I have a question regarding 7.1 and 7.1.4. We are a very small shop (just the owner and myself) that produces printed wire harness labels. Our largest customer is requiring us to achieve TS certification. I have researched the forums for answers to these questions, but haven’t found a situation similar to mine. All of our labels are on the same substrate we only change the width or print on the label. The customer provides all of this information we are not responsible for any design. With this short background in mind these are my questions.

7.1 states: “the organization shall plan and develop the processes needed for product realization.” Etc. etc.
Since all of our products are on the same substrate, only different widths and print. I am assuming I could use just one process for all our products regardless of the print or width. This process could include provisions for different widths and prints. Is my assumption correct?

7.1.4 states: “the organization shall have a process to control and react to changes that impact product realization.” What additional information should I be covering in this process that hasn’t already been covered by, contingency plans, approved suppliers, equipment preventive maintenance, etc. etc.
I know many section overlap in the standard and interlace, hence determining interaction of processes. What additional information are they looking for in 7.1.4 that hasn't been covered in other sections of the standard.

Thanks for this great forum and the wealth of information I’ve gained!

I would not be convinced your company is even eligible for certification. Is your customer one of the Big 3? I can certainly accept that you need to be compliant with TS but IMHO I can't see certification. It would seem to me a 2 man shop making labels would have to hire someone else just to keep up with TS. The certification alone will be very expensive and there is a continuing surveillance requirement. I would get with your customer and determine if certification is truly necessary. I wouldn't go to the buyer either - talk to someone with the knowledge and authority to provide a waiver for that requirement. If certification is really a requirement, maybe you and the owner need to do some serious contract reviews. JMHO.

Dave

Thanks for the reply Dave,

I would agree with you on every point you made, however we have checked with our customer, (not one of the big three, but a large tier one supplier) our consultant, and our registrar and they all believe we need to be certified, and are eligible. The owner is aware of the expense, and willing to absorb it. As far as hiring someone to take care of the TS for now it’s me, the man with all the different hats. Down the road I will probably be dedicated to this with someone else taking over the production aspect of the business. After knowing this is there anything that would prohibit us from becoming certified?

Any thoughts on the original question would be greatly appreciated. I’ll still continue developing our QMS until I run into a roadblock.

Thanks,
Bill

I guess when the customer speaks, the lion roars. Along with D. Scott I'm not convinced you need certification but the customer has made their wishes clear.

I don't see anything in you way to certification other than that documentation might be your largest stumbling block. With the limited product line there is still the need to have the system in place but look at it from the bright side: You are small at this time and following the "rules" should not be hard, just time consuming. And when the system is documents you will be ahead of the 8 ball when it comes time for the company grow.

Always available to help!!!

Al...

Thanks Al,

I’m with both of you as to the “need” for certification, but as you say the customer has made their wishes clear. This requirement came about after one of our customers was taken over by a bigger company. That company is requiring the cert. As for documentation we do have a jump-start. We have been supplying the automotive industry for five years. I’ve been working on the quality manual, procedures, forms, processes, etc. etc. for about six months and hope to get our pre certification audit this quarter. My only concern is our small size makes it hard to utilize the “cookie cutter” procedures used for much larger companies. I’ve been lurking on this site and taking bits and pieces from many to formulate things that will work for us. I just hope the note in 4.2.1 holds true, “The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities.”

Bill