Ken Taylor, Pharmaceutical SME
By Ken Taylor, Pharmaceutical SME

Pharmaceutical Manufacturing is one the most risk averse manufacturing environments in the world. The professionals who inhabit this sphere must be of the highest caliber, with world class manufacturing systems and facilities. Risk Management is not some fancy buzz word for this industry, but a foundational building block that infuses the very DNA of these organizations. The industry has developed a set of powerful assessment and analysis tools to enable data based determinations of risk and counter-measures.

Most pharmaceutical OEM’s make an effort to develop a Risk Management system. They use the buzzwords and are most likely sincere in their efforts. Unfortunately, if the harried professional doesn’t ask the necessary follow-up questions, fundamental gaps in the service provider’s abilities may escape detection. We suggest that when it comes to your manufacturing systems, your supplier should be able to answer the who, what, when, where and why of their risk management system.

  1. Why Risk Management?

Risk Management is required for regulatory and industry standards compliance.


The Code of Federal Regulations has specific requirements for Risk Assessment based on product classification. In addition, the International Conference on Harmonization – Q9 Risk Management provides guidance on the development of robust assessment systems.

Industry Standards

ISO31000 – Principles and Guidelines of Risk Management

ISO31010 – Risk Management – Risk Assessment Techniques

  1. What are your Risk Assessment Techniques?

Can your OEM explain what their risk assessment techniques are? If they suggest statistical analysis tools such as ANOVA, be sure they can articulate the assumptions required for effective use of the technique (normality, homoscedasticity, independence) and what types of failure could result from improper use of the technique.

  1. When in your process do you deploy your risk assessment techniques?

Not every OEM employs Risk Assessments milestones in all phases of their Development process as Clarke does. Be sure you request a copy of the program planning documentation and verify that sufficient time and resources are dedicated from the Design Phase(DFMEA/HAZOP) to Packaging(ANSI/PMMI B155.1).

  1. Where are the Risk Management activities completed?

Beware of the OEM that doesn’t clearly define where the CQV activities will be performed at each stage of the development process. Be sure your purchase orders terms clearly define that CQV will take place at the OEM site to ensure you have access to the equipment expertise to complete CQV in a timely manner. Clarke uses the latest CQV techniques at our facility that enables our customers to run their old equipment until the last minute before they install our turn-key systems.

  1. Who are the people completing your Risk Assessments?

21 CFR 211.25 requires the personnel performing mission-critical assessments be of the highest caliber and training. Clarke uses some of the industry’s most rigorous employee standards and testing requirements. The training records and CV expectations for mission critical personnel should be explicitly documented in the CQV terms.

In conclusion, just a handful of additional questions can be the difference between success and failure in Risk Management. Be sure to ask these questions of your OEM and success will be yours!

To learn more about our solutions, contact us for a free consultation today.

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