PDCA Cycle

PDCA is an acronym for Plan, Do, Check, and Act, which defines the four stages of the PDCA cycle. This cycle was first introduced in the 1950s by Dr. William Edwards Deming, who has been dubbed the Father of Quality. Dr. Deming originally named it the Shewhart Cycle in honor of his mentor, Walter A. Shewhart. Ever since its introduction, the PDCA cycle has been used as a universal guide for implementing continuous improvement practices across all industries. That’s because the PDCA model lays out simple, guiding principles for systematically implementing best practices. Let’s understand what each stage in this cycle means:

Stage 1: Plan

In this first stage of the PDCA Cycle, the potential opportunity is identified and the process is planned. This includes the following steps:

• • Defining the scope is crucial to clarify the goals and objectives of the change:
    • What is in and out of the scope of the change process?
    • What is the expected improvement in the quality?
  • Defining the roles and responsibilities of the stakeholders. This is the second step in the Plan stage. It is critical to clarify the expected deliverables from each person involved in the change process, such as:
    • Who will be responsible for planning the change?
    • Who will be responsible for change execution?
    • Who will be responsible for assessing the change?
    • Who will be responsible for rolling out the change?
  • After defining the scope and deliverables, the next step is to define the budget for the change process. It is essential to have a check on the budget because the cost of implementing the change process must be lower than the expected returns. Otherwise, the change process will fail to create a valuable business proposition. Therefore, the budget may include details like:
    • What is the annual budget for the change?
    • What is the expected return on investment from the change?
  • A delay in implementing the change process may significantly reduce the relative returns from the change process. Therefore, even if a change process promises a valuable business proposition, its value may be relative to the timeline in which the goals and objectives must be achieved. Therefore, the budget must be accompanied with a detailed timeline, asking questions such as:
    • When will the process of change begin?
    • What will be the timelines for achieving different milestones?
  • Although the roles and responsibilities clarify the deliverables from each individual, it may be necessary to describe each step in the change process with more granularity. Therefore, written instructions or protocols for implementing the change process should be created at the Plan stage when applicable, including:
    • Step-by-step work instructions on how to implement the change.

Stage 2: Do

In this stage, the responsible stakeholders execute the change as per the plan.

Stage 3: Check

Here, the person responsible for assessing the change analyzes the quality improvement and return on investment.

Stage 4: Act

In this stage, the person responsible for implementing the change rolls out the organization-wide change if it results in significant quality improvement and returns on investment. The PDCA cycle repeats if the objectives defined in the plan stage are not met.

PDCA Life Sciences
Case Study

Let’s take an example of a Life Sciences organization planning to change to a more cost-efficient raw material vendor for their blockbuster product. Let’s see how the PDCA cycle for this change would look like:

Stage 1: Plan

• • • Scope: Changing raw material ‘A’ in the manufacturing process of ‘X’
    • Out of Scope: Changing other raw materials in the manufacturing process of ‘X’
    • Expected Improvement: Manufacturing cost reduction by 10%
    • Budget: No constraints
    • Timelines:
      • Start date: September 19, 2022
      • End date: September 22, 2022
    • Roles and Responsibilities:
      • Supply chain personnel: Raw material sample procurement
      • Manufacturing personnel: Trial batch execution
      • Quality control personnel: Trial batch sample analysis
      • Quality assurance personnel: Change approval
    • Execution plan:
      • Supply chain personnel: Procuring sample quantity for raw material ‘A’ from a new vendor at 10% lower cost
      • Manufacturing personnel: Trial batch execution
      • Quality control personnel: Analyzing trial batch specifications against established internal standard
      • Quality assurance personnel: Taking a final decision on a permanent change in raw material vendor
        
        

Stage 2: Do

• • • • The new vendor’s sample quantity for raw material ‘A’ was obtained at a 10% reduced cost
      • Trial batch 1 was manufactured using the newly procured raw material ‘A’
        
        

Stage 3: Check

• • • • The QC personnel evaluated that the test samples meet the internal standard ‘XXX001’ specifications
        
        

Stage 4: Act

• • • • The QA personnel concluded that a permanent change in raw material vendor for ‘A’ would result in a 10% cost reduction for the manufacturing process of the blockbuster product ‘X’ without compromising the quality of the product
      • Hence, the QA personnel approved the change in raw material vendor for ‘A’