Simple ISO 9001 Compliant Document Control

[Krazykev32]

Scenario:

No doc control system/ Change note system
No budget for a fancy electronic system. Paper based system wont work as resource to maintain not viable.

Any ideas or fancy PDF based template forms out there?

 

[AndyN]

Re: Simple ISO compliant Doc control

Well, looks like you're out of luck, Kev... Someone's gotta own the process and make it work!

 

[normzone]

Re: Simple ISO compliant Doc control

No promises, but here's the tack I'm taking with a similar Wild West scenario. I've created the following form, and for every document group I identify I get the players to give me the following information. It's yet to be tested by external auditor, so fingers crossed.

CONTROL OF CHANGES, DOCUMENTS, RECORDS : TEMPLATE – XX – XXXX F Rev. A

The categories underlined below must be completed.
Example answers are shown between underlined categories. Replace that text as appropriate.

Document or record description:
What is this thing? A drawing, technical specification, work ticket, corrective action, etc.?
Unique identification (document number if applicable) :

This item has a document number, has no document number but has a job number, etc.

Process owner(s):
Which department(s) or group(s) executes the process(es) resulting in the change, document, or record ? Operations, Sales and Engineering, Field Application Engineer, etc.

Storage method / location
This document/record is kept on my hard drive, on the engineering server, on the network, in a file cabinet, in email folders filed by customer, DocShare, public server location, etc.

Review authority / mechanism
This document is generated and approved by the Operations Manager, generated by engineering and approved by the Design Review Board, etc.

Authority to revise
This assembly instruction may be revised by Operations, this customer communication by Engineering, this work ticket by the Director of Operations, etc.

Revision / Change status identification method
Revisions are identified by alphanumeric, datestring, not identified but previous version destroyed/archived and new version distributed, etc.

Obsoletion control method
Previous revisions are archived on the server, put in the shredder, maintained as records in email, do not exist because each new document overwrites the previous one, etc.

Record retention duration
Records exist forever in XYZ200, are retained for five years, are retained as required by regulatory and contractual requirements, exist until the email server is purged, etc.


I'm going to put a cover sheet over that stack explaining that this is how we do it. I think it is legitimate and vaguely compliant - auditors will help me poke holes in it and we'll fix it, repeat as necessary.

 

[Krazykev32]

Thanks for your help.

 

[Kronos147]

FWIW:

I am revising the QMS documentation for my new employer. The system I inherited has all sorts of forms; POL's were policies, ENG's where for the engineering department, etc. It was a mess. No one understood how to find things or understood ownership.

First thing I did was revised the structure. We now have Procedures, Work Instructions, and Forms.

I started with a form called a Document Change Notice (DCN) that gets filled out for every change. When a new form/procedure/quality manual is added, or an existing form is revised, we fill out a DCN. The form also has sign offs from process owners, and a section for training, again with sign offs.

A 3 ring binder has hard copies of all documentation. When something is revised, the old form is removed, the new revision added, and the Document Change Notice is filed in the binder as well. The binder has all of the DCN's there for each form.

All of my forms are number (0001 is the first form, the master form list). Work Instruction start 'WI-' and then have a dept code and a number. Procedures are SOP's and are numbered after claused (i.e. SOP-4.2.4 Control of Records).

The master forms list is in Excel. I have turned each document title into a hyperlink to the document. Part of my DCN has a checkbox to update the hyperlink. I have a separate sheet in the Excel file that has the list of obsoleted forms, work instructions, procedures, etc.

Additionally, for every department, there is a work instruction number -001. Each -001 is the department index, and it references procedures, work instructions and forms that pertain to that department.

Finally, there is a training matrix that basically is like all of the work instruction indexes put together into one form, showing what procedures and work instructions each department should know. Training for FOD and Control of Records is done across the board. Training for filling out a final inspection report is done for the Inspection & Compliance department, and not for Purchasing.

I hope this helps!

Eric

 

[normzone]

Nice setup, I like it.

We did recently suffer a windows update breaking a lot of links we had established in a similar manner, so I've not gone down that road recently.

 

[josephs6801]

Re: Simple ISO compliant Doc control

Sounds like we could be twins! Exactly what I have done with great results. Thanks for validating my thought process.

 

[John Broomfield]

Eric,

4.2.4 Control of records tells me that you may have an elemental management system built around the standard instead of a process-based management system structured around your organization.

Please tell me I'm wrong and why you chose such a document coding scheme*.

John

* of course, the clause numbering changes next year.

 

[Kronos147]

Hi John,

I did appreciate the fact that procedures were linked to clauses or sections of the standard. I guess I didn't find a need to give that up. We only use 14 procedures here:

SOP-4.2.3 Control of Documents
SOP-4.2.4 Control of Records
SOP-5 Management Responsibility
SOP-6 Resource Management
SOP-7 Product Realization
SOP-7.2 Customer-Related Processes (CRP's)
SOP-7.4 Control of Purchasing
SOP-7.5.1 Control of Production and Service Provision
SOP-7.6 Control of Measuring and Monitoring Equipment
SOP-8.2 Monitoring and Measurement
SOP-8.2.2 Internal Audit
SOP-8.3 Control of Nonconforming Product
SOP-8.4 Analysis of Data
SOP-8.5 Improvement
​

For the processes, we use work instruction. 5 processes, 5 work instruction catagories:

WI-CRP-101 Customer Related Processes Index
WI-I&C-101 I&C - Inspection & Compliance Index
WI-MAN-101 Management Index
WI-PROD-101 Production Index
WI-PUR-101 Purchasing Index
​

Each catagory will have as many work instructions as they need.

SOP's tend to be more conceptual and written for outside parties (a.k.a. auditors), WI's are what get the job(s) done.

How about you John, what are you doing at your plant?

Eric

 

[John Broomfield]

Eric,

Thanks for asking.

Recommended document coding scheme:

AA-BB-CC(DD)

AA = document type, eg MA, PR, IN, FM
BB = process owner dept, eg SA, EN, MA, AC, EX, QA
CC = unique number starting at 01 for each AA-BB
DD = issue status (letter indicates draft comments requested, number indicates approved for use and improvement)

A conformity matrix shows the relationship between the MA and PR docs versus the clauses in the standard.

I've found this structure supports any organization's process-based management system that conforms to any number of management system standards.

John