8.6 Release Of Products And Services & 8.7


8.6 is the release of products and service as products are manufactured and or assembled. There are usually repetitive steps used to verify products are conforming it's customary to have verification activities at each step prior to moving to the next step to ensure that processes are performed correctly and that the outputs meet the requirements. Typically, this is accomplished through some sort of inspection or verification activities. This doesn't, necessarily mean that there's an old school.

Inspector pouring over every widget that comes off the line. But instead may certainly be something internal to the process such as error proofing or an automated verification. Either way ISO 9001 is very clear that steps must be put into place to ensure products meet the expectations prior to the release to the customer. And this includes pick checks advancements in technology can still ensure. This requirement is fulfilled as long as conformity evidence and traceability can be observed. This means. That at some point in the process of assembling and pulling the product for an order, we must have documented information that provides evidence of conformity and traceability to the person authorizing, the release having these checks in place will help us weed out those nonconformances.

And that brings us to 8.7 control of non-conforming outputs, 8.7 applies to process products and service that do not conform with the established requirements. We must have controls in place with responsibilities. Signed to contain and prevent further processing of non-conforming outputs. We need to prove that we take appropriate action based on the nature of the non-conformity and its effect on the conformity of products and services. This also applies to non-conforming products and service detected after delivery of products during or after the service have been provided. And this really all ties into 10.2 non-conforming and corrective action, which we already have a procedure for called non-conforming and. Corrective action, this procedure includes requirements in 8 7 and 10 2 that are available in our quality documentation here you'll find methods.

We used to identify and process non-conformities and implement corrective actions. We'll go over this in more detail in 10.2. But right now in eight, seven we're talking about control of products that are non-conforming or suspect, non-conforming to prevent them from their unintended use or delivery if a product is non-conforming, or you think it might be it.

Needs to be clearly identified and isolated in a way that it cannot be mistaken as usable inventory. We have a non-conforming tag that needs to be filled out complete and placed with the product. This tag will include details of the problem, or what the problem might be it's. Not enough to simply say, the item is bad or defective. We need to actually describe the issue as we see it this way.

There is no question as to why the material is not available in an audit situation. We need to be able to. Provide documented information with details that describe our nonconformances, including the actions taken any exceptions or justifications for use as is scrap or return to vendor.

It also needs to be clear who initiated the non-conformance and who is responsible for the disposition. An important thing to take away from this is that non-conforming or suspect, nonconforming are clearly identified segregated and reported to the responsible authority, that's your supervisor manager or QA. Representative and that's, all of section 8. Next up is clause 9, which is performance evaluations. This clause includes monitoring measuring analysis evaluation customer satisfaction, internal auditing management review customer feedback and customer complaints. Now, it'll take a few segments to get through all clause 9.

But it won't be as long as clause 8. I promise, but thanks for hanging with me through that one and that's all the time I have for you today. Thanks for tuning in till next time.

Dated : 19-Apr-2022

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