I've been asked to lead our company into QS-9000/TE by the end of the year. I have no experience in this. Does any one have any suggestions on where to start or who I can contact for more information. We are a tool and die manufacturer in southern Ontario if that helps. Thank you in advance.
I have been asked to implement QS-9000 and/or TE. We are a medium size tool and die manufacture. We have some procedures in place but the majority are verbal controls. I've read both manuals now and I don't know where to begin. I am getting each department to write down their procedure in point form. We run with limited management and their jobs over lap all the time. I've tried to define responsibilities and asked them to review the part of the manuals that would apply to them.
However in the manuals I don't know how to apply them to our circumstances. For example: QS-9000, Process Monitoring and Operator Instructions 4.9.1, states "The supplier shall prepare documented process monitoring and operator instructions for all employees having responsibilities for operation of processes. These instructions shall be accessible at the work station." First of all our employees are all skilled trades men and every single block, which we use, goes directly into the quality of our product, which is our dies. If I were to ask them monitor each process we wouldn't have time to build our product. Second every operation we do is unique to that particular block so writing operator instructions is impossible. This is only the start of our problems understand how these manual apply to us.
Is there a way to fully understand how these manuals apply to us and put them into terms more people can understand. I believe I have a good understanding what the manuals want but I'm not sure how they apply to what we do. We produce excellent tooling but we think it could be better. I have buy in from our upper management but they have stated to keep the paperwork down to a minimum.
My big concern is pfmea, control plans, PPAP, statistical techniques and customers not buying in (ie will not sent current part prints).
Anyone with any suggestion would be appreciated. Thanks in advance.
I work for a company that basically does the same type work, we have been TE registered for a few years now so I may be able to help you. First look at the TE supplement, 4.9.1 replaces the QS requirements. It says the instructions "shall be adequate to document the ...... process". Use your process sheet, etc.
The TE supplement is a filter for QS. You have to use them in combination, plus the TE will tell you when something replaces a QS requirement, the 2nd para under Intro/Approach hints at this. Also look at Implementation.
For your Control Plan issues look at TE 220.127.116.11, as for PFMEAs it states that they shall be documented for "all manufactured products", use the generic ones for your die manufacturing process, maybe split into commodity groups.
This is a starting point and remember to keep it as simple as possible and do not re-invent the wheel. You probably have most item covered being in a "skilled trade" business.
If we develop our procedures in a process flow type chart can we not write detailed procedures? If so, what information must be in the flow chart? (form #, responsibility ID, gerenal description of the process)
Does any one have or know of, an example of this type of procedure type flow chart?
We manufacture and design dies which produce our customers product, however, we have no say in the design of the customers produce nor can we change our customers product, does this allow us not to include design control in our process?
#1 Keep it within your Document Control system. If you state that only the Owner will make changes then that is what it must be. If you leave it up to the Department Mgr. then establish what he does to ensure the change is correct (sign, date, etc.).
#2 My answer is no. If you're similar to our operation, we receive the product design and have to reverse engineer it to get the tooling to make the end item. So die design is applicable.