The battle of the Common Sense versus Common Knowledge.

The cGMP trends published a report named “The Top Ten cGMP Cited Violations for The FY2018”.

The report is very comprehensive and detailed. It identified five root causes per violation. Some examples are:

  • Making manual changes in master batch records, but not been formally approved and communicated.
  • Deviation in the operation’s parameter such as temperature not investigated.
  • Procedures not followed.
  • Procedures not been updated.
  • Investigations not been adequate.
  • Investigations do not find root causes.

In safety, the story is not different. Let’s analyze the stats from the Association of Worker Compensation of Canada and OSHA in the USA.

  • The top ten incidents ranking has not changed in 13 years.
  • The numbers of recordable incidents started increasing again.
  • Workers, not following procedures.

Both areas have something in common, people and behaviours.

People and behaviours are forcing organizations to focus on creating more procedures, more interminable meetings and debates of who is right and who is not.

What is causing all these issues?

In my personal experience, when people get injured, I had heard he did not exercise common sense

 

In quality is not the case; however, many of the conversations occur around what a major or minor change is according to each person’s interpretations and their points of view.

I call this the common syndrome.

This syndrome lays down on the peoples and behaviours, an internal bias, personal interpretations and so on.

Currently, there has been a battle between the two commons.

What are the two main fighters in this battle? Common sense versus common Knowledge

My question is, do we know what common sense is?

Common sense according to the Merriam-Webster dictionary “sound and prudent judgement based on the simple perception of the situation or facts.”
Let’s review the definition of common knowledge for the same source “something that many or most people know.”

Although both definitions look the same, in  reality, they are not,

Why?

Common sense works on people’s perceptions of situations or facts that depends on personal and professional experiences.

For example, one time an operator tried to climb a fence guarding of a machine to adjust a piece as quickly as possible. Although this behaviour looks out of proportion, it is ubiquitous to see it in factories.

 

The operator decided to climb it because he can reach the piece to adjust faster, with less effort instead of going around, open the door, activate the interlock, place the lock and proceed.

In quality, we have some examples such as replacing a vessel with the same specifications. Some managers consider it a significant change; others view it as a minor change.

As you can see, these two examples are based on perception.

Establishing common knowledge helps organizations to reduce injuries and cGMPs violations because of creating an understanding that will help them to eliminate internal bias.

QA experts or specialist can elaborate a list of possible scenarios establishing what a major or a minor change is.

The same in safety,  you can establish in your machine guarding policy that machine guarding fences are not intended for climbing and re-enforce the rule by posting it around the guard.

In conclusion, I am aware that are other causes contributing to having injuries and cGMP violation. However, establishing common ground and knowledge in these two critical areas will help managers to solve many discrepancies and save time on discussions that occur over and over again.

Do you want to know more about this topic?

Contact me on LinkedIn

edarfernandez@pharma-chemicalsafety.com or call me directly at

☎️ 613-464-0562