What's meant by ISO9001 clause 8.7 non conforming output?

[sunrizenew]

What mean by clause 8.7 non conforming outpt?

Is this mean non conformin in final products and services or is it mean nonconforming output from any enteire process such as sales, hr, production, maintenance.... Etc

 

[Jen Kirley]

The standard viewpoint is that the clause is directed to production. The specification ISO TC 9002:2016, Quality management systems — Guidelines for the application of ISO 9001:2015, clarifies by saying

8.7.1 The intent of this subclause is to prevent the unintended delivery or use of non-conforming outputs (at all stages of production and service provision).

I hope this helps.

 

[sunrizenew]

i understand that any other activities or process related to the final product or services have a nonconformity could treated as a non confiming outputs from these process or activities ?

is i am correct

 

[malasuerte]

Good business = Non conforming anywhere! It can be a single step, it can be the final product. It can be an incorrect PO/order.

You should have defined the "scope of your QMS". So at minimum, it would anything within that scope.

 

[Tagin]

i understand that any other activities or process related to the final product or services have a nonconformity could treated as a non confiming outputs from these process or activities ?

is i am correct

As Jen indicated, the "outputs" in 8.7 refer to the deliverables (services or products) to the customer.

Yes, you can certainly have nonconformances in your processes that either do or do not affect deliverables. For example, part of the production process might be to store a record internally of some activity, yet for some reason employees are failing to do so. They are doing the activity properly but not recording it properly. You now have a nonconformance in the process, but the delivered product to the customer is conforming because this particular internal paperwork nonconformance did not affect the final output. In other cases, nonconformances (e.g., forgot to screw the cover onto the widget) could affect the final output.

The point is that 8.7 is a special subset of of nonconformances that is called out explicitly, because it speaks to what the customer receives. The more general clause regarding nonconformances is 10.2, which is how you want to handle nonconformances in general throughout the QMS.

 

[Sidney Vianna]

As Jen indicated, the "outputs" in 8.7 refer to the deliverables (services or products) to the customer.

I don't agree with that.

For example, if a foundry produces a defective mold, that's a non-conforming "output". The mold is not a deliverable item for the end customer, but still, needs to be addressed.

If purchasing issues an incorrect PO to a supplier mis-specifying the raw material to be purchased, the PO is a non-conforming output (of the purchasing process). That PO, obviously is not a deliverable to the end customer, but can lead to defective products which would reach the customers.

 

[Jen Kirley]

I want to make clear that non conforming outputs that could affect the customer can certainly be in upstream production, as Sidney described. We should absolutely not forget that good outputs rely on good inputs. Remember the key phrase "...at all stages..."

 

[Tagin]

My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product...

It also seems that the placement of 8.7 in clause 8, directly after 8.6 Release of products and services, indicates that 8.7 refers to nonconforming products or services, and not to nonconformances in outputs of intermediary steps.

It also seems that since 10.2 covers all nonconformities, whether they are input ncs, output ncs, process ncs, etc., that 8.7 would be redundant unless it had a particular intent.

I could be wrong...there's a first time for everything.

 

[Jim Wynne]

My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":


It also seems that the placement of 8.7 in clause 8, directly after 8.6 Release of products and services, indicates that 8.7 refers to nonconforming products or services, and not to nonconformances in outputs of intermediary steps.

It also seems that since 10.2 covers all nonconformities, whether they are input ncs, output ncs, process ncs, etc., that 8.7 would be redundant unless it had a particular intent.

I could be wrong...there's a first time for everything.

The bit you quoted says that NC product shall be controlled "...to prevent its unintended use or delivery." (My emphasis) It seems that "use" is being differentiated from "delivery."

 

[Sidney Vianna]

My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":

As Jen already mentioned, earlier in the thread, the ISO TS 9002 could not have been clearer: at all stages of production and service provision. We can't spin that. If your interpretation was correct, the title of the subsection 8.7 would have been Control of non-conforming PRODUCTS.