Solving the Right Problem in Your Quality Assurance Team

As the Quality VP for a life sciences company, you’re in a tough spot when balancing quality & efficiency.

You hold the most critical responsibility that a drug manufacturer has: to produce safe and effective pharmaceuticals and medical devices that improve or extend peoples’ lives. Any lapse can have disastrous consequences, so strict compliance is a must. At the same time, the top executives are looking for ways to cut costs and, your area is a frequent target.

This is a slippery and dangerous slope that must be navigated with caution, as measures intended to reduce costs could actually end up damaging your bottom line. So what’s more important – quality or efficiency? The answer: Both.

Here are a couple of tips to help you maintain that critical balance.

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Gaining Efficiency in Quality & Regulatory

The constant struggle to reduce costs is not a fleeting phenomenon. Given the increasing pressure on drug prices, difficulty in securing reimbursement, and the rising costs of new product development, the pressure is undoubtedly here to stay. At the same time, there’s inherent validity in the pursuit of efficiency. If executed properly, efficiency measures can reduce fixed costs, improve margins, and drive up stock prices. The key term here: “if executed properly”.

“Successful problem solving requires finding the right solution to the right problem. We fail more often because we solve the wrong problem than because we get the wrong solution to the right problem.”   - Russell Ackoff

Many cost-cutting initiatives begin with a haphazard reduction of headcount. While a close look at labor output in the Quality area is key to responsible efficiency, going too far with such measures could have unintended, harmful consequences on product quality.

To achieve greater efficiency, let’s first start with understanding what efficiency entails.

“Efficiency is a level of performance that describes a process that uses the lowest amount of inputs to create the greatest amount of outputs. Efficiency relates to the use of all inputs in producing any given output, including personal time and energy. It is a measurable concept that can be determined by determining the ratio of useful output to total input.”   - Investopedia

Now, get a grasp on the true efficiency problem in your organization. Does headcount come into play when assessing efficiency? Absolutely. Headcount contributes to input. The key, however, is not necessarily to reduce the number of people but to first assess the fit, skill sets, and attitudes of your quality assurance team. Further, determine whether you are equipping them with the right tools and equipment to maximize efficiency. You may find that labor surplus is not the issue.

Avoid Trimming the Muscle From Your Quality Assurance Team

If you're not sure that headcount is the efficiency problem within your organization, take some time to evaluate other areas within your realm to avoid trimming muscle in the wrong places.

Trimming muscle: Making reductions that you can’t afford to make, reductions that significantly increase the likelihood of compliance-related Quality issues.

Missteps or deficiencies in this area can have far-reaching consequences that prevent you from achieving your cost-reduction goals and can bring about considerable incremental costs such as scrap, waste, rejects and rework, testing and validation costs, inspection costs, and others. Trimming muscle can put considerable stress and overwork on your remaining employee base which could lead to carelessness, imprudent short-cuts, inadequate supervision, and ultimately higher turnover levels.

Before making personnel cuts, ask yourself:

• Have you conducted a 360-degree talent assessment of the personnel in your Quality department?
• Are there sub-par performers in your departments that can be better coached, better mentored, or reassigned?
• Have you re-evaluated your training materials to ensure they are not stale, giving your team access to the latest methods and protocols?
• Have you re-looked at your technologies and pursued opportunities to further automate your processes?
• Have you performed formal and informal assessments of your processes? Do you feel they are fully optimized?
• Are there certain tasks or initiatives that are better suited for outsourced employees who can bring specific expertise for a specified period of time to get the job done without the overhead costs associated with a permanent employee?
• Have you participated in industry groups or tapped your network of peers to see what others are doing?
• Have you reached out to other departments within your own company to brainstorm efficiency ideas?

Yes – some of these are headcount-related questions, but they are questions that can result in significant improvements without necessarily trimming muscle that often comes with headcount reductions.

Lead Your Quality Organization to Efficiency

Demands for increased efficiency are not going away, in particular with respect to the Life Sciences industry where heavy regulation and increasing competition are putting constant pressure on earnings. However, the temptation to sacrifice long-term quality for short-term gains must be sustained.

While certain situations call for cuts in headcount, keep in mind that the Board of Directors and many top executives do not have the specific expertise in Quality, or the related day-to-day risks, to know when you've gone too far. You and your team members do have that expertise. Trust your knowledge, speak up, and take action.

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