Are Nonconformance inputs to the product also NC product?

Jim Wynne

Leader
Admin
Our product is a written report

8.3 of 9001 states ..... that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

Our reports that do not conform (containing errors) are simply re-edited until they are right, but what about the inputs to the product (report) such as data that is lost or destroyed upon which the report is based. Should this also be treated as non-conforming product?

First you need an objective definition of "product." The term isn't limited to only those things supplied to a customer. A product is the output of a process, and is produced according to specified requirements and could be a palpable thing, or data (for example). If the product doesn't fulfill specified requirements, you have a nonconformity.

It's helpful to think of this in terms of a manufactured assembly. The assembly is what's supplied to the customer. Nonetheless, each of the components in the assembly must be produced according to specified requirements, regardless of the fact that they might never be supplied to the customer in individual form.

In your case, if there is a specified requirement to preserve the constituent parts of the report--the data, design records, whatever--there is a nonconformity if those things aren't preserved. You can't have a nonconformity, in the orthodox sense of that term, without specified requirements, so if there are none, there is a problem but not a nonconformity. This means you need specified requirements for preservation of what needs to be preserved.
 
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T

treesei

Yes definitions first.:)

From the OP I draw the following:

Data = input = (raw materials in an assembly).

Product = finished report which contains all data needed = (finished assembly with all components needed)

Report with errors = NC product which can be corrected by editing.

Now I start guessing:

If the OP meant errors in data, it seems to = NC raw materials. They should not be used in writing the report. They are NC raw materials but not a NC product. Data should be reviewed and verified to ensure the useability first.

If the OP meant a report containing NC data, it will be a NC product.

If the data are technically correct but are missing/destroyed after the report is written, it seems to be a preservation/traceability issue. The consequence is that the report lost its creditability wo/o the support of data (evidence). Does this make the report an NC product? It may depend on the internal procedures. But, if I were a cusotmer, I probably will not knowingly purchase a report that does not have references that I can verify.

If the data are technically correct but are missing/destroyed before the report is written, there will not be a report (product).

:2cents:
 
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