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How can you use quality management principles to identify areas for improvement in your process design?

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Process design is the planning and implementation of the activities, resources, and systems that transform inputs into outputs to meet customer needs and expectations. Quality management principles are the guiding standards and practices that ensure the quality of products, services, and processes. By applying quality management principles to your process design, you can identify areas for improvement, increase efficiency, reduce waste, and enhance customer satisfaction. In this article, you will learn how to use four quality management principles to evaluate and improve your process design.

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Pranshu Kulshrestha

Strategic Growth Partner at Kulsys Technologies | Process Engineering | New Product Development | Project Management
Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) ||…

1 Customer focus

The first quality management principle is customer focus, which means understanding and meeting the current and future needs of your customers. To apply this principle to your process design, you need to define who your customers are, what they value, and how you can measure their satisfaction. You also need to collect and analyze feedback from your customers regularly, and use it to identify gaps and opportunities for improvement. For example, you can use surveys, interviews, focus groups, or complaints to gather customer insights, and use tools like the Kano model, the voice of the customer, or the customer journey map to translate them into process requirements.

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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) || Biorisk Manager || Committed to Elevating Quality Standards in Medical Laboratory Diagnostics.
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Customer focus is a fundamental quality management principle that drives the identification of areas for improvement in process design. By understanding the needs, requirements, and expectations of the customers involved in a particular process, organizations can align their process design with these key stakeholders. This ensures that the process serves its intended purpose effectively, leading to higher customer satisfaction and loyalty. Customer focus encourages organizations to actively listen to customer feedback, adapt to changing needs, and continuously improve processes to meet or exceed customer expectations, resulting in enhanced product or service quality.

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Pranshu Kulshrestha

Strategic Growth Partner at Kulsys Technologies | Process Engineering | New Product Development | Project Management
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One thing I have found helpful is the agile nature of a process design especially for third party manufacturers. While quality by design is of paramount importance with prime customer focus approach, sometimes even the best designs lack a long term perspective. Using descriptive, diagnostic and predictive analysis techniques can really help towards this

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Eng. Ayman Botros

Freelancer Trainer, Consultant, and Lead Auditor
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First of all, when organization decide to express its processes needed in flowcharting (process approach), in many case we discover better way for communication and effectiveness. Also, in reviewing how long and deep people are involved and engaged, we shall find better way to do.

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2 Process approach

The second quality management principle is process approach, which means managing your activities as interrelated processes that function as a coherent system. To apply this principle to your process design, you need to map out your processes, identify their inputs, outputs, and interactions, and establish their objectives, indicators, and controls. You also need to monitor and evaluate your processes regularly, and use tools like the PDCA cycle, the SIPOC diagram, or the process capability analysis to identify and implement improvements. For example, you can use the PDCA cycle to plan, do, check, and act on changes to your processes, and use the SIPOC diagram to visualize the suppliers, inputs, processes, outputs, and customers of your system.

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Pranshu Kulshrestha

Strategic Growth Partner at Kulsys Technologies | Process Engineering | New Product Development | Project Management
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Actually I disagree with this that a PDCA is enough for a process approach. Most of the process improvement happens by detailed analysis of the process and the projects should aim to have a robust baseline established by available techniques. The Feasibility stage of the project is very important

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3 Continual improvement

The third quality management principle is continual improvement, which means seeking to achieve consistent and incremental enhancements to your products, services, and processes. To apply this principle to your process design, you need to foster a culture of improvement, where you encourage and reward innovation, learning, and problem-solving. You also need to use tools like the 5 Whys, the fishbone diagram, or the Pareto chart to identify and prioritize the root causes of issues, and use tools like the SMART goals, the action plan, or the A3 report to implement and track solutions. For example, you can use the 5 Whys to drill down to the underlying reasons for a defect, and use the SMART goals to set specific, measurable, achievable, relevant, and time-bound objectives for improvement.

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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) || Biorisk Manager || Committed to Elevating Quality Standards in Medical Laboratory Diagnostics.
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Continuous improvement is a core quality management principle that plays a pivotal role in the process design. It involves an ongoing commitment to making incremental enhancements to processes, products, or services. By constantly seeking ways to optimize and refine processes, organizations can adapt to changing customer needs and market dynamics. This principle encourages a culture of innovation, learning, and adaptability, driving long-term growth and excellence. Continuous improvement is marked by a cycle of planning, doing, checking, and acting, where organizations assess their current performance, implement changes, measure the results, and refine further, resulting in an ever-evolving and more efficient process design.

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4 Evidence-based decision making

The fourth quality management principle is evidence-based decision making, which means using data and information to support your choices and actions. To apply this principle to your process design, you need to collect and manage relevant and reliable data and information from your processes, customers, and environment. You also need to use tools like the SWOT analysis, the decision matrix, or the cost-benefit analysis to analyze and interpret your data and information, and use tools like the balanced scorecard, the dashboard, or the feedback loop to communicate and review your decisions and results. For example, you can use the SWOT analysis to assess the strengths, weaknesses, opportunities, and threats of your process design, and use the balanced scorecard to align your decisions with your strategic goals and measures.

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5 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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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) || Biorisk Manager || Committed to Elevating Quality Standards in Medical Laboratory Diagnostics.
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Maintain comprehensive documentation of the process design, changes made, and their outcomes to track improvements over time. Also establish a feedback loop with customers and employees to ensure that the improvements meet their needs and expectations. Ensure that the improved process is standardized and documented for consistency and ease of future reference. By following these quality management principles, you can systematically identify and address areas for improvement in your process design, leading to increased efficiency, customer satisfaction, and overall performance.

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kamran khan

Sr! Ass.Manager Regulatory/ QA
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First create a template and select the person in your team who has exposure to all the departments and all the factors identified by the team in advance, all these factors are reviewed by this skill person. Like enough gaps will be known, now you can do the improvement calmly

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How can you use quality management principles to identify areas for improvement in your process design?

1

2

3

4

5

1 Customer focus

2 Process approach

3 Continual improvement

4 Evidence-based decision making

5 Here’s what else to consider

Process Design

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How can you use quality management principles to identify areas for improvement in your process design?

1

2

3

4

5

1 Customer focus

2 Process approach

3 Continual improvement

4 Evidence-based decision making

5 Here’s what else to consider

Process Design

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