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Measuring Process Effectiveness - Measures of Effectiveness (MOE's)

insect warfare

QA=Question Authority
Trusted Information Resource
#21
It was simple...We had a procedure (which IS required...but we were TS..don't know about AS) that covered Document Control..there is nothing requiring that it be a process...
Have to disagree on that one, GoKats, for surely Document Control – just like any other required ISO 9001 procedure such as Record Control, Internal Audit, Corrective / Preventive Action, Nonconforming Product Control and others – is a process which depend on inputs and outputs to deliver intended results.

The fact that you have to have a Document Control procedure proves this is a process (by definition), not because of the lack of a “shall” within the Standard, as I am assuming your justification for:

there is nothing requiring that it be a process...
ISO 9000 defines process as a “set of interrelated or interacting activities which transforms inputs into outputs”. Combine that with the definition of procedure as a “specified way to carry out an activity or a process”, and you can see why. Document Control is also more than simply an “activity” in that many things are going on during its execution, elevating it from a mere task to a full-fledged process.

If you still don’t believe me, I stated earlier that processes depend on inputs and outputs to deliver intended results…well consider the following example sequence of events:

Document Control inputs: Change Request, Need for New Documents Identified

Document Control process applied: (reviews, gathering signatures, etc.)

Document Control outputs: Approved Change Request Record, Updated Documents, Updated Master List

Notwithstanding the required 6, not all processes have to be documented, but saying that a process you have documented is not a process is simply incorrect.

Brian
 
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insect warfare

QA=Question Authority
Trusted Information Resource
#24
In ISO 9001, the required 6 documented procedures are:

4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audit
8.3 Control of Nonconforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action

Let's also not forget - quality manual + documented statements of quality policy and quality objectives + any additional documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

There is also a note in 4.2.1 stating that "A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document."

I'm not sure if there are additional documentation requirements for AS9100, though...

Brian
 
G

GoKats78

#26
We went through many TS audits...never had an issue with Doc Control NOY being a process...

Is your Control of Records a process?
 

LUV-d-4UM

Quite Involved in Discussions
#27
Ways of Measuring effectiveness are:
Internal Audit effectiveness - no. of open Corrective Actions

Process effectiveness - No. of rejects before and after implementing improvement

Training Effectiveness - Employee evaluation and test scores after training.:bigwave:
 

insect warfare

QA=Question Authority
Trusted Information Resource
#28
We went through many TS audits...never had an issue with Doc Control NOY being a process...

Is your Control of Records a process?
Yes, for the reasons stated in my previous posts.

I believe you when you say that you've never had an issue with it. But have you ever explicitly declared to an external auditor that this is not a process? You may not like what he/she has to say about the subject...:nope:

I don't want to derail this thread any further, since the topic of discussion is MOE. If you would like to continue this discussion on a different thread, I'd be happy to join in.

Hope I've Helped...:rolleyes:
Brian
 

LUV-d-4UM

Quite Involved in Discussions
#29
Here are some suggestions for measuring effectiveness:

Calibration plan - measure equipment deviation from calibration or breakdown

Training - administer test after training

Document Control - Zero violation during Internal/External Audits

Corrective Action - Zero recurrence after identifying true root cause

Process - Measure Defects before and after improvement; measure Right First Time

Hope this helps
 
P

ProDad

#30
@LUV-d-4UM

I happened to have gone back and re-read this thread after many months of further head scratching over MOE's. I thought it ironic that the MOE you suggest for Document Control is precisely the one I was using that the auditor didn't like. See my very first post in this thread.

Some things just have to be audited (also referred to herein as spot checks, monitoring, etc.).
 
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