Corrective action for failure in documents control

#1
Dear fellows:

In the last audit, the following non-conformity was established:
"Some documents have not been included in the master list, such as: (quoted 3 SOPs ...). Additionally, the distribution and diffusion of some documents was not evidenced, such as example: (quoted 3 SOPs ...) "

At the moment the documents are stored electronically but there are also printed copies, there is no an application to automate the control of documents.

Staff have intended to do a cause analysis to take the right corrective action, but the conclusion has been that the problem was due to ineffective document control by the person responsible for this activity, who is the responsible for quality. However I am sure this is not a root cause, so, an efficient corrective action could not be taken.

Could someone who has had a similar non-conformity give me ideas to help me solve this finding?

Thanks in advance.
 
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John Broomfield

Staff member
Super Moderator
#2
Everyone is responsible for the quality of their work but who beyond the chief exec is responsible for the documented parts of the management system?

To fulfill this responsibility, the system manager and deputy needs authority delegated from the chief exec. Some chief execs make the process owners responsible and delegate authority to them.

From what you say it appears that process owners (or document users) were able to create system documents without informing the system manager.

Were they given this authority or did they just take it? Why did they create system docs without informing the system manager? Could it be that it took too long or was considered too bureaucratic?

What were the consequences of this nonconformity? Could it be that the only docs readily available for use were the current approved docs?

If the master list is essential to making only current and approved docs readily available for use then you may have no choice but to reinforce the controls over the master list. Perhaps by uniquely identifying each system document with a code that is issued by the system manager.

Or, your corrective action team may find the documented parts of the system work just fine without the aid of a master list. No out of date of unapproved documents are readily available for use. All superseded docs are archived to prevent inadvertent use. From this investigation they may conclude that the master list is unnecessary. It which case the nonconformity was caused by the creation of a redundant master list.

What does the evidence show:

A. Poor delegation of authority, and/or
B. Lack of awareness of users, or
C. Master list redundancy?
 

Tagin

Trusted Information Resource
#3
I would think in terms of PDCA; specifically, how does your document control process Check that the necessary tasks (e.g., update master list, distribute paper documents) are performed, and what Act occurs if they are not performed?
 

Randy

Super Moderator
#4
I would verify whether your document control procedure say "all" documents "will/shall" be listed or "documents should/can/could" be listed. Explicit language is important.

What is "your", not the auditors desire/wish/hope or want, but "your" requirement?
 

AMIT BALLAL

Trusted Information Resource
#5
Ask further questions like following to reach to the root cause. Keep asking why until you reach to a systemic root cause:
"Why documents were not controlled properly by the person responsible for controlling documents?"
 
#7
Hello all. In our last IATF audit, I have received the same NC, regarding the control of the documented information through the whole organization (a big company with a lot of processes and 1200 employees). We have internal web based system for all the procedures, instructions etc., but some "home made documents" on paper, without identification were observed almost in each working place. This is a huge problem and escalate every day. What we have done to resolve it. Together with HR team we`v done education for the whole process owners. The topic was, how our QMS it works, What is controlled and uncontrolled doc, why we have to keep tracks, why we have to avoid issuing instructions, rules, procedures, how our internal system is working, how to distribute the documented information... After this internal training we include weekly audits in the working places to check how the situation with document flow has been changed. It was accepted as a root cause and corrective actions. Good luck!
 

John Broomfield

Staff member
Super Moderator
#8
Those “home-made” notes may show where the official docs need improvement.

So, they may be evidence that employees did not know how to change the system.

BTW, the users of documents are also responsible for document control as they seek to avoid use of invalid information.
 
#9
Everyone is responsible for the quality of their work but who beyond the chief exec is responsible for the documented parts of the management system?

To fulfill this responsibility, the system manager and deputy needs authority delegated from the chief exec. Some chief execs make the process owners responsible and delegate authority to them.

From what you say it appears that process owners (or document users) were able to create system documents without informing the system manager.

Were they given this authority or did they just take it? Why did they create system docs without informing the system manager? Could it be that it took too long or was considered too bureaucratic?

What were the consequences of this nonconformity? Could it be that the only docs readily available for use were the current approved docs?

If the master list is essential to making only current and approved docs readily available for use then you may have no choice but to reinforce the controls over the master list. Perhaps by uniquely identifying each system document with a code that is issued by the system manager.

Or, your corrective action team may find the documented parts of the system work just fine without the aid of a master list. No out of date of unapproved documents are readily available for use. All superseded docs are archived to prevent inadvertent use. From this investigation they may conclude that the master list is unnecessary. It which case the nonconformity was caused by the creation of a redundant master list.

What does the evidence show:

A. Poor delegation of authority, and/or
B. Lack of awareness of users, or
C. Master list redundancy?
Many thanks John. Your indications are very orientatives, I will consider them so much to execute further cause analysis and finally resolve this non conformity.
 
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