Issue 133 – How do you know if a document needs to be controlled?
ISO 9001:2015…
How do you know if a document needs to be controlled?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications. In my last Newsletter (ISO 9001:2015 Newsletter Issue 132) we discussed the topic of “How far back in time can an auditor go?”, and now in this Newsletter we will discuss “How do you know if a document needs to be controlled?”.
The ISO 9001:2015 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Is this document/process/activity “In or Out?” of ISO 9001… My response to this question is typically: A) Does this document/process/activity affect the customer directly? BTW, most people will think “product” here but this question also allows for the “…and services” part of ISO 9001… for example, an activity in the Delivery/Shipping area, such as how we email the Customer with shipping information; and/or B) Is this activity used for product (or service) release?; for generating the Certificate of Analysis (COA)?; for releasing Shipping/Delivery/Order Status information?; etc… Other questions I might ask would be: “Is it important that we document how this activity is done so that we can reduce variation and maintain consistency of the output from this process?”; and/or “Is it important to keep a record of this activity so that you can go back in time to investigate what happened?”.
Another approach to answering the above question… If you want to look at this from another perspective then perhaps you can ask: “Is this activity important to how you run your business?”… and if the answer is: “Well… yes it is”, then if it’s important to how you run your business, and your Customers are the only reason you are in business, then doesn’t it mean “It’s IN the scope of ISO 9001″? The only exceptions would be the Safety Dept and the Environmental Dept… and I would place those documents outside the scope of ISO 9001 since they have their own International Standards to comply with. I subscribe to the big “Q” approach to Quality, which means that almost every activity an organization performs only exists because of the Customer. I know I may make it sound simple, and I realize it definitely is not… but my approach is “It’s IN” until you justify why “It’s OUT”!
So let’s get back to the question in the title of this Newsletter?… A common question or statement that I often hear is “That document has nothing to do with quality” or “What does that document have to do with quality?”… In the past I would respond with “Well if you thought it was important enough to create this document then why would wouldn’t you want to control its content?”… however I am thinking a better response would be “Is this document needed to run your business?”… if the response is “No” then I would ask “Then why does it even exist?”. If on the other hand, the response is “Yes we need it to run the business”, then I would ask “Then why don’t you care what it says?”… and if the response is “Yes we do care”… to which I would ask “How do you show that you care about what’s in this document?”… which should get responses like “Well, the person who understands the area/activity, creates/writes it” and “We make sure everybody who needs to use it is reading the correct version”… which is exactly what “control” means in the ISO 9001 Standard!
The logic is that if you think the document… is important enough to “write it down” then it’s worth making sure that it is approved by someone in authority, and that everybody is using the same version of that document. The complaint I hear most often is: “If I had to control every piece of paper in this company I’d go out of business”. So let’s take a look at how much time and effort it takes to “control” a document. If it’s a document that rarely changes then most of your time “controlling it” is spent ONCE, upfront at the beginning… after that it gets on a 3 year “review” cycle, at which time it probably won’t change its content, so then only the date/rev level needs updating.
If it’s a document whose content changes very frequently then you will spend time initiating a revision to it each time, in order to change its content (as well as updating its date/rev level), but in this case the time invested should be worth it since you don’t want Employees using an old form/document, and not collecting the right information or not following the right instructions, do you?
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
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Need Help?
ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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Internal Process Auditor Training for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!