Feedback on proposed restructure of Quality Management System (QMS)

01mercy

Involved In Discussions
#1
Hello all,

I'm here to ask you a few questions on my road to restructure our QMS.

Our company has for a few years now had a external bureau that made a QMS "just to fulfil ISO audits" now I've start working there and I'm committed to set up a QMS that works for the work floor and that gives structure and clearity to the different departments, in short to make it practical.

Attached I have the situation and my plan high lvl how work through it.
Can anyone have a look and tell me if you have other ideas or maybe you find it ok.

Next to that I have a other question.
We talk about Q manual, procedures and work instructions. My experience is that SOP's standard operating PROCEDURES are used as instructions. I have experienced this in the past. Does anyone have a logic abrevation system for this?
My thoughts go out to PRO for procedures and INS or LWI for instruction or local work instruction.
Can anyone please share what you use, its mainly for me to set-up a logic coding of the documents.

Thanks!
 

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Ajit Basrur

Staff member
Admin
#2
Hello 01mercy

Typically organizations have the 4 tier quality management structure with Level 1 as the Quality Manual, Level 2 as procedures supporting the requirements of the Standard, Level 3 as work instructions supporting the operations and Level 4 as Records.

The Procedures are typically telling "WHAT" to be done while the WI tells "HOW to do. As you rightly mentioned, I have seen in many organizations that the work instructions would be termed as Procedures.

On the abbreviations, its purely based on what your organization and employees are familiar with as they have to use in the long run but typically, PROCEDURES are either refered as PROC and WORK INSTRUCTIONS as WI.

Did you check what your coworkers would like to have ?
 
T

t.PoN

#3
Set up the level of documentation or the hierarchy of documentation. then you can state what is needed as a Procedure or what is needed as a work instruction.

for example:
You can start with Top Management Manual, then Procedures and go down to the production floor work instructions.

there is no exact science in identifying what is procedure and what is work instruction, it is up to you.

For example, some use SOP as for equipment operating procedure, and others use it as a instructions in the production floor.

this link might help you:
http://elsmar.com/level2/doc-hier.html
 

01mercy

Involved In Discussions
#4
Thanks for your feedback Ajit Basrur and t.PoN.

Ajit Basrur,
The situation is now that my co workers don't really work with the system and that procedures and instructions are actually created on ones own computer locally (in worse case).
In general the system used now for coding is the department short with p or I or F for procedure instrunction and form. But this coding does not work when creating a overal document register to track changes and versions. So I basically have to start from scratch with the logic and next step is the content. I think a three letter combi PRO, LWI and FRM will be good to use.

t.PoN,
Thanks for the explanation, I'm aware of the hierarchy (but still thanks for the pyramid link it's better than the one in the ISO TR 10013 2001). I'm now thinking of the structure to put this hierarchy in and what I know from my previous work is that the structure of the clauses in ISO9001 are followed as a structure in the Qmanual and I want to use it also for the folder structure of the documents. Than the structure in the manual is one on one the same as the storing structure of the documents.
 
T

t.PoN

#5
how are you writing your procedure?
Some write it for process, others for department and others for certain job or tasks.
what flow are you keeping track of? is it information, is it customer, material ...etc?

for the coding, you can use general coding like the one you suggested PRO, WI , SOP.

but I usually prefer that a person looking at document number will understand what does it mean?
for example: you can use department or process abbreviation to indicate the document: Purchasing procedure 1, Pur01, Supply Chain SC01, Main01...etc.
you might have a huge list of abbreviation but it will be easier reference.

what i'm trying to say, don't get stuck in the procedure, sop, WI structure.

you are already trying to get out of the ISO structure, so make it suits u, and invent what ever make u feel better
 

John Broomfield

Staff member
Super Moderator
#6
Document Coding Scheme

Objectives:

  1. Uniquely identify QMS documents
  2. Enable control of QMS documents
  3. Identify process owner
  4. Indicate status of QMS documents

Bottom right corner of each page:

A-B-C (D)

Where:

A = document type (MA, PR, IN, FM, SP or as required)
B = department ID of process owner (example EN for Engineering)
C = document number (01 to 99), 00 can be master list
D = letter or number
D = A would be first first draft - comments requested
D = 01 would be first issue - approved for use and improvement

Process Owner ensures PR accurately defines the process objectives and who does what, suppliers and their inputs, tasks including the control measures, outputs and their customers.

Process Owner links PR to supporting docs such as IN and FM before coding the documents. Supporting documents, coded for an earlier process, keep their original codes.

Process Owner shows System Manager evidence of review and approval to enable the System Manager to update the doc's status.

System Manager then makes the QMS document available to reviewers and users.

Cross-reference links only to the A-B-C part of the code and avoid including D part of code in file names of electronic docs.

John
 
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01mercy

Involved In Discussions
#7
Thank you all for your input.
John, thank you that's very clear.
I was thinking of pretty much a similar coding
i.e. doctype-dep-depdocnr-version : PRO-QUA-001-01_Title (where 00 stands for draft version)

One more qeustion that's bugging me a bit on how to control it.
Since our plant is larger than the previous plant i worked, here it doesn't work to track all corrective actions from each department in one file. We do that now and it's not a succes. I want to break it down to corrective action tracking per department to keep clearity, ease of drawing metrics and to deligate ownership.
However during iso audit we've been told to improve on our effectiveness checking of our corrective actions. Ofcourse i can put a "checked-status" in the tracking document but how would i best store the proof of it in a controlled way?
For the quality system that is covered by system audits which i can follow up in the internal audit section. But I'm talking about the proof of effectiveness not of the follow up of the changed document but what practical result that was intended with the changed content.

Would you check this case by case or could this be covered with an audit to? If case by case how to store the results of the checks in a controlled way?

(Sorry for using a lot of words I'm not an USA or UK native :) )
 

John Broomfield

Staff member
Super Moderator
#8
Thank you all for your input.
John, thank you that's very clear.
I was thinking of pretty much a similar coding
i.e. doctype-dep-depdocnr-version : PRO-QUA-001-01_Title (where 00 stands for draft version)

One more qeustion that's bugging me a bit on how to control it.
Since our plant is larger than the previous plant i worked, here it doesn't work to track all corrective actions from each department in one file. We do that now and it's not a succes. I want to break it down to corrective action tracking per department to keep clearity, ease of drawing metrics and to deligate ownership.
However during iso audit we've been told to improve on our effectiveness checking of our corrective actions. Ofcourse i can put a "checked-status" in the tracking document but how would i best store the proof of it in a controlled way?
For the quality system that is covered by system audits which i can follow up in the internal audit section. But I'm talking about the proof of effectiveness not of the follow up of the changed document but what practical result that was intended with the changed content.

Would you check this case by case or could this be covered with an audit to? If case by case how to store the results of the checks in a controlled way?

(Sorry for using a lot of words I'm not an USA or UK native :) )
Mercy,

Why three characters instead of two? I do not understand the benefit of three. PR-QA-01 trips off the tongue a lot easier than PRO-QUA-001. Try not to make the QMS look too bureaucratic.

Uniquely identifying your PARs and CARs in a way that enables you to see trends for further action should be system-wide. I do not understand the benefits of a departmental breakdown.

Each CAR needs clearly defined milestones for effective tracking, such as:

  1. Accepted and Issued
  2. Containment Effective
  3. Investigation Complete
  4. Root Causes Removed/Mitigated
  5. Verified as Effective
  6. Closed
2 may not be on the CAR because it is part of the NCR for control of nonconforming product.

Of course, 5 should completed by the manager responsible for the CAR before the issuer verifies the evidence used to verify effectiveness. So, you could have 5a and 5b.

John
 

01mercy

Involved In Discussions
#9
Hi John, if dep abbr are used, 3 chracters is already the trend. But maybe it's better to change this to.

To clearify on the CAR reporting, with corrective actions it is undoable now to make a report on each one.
We are a 24/7 plastic waste plant and if we would make a CAR for each CA that would mean a plant standstill and everybody writing reports :) .

Optimal we would like to have the proces stability to do that but that's not the case. In fact the people are unfamilliar with this discipline so at first it must be really easy and as little work as possible.

What would really be the minimum proof to follow up to verify the effectiveness of a CA so that we don't get burried in report writing? Any ideas?

I already do have ideas how to follow up the verification results (thanks for the inspiration)
 

John Broomfield

Staff member
Super Moderator
#10
Hi John, if dep abbr are used, 3 chracters is already the trend. But maybe it's better to change this to.

To clearify on the CAR reporting, with corrective actions it is undoable now to make a report on each one.
We are a 24/7 plastic waste plant and if we would make a CAR for each CA that would mean a plant standstill and everybody writing reports :) .

Optimal we would like to have the proces stability to do that but that's not the case. In fact the people are unfamilliar with this discipline so at first it must be really easy and as little work as possible.

What would really be the minimum proof to follow up to verify the effectiveness of a CA so that we don't get burried in report writing? Any ideas?

I already do have ideas how to follow up the verification results (thanks for the inspiration)
Mercy,

Do not initiate CA until you have completed your 80:20 (or 50:4 for an even sharper focus) analysis to separate the vital few (most expensive) problems to solve Continue correcting the trivial many until they are one of the vital few. The cost of repeated correction is part of the price of nonconformity (PONC)

Annualized PONC can help enormously in prioritizing problems for CA.

Monitors of processes (8.2.3) and your Auditors (8.2.2 and ISO 17021) should also bear this rule in mind when adding value with their well-crafted nonconformity statements to initiate CA.

CA is once done never to recur. Sometimes it is ineffective and your problem solving team has to try again and you need to know this. After all, CA often is a bit of an experiment that needs repeating for the organization to learn.

Verification of the effectiveness of CA should first be done by the manager responsible for the CA and the manager should be required to record the evidence of effectiveness. Too often I see the issuer of the CAR doing this.

Both these actions help you to maximize the return on the investment in CA and enable your organization to learn what constitutes evidence of effective CA.

John
 

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