How to for QMS

1. Quality Management Systems
Troy Burrows
Dominion Virginia Power

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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