Rob Kantner answers your questions:
Design Control-- Or Process Control?
We recently had our pre-audit (ISO 9001) and thought everthing was up to snuff. Well we had a major non-conformance in design control. Our company manufactures hot stamp paint.Our customers receives the dry paint on polyester in which they hot stamp onto their parts. Our R and D releases a formula to production. Because of our process and enviromental conditions we have to add additives to the paint that will help the paint dry. These additives are expensive so it not practical to incorporate into all formulas. Also these additives will not and do not affect the final performance of the product( actually if we do not add them it will affect the final quality) . These additions are not always necessary so R & D did not incorporate them into the formula.
My question is: How do we incorporate an ingredient into a formula(s) that we do not always need yet still remain in control of the design as far as ISO 9001 is concerned?
Our auditor also started to scrutinize process control because we have proven that we do not have control over our process if the environment is having an affect on our product. Catch 22.
I love design questions. Thanks for providing such complete information. It's an interesting issue.
Actually I don't think it's so much a design issue as it is a process control issue. That is to say, both things come into play. Sounds to me like it's variation in environmental conditions (heat? humidity? etc.) that make it necessary to use these additives. Maybe it also depends on the type of paint you use for a particular design.
Clearly you need to document the use of the additives, both from a design standpoint and from a process control standpoint. Could you not create some sort of matrix (as part of the design) that specifies when and how an additive is used, depending on a) the type of paint and b) varying environmental conditions? Somebody has to already know what these rules are or you would not be able to make the product successfully.
Bottom line is that, in your design end, there's documentation of the need for and use of the additives. Then in the process control documentation there's written rules on what additives to use and under what conditions. That should cover it.
Well, not quite. You would also need to have instrumentation that monitors those environmental conditions that affect the process. And that instrumentation would need to be controlled and calibrated. (Great. Why is it that so many things come back to calibration???)
One other note. I don't agree that you have no control over your process if the environment is having an effect on the product. You're dealing with it by applying these additives. Your other option is to strictly control the environment, which is possible in some scenarios but most likely not in yours. Anyway, you've found the most effective and cost-effective way to deal with it; now you just need to document it so it isn't people-dependent.
What exactly IS "Design"?
What is the definition of design? When does design control 7.3 need to be followed on changes to the product? 7.5 Control of Production and Service Provision - does it only effect the process centered around the product or does it encompass the system?
"Design" truly means new designs; it does not mean simply modifying existing designs. If all you're doing is modifying existing designs, then you are not "design responsible" and 7.3 does not apply to you.If you design a product from scratch, and then modify the design, 4.4 applies and you are design responsible. But if you are making a product from an existing design, or modifying an existing design, then changes to that design do not fall under 7.3.
Process control has to do with the process of producing the product / service. It is one of the elements of the overall quality system.
Subcontracting Design Activities?
Our company is an ISO9001 certified company. Some of our design activities have been subcontracted out,since the ISO guideline didn't mentioned any subcontractor control in 7.3. As long as we have done all the thing in 7.4 (about the subcontractor evaluation) would it be necessary to to put this in the scope of design control?
Well, you have to cover it somewhere. 4.1 requires that you control outsourced processes that have an effect on product conformity, and this clearly fits that definition. Usually I have clients document this kind of thing in an "outsourced processes" section of wherever it fits - in this case, in your design procedure.
