Performance Indicators for Document Control

[Illek]

I personally will be watching to see if our Document Control is integrated into the Training Program since changes to manuals and procedures can affect the training level of personnel. Awareness of our document site (orientation), uncontrolled training material etc. Not sure HOW to manage the performance indicators yet but it is a goal.

illek

 

[tony s]

I would NOT attempt to devise performance indicators for document control, as this is not a core process

Agree not a core process. However, I consider document control as a support process. We have a Document Controller to ensure that the right documents are available at points of use. I believe ISO 9001:2015 clause 4.4.1 doesn't refer to core processes only as stated below:

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

 

[Jen Kirley]

Don’t error in your thinking that you must develop a measurement for each clause of ISO 9001:2015. Your organization is required to define measurements for each process of your system (see 4.4). [FONT=&quot]We treat document control as process control because it exists within every process of the organization. Because it is not an organization defined process (4.4) it does not require a measurement.[/FONT]

It also appears that based on the ISO/IAF “9001 Auditing Practices Group Guidance on Processes” (published 13 January, 2016) that not all measurements need to be quantitative. This authoritative document clearly states: “that a process must have defined objectives (but they need not necessarily be quantitative measurable)”.

I'd like to point out that document is directed to auditors and the verification of conformance to requirements. In that context the guidance document did say "Quality objectives are to be measurable and verifiable" and is describing that the auditor need not quantify conformance has been verified, but may indicate yes/no.

I've held onto the idea that measurable objectives are not needed for support processes, but was told that all QMS processes do need a measure of effectiveness.

 

[Jen Kirley]

Unless documentation has been (historically) a source of problems leading to product conformity and/or customer dissatisfaction, I would NOT attempt to devise performance indicators for document control, as this is not a core process and, in my opinion, it would amount to busy work and unnecessary bureaucracy.

On the other hand, if documentation HAS led to quality problems, we should use the actual failure modes in the document control monitoring process. I.e. If we've had nonconformities due to obsolete process specs being used, existence of obsolete documents should be a meaningful indicator to be tracked.
In other words, devising indicators that have no connection with your context makes not much sense.

I do agree but am being compelled to require a measurable objective for every process, based on 4.4.1c. I've pushed back but expect to lose the argument. I'm just a peon. ISO needs to provide an interpretation for users and auditors. :

 

[Sidney Vianna]

I do agree but am being compelled to require a measurable objective for every process, based on 4.4.1c. I've pushed back but expect to lose the argument. I'm just a peon. ISO needs to provide an interpretation for users and auditors. :

Jen, many people in technical management positions for CB's are given the responsibility and authority, but are not necessarily made competent for the function they exercise.

There is a lot of CYA :ca: in the CB community with moronic instructions being flown down to auditors just to "appease" accreditation and oversight bodies.

On this specific case we are discussing in this thread, an EXAMPLE of a performance indicator for the document control (which is a resource) process could be a quarterly/annual/monthly (whatever meaningful) frequency review of nonconforming products which could be attributed for erroneous command media (documents) being used. Together with similar findings from internal audits on the issue of doc. control, could be aggregated and be used as a "performance indicator" measure for this support process.

As we all know, ISO 9001 does not have a requirement stating that common sense needs to be deployed, but we know we must do it, in order to develop and improve a QMS that supports the business and NOT the other way around.

 

[BoardGuy]

I'd like to point out that document is directed to auditors and the verification of conformance to requirements. In that context the guidance document did say "Quality objectives are to be measurable and verifiable" and is describing that the auditor need not quantify conformance has been verified, but may indicate yes/no.

[FONT=&quot]This may be true but the same information can be used by organization implementing a QMS to assure that the auditor and the organization they represent do not over reach during the audit. My organization was once told by our CB that we must have effectiveness measurements that contained both a measurement of quality and also on time delivery for each process. After the CB did some consulting with ANAB the CB stopped requiring those measurements because they were not required by the Standard.[/FONT]

 

[JoShmo]

We usually establish performance indicators for the core processes such as production yield, acceptance rate, etc. We also tried to determine performance indicators for internal auditing. I would like to ask my fellow covers, what would you recommend if I have to determine performance indicators for document control?

Is doc control a core process? Can't imagine why, if it isn't, you'd have any real reason to bother. Like your car, you could count the number of times the wheels go round. Interesting but useless and doesnt help driving/ecomomy/safety one bit.

 

[Marc]

Without robust document control, a company has big problems. To not recognize the significance of document control as a core process is, to me - Unimaginable.

 

[tony s]

Is doc control a core process? Can't imagine why, if it isn't, you'd have any real reason to bother. Like your car, you could count the number of times the wheels go round. Interesting but useless and doesnt help driving/ecomomy/safety one bit.

Document control is a support process. Since it is a process, 4.4.1c of ISO 9001:2015 applies to it. Just want to ask fellow covers on what they can recommend as performance indicators for this process.

 

[Candi1024]

Review meetings held in a timely fashion?
All issues found in review meetings resolved in a timely fashion?
All employees required to be at review meetings attend?