7.5.3 controlling po´s, autocad drawings, invoices as well?

Hello everybody

Please give input in this issue regarding the control of documents but considering as well 7.5.3.1
which states" documented information required by the quality management system"
in a company with 9001:2015 including 8.3.

1-ERP
In a company they have an ERP system
Into the ERP, are created PO´s of raw material which are sent to suppliers
and into the procedure of purchasing process, only is mentioned that PO are
created into the ERP system no more detail. so the requirement is done into the ERP system.
Into the system a PO number is generated with a special code which is managed by the ERP.

2-EDMS (engineering document management system)
The company also has an EDMS system, which controls Autocad drawings regarding the numbering revisions, status of drawings (sketches, revised, approved, etc.), runs closely integrated with Autocad drawing system, into that systems exist a method for the coding of the drawings (different code vs the management system).
The users who design have a procedure to create the drawings and just mention that drawings are created into the EDMS app , also into the app the revision and approvals take place.
and don´t give more detail of the drawing process.

3- Similar situation when the finance process generates invoices for clients (Do they need control)

Into these activities two issues came to my mind.

1 Control of documents
The standard requires to control documents required by the quality system.
Do the drawings of EMDS and PO´s of ERP, and invoices of an accounting APP need to be controlled into the management system?
In fact they are required by the management system, they are records or not?. although they are already controlled by the apps.
what should be my control of all these documents?
Should I have to include on these documents the management systems codes of numbering?
Should I have to mention into my control of documents procedure, that there are a control of document for the Management system and other for the ERP, EDMS and Accounting App?
2 Identification and traceability (8.5.2)
In this point the traceability are not into the Management system, because
such documents are contained into the apps with their proper code,
But is possible to enter into app systems and get the traceability.
For example the code of one document in the management system is: PRO-PUR-001 (procedure-purchasing process-consecutive)
while the Autocad code (managed by the EDMS) is AD-D-01 (autocad drawing -design-consecutive)
and that of the ERP is PO-01 (purchase order and consecutive).

Please share your thoughts regarding control of documents and traceability.


Thanks

 

Good day @Qualmx ;
Here are the aspects you should consider...
1- PO (ERP system activity) :
a) Is only the current version of the PO available for use? (i.e. No "old" version of the PO, which your team can inadvertently obtain and fill).
That is the primary concern here. The PO is a record of an agreement with your customer. As long as the PO has been confirmed and any concerns addressed (clause 8.2), is accurate, and multiple versions of the same PO are not available to confuse the organization, then the intent of the standards is met. (more importantly, your organization is protected against committing to a PO that you can not fill and/or filling an old/obsolete PO).

2- EDMS (engineering document management system):
Product drawings need to be controlled, (i.e. if + WRONG or GONE, it can lead to a nonconformance). ...
a) Is only the current version available for use?
b) Is there a history of changes that are traceable to the product which they governed? (8.5.2---traceability)
c) Is there a record of changes and who approved any changes (8.5.6)?

If the answer to each of these is "yes", then your organization is meeting the intent of the standard (more importantly, your organization is protected against any unauthorized changes and/or the potential to build product to an obsolete drawing.)

The method for which your organization accomplishes the above is up to your organization. Whatever works best for your organization is the BEST method.

Hope this helps.

Be well.

 

Don't overthink it. Things can be controlled without all kinds of complex numbering and filing systems. KISS works really well in many cases.

 

Thanks John

Point 1
First do these Purchase orders (are part of the management system)?
a) yes the PO placed to the supplier is ok, and is controlled by the ERP system, no problem for other versions.
but the code of the PO can be assigned by the ERP or have to have my codes? (the ones defined in my management system)
b) Is possible to have traceability into the ERP system.
c) Yes there evidences of changes into the management system and also in the ERP.

Point 2

a) Yes, only the current version is available?
b) There is traceability into the EMDS
c) Yes there are evidences of changes into the EDMS and into the management system.
In this case the code of the drawings can be assigned by the EDMS or need to have my codes? (the ones defined in my management system)

So I may have two different control of documents into my Management system?

Thanks
​

 

Not necessary.

So, it already satisfy the intent of 7.5.2 (i.e. "the organization shall ensure appropriate: a) identification and description (e.g. a title, date, author, or reference number)").

Questions: 1) Are drawings made available and suitable for use? 2) Are drawings and the contents of the PO adequately protected? 3) Do they conform with the requirements re: distribution, access, storage, legibility, control on changes, retention? If you answered Yes to all these questions, then the ERP and the EDMS satisfy the requirements of 7.5.3.

Why do you need to assign a code for the template of drawings or the PO form generated by the ERP? If the use of the drawing template and the PO form don't create problems since they are system-generated, why are you looking for trouble against 7.5.3

 

Thanks Tonys

First, according to the standard:

7.5.3 Control of documented information
7.5.3.1 Documented information REQUIRED by the quality management system and by this International
Standard shall be controlled to ensure:...…..

1- Should the documents produced by the apps are REQUIRED according to 7.5.3.1 ?
2- How to determine if are required, required to control the management system or required for what?
into the apps are generated a lot of documents, RFQ, Technical analysis in spreadsheets, power point presentations, etc.
is it worth to apply that control in all the documents considering the quantity and that if control is applied, it may be
cause bureacracy and problems to users? I think not all the documents need to have that kind of control.

3-I have a procedure for the control of the documents of the management system.
So in this case, should I include into my procedure, the control that is done for that apps in that documents?

4- How to limit that control, I mean that into my procedure only be mentioned the control of the documents part of the management system
and that the products of the apps. be controlled in their apps?.

5- Where to establish that limits?, in my procedure of control of documents?

Thanks for your help

 

Aren't they controlled? Have you answered Yes to my three questions post#6.

If you mean assigning of document code like PRO-PUR-001, no, not necessary.

Is it a requirement to document a procedure? If you want, then, by all means, include that in your existing procedure. If you don't include, there's no problem. You can still demonstrate control even without the procedure.

Why will you limit the control? Systems-generated documents, like in EDMS and ERP, are part of the QMS and must be controlled. But control doesn't mean assigning of document codes like PRO-PUR-001. You are just complicating your approach. Just demonstrate how your organization control these systems-generated documents as per the requirements under 7.5.

 

- How to determine if are required, required to control the management system or required for what?
into the apps are generated a lot of documents, RFQ, Technical analysis in spreadsheets, power point presentations, etc.
is it worth to apply that control in all the documents considering the quantity and that if control is applied, it may be
cause bureacracy and problems to users? I think not all the documents need to have that kind of control. Thanks
Two last questions
In the last paragraph, in all kind of documents.
1- is worth the control?
I mean the control according to 7.5 3, evidences of revisions , approvals, changes,not only the name, can you image that control for transmittals, memorandums, emails?
2- what determine if are part of the qms?
Thanks

 

Can you just change the information already saved in the ERP? Can you just edit what is specified in the drawings generated from the EDMS? Can you use the superseded versions of the engineering drawings for your current operation/production? Can you just reproduce the drawings and give them to competitors? If you can't do these things or prohibited to, then there must be some form of control.

Can you identify what are the latest versions of the drawings? Can you identify which supplier served a certain PO? Can you know when the PO was issued? Who issued? Issued to what supplier? Do you know what drawing is intended for a certain customer? If you can do or know these things, then there must be some form of control.

These are the controls I'm referring to - not the artificial controls that you have in your control of documents procedure (e.g. document coding)