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Recently, ComplianceQuest published a whitepaper titled “Measuring Quality Performance with Metrics That Matter.” The paper focused on the following key aspects:

  1. Quality management has become fundamental to driving operational excellence and delivering customer satisfaction. For the quality system to remain effective, there has to be a periodic assessment of its performance.
  2. The best way to drive quality performance is by “measuring what matters”. The quality team must identify relevant KPIs – both leading and lagging indicators – to enable continuous improvement (CI).
  3. Businesses often make the mistake of tracking only lagging indicators like no. of complaints (or) no. of recalls, while ignoring leading indicators like no. of preventive actions taken or successful risk mitigation steps. For real improvement of the overall QMS, it is critical that both lagging and leading indicators are measured.

All regulations and standards, such as ISO 9001, require constant refinement of the QMS to continuously improve the performance of key metrics. It requires an ongoing effort to improve the products, services, and/or processes by doing the following:

  • Ensure incremental improvement of the QMS on an ongoing basis
  • Lookout for breakthrough improvement opportunities and ensure swift implementation if and when an opportunity arises
  • Closely track the entire product lifecycle using data and metrics

Aiding in this continuous improvement effort is the Plan-Do-Check-Act (PDCA) approach, providing a continuous feedback loop to make goal-oriented progress.

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PDCA Approach for Quality: First conceptualized in the 1950s

Dr. William Edwards Deming, a management consultant, developed the PDCA method in the 1950s. It helps identify the reasons for some products or processes not working as expected. The PDCA method requires:

  • Developing a hypothesis about changes needed
  • Testing them in a continuous feedback loop
  • Learning and gaining insights for further improvements

The improvements are undertaken on a small scale before being implemented across the organization.

Its four stages include:

1. Plan: Planning can be divided into a three-step process.

Step 1: Identify the problem – Make sure the correct problem is identified. Solving it should make an impact on the organization’s efficiency and growth. Also understand which aspects of the business are affected by the problem and how resolving it will benefit the company.

Step 2: Analyze the problem – Determine the root cause of the problem. Assess the available information, spot gaps and gather additional data as needed. Identify resources that can throw light on it. Evaluate whether it can be solved and the economic feasibility of the solution.

Step 3: Identify viable solutions, design an experiment, identify the people who will be involved in the experiment and assign responsibilities. Define the objective clearly and the parameters to measure the performance. Assess its potential to scale.

5W2H (5 Whys and 2 Hows), A3, and Fishbone Diagram are some of the methodologies used to identify the problem and its root causes.

2. Do – In this stage, a pilot (whatever was decided in the Plan stage) is implemented on a small scale. This helps to test the solution’s viability to achieve the desired outcome with minimal disruption. The test could be run at the department level, in a small geographical area, or with particular demography.

3. Check – The data generated during the Do stage can help assess the effectiveness of the solution. Analyze the results of the pilot and measure its success based on the parameters established in the Plan stage. If it succeeds, go to the next stage, which is Act. If it fails, go back to Plan.

The plan may need some changes or a completely new approach. Either way, once the new plan has been finalized, it should undergo the Do and Check stages.

4. Act – This is the implementation stage where the learnings are implemented and the project scaled to the enterprise level.

PDCA: A Proven Approach for Continuous Improvement

While that may be the end of the PDCA cycle for that particular plan, the improvement process itself does not end. Once the plan has been implemented, the improved process or product becomes the new baseline and further improvements are planned using the PDCA approach.

Total Quality Management (TQM) and Six Sigma initiatives are areas where PDCA has proven to be very effective.

PDCA can be used effectively for any of the following use cases:

  • A new improvement project
  • To develop a new or improved process, product, or service
  • Defining a repetitive work process
  • Collecting and analyzing data to verify and prioritize problems or root causes
  • Implementing changes
  • Essentially any continuous improvement effort based on audit findings

By implementing the PDCA methodology, businesses can experience the following benefits:

  • Minimum errors with optimum results
  • Continuous learning and understanding of processes, identifying problems and devising effective solutions

ComplianceQuest for PDCA Implementation

ComplianceQuest is a cloud-based quality management solution aligned with leading regulations and standards and aimed at enabling continuous improvement. It facilitates adapting the ISO 9001 PDCA (Plan, Do, Check, Act) process model and incorporates features such as Change, Audit, 5 Why Root Cause Analysis, CAPA and Document.

Change Management: Manage the change workflow from the time of initiation to review/approval, execution tracking, verification and closure. It connects automatically with other QMS processes including CAPA, Document Management and Training Management to ensure seamless integration between QMS processes.

Audit Management: CQ facilitates collaboration between stakeholders during different stages of an audit to helps the enterprise build a QMS workflow that is data-driven and enables Continuous Improvement (CI). CQ’s Audit Checklist feature helps quality leaders “know their gaps”, take preventive action and, overall, stay compliant to all regulations.

5 Why Root Cause Analysis: This feature helps quality leaders identify the multiple root causes for any problem and their interrelationships, enabling taking corrective and preventive action. Collaboration and sharing of findings with other stakeholders can help in an organization-wide improvement.

CAPA: Corrective and preventive action form the foundation for continuous improvement. Once the root cause has been identified, finding the appropriate solution and its successful implementation becomes essential to prevent future recurrence. This also helps with continuous learning and improvement.

Document Management: All processes are documented and stored in the DMS. This helps with easy retrieval, reference, and reporting, and facilitates continuous learning.

Training Management: The gaps identified in the processes by implementing the QMS in PDCA can help plan training for the employees to minimize errors and maximize outcomes.

To Overall, a robust audit management process is critical to drive CI efforts. To know more, visit:
https://www.compliancequest.com/audit-management-software-system/

Request for a demo here: https://www.compliancequest.com/online-demo/

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