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What is Root Cause Analysis (RCA) in Pharmaceuticals?

Many industries, not just pharmaceuticals, use the Root Cause Analysis (RCA) tool. Root Cause Analysis (RCA) is a technique for determining the root cause of a problem and assisting in its resolution. Root Cause Analysis (RCA) improves the quality of the problem investigation.

Techniques for Root Cause Analysis (RCA):

Root cause analysis (RCA) techniques include Why-Why Analysis or 5 Why analysis, Brainstorming, Process mapping, and the Fishbone diagram, which aid in determining the root cause of a problem (well known as the cause and effect diagram or Fishbone diagram).

A single tool or a combination of tools can be used to determine the exact cause of the problem.

1.  Why-Why Analysis or 5 Why Analysis
  • 5 why can be very useful and effective when it comes to the manufacture or analysis of pharmaceutical products. It works by simply asking the question and determining the precise answer.
  • 5 Why is one of the tools for determining the root cause of a problem. It performs as its name suggests. It is a series of questions; you should ask yourself 5 whys sequentially to determine the final cause.

2.  Brainstorming
  • One of the most popular RCA tools is brainstorming. When the group meets, all of the information and facts are presented, and the group continues to look for other potential causes.
  • In short, a group of experts gathers to determine the precise cause of the deviation and to propose a solution.
  • Brainstorming is a meeting in which anyone can share their ideas to determine the cause of the problem. The source of the problem can be easily resolved using the information or ideas gathered.

3.  Process Mapping
  • Another RCA tool is process mapping. This tool is a visual representation of the process. We can use this tool to check the entire process at each step. Visual presentation increases the likelihood of discovering the potential root cause of the problem.
  • By breaking it down step by step, the process mapping technique is a great way to identify what might contribute to a problem.

4.  Fishbone Diagram
  • A Fishbone Diagram, also known as a cause-and-effect diagram, includes categories that vary depending on the scenario. "People" are always represented as a category on the diagram, along with methods, machines, and materials. This demonstrates that each has its own set of potential causes.
  • Man, Material, Machine, Method, Measurement, and Mother Nature or Environment are the 6Ms of this tool.

People: The person who is involved in the activity.
Materials: It contains Raw materials, Packing material, and the Items involved in the process.
Machine: Equipment or Instrument that is involved in the process.
Methods: SOP, STP, guidance documents and other procedures involved in the process.
Measurement: Measurement of product quality is based on data generated during the measurement process.

5.  Mother Nature (Environment):
  • Conditions such as temperature, humidity, pressure differential, and the environment in which the process or activity takes place are included.
  • These are the main causes but sub-causes are also a part of the Ishikawa diagram to get the root cause.
  • When the investigative team completes the diagram, it will have an outline for the investigation report.
  • These are the tools used while the root cause analysis (RCA) of the problem.

Types of Root Cause Analysis (RCA)
There are different types of root cause analysis (RCA) on the basis of what kind of problem root cause you want to find.
  1. Safety based RCA
  2. Production-based RCA
  3. System based RCA
  4. Process-based RCA
  5. Failure based RCA

1.  Safety Based RCA
  • Safety-based RCA arises as a result of occupational safety and health, as well as accident analysis. This type of analysis is performed in order to determine the reason for why an accident occurred on the job (such as why a worker dropped a part from a height accidentally).

2.  Production-Based RCA
  • Quality control is ensured in manufacturing through production-based RCA. If the plastic injection-molded parts are coming off the line warped, you might use this to figure out why.

3.  System Based RCA
  • In this method, two or more RCA techniques are combined. The systems-based RCA technique originated when some of the here-discussed root cause analysis techniques were combined. It can be applied to a wide range of different fields or situations.

4.  Process-Based RCA
  • Businesses and manufacturing industries use process-based RCA to find faults in processes or systems.

5.  Failure Based RCA
  • The analysis of equipment failure based on failure-based root cause analysis is used in engineering and maintenance.

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