Quality Control - Investigation Process flow

”Being happy with a process that cannot be made more fun, but it can be made more fluid”

A pharmaceutical production company asked Progress to help improve the process and procedure for investigating and reporting Out of Specifications, Out of Trends and Out of Expectations. Due to rapid growth, the number of production batches had expanded considerably and there was a need for efficiency improvements in the OOS, OOT and OOE work processes. As a Progress consultant, I was asked for this assignment because as an external party I could give this improvement project the attention it needed without disrupting the routine of the QC laboratory.

Current State

What I found was that more than one investigation was reported per day, there were many unfinished investigations, and the procedure did not clearly state when to start and end a report. Due to my experience with regulations at the companies I previously worked for, the content of investigations and the steps to be taken when changing a process, I have the right background and skills to carry out this improvement assignment.

Together with the team leaders and QC analysts involved, I tackled the issues from the shop floor and defined improvement steps:

  1. Map the current process
  2. Identification of bottlenecks and gaps
  3. Collect and share knowledge
  4. Define and standardize concepts

It was great to work with everyone involved and to see how much knowledge they have in house. The issue was that they did not know who was doing what in the different phases of the investigation and there was no feedback on how it was done.

The next step

With a multidisciplinary team of QC and QA, consisting of an analyst, investigator, team leader, QA officer and QP, we mapped out the improved process and created a flowchart. The flowchart created insight into the different steps within the investigation. Based on current GMP regulations, a description of the process steps has been implemented in the procedure, together with the flowchart and roles and responsibilities. Checklists have been prepared to assist the QC analysts in starting the investigations and critically assessing the analysis performed.


All staff  involved in the investigations were trained for the new procedure and guided “on the job” in the investigation steps to be taken. By focusing on obtaining information about the analyses performed at the beginning of the process, the root cause of OOS or OOT results could be found at an early stage. Subsequently, impact and preventive and corrective actions could be defined.


The project was successfully completed after six months. The content of the investigations has been improved, reporting of investigations has been standardized and the cycle time of the investigations has been reduced by 25%. The improved process flow also made it possible to reduce the number of investigations by 40% as well as the backlog. By mapping out different steps in a logical sequence, people are involved in the thinking of the investigation. Moreover, the team leader mentioned:

”Being happy with a process that cannot be made more fun, but it can be made more fluid”.