Thanks for the response. The qualifier is in the first line -- "as applicable." And it ABSOLUTELY depends on the criticality of the specified oil to the process. And that is the issue. In our business, oil is more of an art than a science. We have 70+ years experience dealing with it. The problem is it's not a low cost/effort activity. It's actually a lot of effort for zero return -- it's very difficult to keep labels/writing in tact in an environment where nothing sticks -- so it has to be "policed." Why doesn't our expertise rule the situation? Why does the auditor's opinion that ". . . should have been implemented" outweigh our expertise?
Appeal of Nonconformance Finding
- Thread starter Golfman25
- Start date
Determining the necessity of more detailed procedures may be part of your risk-based thinking but such thinking may have become second nature and unrecorded.
But you may have recorded this determination indirectly when the employees responsible for completing these undocumented tasks well, were assessed as competent. Your auditor should have included records as evidence of the adequacy of system documentation.
Add this to the fact that you’ve not experienced any problems with this process or it’s undocumented tasks nor with the results is evidence that the process is document sufficiently for planning, operating and controlling the process.
It seems to me that your auditor did an inadequate job of seeking evidence of effectiveness and conformity.
But you may have recorded this determination indirectly when the employees responsible for completing these undocumented tasks well, were assessed as competent. Your auditor should have included records as evidence of the adequacy of system documentation.
Add this to the fact that you’ve not experienced any problems with this process or it’s undocumented tasks nor with the results is evidence that the process is document sufficiently for planning, operating and controlling the process.
It seems to me that your auditor did an inadequate job of seeking evidence of effectiveness and conformity.
qualitymanagerTT
Involved In Discussions
Insufficient information.
1) How many types of oil are available/used?
2) Does the type of oil affect, or could affect the product? E.g., you are a bakery, and any type of cooking oil can be used to reduce dough from sticking on prep surfaces or in baking tins
3) Has the absence of labels on containers led to incorrect use of the oil?
1) Six. But, two are used to fill machines in the morning and the containers returned to the master barrel. The 4 other are forming oils. But only 2 can be sprayed — one is yellow colored, the other clear colored. The other two in a spray bottle would be useless.
2) No the type of oil would have little effect on the quality of products in question.
3) oil is more of an art than a science. There is no right/wrong oil. Oils are frequently mixed to get the viscosity we want. It’s all dependent on how the material is forming that day.
The auditor‘s response was all about “how” you can identify the oil without a label. That obviously assumes somebody put the “right” oil into the container from the master drum. Which leads to the true answer — we can ask (it's kind of a new thing). If need be we can use our experience and easily identify the oils by color, viscosity, etc.
So it becomes a question of whether you create a beast to label everything and then feed it by ensuring the labels stick, are legible, etc. or continue to do what has worked for 79 years.
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Matt's Quality Handle
Involved In Discussions
I'm not an EH&S expert, but across all 5 industrial companies that I've worked for, safety has required labelling of secondary containers. You may be violating OSHA requirements as well.
I absolutely would not fight the audit finding on regarding the issue of secondary containers. Not having secondary containers labelled is asking for problems, even on the "happy path" of imagining the floor is working exactly as intended. As soon as we imagine that somehow another unlabeled container appears, all controls are out-the-window as far as what is in what container. There is no way to know what may have been, or is supposed to be in, an unlabeled container.
As for "determining" what is appropriate for a work instructions: Typically work instructions are approved (minimally) by TWO people. One of them is the person with responsibility for the WI(s), the other is an independent quality associate. If you have records that the WI was released via a process with the recorded approval of such people... that should be all you need to demonstrate that there was a determination of the appropriateness of WI(s). Of course, it is impossible to prove a negative. However: if all the WI for an area go through such an approval process I believe that it isn't a great leap to assume that should (currently undocumented) activities be required to have their own WI, the company would have landed on them.
As for "determining" what is appropriate for a work instructions: Typically work instructions are approved (minimally) by TWO people. One of them is the person with responsibility for the WI(s), the other is an independent quality associate. If you have records that the WI was released via a process with the recorded approval of such people... that should be all you need to demonstrate that there was a determination of the appropriateness of WI(s). Of course, it is impossible to prove a negative. However: if all the WI for an area go through such an approval process I believe that it isn't a great leap to assume that should (currently undocumented) activities be required to have their own WI, the company would have landed on them.
We’re talking about ISO 9001 requirements. We fall under exceptions for everything else.
So where is the ISO 9001 requirement regarding secondary containers? I hear what you’re saying, but context is important. It doesn’t freaking matter. So how do we know what is in a labeled container is what it says is in there? Could someone not fill the container with the wrong substance?
As for work instructions, we are talking about decisions made on the fly In the ordinary course of the day. Say for example a tool breaks and leaves a mark on a part. We stop production and send the tool for repair. But we have a barrel of good and bad parts. So supervisor brings them to the inspector and says check these parts for marks, maybe even shows a sample. Do I need to write up a WI go thru your two step approval process?
So if you have TWO unlabeled containers, what substance is in each container? This sort of stubborness reads as very petty.
Do you have ANY work Instructions? Are all the inspections being done on-the-fly?
qualitymanagerTT
Involved In Discussions
In general, I'd say ISO 9001 clause 8.5.2 Identification and traceability: "The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services ... The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability."
Because it's a secondary container, it follows that the oils being there is the output of a dispensing / pouring process (or activity, but that's a different discussion).
However, because you previously stated "the type of oil would have little effect on the quality of products in question", from a risk-based perspective there is little risk that the conformity of products would be affected, and clause 8.5.2 may not apply to the oils.
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