Saturday, December 25, 2010
So…you’re the new QA person?
New heads of Quality Assurance come into pharma companies all the time for various reasons. If you are the new head of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation.
I have heard such explanations as: we’re looking for a fresh approach; we’re looking for someone with more of a business perspective; we’re looking for a partnership with QA; we’re looking for an operations-oriented QA; or we’re looking for a more progressive QA.
Actually, these all sound very positive and a highly desirable situation for a new, enlightened head of QA looking for a challenge. But like the Rorschach test, these explanations could be interpreted various ways, some of which would be troublesome for the newbie who understands the regulatory role of QA.
Rarely is the expectation as clear as one example in my own career when a company president that interviewed me spoke very directly and took out all the guesswork.
The interview lasted three minutes—because I ended it. The president of the company said, “If you reject my product, blood will be let.” After a moment of nervous laughter I understood him to be quite serious, and that he was talking about my blood. I responded by plucking my resume out of his hand, tucking it back into my briefcase, and responding, “Would you please ask your admin to call me a cab?”
But there is no more popular reason for changing of the guard than being the incumbent on whose watch the company received a Warning Letter. The termination of the QA person is served up as a peace offering and symbol of turning over a new leaf.
The problem with turning over a new leaf is that sometimes it looks the same on both sides. The new QA head has the same struggles as the former head of QA, because the issue was not one of understanding and applying CGMPs, but facing a pervasive company culture of antagonism toward FDA regulations.
The FDA recognizes the possibility of antagonism when we read in recent Warning Letters: “QA was either unable, or not permitted to exercise its responsibility.” (See The QA Pharm 9/25/10.) However, neither is an excuse, because you had the option to resign.
As the new head of QA, you want to make a positive impression as a leader who can be trusted; who is a collaborator; who is a builder; and who makes mindful decisions. So here are some suggestions on what should you do before the honeymoon period is over.
1. Know for yourself the state of compliance.
Gather your own intelligence on the effectiveness of the Quality Management System QMS) and the general state of regulatory compliance. This should include CGMP compliance as well as compliance to the Chemistry and Manufacturing Controls (CMC) of your drug application. Don’t rely on hearsay, or solely on the results of previous inspections.
2. Establish a governance process.
Determine the appropriate performance metrics for each element of the quality system that reports both how well the system is working, as well as what the system is detecting. Report these in a decision-oriented forum of your peers. Solve the problems at a lower level, if possible. However, ensure that each problem rises to the appropriate level and person who has the approval authority for the cost of the solution. Be sure you have allies in the room. Document the decisions, even if the decision is to do nothing, or to postpone action.
3. Build relationships with other functional heads.
Build trust with your peers. Work together to identify and resolve problems. Give credit to other areas when they identify problems and come forward to resolve them. Don’t blindside a peer in a public governance process. Offer to resolve problems that other areas have with inefficient quality system processes.
4. Integrate the quality/ compliance plan into the business planning process.
Develop a quality planning process based on the problems and risks identified from the management review (governance) processes. Integrate the quality plan with the normal business planning process.
5. Speak the universal language of money.
Resolving waste streams, rejections, and nonconformance, etc. all have associated cost. Resolving these issues not only save money, but improves quality and CGMP compliance. Never allow cost to enter your judgment when making a market release decision; however, keep focus on problems that improve the bottom line, and get the compliance for free.
6. Use the fine art of writing proposals.
Write proposals to improve the way of working, to implement a new program, or to make a capital expenditure. Putting proposals in writing helps you to make the case to support. Be sure to capture the return on investment, cost avoidance, or risk mitigation. Shop your proposal to other functional heads, and allow them to sign on to the proposal to signify support.
7. Strengthen the Quality function.
Make time to visit each functional head during the first month of your tenure to ask: What does the quality function need to do more of? What does the quality function need to do less of? Be willing to accept the feedback. Loop back with each one to let them know your assessment of the situation and the action you are taking.
I invite you to share your thoughts and experiences that would benefit our readers, especially the person walking into a new QA leadership position.
The QA Pharm