Quality Management System Implementation

 

In quality management, it’s a popular saying that if something is not written, it didn’t happen. Businesses which follow a management system need a well-conceived and systematised Quality Management System (QMS). 

What is a Quality Management System and why is it Important?

A QMS consists of written and controlled guidelines and procedures that form a foundation for all procedures.

An organised QMS ascertains the steps for key processes and forms methods in preventing failures in a timely manner.

The QMS is structured to protect the brand, organisation processes, and the customers’ interest.

What are the benefits of implementing a Quality Management System?

Implementation of the quality management system should result in many long-term financial gains. Here is the list of few benefits of an effective implementation of a QMS: 

  1. Achieve organisational goals.
  2. Reduce costly errors. 
  3. Improve customer satisfaction. 
  4. Market your business more effectively.
  5. Manage growth more effectively.
  6. Improve documentation availability. 
  7. Correct issues to improve products and services. 
  8. Grow market share in new territories and market sectors. 
  9. Creates a culture of quality. 
  10. Embeds a vision for all projects. 
  11. Better internal communications.
  12. Consistent products.
  13. Measure the performance of individuals and teams. 
  14. Improve compliance. 

What does a Quality Management System need?

A quality management system requires many important elements. Here are a few of them: 

  • Documented quality policy and quality objectives.
  • A quality manual which will document scope, exclusions with justification. A QMS includes documented procedures, guidelines, checklists. 
  • Documented procedures mandated by the compliance standard.
  • Documents required by the company for effective planning, operation, monitor, and control.

The Importance of Hierarchical Organisation

An organisation is spirited when working with controlled documents. A suggested hierarchy for QMS documentation management is:

  1. Quality Manual
  2. Policies
  3. Procedures
  4. Work Instructions
  5. Lists
  6. Checklists
  7. Forms

Steps for the Creation of an Effective Quality Management System

The steps required for the conceptualisation and implementation of a QMS include the following:

1. Define and Map Your Processes

Process map creation will force the organisation to visualise and define their processes. In the process, they will define the interaction sequence of those processes. Process maps are vital for appreciating the responsible person. Define your main business process and converse the flow.

2. Define Your Quality Policy

Your Quality Policy communicates the duty of the organisation as it is about the quality. The mission may be what customers need, a quality mission. When constructing a quality management system, consider the commitment towards customer focus. It may be Quality, Customer Satisfaction, and Continuous Improvement.

3. Define Your Quality Objectives

All Quality management systems must have objectives. Each employee must appreciate their influence on quality. Quality objectives are derivative of your quality policy. It is measurable and set up throughout the organisation.

The objective may be in the form of critical success factors. This helps an organisation in emphasising the journey towards accomplishing its mission.  These performance-based measures deliver a gauge to determine compliance with its objectives.

Some Critical Success Factors are:

  • Financial Performance
  • Product Quality
  • Process Improvement
  • Customer Satisfaction
  • Market Share
  • Employee Satisfaction

4.  Develop Metrics to Track and Monitor CSF Data

Once critical success factors are known, measurements and metrics keep track of advancement.  This can be done through a data reporting procedure used to collect specific data. Share the processed information with leaders. A process goal is to enhance the customer satisfaction index score. There needs to be a goal and a measure to establish the achievement of that goal.

5. Define Defects for Every Process

Defects are non-conformances that happen as a product flaw or a process deficiency. Whenever a defect occurs it needs to be measured and corrected. Identify the required corrective action. When defining your defects:

  • Determine operation volume
  • Determine defects in product and process
  • Define a process to record defects
  • Define a process to report defects in specified formats

6. Develop Documents and Records

A QMS needs to have some documented information and formats. Start with the minimum required document set and add when needed.

  • Create mandatory document information as per the business model
  • Create essential Quality policies, procedures, and forms
  • Create documented  information and formats (records) for each defined process

7. Define Quality Process

Your quality procedure includes internal audit, Management review, Corrective and preventive action process and communication processes.

8. Determine Training Needs

Everyone needs to exhibit competency in the job. Training is only the start and can happen on the job, it can be a classroom or e-learning. Some important training areas are Internal auditor competence, Corrective Action training. Failure Modes Effects Analysis (FMEA) training. 

9. Use the Quality Management System

Using the QMS means producing the best quality product. In the process

  • Collect non-conformance and record them.
  • Review this data for corrective and preventive action.
  • Review FMEAs for risk and actions, as and when required.
  • Perform internal audits and conduct management reviews.

10. Measure, Monitor and implement activities to Improve the Performance

Using the quality management system means collecting data. Analyse this data to check if the collected data is good to use and if the intended results can be derived.

You need to:

  • Track Quality Objectives and its performance
  • Define few new performance yardsticks
  • Determine improvement chances in the data by recognising trends, patterns, or correlations.

If you have identified trends through data, then it is time to act. The goal is to bring improvement and this occurs by:

  • Arranging your improvement opportunities
  • Choosing prospects that make a difference
  • Supporting ‘commitment to quality’ to attain better results

Tools to be used in Quality Management System

Process Maps or Flow Charts

It is important to create a flowchart (process map), it is a popular statistical tool. It helps in streamlining the overall manufacturing process. Easy to understand and very useful, it helps in the visualisation of the entire process. It helps in identifying all possible problems that may occur. A properly constructed flow chart showcases quality checkpoints, documentation expectations. It also shows other parts of the formal control plan.

The control plan is approved or signed off by quality assurance leaders. All concerned departments approve the final process steps and flowchart. The critical steps of FMEA come thereafter.

A Closer Look at FMEA

FMEA helps in the identification of potential failures. It also identifies the team’s ability to apprehend and detect failures. It is important for the FMEA team to estimate these factors and rate them on a scale of one to 10. Then, they identify high-risk priority numbers (RPN). RPN forms a platform for the development of all written quality procedures as well as controls. Thereafter, measurements are taken on the basis of RPN results. It happens to the manufacturing process.

Citing an example, NASA had used FMEA for identifying the potential failures in the process of getting US astronauts to the moon and returning them safely back to Earth.

Measuring Systems and Tools

For assuring greater accuracy levels, calibration is required. It is to ensure that measuring systems refrain from inducing errors in the involved processes. Proper calibration of manual as well as electronic measuring devices is a must. Especially for pre/post- calibration readings that are recorded for more critical features. The measurements conducted at this stage are important parts of Gage Repeatability and Reproducibility. These are generally expressed in the form of a percentile of measurement error.

While certain quality management systems use Six Sigma for removing the causes of defects/errors, Six Sigma is used for minimising variations in manufacturing processes. Others include trace audits and varied statistical tools for reducing costs and increasing profits.

Role of Current Good Manufacturing Practices [GMP]

Most businesses need assurance that their products and processes follow the specific requirements. Also for requirements of identity, strength, and purity. The creation, implementation, and maintenance of GMP compliance is a tough task. Involvement of a devoted management team, routine audits, and committed employees is a must. GMP also requires a well-written and effective quality management system. Companies that follow these regulations presume their suppliers and vendors to do the same.

Conclusion

Make sure every employee understands the vision. Look for methods to guarantee that all internal processes are consistent. Employees must have the training to comprehend standardisation.

Successful quality enterprises need continuing Senior Leadership. It needs support through a well-defined structure, processes, and transitions.

Stakeholder engagement is essential to the effective application of a quality management system.