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Organizational Knowledge Requirements - Meeting ISO 9001:2015 Clause 7.1.6

somashekar

Staff member
Super Moderator
#21
Re: Meeting ISO 9001:2015 7.1.6 Organizational Knowledge Requirements

Thanks for the comments. I think that I am going to keep this is as simple as possible and the competence angle captures the knowledge the guys who build things need to have to produce acceptable quality product. We keep a design library for technical design elements, and as new technology becomes available, we identify the knowledge we need to integrate into our designs and this gets added to the design library.

Is it wise to document how we go about it? i.e. how do we identify, obtain, store, maintain, review and communicate the knowledge required by the company, or just demonstrate that we do it.
Demonstration with confidence and assurance is the way to go. As a document, I would double up a good process validation document and record for this purpose, where the validation team members are named.
 
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QChas

Involved - Posts
#22
Re: Meeting ISO 9001:2015 7.1.6 Organizational Knowledge Requirements

Just remember what Dean Wormer instilled into the minds of Faber College students ..... "Knowledge Is Good"

 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#23
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

With knowledge management we hope to maintain craftsmanship in addition to skills. There are things schools can't teach. The long-experienced machinist also knows how the equipment behaves and how to use it, especially with older equipment. There might be pairing up so the more experienced craftsmen can teach the newer, younger technicians.

For HR Managers, it can mean establishing a "skills inventory" so projects can tap into a special skill that did not get included in employees' resumes because the job advertisement did not originally include it.

It can also mean ensuring all the needed tasks are done during reorganizations. I once went to a recently assigned ESD program manager in order to schedule an internal audit, only to learn he had never been told he was now the ESD Manager (and all the other stuff that comes with new responsibilities). Yes, really.
 

Billy M

Starting to get Involved
#24
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

I am also including items such as subscription to industry periodicals, persons who participate in industry forums, as well as the documented information in a company. I have added a section to the Management Review meeting template to identify areas where the company has determined how some of the organizational knowledge is identified and present within their system.
 

Englishman Abroad

Involved In Discussions
#25
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

All,

In addition to keeping information, we are looking into the succession planning process from a remplacement time perspective (i.e. risk of loss of knowledge perspective ).

e.g. It may only take a few months to find a new HR manager who has the competency and qualifications to replace the current person, but to replace the skilled production team leader that everyone uses to perform difficult job set ups in production may take years of specific experience of our parts, processes and machinery.

I think that a documentation (information only) based response to this clause will not (in our case) be sufficient. We are also evaluting mentoring etc. as a possible response in these cases.
 
S

sadamson

#26
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

Hi,
1. If no documentation is required (no process, no procedure, no records) how do prove that you have determined what knowledge is necessary?
2. How do you maintain, capture and share the knowledge if there are no records?

As stated in ISO knowledge is gained by experience and it means an event must take place (success/failure). Does the standard just ask that we have a discussion afterwards and that's that (no records needed)?

or to make everyone's life easier would it be better to maybe add a knowledge section in the monthly review and document?

or is it better to have a shared folder were people can dump stuff like conference papers, new standards, articles?

Lastly, 99% of people who leave couldn't give a damn about sharing anything!

I'm in the pharmaceutical wholesale business.

Thanks
 

Kronos147

Trusted Information Resource
#28
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

This is new territory. No one has figured it our yet.
I believe most successful companies do these things, just that they might not have established the "documented information" required to provide objective evidence yet.
 
B

bigqman

#29
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

ERP systems - depending on the degree to which they are implemented - serve as a organizational knowledge management system component, since its underlying technology is the relational database.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#30
Re: Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements

Hi,
1. If no documentation is required (no process, no procedure, no records) how do prove that you have determined what knowledge is necessary?
2. How do you maintain, capture and share the knowledge if there are no records?

As stated in ISO knowledge is gained by experience and it means an event must take place (success/failure). Does the standard just ask that we have a discussion afterwards and that's that (no records needed)?
There is no simplistic, one-size-fits-all answer to this. The knowledge acquired from a business blunder might get hard coded in a Verification & Validation protocol; for example, if I am a global organization which just spent billions of dollars in a product recall of products having their batteries exploding and being banned from all commercial flights, worldwide, I will make sure that, as I am validating new products which also contain batteries, the lessons learned (organizational knowledge) from the previous fiasco never get repeated, by instituting a much more thorough V&V process, defined in a NPI (New Product Introduction) Manual.

If I am an organization that got stiffed by a customer for lack of payment, which almost took me out of business, I will institute a process in my customer acquisition process that requires a credit check of that potential customer, before I engage in any project that requires significant expenditures. That "knowledge" is captured in a process and associated accompanying procedure titled "Customer acquisition and engagement"

Organizational knowledge, just like corrective action, is designed to make organizations, more effective, efficient and, as importantly, avoid repeat mistakes. Failure to learn from mistakes is just another trait of dysfunctional organizations.
 
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