Entry Level: BioTech

Performing a Deviation Interview

Simulation vetted by professionals from a biotech in Greater St Louis and a CDMO in Texas

Simulation Objective:

Document the details of a deviation

Associated Simulation Library:

Background

Biopharma companies are committed to a spirit of continuous process improvement. And naturally, through the course of any process, deviations will occur. In the spirit of continuous improvement, a major goal is to focus on knowledge gaps in the process that open the door to deviations and closing them, not to point fingers. The first step to strengthening any process is gathering information about the deviation. The lab technician’s role will be to provide the information to be documented in the deviation interview.

The Process

  1. Deviation Occurrence - Note that a deviation has occurred and inform necessary persons a deviation interview is needed

  2. Deviation Interview - Gather information about the occurrence

  3. Analysis - Apply problem solving methodologies to determine the nature of the deviation and propose solutions

  4. Problem solve using a Fishbone Diagram - A diagram used to visually organize issues by category.  The layout of the diagram resembles fishbones, hence the name.

  5. Improve - Implement solution, communicate changes, and provide necessary training

Resources

The Exercise

Your role as a lab technician is to note when a deviation has occurred, complete the deviation interview, and notify the necessary individuals.

For this exercise, you will be both the interviewer and the interviewee. As the interviewee, you will review the example SOP and deviation that has occurred. As the interviewer, you will assess the deviation and document the deviation and any other information that will be used in the evaluation of the deviation.

Task 1 - Understanding the Deviation

At this point you want to retrace your steps, take things slowly and review the SOP against your work - were any steps missed or forgotten?

Review the sample bioreactor batch record and the deviation noted on Sample 8 of Appendix A. Consider these critical details when you read through the deviation interview: 

  • How is the process written?

  • What could have happened that led to the deviation?

  • Did anything occur that didn’t follow the process?

  • What is the nature of the deviation?  E.g. Equipment breaking down or not calibrated.

Make note of the details you find related to this for the deviation interview.

Task 2 - Deviation Interview

Begin the deviation interview and refer to the batch record and your notes. When interviewing a first time employee for their first deviation, remind them that the goal is to set up a culture of continuous process improvement. Ask the employee to consider a really broad spectrum of possibilities. Sometimes it may not be related to the procedure, root cause analysis is a creative thinking process. Employees may be asked:

  • How was the process written?

  • Was the process easy to follow as written? 

  • Were there any inconsistencies with the instructions? 

  • Was there any part of the process that did not make sense that could have led to a deviation by way of error through misunderstanding?

  • Did anything happen during the procedure that didn’t follow the process?

  • What is the nature of the deviation?

How else would you set the employee at ease before starting the interview and to encourage an open conversation?

Task 3 - Problem Solving

Review the deviation interview and apply the fishbone problem solving exercise. A fishbone problem solving exercise is a root cause analysis (wiki) to understand the role of the equipment, employee action, and process. The goal is to understand the main contributing factor to the failure. For example:

  • a process related issue is - the batch record tells you to take a sample before this step, but it’s better to sample after this step. 

  • an equipment-related issue is -if you’re trying to feed media into the bioreactor, it tells you to 100mL at a time, but the pump only adds 80mL at a time, that would be a machine issue that you might uncover in an interview

  • an employee-action issue

Fishbone diagrams can be a useful tool in problem solving by helping you group issues visually by category. The team would sit together and brainstorm answers and place their responses on the diagram. A team might find that more responses are being recorded for the materials category - which would indicate where to begin further investigation. The diagram groups categories and resembles fish bones, hence the name, and teams use this to see if patterns may emerge. To use the diagram, take each category and brainstorm ways the issue could have arisen from an issue with machine or manpower. Then continue brainstorming and problem solving for other categories.

Here is an example of what it could look like.

Then, propose a solution based on the problem solving exercise.

Deliverables

At the end of the exercise, you should have a completed batch record for the deviation interview. The batch record will be reviewed by the supervisor for completeness. The interview will be evaluated to determine next steps. Sometimes the result will be to implement a preventable measure, or create a whole new work flow, or even an optimization of the existing workflow. 

Track down the relevant issues and what could have gone wrong. You may need to do detective work and note relevant information that can be used to brainstorm and problem solve why the issue occurred. For example, if the window was missed:

  • For the machine category - what could the machine have done to miss the window - maybe it added too much glucose and growth was too fast

  • Manpower - human error - i lost track of time, i should have taken an additional sample

  • Material wise - maybe the starting culture was aggressive or really healthy and reached the exponential phase

  • Method - instructions was to take 4, 8, and 12 - maybe the timepoints in the process are too far spread out and prone to missing the window, and we need to take samples more often.

Additional Tasks

A professional in the field of biomanufacturing may also perform these tasks:

  • Media formulations and preparation

  • Harvesting cells

  • Packaging Technicians

  • Microscopy

  • Operating bioreactors

  • Quality assurance and Quality control

Skills Used to Perform this Task

  • Attention to detail

  • Accountability

  • Communication

  • Continuous improvement mindset

Skills Used in the Field

  • Clear communication skills

  • Attention to detail

  • Knowledge of problem solving methodologies

  • Knowledge of process excellence philosophies

  • Problem-Solving Skills

  • Teamwork and Collaboration

  • Adaptability and Flexibility

  • Integrity

Career Progression

Laboratory Technician > Cell Culture Technician > Research Associate > Cell Culture Specialist > Senior Research Associate > Senior Cell Culture Specialist > Scientist > Senior Scientist

Sample Job Postings

Typical Pay Range Pay rate: $17-20/hr

Thermo Fisher Scientific

Cell Culture Technician | Pay rate: $35-45K

Formulation Technician | Pay rate: $40-50K


Endeavor Consulting Group

Formulation Technician | Pay rate: contract


Washington University in St. Louis

Research Laboratory Technician II | Pay rate: $16.59-24/hr

Sample Job Posting: Formulation Technician

Our client, a global pharmaceutical corporation, has an immediate need for an energetic Formulation Technician to join the team. In this role, you will be responsible for supporting the formulation and preparation of buffers and media used in the production and development of pharmaceutical products. The ideal candidate should have a strong background in pharmacy and extensive hands-on experience with buffer and media formulations.

This is a day shift role in which you would work 12 hour shifts 3-4 days/week in the client's pharma manufacturing facility in St. Louis, Missouri.

Responsibilities
• Prepare and formulate buffers and media for use in manufacturing processes.
• Develop and optimize processes for buffer and media preparation.
• Troubleshoot issues related to buffer and media formulations.
• Maintain a clean and safe work environment.
• Perform routine and non-routine analytical tests on buffers and media.
• Document all activities according to Good Laboratory Practices (GLP) and Standard Operation Procedures (SOP).
• Collaborate with other team members to ensure timely delivery of materials and products.
• Maintain raw material stock levels, supplies, and equipment

Requirements
• Highschool degree or GED is required
• Bachelor’s degree in a scientific discipline is preferred
• 1+ years of experience in a laboratory or GMP manufacturing
• Buffer and media formulations experience in a pharmaceutical setting preferred
• cGMP manufacturing experience preferred
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to accuracy and high-quality work.
• Ability to multitask and manage competing priorities.