Process FMECA in Pharmaceutical Manufacturing


Process Failure Mode and Effective Analysis in Pharmaceutical Manufacturing

The objective of this study is to explore the understanding of Process Failure Mode and Effective Analysis in Pharmaceutical Manufacturing. The purpose of FMEA is to analyze design characteristics relative to the planned manufacturing process to ensure that the resultant product meets customer’s needs and expectations. When potential failure modes are identified, corrective action can be taken to eliminate or continually reduce the potential for occurrences. It provides an organized critical analysis of potential failure modes of the system being defined and identifies associated causes.


Failure Mode and Effective Analysis (FMEA) technique is used to define, identify and eliminate known and/or potential failures, problems and errors from the system, design, process and/or service before they reach customers. Failures are prioritized to how serious their consequences are, how frequently they occur and how easily they can be detected. FMEA also documents current knowledge and actions about the risks of failures, for use in continuous improvement.

Types of FMEA

1) System – Potential failure modes between the functions of the system caused by system deficiencies.
2) Design – Failure modes caused by system deficiencies.
3) Process – Failure modes caused by process design.
4) Service – Failure modes caused by system or process deficiencies.

When to Use FMEA

1) When a process, product or service is being designed or redesigned.
2) When an existing process, product or service is being applied in a new way.
3) Before developing control plans for a new or modified process.
4) When analyzing failures of an existing process, product or service.
5) Periodically throughout the life of the process, product or service.

12 Steps Involved in the FMEA Process

  1. Select the process – Importance of the process in terms of impact of potential failures is a parameter that has to be taken into account as selection criteria.
  2. Review the process – Form a team including members with various job responsibilities and levels of experience such as Manufacturing Engineer, Design Engineer, System Safety Engineer, Line Foreman/Operators, etc. Give each member a copy of process blueprint for analyzing.
  3. Brainstorm potential failure modes – Look at each stage of the process and identify ways it could potentially fail, things that might go wrong. A visit(s) to the work area with an overview of the process/operation gives team members basic understanding of the process.
  4. List potential effects of each failure mode – If a failure has more than one effect write each. To identify the effect and causes of the effects use Fish Bone Diagram*.
  5. Assign a severity rating for each effect – Give each effect its own severity rating (from 1 to 10, with 10 being the most severe). High severity number indicates product or process redesign may be needed. To quantify or prioritize the effects use Pareto Analysis**.
  6. Assign an occurrence rating for each failure – Collect data on the failures and using this information, determine how likely it is for a failure to occur and assign an appropriate rating (from 1 to 10, with 10 being the most severe). High occurrence number indicates the causes should be eliminated or controlled. When estimating the occurrence rating, consider the probability that the potential failure cause will occur and thus result in the indicated potential failure mode.
  7. Assign a detection rating for each failure mode and effect – List all controls currently in place to prevent each effect of a failure from occurring and assign a detection rating for each item (from 1 to 10, with 10 being a low likelihood of detection). High detection number indicates a need for additional control.
  8. Calculate the Risk Priority Number (RPN) for each effect – Multiply the severity rating by the occurrence by the detection rating. The highest RPNs are considered the most critical and should be tracked.
  9. Prioritize the failure modes for action – Decide which items need to be worked first.
  10. Take action to eliminate or reduce the high risk failure modes – Determine what action to take with each high risk failure and assign a person to implement the action.
  11. Calculate the resulting RPN as the failure modes are reduced or eliminated – Reassemble the team after completing the initial corrective actions and calculate a new RPN for each failure. Then decide to work on another set of failures.
  12. Maintaining Record – After a process has been analyzed in terms of identify, quantify and take initial measures for the potential failures, a person has to be assigned to monitor the effectiveness of the actions taken and the results in case of a failure.

*Fish Bone Diagram – A troubleshooting tool that can be used to visually diagram the causes and effects of a problem.

**Pareto Analysis (Named after Vilfredo Pareto, a 19th century Italian Economist) – Is a statistical technique in decision making that is used for the selection of a limited number of tasks that produce significant overall effect. It uses the Pareto Principle.


The most important feature of FMEA is formulation and implementation of the recommended actions. Actions are developed as part of an over all strategy to reduce the risk of a process failure. Benefits of performing FMEA analysis include higher reliability, better quality, increased safety and its contribution towards cost savings. Cost benefits associated with FMEA are usually expected to come from the ability to identify failure modes earlier in the process, when they are less expensive to address. Financial benefits are also derived from the design improvements that FMEA is expected to facilitate, including reduced warranty costs, increased sales through enhanced customer satisfaction.