Approval for Templates

[EmmaS]

Hi All,

I'm a complete newbie. I've just started a new job with a company that doesn't seem to have any document procedure / control in place. There is no Master Doc Register. I have no work experience in document control but I'm pretty logical and I'm good with procedures/templates etc so I'm currently populating a new server for them and building an MDR.

I have a couple of what I think are quite basic problems..

For processes and work instructions (where there generally aren't any fields that need to be filled in by the user), I have a section at the end of each document for "drafted/reviewed/approved by" and the date for each. No one here is using electronic signatures though so I'm unsure of the best way to record when these documents have been approved.

For templates that are being filled in (reports etc), I don't really have anywhere to put the "D/R/A by" section. And if I did, they aren't using electronic signatures so they would be empty on digital copies.

The other thing I am struggling with is where to put the document template number on some documents as their headers/footer are already packed with other details that they don't want to move. They are using a mixture of word and excel. This might sound very stupid, but it is absolutely critical that the document number appears on every page of a document? Ideally that's what I would like but cramming it into some existing templates is proving tricky.

If anyone had any advice I would be most grateful. I have already found some very helpful threads on here but I think this query is so basic I can't find anything about it.

 

[Eredhel]

Which QMS standard are you all registered to?

 

[EmmaS]

They have the below listed on some of the current documents they are using, so I am assuming these apply. I have to confirm with them if this is still relevant to them though! I haven't any experience with standards so unsure what they require. Can I get access to them anywhere to read up?

ISO9001 (2008 Revision)
ISO14001 (2004 Revision)
OHSAS18001 (2007 Revision)

 

[BoardGuy]

They have the below listed on some of the current documents they are using, so I am assuming these apply. I have to confirm with them if this is still relevant to them though! I haven't any experience with standards so unsure what they require. Can I get access to them anywhere to read up?

ISO9001 (2008 Revision)
ISO14001 (2004 Revision)
OHSAS18001 (2007 Revision)

The documents listed are currently obsolete and you will need to obtain the following revisions:

ISO 9001:2015
ISO 14001:2015
OHSAS 18001:2010

As for document control, you should make the system as simple as possible and here are a few pointers:

1) Documents do not have to be numbered. Standards only requires that they be identified and current revisions known; the name of the document with revision is sufficient. I.e. Record Control - Rev. A, Document Control - Rev. B, Contract Review – Rev. C, Corrective Action Form – Rev. A, etc.

2) Revision pages are not a required element. Have them be a separate document that shows revisions to be made and that they were reviewed before implementation. Doing this will prevent procedures and work instructions from having revisions sections larger than the actual documented information.

3) Have just one person with approval authority for a created document. I.e. Contract Review Procedure approval by Sales Manager, Design and Development Procedure approved by the Engineering Manager, Final Inspection Procedure approved by the QA Manager, Etc. The standards do not require that large groups must approve documents, only that they are approved for release.

4) Not every requirement within standards must have a procedure or work instruction. Use a Quality Manual to address them such as internal communication, customer communication, etc.

5) Make the system work for your organization and a not certification auditor.

 

[EmmaS]

This helps a lot, thank you! I'm going to print off what you've said so I can digest it tomorrow against what I've started doing. I'm not too far in to so if there's something I should or should not be doing I want to make sure I get it sorted early on. I will mention the out of date standards to them as they are currently putting these out on documents to clients.

Edit: At what point do document numbers become a requirement? All the companies I've worked in previously have had document numbers so that's why I had started numbering them here.

 

[Eredhel]

Numbering is a common practice, but I've never seen it be a requirement, and I'm familiar with ISO 9001, AS 9100, and API. It's kind of like a Job Traveler, they aren't required but they fulfill a lot of things that are required and most job shops use them. Does your company have a Quality Assurance manager, or anyone that manages the quality management system? If it's something they're having you do on your own you might consider taking an internal audit class for ISO 9001, if there is a decent one nearby. It could help you get a better understanding of quality management systems in general.

 

[BoardGuy]

Edit: At what point do document numbers become a requirement? All the companies I've worked in previously have had document numbers so that's why I had started numbering them here.

[FONT=&quot]They only become required if you say they must be used. When you start writing your documentation your first pass should be to record what is actually being performed. Once you know what is being done today then see if it conform to the requirements of the standards as written. If it does not then add what is missing.[/FONT]