Quality Management Systems


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Quality Management Systems

  1. 1. Quality Management Systems Troy Burrows Dominion Virginia Power
  2. 2. What is a Quality Management System (QMS)? • A QMS is the collective policies, plans, procedures, practices, and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. QMS integrates the various internal processes within the organization and intends to provide a process approach. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.
  3. 3. Policies • Policies may include: ▫ A Quality Policy Statement ▫ Data Quality Objectives ▫ Corrective Action Policies ▫ Data Storage Policies These policies my be written internally, or may be purchased from any of several Quality Consultants.
  4. 4. Plans • Plans include: ▫ A Quality Assurance Plan ▫ An Audit Plan ▫ A Corrective Action Plan ▫ A Data Statistical Evaluation Plan ▫ An Audit Report Plan ▫ A Continuous Improvement Plan ▫ Training Plans ▫ Record and Document Storage Plans
  5. 5. Procedures • Procedures are used as the specific set of directions to accomplish a specific task. In general, they are written so that someone qualified to perform the task can use them to accomplish it without any other assistance. • Do not write your procedures with so much detail that someone off the street can perform them, or they will not be helpful to the personnel who are really using them.
  6. 6. Procedures (cont’d) • Too much detail makes a procedure difficult to follow, and nearly impossible to use. • Too little detail leaves many tasks with variables that can effect quality, that are not performed uniformly every time. • Write the procedure, and then let someone who is knowledgeable of the task perform it using the procedure, redlining it as necessary. • This trial and error method will give you good, useable procedures.
  7. 7. Practices • Practices are the methods used within your organization to accomplish your quality goals. These may include internal audit programs, corrective action programs, quality training programs, and quality prioritization programs. • Each organization uses slightly different programs to accomplish their specific Quality Management goals.
  8. 8. Supporting Infrastructure • Supporting infrastructure may include a Quality Manager, Internal Auditors, databases and reports. • It should also include management and executive support for the QMS. • Without top level support, the Quality Management System WILL fail! • If personnel see that management is not concerned with the Quality System, the personnel will not support it.
  9. 9. Reduction of Non-Conformance • Reducing non-conformances is beneficial to every organization • It makes the personnel more efficient, and saves time on task performance. • It also makes customers happy, and helps to maintain good business relationships. • Everyone makes errors, but if an organization has a method to deal with the errors, and reduce their occurrence, errors are easier to forgive!
  10. 10. Identify… • Audits and surveillances help to identify opportunities for improvement • Identify the processes that are to be audited • Create audit/surveillance plans and checklists • Use observations and deficiencies to identify problem areas/processes • Review the area or process to identify what corrections will make the most improvement.
  11. 11. Measure • Measure how well your processes are working. • Measure your number of observations and deficiencies, and try to lower these every quarter. • Measure how effective your corrective actions are. • Use Annual Audit Reports to measure your improvement year to year.
  12. 12. Control • Controlling your processes is a major part of how effective your QMS becomes. • Use plans and procedures to control your regular processes. • Train personnel to perform the processes the same way every time, by the procedures. • Control your quality data in order to use statistical analyses on the data for performance improvements.
  13. 13. Improve • Use your observations, • Improve your company deficiencies, and corrective training. actions to decide what areas • Improve personnel awareness need improvement. of the importance of your • Select improvements that are QMS. the most likely to be effective. • Improve management’s • Implement the improvements, awareness of the importance and re-audit to ensure that of quality, and get their they are working. support for your QMS. • Change plans and procedures • Enjoy the benefits of improved as necessary to maintain the quality, effectiveness, and improved condition. efficiency in your business performance.
  14. 14. Corrective Action Program • A very important part of the QMS is a good Corrective Action Program (CAP) • The CAP helps you to make improvements and maintain them throughout your organization • Requires a major portion of the time spent with the QMS
  15. 15. What is a Corrective Action Program? • A program that identifies and eliminates the causes of problems in order to prevent recurrence • Policies and/or procedures that help to identify and eliminate the causes of problems • The various steps used to identify and eliminate the causes of current, or potential, problems • All of these definitions have a commonality – the identification and elimination of the causes of problems, not just the problem itself!
  16. 16. Identifying the Problems • Surveillances are quick • Audits are more in-depth checks to verify that verifications of all of your procedures are followed processes and correctly, and that procedures. They can records are created and show whether or not maintained as necessary personnel are trained, and following all of the policies and procedures as written
  17. 17. Findings • In order to identify problem areas, you must find specific issues • I use three different levels of findings for issues discovered during an audit or surveillance: ▫ Observations ▫ Deficiencies ▫ Nonconformances
  18. 18. Category Definitions • An Observation is: • A Deficiency is: ▫ A small finding that ▫ A larger scale finding can be corrected on- than an observation the-spot ▫ Must be corrected ▫ A finding that should before the audited be avoided in the future process can continue ▫ A finding that does not ▫ May be a result of affect the data collected repeated observations or reported for the same issues
  19. 19. Category Definitions (Continued) • A Nonconformance is: ▫ The highest level of finding ▫ A finding that can cause a ‘Stop-Work’ order ▫ A possible violation of the procedure or applicable regulation ▫ Generally requires a Root Cause Analysis
  20. 20. Audit Reporting • Management Review • Annual Audit Report ▫ Usually held quarterly ▫ Required by ASTM ▫ Involves informing the D7036-04 Manager of all QA ▫ Summarizes audits, activity from the surveillances, and previous quarter findings from the ▫ Issues are assigned for previous year resolution ▫ Includes a QA plan for the coming year
  21. 21. Finding the Causes • In order to find the causes of the problems, you first have to build a complete record of the problems you are having • You must then track the problems to find the most common occurrences, or the most common personnel that experience the problems • Perform a ‘Root Cause Analysis’ to narrow down the potential causes
  22. 22. Finding the Causes (Continued) • Tracking the recurring problems • Tracking Staff Issues ▫ Maintain a database of issues ▫ DO NOT make this a ‘witch and findings hunt’, or your program will fail! ▫ Query the findings looking for ▫ Find out through your database repeat problems if any one person (or several) ▫ Begin with the problem that has significantly more repeats the most frequently problems than the average ▫ Investigate possible causes ▫ Investigate possible causes ▫ Correct the most likely cause ▫ Look at your policies and ▫ Re-evaluate the problem – did procedures you reduce the occurrence? ▫ Is training sufficient? ▫ Start on the next most frequent ▫ Is communication occurring as problem it should to spread new ▫ And so on… information? ▫ Make corrections and re- evaluate as necessary
  23. 23. Finding the Causes (Continued) • Training Programs • Root Cause Analysis – A Root ▫ Maintain a formal training Cause: program ▫ Is used to identify the main ▫ Keep specific competency and cause for the occurrence of an training requirements in unwanted effect writing ▫ Is the most basic reason for the ▫ Ensure that job descriptions effect, and if corrected would are consistent and adequate prevent the effect from ▫ Maintain good training records happening ▫ Periodically audit your training ▫ Has three primary records characteristics; it causes the ▫ Make sure that all personnel effect, it is controllable, and its are familiar with your policies elimination or correction will and procedures – and reduce or eliminate the effect document it!
  24. 24. Finding the Causes (Continued) • The Root Cause Analysis is a very beneficial tool to use to find the real cause of the symptom you are experiencing • Think about all of the possible causes of the unwanted effect • Many methods are available for analyzing the data to determine the root cause ▫ Flowcharts ▫ Process Control Charts ▫ Trend Analysis ▫ Brainstorming ▫ Cause and Effects Analysis ▫ Fault Tree Analysis
  25. 25. Assessing the Possible Corrective Actions • Corrective Action Teams (or committees) • Brainstorming Sessions • Failure Mode and Effects Analysis • Formal Corrective Action Requests • Listen to ALL of the ideas presented • Sort out the ideas that have little potential • Use the ideas that have the best chance of solving the issue
  26. 26. Choosing and Implementing the Right Corrective Actions • Choose the Corrective Actions that you believe will prevent the problems from recurring • Record the Corrective Action and the Date of Implementation • Perform follow-up audits or surveillances of the process or activity in question • Assess the effectiveness of the Corrective Action • Implement further actions as necessary to improve the process
  27. 27. Lasting Corrective Actions • Procedural changes and improvements • Policy changes • Additional Training ▫ Make it pertinent ▫ Make it effective ▫ Make it interesting • Communication is key ▫ Ensure that everyone is made aware of any changes to policies and procedures, and be sure that the right people receive the proper training
  28. 28. Summary • A good Corrective Action Program is essential to any Quality Management System • Finding the problems, and the causes of them is a must in order to effect improvements • Correcting the Root Causes will improve your staff and work efficiency • Everyone must be involved, not only QA and Management, but all of the employees • Every employee should be familiar with the Corrective Action Process, and should be able to participate as necessary
  29. 29. Summary (continued) • Quality, and a good QMS is necessary to comply with ASTM D7036-04. • Full compliance with the standard is required by 40 CFR part 75. • An excellent, highly supported QMS will improve your business processes overall, and lead to better performance and higher customer satisfaction! Use the opportunity to implement a QMS and improve your business.
  30. 30. Questions? Thank you for your attention. Contact information: Troy Burrows, ASQ-CQA, QSTI Dominion Virginia Power, EMSG 1100 Coxendale Road Chester, VA 23836 troy.m.burrows@dom.com