Are QA Departments out of control?
Let me tell you a story.
Back in the dark ages of the 1990’s there were no tests available to check that the green powder a customer has just received was actually Wasabia japonica.
It was only when a Swiss Government facility finally developed and published a definitive test in 2011 to determine if a product actually contained Wasabia japonica.
Why did the Swiss do this?
The main reason was to combat food fraud. It still goes on today because of the ingrained usage of Wasabi to describe the taste and look of actual Wasabia japonica.
Why this was (is) causing a health problem is that Wasabi is a blended product which usually contains Mustard and Horseradish with green colouring (and other stuff). Mustard in particular is an allergen which must now be declared on the label, however that was not always the case.
Back in the early 2000 an approach was made by us to the EU via an MEP to try and get the law changed to outlaw people calling their product “Wasabi” if it did not contain any Wasabia japonica. At the time nothing was done as it was felt that the word Wasabi was an inherent part of the normal language and merely indicated a spicy powder.
Testing
Prior to 2011 there were a few proprietary methods developed by individual laboratories that purported to test for Wasabia japonica. (We actually partly funded one such method).
All of these methods used HPLC to determine the levels of the various chemicals in the product being tested. This at best was 50% successful and was reliant on having a specialist to interpret the results correctly.
In many cases today the main testing tool is the HPLC instead of using the definitive PCR method developed back in 2011. (A copy of this PCR method is available on request*).
* Contact [email protected] for a copy.
History
From 1990 to 2015 our company had a total of 2 queries about contamination of our product.
From 2015 to date we get an average of 2 or 3 queries per year and that number is growing each year.
Because of this we started to analyse why this was happening and who were the main culprits. These are the results we found about the companies making the complaint.
- The company had already received and used 300/400 Kgs of our products over the previous few months in a number of separate deliveries with no problems.
- The company had asked us for credit for larger quantity deliveries.
- The company had a substantial sized QA department (more than 10).
- They “demanded” to carry out an audit on our facilities and review “all” our paperwork including proprietary information to ascertain if we met their supplier standards. These demands come after or with their query/complaint.
Our Response
To date our response to such demands has been NO, NO and NO. This will continue to be our response into the future.
Since 1990 we have only dealt with 100% Wasabia japonica and have only ever had that product on our premises. Therefore there is no possibility of cross contamination with any other product on our premises.
We have had customers going back to the 1990’s who order on a regular basis and do random tests. None of these customers have raised queries or complaints.
It is only the new customers who have problems with our products. Strange isn’t it?
We always tell people we offer 100% Pure Wasabia japonica powder and only that. They either want it or they don’t.
History of the Author
Back in early 1972 Michel became involved with Management Services (which is what QA was known as back then). It was regarded as a Tool that reported directly to Production and the main thrust was to ensure that the customer got what they wanted. It covered many disciplines but all with the same end goal.
Over the years systems were developed and changes were made to improving the overall productivity, quality and reduction of waste. Some such as Kaizen was borrowed from the Japanese and other countries.
By the early 1980’s he became qualified as a Lead Auditor and helped introduce ISO9001, ISO9002 and ISO9003 into New Zealand as a Quality Consultant.
Yes, in those days there were 3 Quality Standards. Over the years they have morphed into the ISO9001 Standard that dominates the Quality Assurance Industry today.
The downside of this is the fact that QA is no longer a tool for production to benefit from. It has grown into a multiheaded monster that dictates to Management throughout a company, how each department MUST operate with virtually no responsibility for the effectiveness or efficiency of that department.
In many companies it has actually become a bottleneck that hinders production and productivity.
Many QA managers and directors build large and unwieldy empires that serve no useful purpose within the company.
The continued demands for more and more paperwork from suppliers, department heads by QA for their files adversely affect the various companies bottom line.
As a retired QA Consultant who has watched this QA monster develop Michel feels that it is time to go back the basics of improving quality, productivity, efficiency and effectiveness. This will be a positive direction instead of the paperwork mountains being accumulated for no good reason which is negative in all aspects for improvement.
The initial reason for QA was “Is the product produced fit for purpose?”
The rest of the BS is just gilding of the lily.
It does not take a pile of paperwork filed and evaluated by untrained and unqualified personnel to make this evaluation. The Customer will decide!
Final Comments
You might wonder why I wrote the above opinion piece in November 2021. Now in 2022 re-reading this article I find that nothing has changed - in fact the BS may have got worse.
The Covid epidemic and the world's freight and shipping systems in disarray has pushed the end users requirements further back in organisational priorities. Concentration on logistics and employee problems has allowed QA departments almost free rein to take over the conversations between suppliers, end users and the organisation. Production systems are now tied to QA paperwork requirements. Most of these bits of paper have no relation to production activities or end user requirements.
In my view it is necessary that people external to the company (not me) look at internal and external paperwork requirements and systems to ascertain how they affect the organisation. I suspect that it will found that in excess of 80% of the paperwork is either "make work" or irrelevant to the bottom line.