One Course covering all of the recommended Risk Management Techniques

On May 3, 2023, the FDA adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management. It was released as a Guidance Document that advises pharma companies on risk management methodology, risk-based decision-making, and managing subjectivity. And it recommends the use of eight Risk Management Techniques.

The guidance document, entitled “Q9(R1) Quality Risk Management,” was prepared under the auspices of the ICH. It is a revision of the 2006 guidance for industry and addresses…

• product availability risks due to manufacturing quality issues,
• lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work,
• lack of clarity on risk-based decision-making and
• high levels of subjectivity in risk assessments and QRM outputs.

The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality.

Suggested Quality Risk Management Methods and Tools

Annex I lists recommended Quality Risk Management Methods and Tools, namely,

• Basic Risk Management Facilitation Methods
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects, and Criticality Analysis (FMECA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk Ranking and Filtering

A general description is given of each tool and suggested areas of use. But no more.

deGRANDSON Global Course ‘Risk Management Techniques – Foundation’

This Course includes all of the risk management tools mentioned in Annex I.

After a Module on the Risk Management Process and the various terms used (and abused) regarding risk, each tool is described in detail as….

• Background and Use
• Inputs
• Process
• Outputs
• Strengths and Limitations
• Examples

This is the level of detail needed to implement these tools effectively.

If you would like full details, please click on the button below.

We have three Risk Management Courses being readied for launch. These are...

• Course 725: ISO-IEC 31010, Risk Management - Foundation (published) 

• Course 726: ISO-IEC 31010, Risk Management - Advanced (available in October 2023)

• Course 725: ISO-IEC 31010, Risk Management - Expert (available in November 2023.

You can visit our Risk Management Courses page for full details of the various Courses available if you'd like.

Related Articles

• ISO 14971: Choosing the Right Risk Management Tool
• ISO 14971 Risk Management: 12 FAQs answered

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