Life Science Quality Assurance in 2020: 5 Key Trends

A whopping 90% of our respondents identified “maintaining compliance” among their top three challenges in the new year. “Improving manufacturing/production performance” followed at 63%, and “bringing new products to market” took the number three spot at 46%.

The overwhelming focus on compliance aligns with findings of a similar study conducted by Deloitte, which interviewed 11 major life science leaders to take a more granular look at the specific challenges life science firms are facing in the realm of compliance. 

“The life sciences industry continues to face unprecedented challenges amid increasing regulatory scrutiny. Globalization, alliances and partnerships, heightened transparency expectations, increased emphasis on innovative technologies, and the ever evolving needs of existing and emerging customers are driving companies to re-examine their approach to compliance.”  – DELOITTE CENTRE FOR HEALTH SOLUTIONS

The conversation around compliance flows into the second most-identified goal: improving manufacturing/product performance. Since quality teams are naturally intertwined throughout the entire production chain, their effectiveness is often a signal of broader operational and organizational health.

Issues in quality operations, whether due to chronic understaffing, skillset gaps, process problems, or any other underlying problem, inevitably increase risks and costs. High-performing quality teams keep these issues off the radar by putting a premium on preventive action.

When problems do arise, teams can more quickly identify and resolve them to avoid rippling effects that impact production and pose possible safety risks. Prior research has indicated a growing shift toward performance-oriented goals for quality operations, which by our numbers, seem to be holding in 2020.

Quality leaders identified “limited headcount,” “limited budget,” and “limited skillsets” as the top obstacles to achieving their goals in 2020.

Concerning budget, most quality teams also reported they anticipate holding steady at their current rate of investment or expect to receive more support over the next year.

The focus on compliance and resourcing in 2020 also extends directly into the quality system itself. 73% of the quality leaders we surveyed identified “ensuring compliance with relevant regulations” among their top three quality system-specific challenges.

Just as notably, the pervasive personnel problem emerged in a very close second place, with “sufficient staffing/resourcing” receiving 66%. Supplier management, system integration, and user training took the next three positions, respectively.

In considering what practical steps to take based on these findings, perhaps the best place to start in preparing your quality system for a compliant 2020 is reviewing the most recent compliance trends throughout the previous year.

For drugmakers, the most frequent known compliance issues over the last fiscal year primarily concern the basic requirements that every pharmaceutical company should have established as a matter of course. Here are the top five trending issues for drugmakers by the number of warning letters issued over the previous fiscal year, as reported by the ECA.

1. Responsibilities of the quality unit (21 CFR 211.22) – 41 Warning Letters

2. Written procedures; deviations (21 CFR 211.100) – 32 Warning Letters

3. Testing and release for distribution (21 CFR 21.165) – 29 Warning Letters

4. Production record review (21 CFR 211.192) - 27 Warning Letters

5. Testing and approval or rejection of components, drugs product containers, and closures (21 CFR 211.165) & Stability testing (21 CFR 211.166) - 22 Warning Letters

For device makers, far fewer publicly-available enforcement actions make trends far more challenging to define, however, recent data shows that most quality system issues fall in line with those that routinely get the most attention from regulators, namely:

1. CAPA (21 CFR 820.100)

2. Design controls (21 CFR 820.30)

3. Purchasing controls (21 CFR 820.50)

4. Process validation (21 CFR 820.75)

5. Complaint files (21 CFR 820.198)

While it’s no surprise that compliance tops the list of quality system challenges, resourcing as a close second appears to be an emerging point of focus, especially given how little comparative attention it garners among industry thought leaders.

Resourcing is one area where regulators have spelled out specific expectations for compliance. For drugmakers, specifically, FDA’s landmark 2006 guidance, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, offers a practical explanation of the roles and responsibilities within the Quality Unit. We’ve highlighted a number of the critical points for evaluating whether or not a quality function is resourced sufficiently.

The duties of the Quality Unit:

• “Ensuring that controls are implemented and completed satisfactorily during manufacturing operations”
• “Ensuring that developed procedures and specifications are appropriate and followed, including those used by a firm under contract to the manufacturer”
• “Approving or rejecting incoming materials, in-process materials, and drug products”
• “Reviewing production records and investigating any unexplained discrepancies”

Download our free report for a more detailed checklist you can use to gauge resourcing sufficiency throughout your Quality Unit.

In addition to outlining the Quality Unit’s responsibilities, FDA notes that under a quality system, “it is normally expected that the product and process development units, the manufacturing units, and the QU will remain independent.”

Regulators specifically warn against assigning a single individual to perform both production and quality functions except in “very limited circumstances.”

“In very limited circumstances, a single individual can perform both production and quality functions. That person is still accountable for implementing all the controls and reviewing the results of manufacture to ensure that product quality standards have been met. Under such circumstances, it is recommended that another qualified individual, not involved in the production operation, conduct an additional, periodic review of QU activities.”

This expectation is especially salient given the uptick in Warning Letters citing Quality Unit deficiencies in 2018 and 2019.

Many of these issues are rooted not only in establishing and documenting quality roles and responsibilities but sufficiently staffing the unit with the personnel required to adequately carry out the unit’s duties as they’ve been established and documented.

As these Warning Letters demonstrate, regulators expect firms to staff their Quality Unit to reflect the scope and complexity of the manufacturing operations under their oversight. When regulators discover that such a vital function is under-resourced (whether in terms of the number of personnel or the qualifications they carry), it’s often a signal that other deficiencies may exist due to resourcing—sparking further investigation and scrutiny.

4. Quality teams have mixed QMS priorities, but documentation, risk analysis, and CAPA stand out.

43% of quality leaders we surveyed indicated “documentation” was among the top QMS priorities in 2020.

The most varied responses came from our question regarding the quality management system. “Documentation” narrowly edged out “risk analysis” and “corrective and preventive action (CAPA, complaints, and recalls), at 43% compared to 40% for the two runners up, respectively.

While these trends have been the subject of countless articles, seminars, and workshops, a few points are important to highlight:

Documentation

Whether it’s a policy document, product specification, or any other type of written record, ineffective document control can significantly threaten not only the quality team responsible for managing them, but the company at large. Documentation problems often look something like these:  

• Receiving parts or products built to an out-of-date specification
• Quality events arising from lack of awareness or inadequate training
• Scrambling during gap assessments and audits to come up with a required process or specification documents

While it’s often assumed that something as fundamental as good document control is being managed appropriately, experience in assessing firms large and small

across the world has routinely turned that assumption upside down. All too often, poor document control practices quietly create a variety of other problems that compound to create serious compliance and safety risks. In short, having a document control system integrated with your FDA compliance program is essential to keeping everything straight. Effective document control ensures you can do what you say and say what you do, which is exactly what regulators will be looking for.

Risk Analysis

Another prevalent and dangerous QMS gap is an inefficient risk management program. This often stems from an erroneous conflation between risk assessment and risk management. Risk assessment must be viewed as a more extensive process that encompasses hazard identification, risk assessment/ analysis, control implementation, and performance evaluation. At its core, risk management is central in all sectors of life science manufacturing—from design to implementation, supplier management, and postmarket surveillance.

CAPA

Given the numerous inspectional observations citing insufficient established CAPA procedures, it’s worth revisiting what regulators expect to see from your CAPA process. Read our comprehensive white paper on the subject for a deeper dive into CAPA and root cause analysis in FDA-regulated industries. In addition to helping manufacturers meet the broad expectations for effective CAPA, FDA also makes public its inspectional guide, which lays out the specific objectives for investigators when evaluating a medical device CAPA system and related documentation. Read our piece here for a summary of these.

5. Most quality teams see resourcing as a challenge in 2020 and prioritize fit, skills, knowledge, and expertise over price in potential candidates

86% of quality leaders we surveyed prioritize “right-fit skills and knowledge” when evaluating a resourcing firm. 

Our survey concluded by focusing on further unpacking what turned out to be a major theme throughout the research: RA/QA resourcing.

Specifically, when asked to place their likelihood of encountering staffing/resourcing/recruiting challenges on a scale of one to ten (one being not likely at all and ten being certain), the average score landed just over six.

We also investigated the factors quality leaders prioritize when setting out to staff their team by engaging with a life science resourcing firm. While conventional wisdom suggests to many that price and/or rate is ultimately the deciding factor in a hiring decision (whether contracted or permanent placement), most quality leaders we surveyed put a higher premium on “right-fit skills and knowledge” (86%) and “industry-specific experience and expertise” (73%). “Price/rate” took the number three spot at 53%.

Conclusion and next steps for quality leaders

This survey revealed compliance and production performance as general priorities across quality teams, but indicated that resourcing has emerged as a large and growing problem as the labor market tightens for skilled professionals. With over half of our survey respondents anticipating quality budget increases in the year ahead, now is the time for leaders to carefully evaluate the demands of their goals for the upcoming year and assess their ability to achieve them.

If you need assistance, whether in supporting a current or upcoming project or finding a contracted or direct hire resource, The FDA Group’s large network of life science resources have extensive knowledge and experience in relevant regulations, guidance, and best practices related to quality system management throughout the regulated life science industries.

Our resources can be utilized to meet the full range of quality and compliance requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Contact us to learn more about fulfilling life science resourcing needs and be sure to grab the full version of our report below. We help life science organizations secure a wide variety of resources with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects—all at a competitive rate and backed by a Total Quality Guarantee.

 

The Life Science Quality Leadership Report & Benchmark