PDCA Cycle in Pharmaceutical Industry

The Deming PDCA (Plan-Do-Check-Act) cycle is a continuous improvement process that helps organizations systematically solve problems and enhance processes. Let’s break down each phase with the provided format:

Plan (P)

Problem Description
5W2H: A method to describe the problem comprehensively.
What: What is the problem?
Why: Why is it a problem?
Where: Where does it occur?
When: When does it occur?
Who: Who is involved or affected?
How: How does it manifest?
How Much: How severe or significant is it?

Problem Analysis

Why-why analysis: A technique to identify the root cause(s) of a problem by repeatedly asking “why” until the fundamental issue is uncovered.
Root Cause: The fundamental reason for the problem identified through analysis.
Countermeasures: Actions proposed to eliminate the root cause(s) and prevent recurrence.

Goal (Measurable)

Current Condition: The present state or baseline metrics of the process or issue.
Target: The desired state or outcome, often defined with specific, measurable criteria.
Actual Value Achieved: The value or state achieved after implementing actions.
Plan Time: The projected time frame for completing the planned actions.
Actual Time: The actual time taken to complete the actions.

Do (D)

Containment Action (Immediate Action)
Temporary measures taken to control the problem and prevent further issues while a permanent solution is being developed.
Implementation (Long-Term Action)
Execution of the countermeasures designed to address the root cause(s) and achieve the target goals. This includes allocating resources, assigning responsibilities, and ensuring proper communication.

Check (C)

Check/Test Parameters
The specific metrics or parameters used to evaluate the effectiveness of the implemented actions.
Criteria of Checking
The standards or benchmarks against which the results are compared.
Frequency of Checking
How often the checking or testing should be conducted to monitor progress.

Responsibility

The individuals or teams responsible for conducting the checks and reporting the results.
Succeed
Evaluation of whether the implemented actions have successfully resolved the problem and met the target goals.

Act (A)

Implementation Tasks for Established Standard
New Standard Created: If the solution requires new procedures or standards, they are developed and documented.
Existing Standard Updated: Existing standards are revised to incorporate the changes made to resolve the problem.

The PDCA cycle is iterative, and after the “Act” phase, the cycle begins again with the next issue or opportunity for improvement.