Monthly Archives: May 2014

#49 – ISO 31000 & ISO 9001:2015: THOUGHTS ON THE FUTURE – ALEX DALI

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alex-dali-mba-armWe’re seeing more integration of ISO 31000 and ISO 9001:2015.  What does this mean to both standards as well as the generation direction of ISO standards?   Here is my quick impression giving the current trend:

1.  Companies moving from a compliance and control framework to a performance-oriented, risk management framework supporting decision-making. 
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2.  Enterprise Risk Management (ERM) program will refer to the principles, the vocabulary, the framework and the process proposed in ISO 31000, in order to provide a structured approach, a consistent methodology, a common vocabulary for all type of risks which could prevent the organization to achieve its objectives.  Continue reading →

#49 – BEING ANTICIPATORY – DANIEL BURRUS

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BurrusDan_040We are all good at reacting and responding, putting out fires, and crisis management.  In addition, organizations large and small have learned how to be lean and agile, and how to execute a strategy at a high level.

However, despite these skills, General Motors still declared bankruptcy, Blockbuster closed its last store, and Blackberry quickly moved from leading to bleeding.  And let’s not forget Hewlett-Packard, Sony, Dell, and a host of other companies who failed to thrive despite its leaders and workers being responsive, agile, and executing well. Continue reading →

#49 – CORRECTING AND DETECTING CAPA HORRORS – PETER KNAUER

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aaaNote:  The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration’s (FDA) Quality System Regulations—and specifically 21 CRF 820.100 and ICH Q10—implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems.  This, unfortunately, is not always the case.  I am currently spending a lot of time working with client companies in remediation mode; that is, after FDA has found enough flaws to issue a 483 or warning letter.  I would like to point out some common CAPA problems that can be proactively rectified to avoid citations in the first place. Continue reading →

#49 – AUDITING RISK AUDITORS – UMBERTO TUNESI

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Umberto Tunesi pixI’m quite a novice in risk audits, though I have twenty years experience in quality audits and fifteen in quality inspections.

I think that audits’ basics – or sound-track – are the same, be they quality, risk, financial audits: auditors are usually – and officially … welcome.  Auditors are treated like princes, as a colleague of mine once said, they’re told their work is most useful but – in the end – auditors and audits are a nuisance, even to the top management who might ask for them to investigate deep into the company’s business.  Fighting words?  Let’s look at risk auditing: Continue reading →

#49 -PROCESS APPROACH IN C MAJOR – T. DAN NELSON

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T. Dan NelsonIn the movie ‘Sincerely Yours,’ Liberace is playing a live show when he solicits the audience for a request.  Arguably the greatest pianist on Earth, supremely capable of dazzling the crowd with a jaw-dropping rendition of even the most intricate, demanding piano arrangement, he asks the audience for a request with the confidence of a magician saying, “Pick a card, any card.” Continue reading →