Sunday, June 21, 2020

Got No Time For ISO 9001 Quality Systems? Maybe You Need a Time Machine!

“Ticking away the moments that make up a dull day…” go the lyrics of Pink Floyd’s song “Time,” taken from the seminal album The Dark Side of the Moon. This iconic work of progressive rock music reflects on the negative effects of performing mundane or routine actions and how time can control one’s life.

The meaning behind the song’s lyrics, while strongly applicable to everyday life, also is an apt description for the way certain clauses of ISO 9001:2015 are implemented. Often, requirements including Management Reviews, Internal Audits and Calibration of Measuring Equipment are planned according to a misperception that they must be conducted at certain intervals, generally throughout a calendar year. 

However, an examination of the relevant clauses reveals there is zero mention of when to implement the requirements, as seen below. 

7.1.6 Monitoring and measuring resources
“…calibrated…at specified intervals…”
9.2 Internal audit
“…conduct internal audits at planned intervals…”
“…an audit program(s) including the frequency…”

9.3 Management review
“…at planned intervals…”

Of course, there may be external influences that impact when these parts of the Quality Management System (QMS) are implemented. Your contract with a Certification Body, for example, might set additional guidelines requiring you to audit the whole QMS in one year. However, in my experience, when organizations choose to adopt a simple time-based approach to implementing these requirements, significant opportunities are lost and costs incurred which may have otherwise been avoided.

In one situation, a company bought the best (and most expensive) torque wrenches they could find, sending them to an ISO/IEC 17025 accredited lab for calibration every year thereafter. A quick review of calibration results obtained over the next five years revealed no appreciable change in the “as found” condition compared to the previous “as received” condition. So, why bother sending them out at all? Aside from an arbitrary schedule telling them a calibration was due, there was no reason or need to continue having them calibrated in this way. 

Consider another instance where, due to the frequency of use, a thread plug gauge was becoming worn out of specification in a matter of a few months. But, because the organization only checked equipment on an annual basis, the worn out gauge was in use for eight or nine months longer than it should have been, with potentially damaging results in that period.

A further example is when an organization chose to internally audit their management system according to a 12-month calendar. In July, most assembly workers left for vacation and were back-filled with seasonal workers for the first two weeks of the month. The impact on product quality was predictable – resulting in increased rejections, rework and delays. Did the internal auditors ever audit the training process to see if it was actually used during this time? No! Because the schedule arbitrarily directed them to only audit Product Identification (which had never been an issue) in that month. Clearly, despite the audits being completed according to plan, they were almost a waste in determining the cause of the problems in July.

Management Review is a key function of the QMS and, as such, should be employed as a means to examine business operations, identifying the status of plans, related performance and actions needed to keep the organization on track. This is particularly important when encountering situations that are, by their very nature, not what was planned to occur. Since these perturbations in business performance are rarely experienced at a predictable point, management’s review shouldn’t be done to simply satisfy a calendar. 

If any organization implementing an ISO 9001:2015 compliant QMS finds themselves doing mundane things simply “because ISO says so,” there’s a good chance management should revisit their understanding of these ISO 9001 requirements. Otherwise, they are at risk of becoming just like the rest of the song:

“Fritter and waste the hours in an offhand way. 
Kicking around on a piece of ground in your home town, 
Waiting for someone or something to show you the way…”


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