There’s a number of factors that should be considered when facing and fighting risk. Some of them can quantitatively or qualitatively affect the fight.
By quantitative aspects or factors I mean those that are most numerically present when studying a risk analysis project. By qualitative I mean those, that, although may be present as “trace elements”, determine the result of the analysis and the outcome of the risk prediction and prevention. Continue reading
The new edition of ISO 9001 under development will include the concept of risk in the form of definition, guidance and requirements. Previous editions included a clause on preventive action which aimed to prevent the occurrence of nonconformities and to some extent this was risk mitigation by another name.
Risk has therefore always been addressed in ISO 9001. In addition if we look at ISO 9001 through a ‘risk tinted’ lens we would see all requirements in ISO 9001 as risk treatments, therefore risk and ISO 9001 is not a new combination. However, the way in which the term risk is defined, used and explained in the current draft creates some uncertainty as to what the term means and this has implications for users. In Part I, I look at the differences in meaning between the word ‘risk’ as commonly understood and the word ‘risk’ as defined in ISO 9001. Continue reading
OBJECTIVES FIRST
Any humanly devised process is preceded by an objective. We don’t process things for no reason, we process things to accomplish something. After we are clear about what we intend to accomplish, we develop a process to achieve that objective.
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HYPOTHESIS: CERTIFICATION IS A FLAWED BUSINESS MODEL
Hypothesis Boundary
We refer here very specifically to Quality Management System ISO 9000 certifications. However, it naturally extends to any system certifications such as EMS – ISO 14000s, OHSAS 18000s, ISO 22000, and a host of others. Some part of the discussion is bound to extend to the product certification category, but in general the discussion is not meant to cover aspects relating to the business of product certifications. And obviously, this is not to be confused with personnel certifications. Also, please note that, here we are not questioning the intent, content, understanding, implementation, effectiveness of implementation and its added value. We are referring to the specific business of third party auditing & certification after implementation. Continue reading
Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Continue reading