Intuitive Quality Design and Documentation Systems

[pbojsen]

We're trying out "intuitive quality design" and it's having an effect, as expected, on our documentation. While before we had most of the information in the high level QS SOP, (e.g. Design Controls), that information is now being pushed down into the lower level documents at "point of use," which could be in a form instead of the SOP. The high level SOP refers to the lower level document numbers.

We just had an ISO 13485:2016 audit. The auditor has a checklist. "Do you have an SOP for (e.g.) Design Control?" While previously he could get the SOP, read it, and check the box, this time he had to keep asking for documents as the information is at point of use. This results in auditor and auditee fatigue. It also is a big risk that one of the documents in the "web" of related documents could be changed, and then not align with the rest, causing dissonance in the procedure, and a "finding" in an audit. It's also a pain in the backside for change control.

How are those of you who have implemented intuitive quality design dealing with your documentation and structure? I am trying to come up with an elegant way of connecting the docs, so that any system user can find all related docs for changes. Apparently cross-referencing them is not intuitive enough.

Any ideas?

Thanks in advance

 

[Mark Meer]

Not sure if this would work, but maybe adopt a wiki? If references are implemented as links, then most wikis (I think) can tell you all the associated pages ("Documents") that are linked (i.e. all the documents that reference a given document). They will also identify broken links, and orphaned pages, that will help you ensure that all references are aligned.

 

[AndyN]

We're trying out "intuitive quality design" and it's having an effect, as expected, on our documentation. While before we had most of the information in the high level QS SOP, (e.g. Design Controls), that information is now being pushed down into the lower level documents at "point of use," which could be in a form instead of the SOP. The high level SOP refers to the lower level document numbers.

We just had an ISO 13485:2016 audit. The auditor has a checklist. "Do you have an SOP for (e.g.) Design Control?" While previously he could get the SOP, read it, and check the box, this time he had to keep asking for documents as the information is at point of use. This results in auditor and auditee fatigue. It also is a big risk that one of the documents in the "web" of related documents could be changed, and then not align with the rest, causing dissonance in the procedure, and a "finding" in an audit. It's also a pain in the backside for change control.

How are those of you who have implemented intuitive quality design dealing with your documentation and structure? I am trying to come up with an elegant way of connecting the docs, so that any system user can find all related docs for changes. Apparently cross-referencing them is not intuitive enough.

Any ideas?

Thanks in advance

I've got an idea. That was one specific auditor who was making your life difficult because they don't know how to audit effectively. Was it a Notified Body auditor or a regular (accredited) CB? I'd be concerned that they are prescribing how to audit from a checklist, too (before you go running off doing something unnecessary.)

 

[Mark Meer]

I've got an idea. That was one specific auditor who was making your life difficult because they don't know how to audit effectively. Was it a Notified Body auditor or a regular (accredited) CB? I'd be concerned that they are prescribing how to audit from a checklist, too (before you go running off doing something unnecessary.)

I agree with your concerns regarding audit being reduced to mere checklists.

But I think the OP also raises a separate point regarding the adoption of a granular, interconnected system of documentation. If you decide to adopt a complicated "'web' of related documents" where each references one or several others, there is certainly cause for considering preventive action with respect to maintaining those relationships.

Irrespective of the auditor's concerns/difficulties, I think there is still good cause to consider how to best manage a complicated interconnected system of documentation in order to prevent document non-conformities in the future, and facilitate future changes.

My personal approach is to simplify by reducing the number of documents. However, if the "intuitive quality design" is something you deemed worth pursuing then you certainly also have to consider an effective way to manage the documentation control challenges.

 

[Sidney Vianna]

In one of the webinars conducted by Mr. Nigel Croft in advance of the ISO 9001:2015 release, he had a comment that is very appropriate to this discussion, despite being in the ISO 13485 forum. The principle/wisdom still applies.

The comment was along the lines, reminding us all that a quality management system is a documented system, but NOT a system of documents... People confuse processes with procedures, people confuse documents with systems.

As mentioned numerous times, the purpose of documentation is to provide process definition and capture organizational knowledge.

Organizations are dynamic, things evolve, new technologies are introduced all the time and the quality management system has to continuously morph itself in ways to support the business needs.

If an external auditor has a checklist to complete, that is his/her problem, but your system is NOT certified to a checklist. Your system is certified to a standard. Keep that in mind and don't ever stifle your QMS development in order to keep an external auditor happy. They can be very fickle.

 

[pbojsen]

If an external auditor has a checklist to complete, that is his/her problem, but your system is NOT certified to a checklist. Your system is certified to a standard. Keep that in mind and don't ever stifle your QMS development in order to keep an external auditor happy. They can be very fickle.

No kidding! We have to comply with several standards, but these auditors basically wanted to see everything to ONE standard, which isn't going to fit our business.

The "intuitive quality design" is being implemented without any discussion. I'm just getting documents to approve that do not fit our documentation definitions.

 

[Wolf.K]

Just citing the 13485:2016 guideline, chapter 0.5 "Compatibility to other QM systems": "This section provides an outline of the relationship to other management system standards to outline the ability to meet the requirements of each in a common system."


So, if you have a document somewhere, everything is fine as long as you are able to find it... Document management, i.e. information management becomes more and more important.



Personnally, I think that the old (paper-based) system with manual and SOPs and WIs will come to an end very soon. ISO 9001:2015 already does not require a manual anymore. If that is a good idea, I don't know. Somewhere you have to have a starting point.



Probably something like a wiki is a good idea, with audit trail and everything. Especially in the not-so-far future with AIs (artificial intelligence) programming algorithms to control such a wiki, life might get much easier...


W.

 

[John Broomfield]

The "intuitive quality design" is being implemented without any discussion. I'm just getting documents to approve that do not fit our documentation definitions.

pbojsen,

By “intuitive quality design” are the process experts replacing your traditional documented procedures with their tools that help them to get more of their work right the first time?

If so that seem like a good idea to me.

The managers’ process monitoring and your internal auditing may though still use your procedures to verify the effectiveness of these tools.

I’m guessing that the third party auditors have yet to break free of their canned checklists.

John

 

[normzone]

Probably something like a wiki is a good idea, with audit trail and everything. Especially in the not-so-far future with AIs (artificial intelligence) programming algorithms to control such a wiki, life might get much easier...

W.

Yes, and when Eisenhower was president they promised us flying cars in the near future.

:

 

[AndyN]

Yes, and when Eisenhower was president they promised us flying cars in the near future.

:

Yup, and when I worked at Xerox, it was the "paperless office"