Posted: Fri Jun 12, 2009 8:52 am Post subject: Nonconformity requires Corrective Action in ALL cases?
Our registration auditor has stated that every identified nonconformity requires a full corrective action (which, for us requires a very formal root-cause analysis process be performed).
Is it not true that nonconformities must have a correction or fix or control for the specific instance, but may NOT require a corrective action? Is it up to us to determine if a nonconformity must go through a formal root-cause evaluation? I'm thinking of nonconformities that are insignificant in nature, for which we have determined a corrective action is more cost prohibitive than a simple fix, etc.
We interpreted the Standard's statements (8.5.2) to reflect this:
"Corrective actions shall be appropriate to the effects of the nonconformities encountered."
"evaluating the need for action to ensure that nonconformities do not recur" (where the need for action = the need for analysis)
Lots of manufacturing processes cause non-conforming product that is expected and not worth correcting.
For example, the more complex a bare printed circuit board is (many layers of circuitry, very thin complex copper traces and connecting vias, etc.), the greater number of rejects are going to be produced. Such a manufacturer will factor in the risk, and start a work order with enough to allow for scrap. If the customer is buying the circuit boards in paneled groups, the manufacturer will even work out a deal with the customer as to how many "X-outs" (bad boards) are allowable in a panel.
Simply state in the procedure why non-conforming parts are created, how they are sorted out, and what is the acceptable yield of good versus bad parts. Keep records of the yield.
I thought so! We had a consultant working with us to develop our ISO system who has a manufacturing background and he was very clear on the point that all nonconformities do NOT need a corrective action. We are a computer support group (on the service side vs. production side of things), but I'm sure the same kind of thing could apply. A few auditors from this particular company have indicated to a few groups at our facility that every NC requires a CA. <this is a point of great frustration for us and our CA process owner is planning on revamping our procedure and process to remove the option of NOT producing a CA>
To play safe, it is better to have CA for the nonconformity.
Yes, some nonconformity is not necessary to have CA but it is necessary to have record for tracibility. Therefore, many company use CAR to convert both of them. However, some of the company break it down to two part, CAR and abnormality report while abnormality report is to record those nonconformity that no need to carry out CA but it is for tracibility
Sixsigmais said, "To play safe, it is better to have CA for the nonconformity. Yes, some nonconformity is not necessary to have CA but it is necessary to have record for tracibility."
Play safe from what? What would conducting corrective actions that are more expensive than the benefits they could yield be safe for? Or, are you inferring that safeguards must be undertaken because ISO9001 requirements or ISO Registrar auditors require actions that are not cost effective?
ISO is not about creating rules for the sake of bureaucracy.
I'm sorry, but this philosophy is simply not true. Daisylue was very clear and specific that the defects were insignificant, and that addressing them would be a non-value added cost to the organization.
I know of a plastics injection molding company who made jewel cases for compact disks in the late 1980's. Due to the robotic equipment of their customers that placed the CDs into the jewel cases and packaged them, each customer had different microscopic precision size and weight specifications. These specs were down to millionths of a gram and millionths of a meter. It just so happened that there was a band at the center of the overall range of weight and size which was not acceptable to any of the customers. So, when any lot of jewel cases were produced in this band of the range, they had to be ground up for re-processing. Would it make sense to conduct corrective actions because the product was perfect?
Another company needed a certain type of transistor with a super high beta. Two of these transistors went into each graphics engine they assembled that sold for tens of thousands of dollars apiece. They found one manufacturer who made this transistor that in each lot of a thousand, a few of these transistors had this super high beta. The transistor was extremely cheap, less than $.01, so the customer bought the transistor by the bushel, and sorted out the special ones. The customer did the sorting themselves and erased the nomenclature on them, so that competitors wouldn't know how they got these special transistors. But, if the customer had required the supplier to do the sorting, would the supplier continually conduct corrective action on over 99% of their product when they were making a good profit by producing, sorting, and selling less than 1%?
ISO9001 is about improving an organization's performance. Performing corrective actions and collecting records on defects that are expected due to the nature of the process and too costly to avoid would be activity that only hampers the organization and increases the cost of manufacturing the product.
Simply stating why these insignificant defects occur, why they are expected, and why it would not be cost-effective to address them in the process documentation and work instructions will negate the need for performing endless corrective actions and creating useless records. This will then allow the organization to allocate those resources that would have gone into these non-value added activities into activities to improve processes and meeting the real requirements of ISO9001.
You cannot post new topics in this forum You cannot reply to topics in this forum You cannot edit your posts in this forum You cannot delete your posts in this forum You cannot vote in polls in this forum