Informational Required Documents/Records in ISO 9001:2015

ChrisM said:

Does this go to show that no record is worth the paper that it is written on ?? There has to be an element of trust somewhere along the line

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Sure. The idea should be to not create records needlessly. Some people save nothing and others save everything. Neither "strategy" is prudent.

beth.s0321 said:

I am trying to figure out the best way to retain evidence of 8.6, release of product. Specifically the evidence of conformity with the acceptance criteria. Can we have something as simple as a check list of final inspection with job #, date, and person who inspected the items? Or does it need more specific information?

Example:

We have a webbing cutter that the operator sets up to measure and cut a certain number of pieces. The set up for the machine says operator measures the 1st piece and then every 10th piece. So does this check have to be recorded and each measurement documented?

One case we measure and cut each piece manually. A job could have 120 of these pieces, do each of these measurements have to be documented or just one line that says "measured and cut per BOO/BOM" and then the qty and initials of the operator?

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Often the ERP system provides what an organization may need in regard to this. Can't digitally (within the system) move to the next task, or have a bill of lading generated, or...etc..etc....if a task is not completed/product released to move on? ERP and/or current HR records (timeclock? station sign in, etc..etc...) that would provide identification as to who released the product?....identified it as completed?....

I would counsel to look at what already exists within your organization rather than create another layer of tasks/requirements/checksheets, which now will also need managed.

Hope this helps.

Be well.

ChrisM said:

As the saying goes, if it isn't documented, it didn't happen.

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Where's the documentation for the building of the "Spinx"?

Where's the documentation for "Stonehenge"?

Where's the documentation for the "Nazca Lines"?

All those things are there, there's no documentation, so they didn't happen?

John C. Abnet said:

Often the ERP system provides what an organization may need in regard to this. Can't digitally (within the system) move to the next task, or have a bill of lading generated, or...etc..etc....if a task is not completed/product released to move on? ERP and/or current HR records (timeclock? station sign in, etc..etc...) that would provide identification as to who released the product?....identified it as completed?....

I would counsel to look at what already exists within your organization rather than create another layer of tasks/requirements/checksheets, which now will also need managed.

Hope this helps.

Be well.

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Thank you. We are hoping that our ERP will serve as record of most everything that is happening in the actual production process.

ChrisM said:

As the saying goes, if it isn't documented, it didn't happen. You may not have to record the result of every measurement but if there isn't even a tick-sheet, how would you prove to an auditor that every 10th piece had been measured? It's a bit of a tricky one because if for example you place every 10th piece on a fixture to check length and so long as it fits, production continues, you may have a hard job proving to an auditor that this is taking place, and only if there is a fail would you record the result and stop the process to take action. This is assuming it's a human process. If it were automated, the machinery may not need to make any records, only for example to stop and sound a warning tone if it detects a failure. Making sure that your process if sufficiently well documented would help, but again you could be at the mercy of a pedantic auditor

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You really shouldn't insist that a record is needed when it is not a requirement.

And I thought the old (incorrect) attitude that you needed to have some sort of piece of paper (document or record) to prove you met every shall in the standard had long died.

If a record isn't required and you have chosen not to add one, you can tell an auditor tough luck if he insists on one. Invite him to the doo at the same time.

beth.s0321 said:

I am trying to figure out the best way to retain evidence of 8.6, release of product. Specifically the evidence of conformity with the acceptance criteria. Can we have something as simple as a check list of final inspection with job #, date, and person who inspected the items? Or does it need more specific information?

Example:

We have a webbing cutter that the operator sets up to measure and cut a certain number of pieces. The set up for the machine says operator measures the 1st piece and then every 10th piece. So does this check have to be recorded and each measurement documented?

One case we measure and cut each piece manually. A job could have 120 of these pieces, do each of these measurements have to be documented or just one line that says "measured and cut per BOO/BOM" and then the qty and initials of the operator?

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It's a very good question, Beth. You have homed in on one of the few areas of ISO 9001 where the requirement gets quite specific.

Take your example: if the control plan says you measure the first off and then each 10th piece there has to be a record of those measurements having been done. There are many ways of documenting those measurements having been made and that is up to you to decide. IMHO, the one-liner would not be enough.

Fast forward to releasing the product to the customer (to the point of 8.6). The (traceable) individual would have to look at the control plan (however termed) to determine that all the measurements (1st off, 1 in 10 pieces from your example plus any other checks, tests, measurements required in the plan) have taken place and that the evidence of conformity is available before they allow the product to be despatched.

Paul Simpson said:

Fast forward to releasing the product to the customer (to the point of 8.6). The (traceable) individual would have to look at the control plan (however termed) to determine that all the measurements (1st off, 1 in 10 pieces from your example plus any other checks, tests, measurements required in the plan) have taken place and that the evidence of conformity is available before they allow the product to be despatched

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Please elaborate on this expectation vis-a-vis an automobile coming from a high volume production line? Would you really expect someone responsible for “releasing” the car to a dealership or the end customer to “review” the existence of records for all the thousands of inspections and checks that have happened upstream of the delivery point?

I would guess not. The system should have been designed and implemented in a way whereby only conforming components, subassemblies and assemblies were authorized to progress to the next step in the process.

I challenge anyone to evaluate some of the best quality consumer products such as an iPhone or a Tesla model whatever and see if they would be able to find a “traceable individual” responsible for releasing the product, either to the marketplace or the customer. It simply does not happen.

Sidney Vianna said:

Please elaborate on this expectation vis-a-vis an automobile coming from a high volume production line? Would you really expect someone responsible for “releasing” the car to a dealership or the end customer to “review” the existence of records for all the thousands of inspections and checks that have happened upstream of the delivery point?

I would guess not. The system should have been designed and implemented in a way whereby only conforming components, subassemblies and assemblies were authorized to progress to the next step in the process.

I challenge anyone to evaluate some of the best quality consumer products such as an iPhone or a Tesla model whatever and see if they would be able to find a “traceable individual” responsible for releasing the product, either to the marketplace or the customer. It simply does not happen.

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You have asked the question in your first paragraph, Sidney and then answered it yourself in the second. The individual taking the decision to release will base that decision on evidence from the preceding stages. This is one of the requirements of a process audit - starting with a product ready for release. The auditor follows the evidence back through the process (and in time) to demonstrate that the control plan has been followed. and the release decision is valid.

To your third paragraph, Sidney, are you saying that the manufacturers of an iPhone or a Model 3 are not worthy of ISO 9001 certification? Most companies that I see have thought through this requirement and understand the need to be able to demonstrate that all required tests have been carried out. Much of the testing and assurance is automated and often the release, too. The ISO 9001 requirement is for any human decision-making, the context of the post I replied to.

Paul Simpson said:

Much of the testing and assurance is automated and often the release, too.

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So, there is no “identified” traceable INDIVIDUAL connected to product release, is there?

Sidney Vianna said:

So, there is no “identified” traceable INDIVIDUAL connected to product release, is there?

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I can guarantee every single inspection required by a Quality person on these things was traceable, to include torques applied to specific fasteners and required clearances.