Author Archives: greg

#48 – WHAT DOES ISO ‘RISK BASED THINKING’ REALLY MEAN? – T. DAN NELSON

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T. Dan NelsonISO is promoting ‘Risk-Based Thinking’ in all of its standards – even ISO 9001:2015 its flagship Quality Management System standard.  What does this really mean for companies?

IRISK AS PART OF QUALITY
Risk is recognized (finally?) as being part of quality management—which is nothing new.  Risk is involved with every activity in life—some will likely knee-jerk react with an over-blown response to the inclusion of risk-based thinking among ISO 9001 requirements.  To clearly comply with the requirement to apply ‘risk-based thinking’, some companies will no doubt be tempted to raise a ‘Risk Management’ process and maybe even hire a ‘Risk Manager,’ even though neither is necessary to implement ‘risk-based thinking’ or to comply with requirements to apply ‘risk-based thinking.’ Continue reading →

#48 – SIX WAYS TO LEVERAGE RISK – BASED MONITORING & CLINICAL CAPA – CINDY FAZZI

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Cindy FazziA big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years. For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

This is in addition to the requirement that sponsors and CROs integrate CAPA (corrective action and preventative action) as a tool for ensuring patient safety and data integrity throughout the clinical trial. Continue reading →

#47 – #1 REASON TO TRANSITION TO ISO 9001:2015 – GREG HUTCHINS

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Greg Hutchins pixWe’ve been conducting Quality Management System (QMS) audits since 1987.  A very long time.

We’ve seen every manner, shape and form of quality audits.

BIGGEST CHALLENGE TO QUALITY AUDITING
The biggest challenge we’ve seen in quality auditing over the years is that these important assessments don’t get the visibility they deserve. Continue reading →

#47 – SURVIVING THE HOSTED COMPLIANCE AUDIT – WALT MURRAY

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WALT MURRAYCompliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a ‘zipped-tight’ posture toward the investigator? Continue reading →

#47 – QUALITY AUDITING – ONE TOUGH JOB – UMBERTO TUNESI

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Umberto Tunesi pixWhen we look for quality auditors, we don’t look for heroes or supermen, we look instead for very ordinary people – men or women – who know what their job is like and are dedicated to it.

If anything, auditing is becoming the job of the century, for many a reasons: organizations need to control themselves, their suppliers and – why not? – their customers. Organizations also need to accurately know their operational context.  In a word, organizational intelligence is a must for effective management. Continue reading →