ASQ Temecula Valley Section 0713
Invites you to our next meeting Wednesday 5/29/24
“Risk Management - Why, How, Methods, Tools”
By Barry Fischer, BS, MBA
Description:
Risk Management is now a core element of ISO 9001:2015, as well as being critical to ISO 13485, ISO 14971, and other common quality systems. The use of risk evaluation and management tools is no longer used just in the design and validation stage or post-market evaluation, but instead has become a core business tool throughout the entire product life cycle, as well as for the organizational planning and decision-making.
How: Where are common risk management tools deployed?
- 1. Strategic planning for risks and opportunities: evaluating new product proposals, new business opportunities, acquisitions/mergers, product retirements, etc.
- 2. Product development, qualification, launch, and post-market evaluation
- 3. All stages of product realization: supplier and raw material qualification, process validation, manufacturing process controls
- 4. All key stages of Quality Management: document revisions, nonconforming material evaluation, CAPA, supplier evaluation and auditing
- 5. Results of steps 1-4 are routinely summarized and discussed in Management Review
- 6. Steps 1-5 are reviewed and evaluated in Internal Audits
Tools: Common templates are often used; paper-based or electronic, often depending on the platform of other QMS tools.
· Recommend numeric/attribute scoring (choosing from predefined levels for each dimension or variable of the risk evaluation)
· For electronic systems, the scores should be easily retrieved and filtered/sorted for trending purposes
· SOPs typically include decision-making based on risk scores (higher score usually requires more detailed mitigation)
Method: scoring can use one of the following:
1. one-dimensional (e.g. scale of 1-5 low to high risk)
2. 2 dimensions, typically frequency x severity
3. 3 dimensions, commonly used in pFMEA (frequency x severity x probability of detection for each failure mode)
4. hybrid - combination of 1-3, particularly when evaluating outsourced processes or product risks when used by customer
Effectiveness: Internal audits and management review will look at whether processes are working effectively as defined by SOPs (handling higher-risk items appropriately with greater detail, mitigation, and reviews)? Also, during customer complaint investigation, frequency and severity of complaints relative to projected risks from design verification stage – were risks adequately documented and controlled through design stage?
Speaker Biography
Mr. Barry Fischer is an experienced quality professional, with 15+ years experience in quality systems, quality engineering, and lean six sigma. Barry began his career as nuclear propulsion officer in the US Navy, followed by 7 years of various roles in nuclear fuel engineering in the civilian sector. Barry then transitioned to the quality field, with 20+ years of experience in roles ranging from Six Sigma Black Belt at General Electric to QA experience in startup and mid-size companies. Barry currently serves as Senior Quality Manager for the Hydranautics membrane division of the Nitto Denko Corporation, a position held since 2018. In this role, Barry's accomplishments include upgrading the ISO 9001 quality system more effectively conform with 2015 standard, as well as implementing design and manufacturing engineering validation controls, and upgrading core quality systems to thrive in a digital environment (a particularly urgent concern during COVID-19), as well as overhauling the complaint management system.
Barry has a B.S. in Nuclear Engineering from U.C. Berkeley and an M.B.A. from the University of North Carolina, Wilmington.