ISO 9001:2015 – Newsletter – Issue 92

Issue 92 – How will this recent business disruption affect my QMS?

ISO 9001:2015…

How will this recent business disruption affect my QMS?

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 91) we discussed the topic of  “Is this activity ‘In or Out?’ of ISO 9001”, and now in this Newsletter we will discuss “How will this recent business disruption affect my QMS?”.

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

How will this recent business disruption affect my QMS?… I’ve had a few emails asking my thoughts about some issues that have come up as a result of this business interruption.  The topics so far include: a) Everyone in the Quality Department has been laid-off; b) Finished product is being stored for much longer periods of time than normal; c) Regular meeting schedules are no longer on track (including Management Review meetings); d) Employee annual training is falling behind; e) Calibration testing devices/instruments by outside Vendors is not happening, with devices becoming overdue;  f) QMS Internal Audits are being postponed; and g) the ISO External Auditor visit is fast approaching and many Quality records will not be available.

Common sense should provide the most reasonable approach… In terms of my thoughts and suggestions concerning all of those scenarios outlined above, I want to start off by saying that every External CB Auditor conducting audits in a post Covid-19 business environment will be faced with the exact same dilemma.  My point being is that the External Auditor will need to exhibit some common sense when deciding what audit findings will be reported.

Let me address the issues one at a time… regarding the scenario of no one left working in the Quality Dept, item (a), this probably was because all production/operations were halted for a period of time.  Even if you only had a skeleton staff in the Quality Dept, the fact that no production occurred means that Quality checks/tests/inspections were also not needed.  This gap in Quality records should then be obvious to an External Auditor as to why it occurred.

Storing of the finished product for longer than anticipated time periods, item (b), should result in proper checks being done (perhaps more frequently) to ensure the level of Quality has not changed since the item was produced.  You should be able to show evidence that these checks were done, and when they were done.  If expiry dates were exceeded then you’d want to demonstrate that appropriate actions were taken to segregate/disposition those items so that they never reached the Customer… things that you should normally always do but that perhaps you did more often while you endured this business interruption.

If normal meeting schedules are no longer taking place, item (c), then switching over to virtual meetings should be the obvious choice here.  Many organizations are discovering that although not as fully effective as face-to-face events, virtual meetings had already become popular due to lack of availability of key people working at remote locations, along with tight time constraints and schedules.  This current business interruption simply accelerated a trend that was already happening.  This is the exact same response I have for Employee training, item (d), again this activity can easily be converted to online training in the cloud.  Virtual Meetings… Virtual Training… Embrace it.

Getting behind on your calibration cycle can become overwhelming, item (e), especially if you have a lot of testing/measuring devices, and if many of them are calibrated by an outside Vendor.  Outside Vendors may not be allowed to enter your facility to conduct onsite calibrations.  In this situation, the main question you should be asking is: “What impact could this lack of outside calibration have on the quality of our products being shipped out to Customers?”.  If you believe that in-house verification checks are sufficient, as a temporary action, to ensure those devices deemed critical to quality are still working properly (even without outside calibration), and you document that decision in the minutes of a meeting, then that is what you can show the External Auditor during their next visit.

I will leave my response to issues concerning Internal and External Audits, items (f) and (g), to my next Newsletter since it requires a bit more space than I have here.