Earlier this year we attended a conference at which one presenter put up a slide titled, “Pharma Quality at Biotech Prices.” We recall thinking what an odd approach to quality this phrase represents. It could be seen to imply that quality is based on the size of a company and on the amounts spent – i.e., that more is more where quality is concerned. But is this true?
In 1984, Phillip Crosby wrote, “Quality Without Tears” in which he sets out the four “absolutes” of quality. They include:
- Quality is conformance to requirements, not some inherent “goodness”
- Quality is achieved by prevention, not appraisal
- The performance standard for Quality is ZERO defects, not “acceptable”
- The measurement for Quality is the cost of non-conformance, not indexes
Defining quality as conformance to requirements moves it from a vague term and a moral position to a simple operational goal, clear, and concretely attainable.’ Similarly, describing the best-practice for quality as up-front prevention – that is, a built-in part of processing rather than as a post-hoc assessment -- is consistent with the industry notion that the goal is to head off problems soonest rather than react after the fact. And catching a problem earlier generally costs less than catching it later.
As to the next two bullets in Crosby’s list: Setting an appropriate quality level of zero errors as a company standard is a psychologically commanding approach and creates a company culture of quality with a clear focus on the non-acceptability of errors. At the same time, the reality is, and should be, a pre-set ‘error level’ (p value) which pre-defines the small level of error that occurs in most processing and represents a small range of issues that require no additional correction.
Finally, though the size of the company is not referenced on Crosby’s list, he states that the measurement of quality is the cost of non-conformance. It’s fair to concede that Big Pharma has a greater cost than small companies when they do not conform to their customer’s requirements – they have more customers and a larger basis/cost when an error occurs, relatively speaking. But any notion that Big Pharma quality is ’state of the art’ or better than the quality Biotech can produce would be a misguided interpretation based simply on the differential price of failure in the world of big and small companies.
Small companies – at least the good ones – can do the same high level of quality/conformance as big companies – merely faster and simpler and, hopefully, cheaper. The standard image of the Biotech as small and agile, cutting edge and nimble, tends toward truth. Expenditure on quality may differ, but the end game is the same –conformance to requirements and comprehensive testing that specifications have been met.
A non-controversial truth is that quality gates – i.e., points at which quality control measures are enacted before moving to the next stage of execution -- may be handled differently in large and small companies. Here’s one obvious example of a potential difference in execution based on size: Where Big Pharma might require a pre-production signoff by four internal reviewing groups, the smaller Biotech company may require only two. Different? Yes.
But the quality of the product can – and should – be the same.
Watch here for future explorations of quality in the coming weeks!
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