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Do ALL company operations have to be ISO 9001?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by The Machinist, Feb 10, 2016.

  1. The Machinist

    The Machinist Member

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    Hello ALL!
    We are in the very early stages of writing up our QA policy. As I understand, one should write a policy that is very lean and flexible, while meeting all the requirements of the companies needs as compared to the ISO requirements. Risk Assessments much be very different between a 2 man machine shop and Ford Motor Company. So, you are supposed to write a policy that fits your companies operations instead of trying to whittle down what a large company might have for a policy.

    Anyway, my question is do ALL of the companies activities have to fall under our QA program? As per ISO 9000 and AS 9100. (we are going for both out the gate)

    In our case we are a small machine shop with existing customers and we also do work that is not "Machine shop" work. Such as we help rebuild old cars, and car subsystems, etc. I do not want to have to included our "Other" work in our QA program.

    For example if I run to Home Depot to buy a strip of metal I do not want to have to do our standard "receiving inspection" as if we were making aircraft parts. I might be using the phrase "do not want" too much. I should say I want our program to have flexibility.

    I was thinking something like:

    Scope of the Quality Assurance Program
    2.2.1 Scope Statement
    Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, USA MACHINE has determined the scope of the management system as follows:
    Although USA Machine operates in the four markets listed above (see 2.0) the scope of this Quality Assurance Program and any certifications there of shall be limited to: Contract Manufacturing
    2.2.2 Facilities Within the Scope
    The Quality Assurance Program applies to all Contract Manufacturing Services located at:
    100 Main St.
    Any Town NJ USA
    Phone: 201-XXXXXXX
    www.XXXXXXX.com
    2.2.3 Permissible Exclusions
    These statements are made to aid in the audit and certification process by providing a clear line of delineation between customers of USA MACHINE which require Certification and those that don't. Or in other words customers and projects that will not be part of the QA program. As it would be financially and practically unreasonable to include all of USA Machine's efforts within the scope of the QA program.
    · The company claims no exclusions from the ISO 9001 standard, however some additional clarity is provided. As already prescribed in the scope statement above (see 2.2.1) in which the QA Program and any certifications their of shall be limited to Contract Manufacturing. The following provides additional information and examples of how and why the QA Program is not applicable to all efforts of USA Machine.
    · All products and services shall be by default NOT be included in USA MACHINE's Quality Assurance Program.
    The 2 Methods of inclusion are:
    1) As determined or required by the customer.
    2) As determined by the Director of QA.
    Examples of inclusions are, but limited to:
    · ALL Aerospace and medical device components.

    Examples of exclusion are, but not limited to:
    · USA Machine may restore a antique automobile. Unless the customer needs or desires to have their project included in the USA MACHINE QA program, it would by default NOT be included.
    · USA Machine may remodel, maintain or expand its infrastructure. Systems such a HVAC, lighting, etc, may or may not be the property of USA MACHINE. Such infrastructure work would be excluded from the USA MACHINE QA Program by default. IG When moving a window within our production facility, it would not be necessary to included this project in the USA MACHINE QA Program.
    · USA Machine may design and build a custom race car part. This part may be made on equipment and systems which ARE included in the USA MACHINE QA program. IG CNC Machines and Inspection Equipment. It is NOT a requirement of the USA MACHINE QA Program that ALL production equipment and systems be used solely for projects which are governed by the USA MACHINE QA Program.
    · USA Machine's proprietary designs, products and services, shall by default NOT be included in the USA MACHINE QA Program. IG USA MACHINE builds and sells Camera accessories at the time of this draft. the Director of QA shall decided at any time to include or exclude the production of same from the USA MACHINE QA Program. This is consistent with the USA MACHINE QA Program permissible exclusions, as USA MACHINE is the customer.
    · IG USA MACHINE performs CNC programming consulting services at the time of this draft. These services are by default NOT included in the USA MACHINE QA Program.
     
  2. Golfman25

    Golfman25 Well-Known Member

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    If it was me, I would broaden your quality policy to included all activities. Everything you do has some form of quality requirements and expectations to be met.

    Then in your procedures - how you handle different aspects of your business -- make distinctions. So in your home depot example, you may make receiving inspection only applicable to aircraft parts.
     
  3. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I agree. I would have some issues with a few of those exclusions (moving a window) as infrastructure changes can certainly affect the entire product line , like locating a paint booth next to an open garage door, etc. This is true whether the equipment or property is yours or not. Your procedures will have to separate out the lines later.
     
  4. The Machinist

    The Machinist Member

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    I agree. Moving a window could affect product. But, that is the thing I am trying to tease out. Isn't it up to the "Company" to determine their risks and issues as they affect quality?? Your point is well made, but also cant you always find an issue or hypothetical scenario that will affect quality?? Where is the line between reasonable and unreasonable? Or between what is a risk and not a risk.

    If lighting is critical at an inspection station, the necessary lums and light color could be prescribed in your QA manual, but a bagel shop or law office may not need that degree of control over replacing a light bulb.

    So, I want to preclude everything, and only include additions to the QA program on a actually relevant basis.

    How do you frame the QA program so every breath in the building is not part of a procedure? If those same breaths DO affect your product / service then they need to be included. Overall that is the guidance I am looking for. Thanks for taking the time to review my ideas.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your first post confuses me. When you say writing a "Policy" do you mean the Quality Manual? Because everything else you've described looks to me like contents of a Q manual...

    You haven't mentioned an actual "scope" statement as such. Doing this will answer your question. BTW you mix all kinds of terminology here - today, QA is a subset of Quality Management. ISO 9001 is about Quality Management, not QA. Have you got yourself a copy of ISO 9001:2015? A lot of your answers are in "Context of the Organization"...
     
  6. BradM

    BradM Moderator Staff Member

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    "No one can serve two masters. Either you will hate the one and love the other, or you will be devoted to the one and despise the other." :)

    It's a challenging ordeal trying to maintain two processes, two sets of procedures, two of this, two of that, segregation, etc.

    I realize that this viewpoint is old as the hills, but the quality program is supposed to be more than a certificate and/or a customer requirement. It is supposed to help the organization function/compete better. For example, waste/scrap is a non-significant cost for your operation, whether it is for the "contract" side or not.

    What you might want to consider is developing a "pull" approach to your requirements. Instead of "pushing" the requirements of forms/ mandates all through the organization, have the customer's contract/ purchase order "pull" the required quality systems. So when their certification calls for it, you then address material compliance, inspection, etc.

    If I had a classic car and was needing some work done on it, I would like to find a shop that will do it correctly. The first time.
     
  7. The Machinist

    The Machinist Member

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    Sorry, Yes. Its the early days of a Quality Manual. Certainly not polished... Ill worry about making a clearer as I get more answers to my basic issues. I will review "Context of the Organization" Thanks
     
  8. The Machinist

    The Machinist Member

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    I guess maybe that is what I am getting at. A "pull" approach or/and Preventative Action approach. Add stuff as required instead of the opposite bloated approach. No offence.

    Sorry, But I do not get your Two Masters analogy in this case as it applies to my examples, such as the changing of a light bulb. (see above)

    As for the classic car analogy, lots of companies do museum quality restorations, and they are not ISO 9000 certified. Not even close.
    ( Gas Monkey Garage / West Coast Customs)

    I am a believer in Quality Assurance Programs. But, Implying that good value / good quality work cant be done with out it, is a little too QA fan boy for me.

    Anyway, Thanks a lot for the feedback. I am getting the idea a little. I think. Which is consistent with my original ideas on how to do this, I just need to get my nomenclature in order and
    take a few more passes at this. Thanks again.
     
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  9. BradM

    BradM Moderator Staff Member

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    What I am suggesting is it's very challenging trying to maintain/ run two different processes in one area. Trying to remember/ keep up with "is this job ISO or not?", or is this the correct form, or, and such, can be very difficult. That's why I'm suggesting like the others to just have your whole operation under the quality system.

    Either I did a poor job of making a point here, maybe you read a little too much into this, or a little bit of both. ;)

    I have Tradesmen on both sides of my family, including third generation welders and pipeliners. My uncle built killer custom three-wheelers, and he probably couldn't spell ISO 9001.

    I'm not implying that the "non-ISO" work is poor; nor am I suggesting that all "ISO" work is exemplary. I'm merely stating that regardless of your business organization, a properly executed quality system can benefit the business side.

    I am a licensed Master Electrician. If I was to set up my own business, I would structure a quality program in alignment with ISO9001 to assure that service calls are treated consistently, spare parts are recorded correctly, customer interaction/ service call closures are correctly addressed to minimize call-backs. Etc.

    That does not imply that all "non-ISO" electricians are sorry and not doing a good job. I'm just suggesting that I would structure a quality program that would help me gain a competitive advantage and increase profits.
     
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You may need/wish to revisit your understanding here. Nobody said good work can't be done without it. IF you understand what a QA program is (and that's NOT doing ISO 9001, incidentally) the WHOLE purpose is to limit the risk to the customer of making something wrong and missing out on their satisfaction. I've done QA long before ISO came out. We did good stuff x 33. What did we have before the "QA program"? Chaos/anarchy. Not a hope in H*ll of doing what the customer wanted.

    Putting in a formal Quality Management System based on ISO 9001 is a strategic decision, made based on understanding who you customer is, what they need from you and making it work to that end. Sure you can run business to suit contract machining customers (aerospace etc) and old car resto guys like me. You may find you can't be all things to all people, however, and creating a Quality Management System which tries to pick a path through your business processes and document that path will create a monster that you'll have to feed...
     
    Last edited: Feb 11, 2016
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  11. Golfman25

    Golfman25 Well-Known Member

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    Don't over think it. If you have a successful company the odds are you are all ready doing 80% of what is required by ISO 9001. Most of it is just good business practice. This is true whether you make aerospace components or rehab classic cars. Thus, my recommendation to "apply" it throughout your organization but to each facet differently. So for example, we do customer satisfaction reviews for all of our customers. But for our automotive customers, we have to include some specific data in the review - which we only do for those customers. In your case your aerospace components will go thru much stricter/rigorous process controls than what you do when you rehab a car. Good luck.
     
  12. The Machinist

    The Machinist Member

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    Somebody did say it, or imply it. They said, "If I had a classic car and was needing some work done on it, I would like to find a shop that will do it correctly. The first time."
    I am just responding to what was said. He further explained his position, which I understand. All Good :) Thanks
     
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  13. The Machinist

    The Machinist Member

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    I really appreciate everyone's feedback. And I do understand that a QA system will help any business operate in a better manor, or at least a well designed, well implemented QA program should produce a good result. But, I believe we have quickly gotten into a ideological QA conversation. What "I" would do. Or the "best" way, etc. I had a more specific question which I tried to ask in my original post.
    I apologize if I did not formulate my questions in a lucid manor. Thanks
     
  14. James

    James Active Member

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    I'm a machinist as well and QA manager. I started in a two man shop and have also worked in a 40 man aerospace shop. I bet I have a lot of similar experiences to yours. I would focus on making a system that follows everything you do, rather than making everything you do follow a system. That's how we did well with the lean idea. It's easier to include everything you do when you aren't chasing unnecessary things and trying to force pre-conceived notions into a new quality management system. I also built the QMS at this shop from scratch. Feel free to call, text, or email me. I'm still new to a lot of this, but we probably share some common needs and experiences where quality management systems are concerned.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I could only figure out 2 questions:
    Your "policy" is supposed to be applicable to your company. How you derive it, is your choice.

    As I posted earlier, the answer is "what's your scope?" If that's Contract Machining" then anything you do for a customer which falls under that scope is going to be processed through your QMS, in one way or another.
     
  16. hogheavenfarm

    hogheavenfarm Well-Known Member

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    We are also a 'custom machine shop' and make everything from architectural components to passenger rail parts to installation art. Even though each product can qualify under different standards, all are included in the QMS scope. Internally we may treat them differently, some parts are for aerospace, so those get the AS9100c treatment (even though we are not certified to that). The same with TS16949. We know whats involved, and those parts go through that treatment. Installation art may be completely different, yet the basics are always the same. Can the process produce the part to spec? Is our measurement system capable? Are there pathways to defects we can address and close off? Each product may get different levels of treatment yet everything falls under the QMS, all depending upon the risk inherent in the project.
     
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