The ASQ and PMI London, Ontario chapters invited to speak about quality risk in the pharmaceutical industry.

During the lecture, a professional, gentleman asked the following “if I could suggest how to create effective SOPs in the digital era.”

Why did he ask this question?

He stated that people nowadays do not read. Some attendants got upset about this statement.

What did he mean? He meant that people spend more time scrolling their cell phones and tablets.  He did not indicate illiteracy.

It has been proven that the excessive use of electronic devices contributes to attention deficiency, lack of focus and lack of retention.

According to the report from cGMP trends ” The Top Ten cGMP Citations of FY 2018″  one of the most popular violations is not following SOPs.

The lack of retention and focus because of electronic devices is a fact; however, we have not recognized it; therefore we tend to create more SOPs and corrective actions.

Here is how you can create effective SOPs to avoid forms 483

In this section, I want to share the experience that I had as internal ISO 9001 auditor a long time ago.

I was working for Wyeth Pharmaceuticals, and the QA department decided the following to make the SOPs effective:

  1. Use flow diagrams instead of a verbal style.

Creating SOPs that show the steps as a flow diagram are useful because it focuses the attention of the operators in that single task.

  1. Conduct a quality risk assessment per block (per task) if necessary to identify possible non-conformance scenarios.
  2. Assess each block versus codes, standards and regulations if required.
  3. Review the SOP with current senior operators to verify the accuracy of it. In other words, conduct a Kaizen blitz of the intended SOP.
  4. Conduct training.
  5. Conduct coaching. This step is critical to verify the effectiveness and understanding of the SOP. If you have implemented lean manufacturing at your organization, you can conduct Gemba Walks to achieve these steps.
  6. Use Gemba Boards to inform operators of the possible non-conformances that they can face during production and how they can resolve them. It will generate focus.
  7. Review challenges or discrepancies with the operator to updated SOP if necessary.
  8. Repeat the process.

In conclusion, I might suggest the following to avoid non-conformances:

  • Create an organizational culture where the organization can adapt to changes as quick as possible.
  • Create a system where experiences, ideas and skills can be used in benefit of creating a zero non-conformances goal.
  • Base your training system on common knowledge, not in common sense.
  • Develop the creative, problem solving and critical thinking as part of the core skills of your organization.

In my opinion, human behaviour and participation are becoming critical to identify and assess non-conformances scenarios. Having technical knowledge about health regulations is not enough nowadays to achieve your goals.

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