8.5.2/3. Learned Peers, was wondering how you guys determine when corrective/preventative actions should be implemented after a non-conformance is encountered. The way I interpret this baby is: I can implement and complete C/PAs whenever I feel it is necessary as long as I show objective evidence that I am following up on serious problems (I.e. doing something!)...
"The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy,quality objectives, audit results, analysis of data, CORRECTIVE AND PREVENTATIVE ACTIONS and management review." My problem is that I work for a prototype/R&D centre so we only ever make the same part 10 times max...
Could anyone supply me with the wording from their quality procedure outlining under what circumstances a C/PA is initiated?



Al:bigwave:

Isn't the prototype business fun?????
Welcome to the cove Al.
I'll start with letting you know that I work for a prototype stamping company so I know what you're up against.
The structure we have put into place is a 3 tier system starting with a data gathering document.
Due to the constant change taking place and the very low volume of parts, IMO you have to be very process focused. You can't rely on parts or deliverables to point you to issues. So, in a nut shell, here is how our system is used.
1) We sat down and mapped out the process hand-offs. Either from function to function or department to department.

2) Established accept/reject criteria for each hand-off (inputs and outputs). This can be very difficult especially if you are doing hand work. But you must determine what the previous operation was suppose to accomplish.

3) We start collecting data at this point with what we call a Rework/NC report. Because most prototypes are "worked in" by hand there are very few "nonconfoming" products. However, from time to time a punch will break, etc. which will require rework. The operators report these incidents with the rework NC form and pass it along to the supervisor or manager. This information is used for a frequency (pareto) chart. This information is collected and reviewed by the Quality Ops Eng group also (QOE).

4) The Supervisor or Manager has the authority to kick off investigation into the problem if they feel it is necessary. Maybe the tooling is not performing up to expectations due to design, etc. In that case they will initiate an Issues/Action sheet which assigns responsiblity, timing, etc. and requires a 5 why for root cause analysis. They can also initiate a formal investigation by requesting an A3 report.

5) If QOE decides that the problem is systemic or processed based upon review of the compiled Rework/NC reports, etc. an A3 report is initiated.

Prototype is difficult to get the cut and dry nonconformance found in the production world. You must be processed based IMO in order to do any good. Especially if you have design responsiblity. If something doesn't work you can change the design and never truely have nonconforming product to work with. I'll attach our old procedure (less than a year old) to show you our ground work system. I trust with that you will be able to understand how the above steps were developed.
Currently we are going through another revamp of the system to fine tune how our "First Time Quality Teams" will be reporting.
I'd be more than glad to assist Al.
:ko:

If the flow chart can help you, I'll be glad, even if I'm working in mass production.

Vio