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Moving the Goalposts?

By John Henchion , April 5, 2018

Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

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Corporate Quality Risk Management (QRM) Policies are increasingly trending towards applying rigid scoring frameworks across all areas of risk. Does this approach make sense? Let’s examine the pros and cons.

 

Pros:

Standardization of the scoring framework for Severity, Probability, and Detectability results in a consistent approach across all Risk Assessments (RA). Facilitators and participants acclimate to a set scoring framework.

Standardization facilitates the process of governance as risk ranking and prioritization should be less subjective, thus easing the transition from Risk Assessment into Quality Risk Management.

Cons:

The Standard Scoring Framework may not suit the risk question; e.g. when performing an RA on an Environmental Monitoring program the Risk Question is, ‘Is our EM program adequately aligned to our manufacturing process to ensure it reflects the actual environment of product manufacture?’ Severity scoring is therefore a function of alignment between the manufacturing process and the EM program. However, using a Standard Scoring Framework typically aligns Severity scoring with patient impact. To adhere to this scoring system, the participants either inadvertently generate an adhoc secondary scoring system or score everything the same for Severity, thus diminishing the capability of the RA.

 

Solution:

Have a Standard Scoring Framework; however, as part of QRM preparation, check if the Scoring Framework aligns with the Risk Question. If the Scoring Framework does not align; keep the numbers but change the definitions. This flexibility should be built into the QRM Policy.

 

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Topics: Compliance, Quality, Regulatory