Organizational Knowledge Requirements - Meeting ISO 9001:2015 Clause 7.1.6

[DRAMMAN]

It does not. We just went through our audit last week. The auditor said this clause really has no specific requirements so just about anything you do arround hiring, training, or process documentation will allow you to satisfy the requirement. Kind of a useless clause if you ask me (from a standards perspective).

Essentially, it will be very hard for an auditor to ever right you a non-conformance.

 

[Sidney Vianna]

It does not. We just went through our audit last week. The auditor said this clause really has no specific requirements so just about anything you do arround hiring, training, or process documentation will allow you to satisfy the requirement. Kind of a useless clause if you ask me (from a standards perspective).

Essentially, it will be very hard for an auditor to ever right you a non-conformance.

I think we have to keep in mind the tremendous variation among auditors, especially when we are dealing with a new requirement of the ISO 9001 standard where very little "jurisprudence" has been developed. Just because one auditor thinks or acts one way, it does not mean that another one will follow suit.

Further, the aspect of knowledge management depends a lot on the context of the organization and let me offer a few examples:

• A start up organization, for example, is typically acquiring knowledge at a very fast pace and might have serious challenges managing knowledge in overload.
• An organization that has a high workforce turnover rate might struggle with the onboarding of new hires at an accelerated pace.
• An organization that is broadening it's business context, such as, for example, a machine shop that wants to expand from aerospace to medical device customers might have to gain regulatory knowledge in a short amount of time.
• An organization that has a significant number of experienced people retiring soon will experience brain drain if KM is not properly managed.

So, context of the organization will impact significantly the importance of and risks associated with RoCK - Retention of Critical Knowledge.

 

[RCW]

Just started looking at this clause. The first thing that came to mind, prior to getting to Note 1 & Note 2, was "Gee, that sounds like using lessons learned." Glad to see Note 2 gave support to that thought.

I'm working in a manufacturing environment. The knowledge necessary for the operation of my company is all procedures, documents and records within my QMS. For addressing needs and trends my supporting records are the revised inspection requirements that are generated just when you thought your supplier had cleaned up and prevented any further possible error. Also during and after a job is worked on (product is built), the manufacturing instructions are tweaked as required to provide more complete manufacturing information for next time (The official curse here is "We'll never build that part again!").

Some of what I'm seeing here is charts, matrices and other records being generated just to have records to show an auditor. I'd rather discuss with an auditor how I interpreted the requirement and implemented it than to do busy work creating unused pretty graphs.

 

[Big Jim]

Just started looking at this clause. The first thing that came to mind, prior to getting to Note 1 & Note 2, was "Gee, that sounds like using lessons learned." Glad to see Note 2 gave support to that thought.

I'm working in a manufacturing environment. The knowledge necessary for the operation of my company is all procedures, documents and records within my QMS. For addressing needs and trends my supporting records are the revised inspection requirements that are generated just when you thought your supplier had cleaned up and prevented any further possible error. Also during and after a job is worked on (product is built), the manufacturing instructions are tweaked as required to provide more complete manufacturing information for next time (The official curse here is "We'll never build that part again!").

Some of what I'm seeing here is charts, matrices and other records being generated just to have records to show an auditor. I'd rather discuss with an auditor how I interpreted the requirement and implemented it than to do busy work creating unused pretty graphs.

Don't get carried away. There are no record retention requirements attached to this clause.

 

[Russ]

We do a rather good job of gathering this knowledge and making it available with the exception of Packaging & Shipping. Most of this is Tribal through no fault of my initiatives to get minimal information recorded & available for whomever is doing the packing & shipping. Never thought it would be so hard to get a simple thing like this implemented!

 

[Golfman25]

We do a rather good job of gathering this knowledge and making it available with the exception of Packaging & Shipping. Most of this is Tribal through no fault of my initiatives to get minimal information recorded & available for whomever is doing the packing & shipping. Never thought it would be so hard to get a simple thing like this implemented!

Shipping stuff seems to change a lot. Use this freight company. Then 2 months later use that freight company. Go from 50 lb. boxes to 40 lb. boxes. Etc. A real PIA.

 

[Big Jim]

We do a rather good job of gathering this knowledge and making it available with the exception of Packaging & Shipping. Most of this is Tribal through no fault of my initiatives to get minimal information recorded & available for whomever is doing the packing & shipping. Never thought it would be so hard to get a simple thing like this implemented!

In this instance, what is wrong with tribal knowledge? If someone in the organization knows how to do this, great. You can gain depth with cross training so others can learn it to. Create a work instruction for all this if you wish, but the organizational knowledge portion of the standard doesn't require it.

 

[Russ]

In this instance, what is wrong with tribal knowledge? If someone in the organization knows how to do this, great. You can gain depth with cross training so others can learn it to. Create a work instruction for all this if you wish, but the organizational knowledge portion of the standard doesn't require it.

The reason I have tried to get this information documented is so that product is consistently packaged and shipped in such a way as to ensure the product gets to the customer in good condition. We have had a few errors in the past that could have been avoided had this been in place. I think it just makes good sense aside of any ISO requirements.

 

[Big Jim]

The reason I have tried to get this information documented is so that product is consistently packaged and shipped in such a way as to ensure the product gets to the customer in good condition. We have had a few errors in the past that could have been avoided had this been in place. I think it just makes good sense aside of any ISO requirements.

And thus the ageless question. To what level do you micro manage and to what degree do you teach correct principles and let them govern themselves and finding the balance between the two.

Find what works for you, but keep in mind that most people want to do what is right and only need to learn what is expected of them.

 

[Sidney Vianna]

We have had a few errors in the past that could have been avoided had this been in place.

Between having nothing documented, when it comes to packaging and shipping, and having everything documented, on the other extreme, using risk based thinking, it seems that are are CERTAIN products which requires packaging in a certain manner. Why not capture the knowledge for these specific cases and mitigate the risks of product damage due to inadequate packaging by documenting THESE specific cases?

The extent and level of detail in documented command media as an output of a knowledge management exercise should also take into account the risks involved.

Risk. Based. Thinking.