The quality cartel’s assessors ramp up their requirements each year. It’s all supposed to be about the sacredness of compliance with the ISO standards and EC regulations.
But after a few years you see how the assessors are forcing you to obey the increasingly stringent standards they have invented themselves by overinterpreting the ISO standards. Making more work for themselves and less productivity for their victims.
Maybe they do this to keep themselves from getting bored. Maybe they really think they can account for every possible avenue of error…one day. We must remember it is not entirely rational; it is the institutionalisation of Obsessive Compulsive Personality Disorder (OCPD).
First they want you to deal only with companies that also have ISO accreditation or certification. Supposedly this is because it proves the suppliers’ quality, but actually it is because the ISO management standards would not survive the marketplace otherwise. Compulsion is their main argument. However, the assessors still want you to check the products because they know the certification doesn’t prove quality. Now they want you to have a form they can inspect to prove you have read the suppliers’ boring certificates and assessed them appropriately.
First they insist on seeing detailed training records, even for highly experienced professional staff. Then they want records of regularly witnessing those staff doing what they’ve been trained in.
First they insist that well-tested and established lab methods are validated in each lab for each member of staff. Then they want them periodically revalidated because some things might have changed.
There is no court of appeal for inspections, so the assessors have free reign to invent new impositions far above those in the ISO standards. They act against any sense of proportionality.
The standards have to be somewhat vague because otherwise they could not be sold to enough victims. This leaves the assessors to continually invent taxing demands so that no business is ever satisfactory.
The ISO standards maximise the market. The inspection bodies maximise the ongoing, fruitless pain.
It doesn’t matter that the lab does thing much differently now from years ago. The alleged quality remains the same because it relies on the ritual of inspection rather than the validity of the results. More proof that it’s all about inspection; “quality” is just the sales pitch to deceive the politicians, customers and gullible professional bodies.
However, reality is a lovely thing. If anyone bothers to consider it, they will see how the assessors’ faux-paranoid theory of reality is often confounded.
The paper below by Keys et al. is an example. UKAS insists labs do extensive and ongoing monitoring including aspects such as quality control, external quality assurance, certificate-checking, validation, uncertainty of measurement calculations, and inter-operator assessment. In these authors’ (non-UKAS accredited) labs, the majority of samples tested have been shown to be falsely negative for reasons that would escape UKAS’s demands even if they had accredited the work.
The recovery of low levels of Listeria monocytogenes from foods is complicated by the presence of competing microorganisms. Nonpathogenic species of Listeria pose a particular problem because variation in growth rate during the enrichment step can produce more colonies of these nontarget cells on selective and/or differential media, resulting in a preferential recovery of nonpathogens, especially Listeria innocua. To gauge the extent of this statistical barrier to pathogen recovery, 10 isolates each of L. monocytogenes and L. innocua were propagated together from approximately equal initial levels using the current U. S. Food and Drug Administration’s enrichment procedure. In the 100 isolate pairs, an average 1.3-log decrease was found in the 48-h enrichment L. monocytogenes population when L. innocua was present. In 98 of the 100 isolate pairs, L. innocua reached higher levels at 48 h than did L. monocytogenes, with a difference of 0.2 to 2.4 log CFU/ml. The significance of these population differences was apparent by an increase in the difficulty of isolating L. monocytogenes by the streak plating method. L. monocytogenes went completely undetected in 18 of 30 enrichment cultures even after colony isolation was attempted on Oxoid chromogenic Listeria agar. This finding suggests that although both Listeria species were present on the plate, the population differential between them restricted L. monocytogenes to areas of the plate with confluent growth and that isolated individual colonies were only L. innocua.
The authors conclude with a scientific view rather than an inspectionist opinion,
“Continued improvements in L. monocytogenes isolation methods are needed to reduce the chances of false-negative results due to the presence of other Listeria species.”
Better science, not more method validation and staff witnessing, is needed.
But for victims trapped in the accreditation cycle there’s always the next inspection. It cannot bring perfection, therefore inspection can never end. The purposelessness is essential because it validates itself.
Does that make sense?