ISO 9001:2105 - Are OFI or Corrective actions required?

AndyN · Dec 17, 2018

To best answer your question, let's go back to basics:

Non-conformities may be "dispositioned", one of which may be "correction". Records should be maintained, which permit analysis and evaluation to detect trends which may indicate systemic issues, for which corrective action (root cause) may be necessary...

Sidney Vianna · Dec 17, 2018

embedded said:
Wow you all are awesome, thanks so much for all the suggestions.

To clarify a bit. When a problem is found there are different severities of problems. We don't want to go overboard and do a root cause analysis for every minor problem. So if the management team deems a problem not significant enough to warrant a root cause investigation(CAR), then my question was, do we need to have some lesser processes to capture the problem and actions taken. Section 10.2.2 seems to say we do. Although, it leads me to question of what qualifies as a non-conformance? I don't think a day goes by where minor issues don't arise and it's not feasible to document every one of them.

Also to clarify I thought a correction is a situation where something goes wrong but it's deemed not severe enough to warrant a root cause analysis so it is fixed without a root cause being identified. If I'm understanding correctly we need to have a process for corrections where we document every non-conformance(not clear what qualifies as a non-conformance) and actions taken(per section 10.2.2). Section 10.2.1 seems to say it's up to us to determine when a root cause investigation(aka CAR) is needed.

We're a really small company where we all wear lots of hats and we are fairly new to ISO so are trying to create effective processes, but can't afford to go overboard.

As you can imagine, over the years, this discussion has been had many times. Have a look @ Informal Corrective Actions - AS9100DCl. 10.2.1 A-H discussion. It was filed under the AS9100 Standard, but the same applies to ISO 9001:2015

embedded · Dec 18, 2018

Thanks so much I think I've got a much better understanding now. In a nutshell it sounds like if a requirement is not met, then it is a non-conformance and all non-conformances must be documented including actions taken.

I've got an issue that was brought to me this morning that I'm unclear if it's a non-conformance or not... The pack slip from a vendor has the wrong job number listed, and this is the fourth time this year this has occurred from the same vendor. I don't have a requirement for a packslip I can reference, so it seems like a bit of a grey area. How do you handle situations where there is no explicit requirement but it's clear there was an issue. I assume it's a judgement call. If so who typically makes the judgement call what is and is not a non-conformance? I ask as engineering management is of the opinion we're being petty and upsetting our vendors if we push to hard(our prices will go up), and production feels the vendor needs fix their mistakes and stop wasting our time so a CAR is appropriate.

AndyN · Dec 18, 2018

embedded said:
The pack slip from a vendor has the wrong job number listed, and this is the fourth time this year this has occurred from the same vendor. I don't have a requirement for a packslip I can reference, so it seems like a bit of a grey area.

Not even a grey area. If not having YOUR job # on THEIR packing slip is an issue, then make it a contractual requirement. If it isn't (yet) then you'll have to suck it up (for now)

embedded · Dec 20, 2018

This all makes a ton of sense and removes a lot of the subjectiveness I've been struggling with as a new quality manager. Thanks so much!

Ninja · Dec 20, 2018

Agreeing with Andy, but pointing out something easily misunderstood...

AndyN said:
If not having YOUR job # on THEIR packing slip is an issue

Before going CA, or contractual requirement, or whatever...consider whether or not this is actually an issue for you.
If the vendor simply left off any "job number" from the packing slip...would it really hurt you?
If not, don't ADD to the requirement...REMOVE that requirement.
That may be why you got the response you did from engineering mgmt...they may not care if its there or not...I never cared except when it was wrong...if it was simply missing, there was no problem...

Pancho · Dec 21, 2018

AndyN said:
Not even a grey area. If not having YOUR job # on THEIR packing slip is an issue, then make it a contractual requirement. If it isn't (yet) then you'll have to suck it up (for now)

Yup, I agree with Andy. And yet, if the number isn’t on the packing slip, but you need it and it is not in your contract, maybe there is better way than sucking it up. A correction might involve a change in this contract, or inspection and labeling upon receipt of goods from the supplier. And a renewal should certainly have the missed requirement.

But more importantly in the long run, perhaps there is a nonconformity in your contracting procedure. Why was the requirement missed? You may want to find the root cause of this. There may be other contractual requirements being missed, or purchasing contracts with other vendors may also be defective.

Jim Wynne · Dec 22, 2018

embedded said:
I've got an issue that was brought to me this morning that I'm unclear if it's a non-conformance or not... The pack slip from a vendor has the wrong job number listed, and this is the fourth time this year this has occurred from the same vendor. I don't have a requirement for a packslip I can reference, so it seems like a bit of a grey area. How do you handle situations where there is no explicit requirement but it's clear there was an issue.

First, if there is "...no explicit requirement," there can't be a nonconformity. This doesn't mean that there isn't a problem, however. It just means that a requirement might need to be established. If I read you correctly, not only is there no requirement for a job number to appear on the packing slip, there's no requirement for a packing slip. In most cases, a packing slip should at least reference:

Part number
Purchase order number
Quantity

There are usually other requirements as well. These requirements are communicated via the purchase order. If it's important to have the job number specified, you need to tell suppliers that. In the case of a "blanket" PO that has multiple timed releases, the PO should tell the supplier which releases should be associated with a particular job number. If all if that is done and the supplier still references incorrect information on the shipping paperwork, then there might be a need for CA.

embedded · Jan 10, 2019

One more situation where there is a some internal confusion / debate if you don't mind helping steer me in the right direction.

Issue: Sales gave ops the details for an order which was entered into the system accurately. Later the customer contacted sales and asked the date be moved up, which sales agreed to do, but sales failed to communicate to ops to update our system so the order shipped late. Please note the order already shipped on time per the date in the system, so ops followed all documented procedures correctly(there is nothing to correct at this point).

I'm not aware of any procedures or requirements that were violated(e.g. nonconformance) so some of the team is saying this is a problem for management to address, where others are arguing this is a quality issue and needs to be documented and reviewed in the periodic quality meeting.

Suggestions?

AndyN · Jan 10, 2019

embedded said:
Suggestions?

What's your process for making changes?

ISO 9001:2105 - Are OFI or Corrective actions required?

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