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QA & RA in a regulated industry?
4 answers
With the right QA and RA partners, they are an enabler.
I've seen both sides. Completely depending on the organization, and the people in QA and RA.
Those that are enablers, quickly identify the regulatory setting that the idea falls into. This helps the team size up the timeline for the opportunity. QA/RA then helps identify what countries require what registrations. This helps the team identify their launch strategy, even their design validation strategy. I've seen QA/RA help the team scope the project accordingly, so that we had products in the markets at all time. (allowing legacy product to stay in certain countries while we waited on registration for the new products)
In a sentence they make sure innovation becomes a sustainable successful business. If one is focussed on the long term perspective, both QA and RA have to be on board.
The challenge for the developer is how to involve them without being drawn in their specifics. These partners should act as consultants and advisors, not drivers. The driver role must be played by the developer.
Beyond good innovator you have to be good moderator.
It is part of Quality Assurance mission to assist the organization move to competitive levels of performance; employees are critical factor in the success of an organization. There are reasons why regulations exist, and most are to protect us.
If the Quality Assurance may be perceived as inhibitor, there is an opportunity for leadership and staff to address the situation, even to set the path of innovation. Organizations such as McKesson, Medtronic, St Jude had come up (and continue coming up) with innovative processes and products.
I specialized in Industrial Organization as part of my Economics major at UC Berkeley. Competition and Barriers to Entry went hand-in-hand in determinng how a particular industry was structured. For example in the auto industry the enormous economies of scale (investment) to create an auto company limited competition and possibly innovation. The entry of foreign competitors into the USA market in the 1970's changed the competitive landscape in the United States as we see today with the industrial ruins in Detroit; US auto companies did not feel the competitive pressure to innovate and suffered the consepquences.
RA lobbys to advise companies how to work around (cheat on) public regulations which is at the expense of the public while profiting for the firms. Public regulations generally encourage a high level of QA by the firms to be in compliance. I do not see the issue to be whether QA and RA enable or deter innovation. I see the issue to be what is in the best of the public interest verus the best interest of the firm. RA is in the best interest of the firm to help maximize profits and certainly is not in the best of the public interest. RA could be argued that it is helps innovation because it helps maximize profits. QA on the other hand is a high cost of doing business that comes out of profits. It could be argued that QA deters innovation because it does not neccessary leade to maximizing profits. Of course, the Japanese auto companies found that employing a high level of splly chain QA in their auto industry transformed them into very profitable world-class competitors that brought new innovations into the industry too.