Issue 121 – Are you using “red stamps” on hard-copy printouts of documents?
ISO 9001:2015…
Are you using “red stamps” on hard-copy printouts of documents?
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 120) we discussed the topic of “How often should you conduct ISO internal audits?”, and now in this Newsletter we will discuss “Are you using “red stamps” on hard-copy printouts of documents?”.
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
Are you using “red stamps” on hard-copy printouts of documents?… Let me begin by saying that there has never been the words “red stamp” in any version of the ISO 9001 Standard, so therefore it is not a “shall” requirement. This is a self-imposed control technique that was implemented many years back, within many industries/companies, when printing hardcopies of QMS documents. The use of stamps or markings can be implemented as part of a visual control or identification system within a QMS, providing visual cues or information about the status or condition of a printed document.
This “red stamp” approach is much the same as having many “hardcopy printouts” of quality manuals distributed throughout the facility, with each one being numbered, and with a list of “who'” had which numbered copy, all of which being very tightly controlled. This approach changed in many organizations with the advent of electronic/digital documents, and with the introduction company intranets, which meant these numbered hardcopy quality manuals could disappear.
Is there a reason to keep the “red stamp” process?… If you take a moment and re-read Clause 7.5 in the ISO 9001:2015 Standard you’ll see that what it basically says is “make sure employees have access to, and follow instructions contained within, QMS documents, that are approved and regularly reviewed by someone in authority”. The red stamp idea was to allow hardcopy QMS documents to be printed out and made available to employees in order to do their jobs.
In this regard, I suppose the first question that comes to mind is: “Why are we printing a hardcopy of something that could also just be read on a computer screen… or a laptop screen… or a tablet screen?”… in other words, is a hardcopy printout of a document the ONLY way to tell employees how to perform a particular task? Using “red stamps” can become very problematic for many reasons… the obvious one being that employees may hold onto them and store them in their work areas, forgetting to throw them out when a new version of that document is released.
By the way, there are situations where “red stamped hardcopies” of QMS documents are being kept in the event of an emergency, where the site-wide computer system goes down not just for a few minutes but potentially for a few hours, or even a few days. In this scenario, it’s possible production personnel would not be able to do their jobs since in some instances, these procedural documents may have steps that have to be initialed by the operator or areas that have to be filled in (form/record), in order to ensure the quality of the final product. The same could also apply to the lab testing area where lab technicians would be prevented from running tests without access to controlled hardcopies of their test methods.
If the above emergency scenarios don’t apply to your organization then I would suggest that the best approach would be to not use “red stamps” at all.
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!