4 Steps To "Right Sizing" Your Personnel Resources To Support Quality

By Christine Park, Quality Architech

We all have them and we all need them. The real question is do you have the right resources?  And, do you have enough to support your quality system?

21 CFR 211.25 specifies requirements for personnel qualifications.  This includes individuals working in the manufacturing operations, quality as well as supervisors and managers.  The regulation speaks to education, job specific training as well as number of personnel to perform tasks and duties.

The following data is extracted from the FDA investigations/observations from 2012:

As I look at these observations, it is clear that the FDA focuses on assuring there are enough employees to perform the work, as well as the qualifications/skillsets of those employees. I don't believe you need an army of people/resources with quality in their title to meet these requirements. In reality, quality is every employee's responsibility.  Employees should be educated and qualified to perform whatever tasks they are assigned within the operations. Additionally, this education should include a focus on the quality outputs of the processes. Not only must employees have the appropriate qualifications/skillsets, it is important to right size your staff to meet the compliance requirements and the business needs.

The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations)  and the Q10 Guideline, published by International Conference for Harmonization (ICH) provide guidance on resources required to support the quality system. This article is going to focus on the human resources rather than the facilities and equipment resources.

The FDA guidance document requires adequate resources for the following:

• Supply and maintain appropriate facilities and equipment to consistently manufacture a quality product
• Acquire and receive materials suitable for intended purpose
• Process materials to produce finished drug product
• Laboratory analysis of the finished drug product, including collection, storage, and examination of in-process, stability, and reserve samples.

As you are looking at the systematic approach to quality, here are four tips to consider related to human resources and staffing:

1. Determine what skill sets you need to have within your operations to assure high quality products. Here are a couple of examples:
   • R&D – There is a big difference in skill set for research versus development.  Many developers could be good researchers but not all researchers have enough understanding to bring the product to market. If you don't do new product development, consider staffing with technical individuals from operations who understand change control and the importance of evaluating changes against the original design.
   • Manufacturing/production – Are you making the product in house or are you outsourcing to a contract manufacturer.  In this case, the decision should drive the types of resources you need. If you are outsourcing, the resources should be applied to supplier quality management to assure oversight of the CMO.
   • Lab testing for final release testing – If you are doing the final lab testing to release a product, the lab techs should have appropriate requirements and education to perform tests and keep equipment maintained.
   • Clinical trials – individuals that oversee this function should be well versed in the GCP (Good Clinical Practice) requirements.
   • Complaint management – This requires knowledge of failure investigation and CAPA (Corrective and Preventive Actions).  At what point does it make sense to turn the complaint investigation over to the technical support team rather than the quality staff?  Who is most qualified to process the information and address the issue?
2. Evaluate current staff and determine any gaps and/or additional training requirements
   • Sometimes people aren't successful in a specific position because they just haven't been given the appropriate tools and/or training
   • This evaluation extends beyond just the individuals who perform specific quality system functions. It should be applied to all employees and functions.
   • Be sure to evaluate positions and personnel from the systems perspective not just specific job tasks. Most employees (and Quality Systems) perform better when the organization understands the touch points and interrelationships of the processes.
3. Once you have completed the first two steps, you can plan the strategy to train/educate or hire staff with the appropriate skillsets.
   • This is often the most challenging part of dealing with human resources. I strongly suggest you work closely with the HR department to be sure the job descriptions are well documented and accurate. 
   • Schedule this assessment during the performance review planning cycle as it will also give you tools and support for those critical discussions with the employees.
4. Workload capacity planning should be considered as you begin this evaluation of the quality system support requirements and needs. 

For example, as you evaluate your complaint handling processes, you should determine how many complaint investigations can one individual handle successfully.  Setting this goal allows you to monitor employee performance, while providing actual data to the executive management to support hiring additional staff.

As you can see, the FDA is focused on assuring employees have the appropriate training and skillsets. You can be ahead of them by implementing the assessment I have outlined in this article.  We all know the needs of the organization can also change over time. This should not be a one-time exercise. Performing this assessment throughout the organization (not just focused on the quality staff) can improve overall quality, as well as business performance.

Remember: The right person doing the right task at the right time. 

It's just good business sense.

*Please note: While this article is targeted at the Pharmaceutical Quality System, the principles are applicable in the Medical Device, Biologics and other regulated industries.

About The Author

Christine (Chris) Park is a proven Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. As a consultant, she uses a pragmatic approach to compliance and quality assurance. Ms. Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations. Her experience in R&D and general manufacturing for medical devices, IVDs, and biotech/pharmaceuticals provides a well-balanced background for her work in compliance. She can be contacted at (678) 480-5411, or visit her website at www.qualityarchitech.com.