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How can you use Value Stream Mapping (VSM) to improve GMP quality management?

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Value Stream Mapping (VSM) is a powerful tool for identifying and eliminating waste in any process, especially in GMP (Good Manufacturing Practice) environments where quality and compliance are critical. VSM helps you visualize the flow of materials, information, and activities from the start to the end of your process, and highlight the sources of inefficiency, variation, and non-value-added steps. In this article, you will learn how to use VSM to improve your GMP quality management by following these steps:

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Baljeet Singh Virdi

Plant Head at Arora Metal Works
?brahim Berksoy

Laboratuvar Akreditasyonu ve Y?netim Sistemi Dan??man?
Rima Patel

Quality & Compliance Lead

1 Define the scope and objectives

Before you start mapping your process, you need to have a clear idea of what you want to achieve and what are the boundaries of your analysis. For example, you may want to focus on a specific product line, a particular stage of the production cycle, or a cross-functional process that involves multiple departments. You also need to define your quality objectives, such as reducing defects, improving customer satisfaction, or meeting regulatory standards.

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Baljeet Singh Virdi

Plant Head at Arora Metal Works
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Follow These steps - *Identify the Current State: Start by mapping out the current state of process. *Define the Value Stream: Determine the value stream in the context of quality management. *Analyze the Flow: Analyze the flow of materials, information, and decision-making. *Identify Waste: Identify and categorize different types of waste in the value stream, such as unnecessary movement, waiting, excess inventory, overprocessing, defects, and overproduction. *Design the Future State: Based on the analysis, design an ideal future state. *Implement Improvements: Implement the changes necessary to achieve the future state. *Measure and Monitor: Establish key performance indicators (KPIs) to measure the effectiveness of the improvements.

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?brahim Berksoy

Laboratuvar Akreditasyonu ve Y?netim Sistemi Dan??man?
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One question: Suppose that our aim is to reduce or eliminate non value added steps in whole process. How to find and distinguish non value added steps clearly in sub processes. Non value added step depends on point of view. Who will decide that s certain specific step is non value added step or not. Instead of finding and eliminating non value added steps, it is better to set an continuous improvement in whole process by focusing sub processes. "Kaizen" (continuous improvement) philisophy mainly focuses on continuous improvement. It will give automatically reducing non effective steps in sub processes.

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Rozalinda Kallushi

Operations & Conformance
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Identifying non value added steps involves analyzing processes to determine if a step contributes directly to meeting customer requirements. Decision makers, often process owners or teams, assess and classify steps based on these criteria to streamline processes effectively.

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2 Collect data and information

Creating an accurate and useful map requires gathering relevant data and information about your process, such as the list of steps, inputs, outputs, and resources involved; the time, cost, quality, and quantity of each step; the flow of materials, information, and documents between steps; inventory levels, waiting times, and buffers between steps; customer requirements, expectations, and feedback; quality standards, specifications, and controls for each step; as well as performance indicators, metrics, and targets for the process. You can collect this data by observing the process, interviewing process owners and operators, reviewing process documentation, and measuring process outputs.

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?brahim Berksoy

Laboratuvar Akreditasyonu ve Y?netim Sistemi Dan??man?
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Collecting and processing "direct data" is relatively easy but it is not so easy to collect and process "non-direct data". Direct data means facts and figures, however, non-direct data are "unmentioned" and 'implied" data which can usually be obtained from costumers.

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3 Draw the current state map

Using the data and information you collected, you can draw a current state map of your process. This visual representation will show how your process operates at the present moment, along with its strengths and weaknesses. Standard symbols and icons can be used to depict the different elements of your process, such as process steps (rectangles), material and information flows (arrows), inventory and buffers (triangles), quality inspections and controls (diamonds), customers and suppliers (ovals), and value-added and non-value-added steps (green and red colors). The current state map should also include relevant data, such as cycle times, defect rates, lead times, value-added times, and quality indicators. By creating this map, you can gain valuable insight into how to improve your process.

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4 Analyze the current state map

Once you have drawn the current state map, you can analyze it to identify the opportunities for improvement. Utilizing tools and techniques such as value stream analysis, waste analysis, root cause analysis, and gap analysis can help you calculate the value-added ratio, overall equipment effectiveness, takt time of your process, as well as identify seven types of waste and determine the underlying causes of problems. This analysis should prioritize the most critical and impactful areas for improvement and generate ideas and solutions to address them.

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5 Draw the future state map

Based on the analysis and improvement ideas, you can draw a future state map of your process. This visual representation should incorporate the changes and enhancements you plan to implement, such as eliminating or simplifying non-value-added steps, reducing or eliminating waste sources, streamlining or consolidating process steps, improving or standardizing quality controls, increasing or balancing process capacity, optimizing or synchronizing material and information flows, and implementing or updating quality tools and techniques. Additionally, the future state map should note the expected outcomes and benefits of the improvement actions, like cycle time reduction, defect reduction, lead time reduction, value-added time increase, and quality indicator improvement.

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6 Create and execute the action plan

The final step of using VSM to improve your GMP quality management is to create and execute the action plan. The action plan is a detailed document that outlines the steps, responsibilities, resources, timelines, and measures of success for implementing the future state map. You can use the SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) criteria to define your action plan. You also need to communicate and involve the relevant stakeholders, such as process owners, operators, customers, and suppliers, in the execution of the action plan. You should monitor and evaluate the progress and results of the action plan, and make adjustments as needed. You should also document and share the lessons learned and best practices from the improvement project.

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Rozalinda Kallushi

Operations & Conformance
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Incorporating the SMART criteria into the action plan provides a structured and effective approach. Communication and team member involvement are key for successful execution, ensuring that diverse perspectives contribute. Monitoring progress allows for timely adjustments, maintaining alignment with goals. Documentation of lessons learned and best practices not only enhances current projects but also informs future improvements. The emphasis needs to be on a systematic and collaborative approach. I have always found it valuable to work with an action plan: for new projects, improvement projects or different audits (internal or accreditation).

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Rima Patel

Quality & Compliance Lead
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VSM is very useful for identifying the process which need to improve in GMP. Once the improvement area is known then further defined objective and analyse cause e.g. RCA, Fishbone, 5why etc. Implement the changes and monitor process state of control.

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How can you use Value Stream Mapping (VSM) to improve GMP quality management?

1

2

3

4

5

6

7

1 Define the scope and objectives

2 Collect data and information

3 Draw the current state map

4 Analyze the current state map

5 Draw the future state map

6 Create and execute the action plan

7 Here’s what else to consider

Quality Management

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How can you use Value Stream Mapping (VSM) to improve GMP quality management?

1

2

3

4

5

6

7

1 Define the scope and objectives

2 Collect data and information

3 Draw the current state map

4 Analyze the current state map

5 Draw the future state map

6 Create and execute the action plan

7 Here’s what else to consider

Quality Management

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