc
Etc
These documents shall make up our configuration management process and provide complete traceability of the serial numbers and part numbers reference above....
Configuration management packets will be controlled per our Control of records procedures P-04-02 and kept on file in the records room for a period of 7 years minimum....
For your configuration management procedure, just simply explain what the procedure is used for and list what is in your "completed job folder". Your doing it right now just document what is in the packet and document it.
k_srinivasan66 4th September 2009, 11:51 AM Hello,
Your understanding on CM is wrong. Contract review is when you receive the PO and the CM is established only after FAI. To be precise, CM is nothing but any change in product design or process design which affects the product fit, function, safety or perfromance.
speck 4th September 2009, 12:36 PM Right - that's why contract review and FAIR become part of configuration management. Contract review must be performed on every order, FAIR does not, it is only required when customers require it. You can't exclude FAIR from CM, it's the egg before the chicken.:read: my post again. Like I said "Configuration management is the combined FAIR and everything that went into making the actual parts that are on airplanes right now." Yes this includes contract review.
You said "CM is nothing but any change in product design or process design which affects the product fit, function, safety or perfromance". By default this is true because the FAIR will have changed and reflected in the CM.
If design changes or any other changes take place on that part the customer will require a FAIR to be reprocessed, not your CM. FAIR is part of your CM. Not vise versa.
I have never received a customer PO that said "Configuration management required". The purchase orders state " First Article inspection Required"
I think you may have FAIR (First Article Inspection Requirements) and CM (Configuration Management) mixed up.
AS9100 Lady 4th September 2009, 12:41 PM I have to disagree with you as far as it happens after an FAI:o. I believe it is needed prior to an FAI....how will ou know what to build to if your configuration is not available?
AS9100 Lady 4th September 2009, 05:14 PM Right - that's why contract review and FAIR become part of configuration management. Contract review must be performed on every order, FAIR does not, it is only required when customers require it. You can't exclude FAIR from CM, it's the egg before the chicken.:read: my post again. Like I said "Configuration management is the combined FAIR and everything that went into making the actual parts that are on airplanes right now." Yes this includes contract review.
You said "CM is nothing but any change in product design or process design which affects the product fit, function, safety or perfromance". By default this is true because the FAIR will have changed and reflected in the CM.
If design changes or any other changes take place on that part the customer will require a FAIR to be reprocessed, not your CM. FAIR is part of your CM. Not vise versa.
I have never received a customer PO that said "Configuration management required". The purchase orders state " First Article inspection Required"
I think you may have FAIR (First Article Inspection Requirements) and CM (Configuration Management) mixed up.
Sorry previously it was not allowing to place attachment.
I know a procedure is not needed for this Configuration Management but I figured if I make one up as simple as possible it can actually prevent the auditor from asking crazy questions with words that only he can understand. I am hoping someone can give me some insight as to whether or not my procedure actually covers the new AS9100 Rev C 7.1.3 Configuration Management :confused:
Mike Scott 6th September 2009, 11:37 AM We also plug this into our purchase orders where necessary.
Configuration Management: The Supplier shall be responsible for controlling / tracking changes to parts and components manufactured to ensure that the end product meets specified functional and physical requirements of this Purchase Order. This includes any part or component manufactured to customers’ or vendors’ drawings, specifications, or special process procedures. At a minimum, with each shipment, the Supplier shall submit “configuration documents,” which define the requirements, designs, build / production, and verification for a configuration controlled item. This record shall be signed and dated by an official of the Supplier’s quality assurance department, and, in addition to the aforementioned required information, shall include the following minimum requirements:
Contract / Purchase Order number and line item number, if applicable
Part number of deliverable item and all traceable / repairable sub-tiered parts
Serial number, as contractually required
Lot number, as contractually required
Drawing number for drawings related to deliverable item(s) and all traceable/repairable sub-tiered parts
Revision level (baseline configuration of drawing to which hardware was built)
Engineering order(s) or equivalent drawing changes as applicable
Customer approved deviations and waivers as applicable
Mike Scott :cool:
speck 8th September 2009, 12:25 PM I have to disagree with you as far as it happens after an FAI:o. I believe it is needed prior to an FAI....how will ou know what to build to if your configuration is not available?
If you really disagree with me why do you make FAI PART of your CM procedure? In section 5.9 of your procedure (which is very good and better than my own) says that changes to CM are validated by FAI. But if the entire configuration management happens before FAI why do you have to perform Configuration Accounting Status and CM audits after FAI?
I really wish they would have put FAI in 7.1.3 rev C between (C) Change Control and (D)configuration status accounting, that's where it really happens, not after CM is complete. After FAI you still have to do (D)configuration status accounting (contract review would be part of this) and then perform (E) configuration audits. That's why I said FAI is really part of CM. This may be much more clear and obvious in my industry than yours.
Now whether you agree with me or not does not really matter, how ever you choose to look at it I think your procedure is outstanding and satisfies every requirement of AS9100C 7.1.3. As always just make sure that you say what you do and do what you say.:)
The flow down requirement of Mike Scott's post, to sub tier suppliers is also a great idea to include on your purchase orders and make part of your supplier approval procedure.
AS9100 Lady 8th September 2009, 12:34 PM If you really disagree with me why do you make FAI PART of your CM procedure? In section 5.9 of your procedure (which is very good and better than my own) says that changes to CM are validated by FAI. But if the entire configuration management happens before FAI why do you have to perform Configuration Accounting Status and CM audits after FAI?
I really wish they would have put FAI in 7.1.3 rev C between (C) Change Control and (D)configuration status accounting, that's where it really happens, not after CM is complete. After FAI you still have to do (D)configuration status accounting (contract review would be part of this) and then perform (E) configuration audits. That's why I said FAI is really part of CM. This may be much more clear and obvious in my industry than yours.
Now whether you agree with me or not does not really matter, how ever you choose to look at it I think your procedure is outstanding and satisfies every requirement of AS9100C 7.1.3. As always just make sure that you say what you do and do what you say.:)
The flow down requirement of Mike Scott's post, to sub tier suppliers is also a great idea to include on your purchase orders and make part of your supplier approval procedure.
Perhaps there is a misunderstanding in what I wrote previously.
I do believe you need FAI in CM. I just think that CM starts before you even begin to manufacture product. I am new to this and maybe wrong. But to me, CM begins the moment you evaluate all required documents that will be used to produce part. All the CM evaluation is done prior to FAI in order to ensure configuration is correct from the beginning documentation. It is later verified at FAI and again re-verified through-out all inspections and testing performed on part. I guess however we interpret an FAI is needed in CM :lol:
|
|