Investigation Tools in Pharma

There are multiple investigation tools in pharma to choose from, including impact assessment, medical opinion, review of complaint history, fish bone diagram, and brainstorming.

What are their differences? Which is the best investigation tool to use in pharmaceuticals? Your long wait is finally over! This guide got your back!

Brainstorming

Brainstorming is where people meet to generate ideas, solutions, opinions, and suggestions to solve a particular problem.

People can think freely and suggest new ideas that may put an end to any adversary. But, more than that, brainstorming is used in pharma to build enthusiasm, engagement, loyalty, and commitment.

It also unlocks and stimulates an individual’s creative talents. Plus, it can develop and strengthen self-esteem.

In any group, the leader should be well-versed in questioning. Some of the possible questions to ask are the following.

–What has happened to the medical product?

–When was the defect realized?

–What was the patient’s current situation?

–What are the probable causes that have resulted in this deviation or defect?

You can also think of any other queries to gather more ideas and suggestions.

Fish Bone Diagram

After brainstorming, a fish bone diagram is utilized.

Commonly called a case and effect diagram, this technique was popularized by Kaoru Ishikawa in the 1960s. Ishikawa is the one who pioneered the management system in the Kawasaki shipyards.

This investigation tool is sometimes referred to as the Ishikawa diagram.

Like the fish bone, the head represents the defect. The major causes of the problem are the ribs. There also sub-branches under each cause. This is how it looks like.

Root Cause

Based on the root cause in the fish bone diagram, you can perform the five whys. It is a tool in which people ask why until they arrive at the best answer to the problem.

The five whys is usually a discussion between teams. Each team consists of experts on quality assurance, process development, quality control, manufacturing, and engineering.

The five whys is used in problem solving, troubleshooting, and quality improvement.

It is developed by Sakichi Toyota, the founder of Toyota Industries, in the 1930s. But it only has gained massive popularity in the 1970s.

Decades had passed, the technique is still used today.

To utilize the method, it is vital to assemble a team, define the problem, ask Why at least four times, determine when to stop, overcome the root cause, and monitor the measures.

Review the Complaint History

A lot of people may not consider the past defect or deviation report. Do not do the same thing. Be sure to include every detail about the complaint history for your reference. Then, identify the root cause of the defect and other crucial information.

Medical Opinion and Impact Evaluation

Ask what will be the effect of a defective product to every patient and assess the impact. From there, you can come up to a conclusion finally.

When creating conclusions, ensure to include the root causes, review of complaint history, a recommendation to the patients, and other details if the need arises.

So, what’s your choice? Whatever it is, you can be confident you can solve a specific problem with a 100% success rate.

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