Do I need Document Control?
In my years of performing third party Quality Management System (QMS) audits, gap assessments and internal audits, one of the most common questions about document control that people ask is:
Do I need to control this document?”
Over the years I’ve noticed Document Control has gotten “a bad reputation” in the quality circles. It does not matter if it is a procedure, work instruction or form;
One of these pesky documents is bound to be in wrong place at the wrong time.
Recently, however, I have noticed that these document control issues have decreased due to so many new tech solutions that help you manage documents. If you are looking for good recommendations on Quality software, let us know. We have experience with several software and can give you a good solid opinion on them. Send us an email at: info@factorquality.com subject: Quality Tech recommendations.
Nevertheless, the question persists, “to control or not control a document?”
To Control or Not Control a document
Without dwelling in the details of ISO 9001 requirements regarding document control and in the spirit of keeping it simple, the intent of the standard’s requirement is straightforward. The aim of the standard is that once your organization determines the need for a document (i.e. means to convey critical information or template to collect data) then logic dictates that you want to make it available to those that need it and want to make sure the information is always accurate.
In short, document control is:
having a way to ensure that information remains relevant, up-to-date, accessible and aligned to the strategy.
The standard (ISO 9001) does not handcuff organizations in dictating specific required procedures. Each organization is free to decide what documents need to be created and controlled.
The expectation is that when you make that decision you always ensure that the document aligns with the nature of the business and any requirements/expectations that need to be met.
Thou shall not use the standard’s name in vain
As stated before, document control has developed a “bad rep”. ISO gives general rules that when used appropriately do help businesses.
I’ve heard statements about document control such as:
This document cannot be used because it is not in an ISO format.
That document requires to be approved by two supervisors, a manager and the CEO per ISO requirements.
That document is missing a document #, what section of the standard it belongs to so that I know how to number it.
That document is only important to our department, so it does not need to be controlled.
ISO provides a general requirement for organizations, it does not tell you how many approvers certain documents need to have. Nor does it prescribe a document format or a document ID# (i.e. QAP-1001ab). These are misconceptions that have been circulating for a long time.
So let’s clear this up:
ISO 9001 does not establish a minimum of approvals required,
it does not provide a format for documents nor does it require you to have a document #.
In my opinion, the “bad rep” of document control has mostly been driven by the way companies have decided to control their documents and some lack of understanding of the standard, leaving many confused and somewhat irritated. All these requirements are self-imposed by each organization. The company defines the policy of how many approvers are needed for documents, what type of format is to be used and how to identify it.
So, if you don’t like how document control is done at your company, ask the owners of document control at your organizations why they consider the current method the right way for controlling documents. And under no circumstance accept “Because ISO requires it,” as an answer.
So, now what? How do we control documents?
Let’s be clear, while ISO 9001 does not mandate any specific format, identifier or number of approvals, the documents that are created for the organization need to meet a certain set of criteria to be considered as controlled effectively. And remember that when we create a document we need to make sure the correct version is always available.
What are some of the requirements that you need to be aware of with ISO 9001?
Documents can be in any media
Any media means that it can be written in paper, electronic, even video formats. The documents can be written, pictorials, flow charts, or a combination of these. Just remember it needs to make sense to your organization.
Documents need to be identified
There is no need to have document numbers unless you believe these are needed & are helpful to your business. A simple identifier is the Title of the document and if this appears in the footer/heater of each page then the document is indeed identified.
Documents need to be approved
The idea is that you designate a person or group of people with the authority to determine suitability for your business. Ideally, that person is always aligned to the strategic direction of the business and understands the implications of such a document.
Documents need to be controlled
Version Control– Documents need to have an identifiable version visible throughout the document allows you to determine if the right version of the document is being used. The version can be alphanumeric or by date.
Distribution Control– Documents need to be available and accessible for use, and they need to be maintained in a manner so points of use can be readily updated when changes occur, that only authorized changes are made and that documents remain legible over time.
Keeping document control effective
Over the years some of the most infamous controls deployed by overly careful doc control administrators are:
Document Stamps: Stamps showing the document status such as: “Reference Only,” “Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.
Footer controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24 Hours,” etc.
Watermark controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.
All these are methods of control, but they are often misunderstood by those that use them.
Before you react let me ask you a few questions:
Could you have the correct stamp, footer or watermark but have no way to ensure that people do not change the document by mistake? Can these controls show the document approvals were adequate?
Can a stamp prevent someone from not having the most up-to-date version of the process?
People think that if the right stamp, footer or watermark is used it is enough to demonstrate robust document control. Unfortunately, most folks forget that these are just controls and as such, auditors will always check for effectiveness. It doesn’t matter how big and bright the stamp/footer/watermark is, but when evaluating Document Control auditors will always consider valid the document the employee/operator points or shows.
Our most common document control issue when employees are asked “what document do you use?”
Employees proudly say, “this one”, as they pull it out from their tool box or desk drawer… In most cases these copies are out of date.
Recap of document control
Document control’s purpose is to help the business document those items that are critical to its own functionality.
These documents should align with the strategy and help the business meet requirements in a consistent manner.
How much or how little you control these documents is a decision made by each company. Our best advice is:
“keep it simple”
The well-being of the organization should always be put before the need of a group or department. Better said, make sure every document is needed, because when a document is really needed it will be easy to control, maintain and keep relevant.
Document control structures can be reviewed, revamped and reset during the lifetime of a Quality Management System. Organizations should review their systems and ensure that they are leveraging existing and available resources to support their own documented systems.
Factor Quality is here to guide you through this unpopular mythical creature called Document Control.
Check out our Process Improvement services .We have experience using several document control systems, from software solutions to self-contained systems, we can recommend the best solution for your business. It will for sure be simple but effective.
