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Mark E. Lynch 6/2/2016
My Vision
A management system is an organized set of elements that serves to achieve one or more goals of the
organization. The goal may be to improve the quality, or to minimize losses due to accidents and injuries, or to
reduce environmental impacts. A management system channels, organizes and simplifies complexity - it
provides order, structure and consistency of purpose.
Some may think that Lean, Six Sigma, TQM, SPC, TPC, SMED, VSM, are management systems. They are not,
but rather these are labels for a typology or approach to continuous improvement. What is interesting is that
these “tool sets” have application in a variety of industries. However, every company is unique, with its own
culture and history, specific to a market and supply chain.
If one is to implement a system then the best way is to start with documenting what you do, then train, then
perform what has been documented. Many companies have several programs in place one overlaid on top of the
other depending on how often the QA, OPS, or leadership has changed. The old ones never go away and the
transition from one to another is always difficult. I am a strong proponent of one system that actually identifies
and mandates the “tools” to be used. Let me explain:
Tools – a combination of specific method and or utilities used to monitor, measure, track, calculate or represent
data. There are many tools used to accomplish specific tasks in many different types of businesses.
Lean uses: Top level X, Top level TTI, Action Plans, bowling charts, Kaizen road maps, value stream mapping.
Quality Assurance typically used – P, Q, R, U Charts, Gage R&R, statistics, histograms, Pareto charts.
The key is to have a leader that is capable of using many tools from different systems to which he can coach and
apply as needed to meet market demands for specific industries. The organization must define processes,
establish standard work, measure the performance of these process to include the linkages to each other in the
form of “Turn-backs” (internal work hindrances) or more significantly “Escapes” (customer perceived non-
compliances). Then continuously strive to review these measures for adherence to objective or needed
improvement.
If the QA Manual or Management system does not mention what tools would be used to accomplish specific
tasks, then we need to rethink the QA Manual. If procedures do not refer to the documenting of performance in
a log or other means then the procedure needs attention. Example; in the ISO system there is a requirement to
perform and document “Preventative Actions” this is often confused with Corrective Action. If you use Kaizen
as a means to proactively improve and or prevent a condition from occurring then the procedure for
Corrective/preventative action should reference a schedule were the pending events are listed, the times they are
to occur and most important the object (linkage) from the Top level X/TTI/Action plan. This is an example of a
robust system that used to actually improve the way you do business.
Many companies have implemented ISO systems using a template from a consultant that only makes the system
compliant to the standard. This does not have value for the company and often only provides a document an
auditor can use to audit from. These types of systems are symptomatic of reoccurring major or minor findings,
duplication of work, reoccurring product defects and never really get down to the floor because they are not
user friendly. This is usually a symptom of a false start.
If a company has a mature system, (more than one cycle) one can look back at previous audit findings (external
and internal) and tell whether or not the intent was to be complaint or continuously improve. The proof is in the
auditable evidence. I have always found that you get what you “inspect” not what you “expect”. The level of
importance from top management down is critical. If the top level management does not participate in
1
Mark E. Lynch 6/2/2016
Management Reviews or Corrective Action, Root cause, or Mistake proofing then the methods will degrade in
quality and ultimately result in being ineffective.
Management Systems:
The power of management system is now broadly recognized and there is a growing trend towards international
standards like ISO 9000 series of standards for quality management system, ISO 14000 series of standards for
environmental management system and OHSAS 18000 series of standards for occupational health and safety
management system.
Quality, safety and environment problems have a common root cause, which is variation. This variation can be
reduced by an effective & efficient management system which takes care of all the three elements (quality,
safety & environment).
All the management systems have one basic approach - "process approach", the famous "PDCA" methodology
can be the simplest or the DMAIC Model for more robust processes can be applied here.
Plan - Establish the objectives and processes necessary to deliver results in accordance with customer
requirements and organizations policies.
Do - Implement the processes.
Check - Monitor and measure processes and product against policies, objectives and requirements for the
product and report the result.
Act - Take actions to continually improve process performance.
Define - Define the end points and document though flow charts the current process and highlight problems
Measure - Measure the performance of the process and compare to established metrics
Analyze - Analyze the process to identify the root causes and if possible the correlation between cause & effect
Improve - Design a future state ensure process remains stable though the change
Control - Establish measures of performance that can be tracked at the cell level make it visual
The Integrated Management System:
Now that quality, safety and environment are unavoidable elements in any organization. The most popular and
accepted management systems for quality, safety and environment are ISO 9001:2000, ISO 14001:1996 &
OHSAS 18001:1999. These are the broadest and most globally accepted. They are in my opinion the strongest
foundation from which to begin.
If you do not apply a proper approach for implementing these three systems in an organization, it can lead to
complexity. This complexity can be poor quality, accidents / incidents, unfriendliness, unnecessary paper
works, poor efficiency, confusions, duplication of work … etc. In order to avoid the above, all organization
shall manage activities more holistically rather than the traditional approach of peripheral arrangement for each
standard - ISO 9001, ISO 14001 & OHSAS 18001.
Different forms of establishing a starting point can be GAP analysis, Value Stream Mapping, Process flow
charting, or group gatherings and brain storming. It is important to realize in the beginning that although
management may set policy it is the employee that will execute. The more the employee contributes the better.
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Mark E. Lynch 6/2/2016
Coming in to the integration of these three management system, the organization should consider the following
elements:
 Holistic – everyone on the same page
 Clear – every employee can understand the plan
 Simple – in presentation and execution
 Value added – adds value the customer is willing to pay for
 Effective and efficient – timeline that can be accomplished without disruption of the business
 Common Sense – If it does not pass this test then we made an error.
An appropriate model for this integrated management system can be:
Policy:
The organization can develop an integrated policy covering quality, safety and environment. This policy
statement may be simple and may clearly express organization's vision and mission towards quality, safety and
environment. However, it must be measurable. The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO14001:1996 OHSAS 18001:1999
1 5.1 & 5.3 4.2 4.2
Planning:
The organization has to plan their integrated management system. The planning may cover identification of
quality requirements, significant aspects / impacts, significant hazards / risks, identification of legal and
regulatory requirements, setting of objectives / targets / program (s), development of structure &
responsibilities, development of documentation (manual, procedures, work instructions … etc), emergency
preparedness & response … etc.
This planning stage can be classified as following.
 Identifications of needs, requirements & analysis of critical issues (1) Top Level X
 Selection of significant issues (2) Top Level TTI
 Setting of objectives, targets & program(s) (3) Action plans
 Identification of resources (4) Skill set assessment
 Identification of organizational structure, roles, responsibilities and authorities (5) Policies
 Planning of operational processes (6) Process Flow Charts
 Emergency preparedness & response (7) Planning, Drill, Practice, Improve
3
Mark E. Lynch 6/2/2016
The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
1 5.2, 5.4.2, 7.2.1 & 7.2.2 4.3.1 & 4.3.2 4.3.1 & 4.3.2
2 5.2, 5.4.2, 7.2.1 & 7.2.2 4.3.1 & 4.3.2 4.3.1 & 4.3.2
3 5.4.1 4.3.3 & 4.3.4 4.3.3 & 4.3.4
4 5.4.2 4.3 4.3
5 5.5.2 & 5.5.3 4.4.1 4.4.1
6 7.1 4.4.6 4.4.6
7 8.3 4.4.7 4.4.7
Implementation & Operation:
Now the organization has to implement and run the planned integrated management system. This can be done
through development and appropriate communication of the integrated management system (distribution of
documentation, meetings, trainings … etc).
This implementation & operation stage can be classified as following.
 Operational control (1) Visual Management, KANBAN
 Management of human resources (2) Skill set assessment
 Management of other resources (3) JIT
 Documentation and its control (4) Standard Work
 Communication (5) Visual Management
 Relationship with suppliers and contractors (6) JIT, KANBAN
The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
1 7.2 - 7.5 4.4.6 4.4.6
2 6.2.2 4.4.2 & 4.4.6 4.4.2 & 4.4.6
3 6.3 & 6.4 4.4.6 & 4.4.4 4.4.6 & 4.4.4
4 4.2 4.4.5 & 4.5.3 4.4.5 & 4.5.3
5 5.5.4 4.4.3 4.4.3
6 7.2.3 4.4.5 4.4.5
Performance Assessment:
Organization has to monitor and measure the integrated management system to see its effectiveness and
efficiency. This monitoring and measurement may look in to policy, objectives / targets / program (s), product,
process, non-conformities … etc. This may cover quality, safety and environment. Internal audit is also a mode
of monitoring and measurement. The data received from the monitoring and measurement should be analyzed
for finding out the trend, effectiveness, efficiency … etc.
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Mark E. Lynch 6/2/2016
This performance assessment stage can be classified as following.
 Monitoring & measurement (1) Bowling Charts
 Analyzing and handling non-conformities (2) 3 in one Pareto Charts, root cause identification
 System audits (3) to include 5S or 6S (the sixth S is Safety)
The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
1 8.2 4.5.1 4.5.1
2 8.3 & 8.4 4.5.2 4.5.2
3 8.2.2 4.5.4 4.5.4
Improvement:
Based on the analysis of data which is accomplished by monitoring and measurement, the organization may
initiate corrective / preventive actions there by achieving the continual improvement.
This improvement stage can be classified as following.
 Corrective action (1) Mistake Proofing
 Preventive action (2) Kaizen
 Continual improvement (3) Kaizen
The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
1 8.5.2 4.5.2 4.5.2
2 8.5.3 4.5.2 4.5.2
3 5.4.2 & 8.5 - -
Management Review:
The top management of the organization should monitor the performance of the integrated management system
in defined intervals.
The linking of clauses for the three standards can be as follows.
ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
1 5.6 4.6 4.6
This document is intended to provide with an understanding of the way I approach
Quality/Safety/Environmental compliance. I do not accomplish this in a vacuum or alone, I am not a hero but
rather an integral part of a large team, I am a leader, coach, mentor, facilitator, change agent.
The entire business approach includes: Market needs, Customer expectations, Competition, Supply/Distribution
chains. I strive to eliminate rework and reduce variation at every opportunity. The entire Value chain is
considered.
5
Mark E. Lynch 6/2/2016
Your comments and suggestions are always welcome, please provide feedback or to ask specific questions
Email; melynch@suddenlink.net
6
Mark E. Lynch 6/2/2016
Your comments and suggestions are always welcome, please provide feedback or to ask specific questions
Email; melynch@suddenlink.net
6

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CQM/OE Certification
 

My Vision

  • 1. Mark E. Lynch 6/2/2016 My Vision A management system is an organized set of elements that serves to achieve one or more goals of the organization. The goal may be to improve the quality, or to minimize losses due to accidents and injuries, or to reduce environmental impacts. A management system channels, organizes and simplifies complexity - it provides order, structure and consistency of purpose. Some may think that Lean, Six Sigma, TQM, SPC, TPC, SMED, VSM, are management systems. They are not, but rather these are labels for a typology or approach to continuous improvement. What is interesting is that these “tool sets” have application in a variety of industries. However, every company is unique, with its own culture and history, specific to a market and supply chain. If one is to implement a system then the best way is to start with documenting what you do, then train, then perform what has been documented. Many companies have several programs in place one overlaid on top of the other depending on how often the QA, OPS, or leadership has changed. The old ones never go away and the transition from one to another is always difficult. I am a strong proponent of one system that actually identifies and mandates the “tools” to be used. Let me explain: Tools – a combination of specific method and or utilities used to monitor, measure, track, calculate or represent data. There are many tools used to accomplish specific tasks in many different types of businesses. Lean uses: Top level X, Top level TTI, Action Plans, bowling charts, Kaizen road maps, value stream mapping. Quality Assurance typically used – P, Q, R, U Charts, Gage R&R, statistics, histograms, Pareto charts. The key is to have a leader that is capable of using many tools from different systems to which he can coach and apply as needed to meet market demands for specific industries. The organization must define processes, establish standard work, measure the performance of these process to include the linkages to each other in the form of “Turn-backs” (internal work hindrances) or more significantly “Escapes” (customer perceived non- compliances). Then continuously strive to review these measures for adherence to objective or needed improvement. If the QA Manual or Management system does not mention what tools would be used to accomplish specific tasks, then we need to rethink the QA Manual. If procedures do not refer to the documenting of performance in a log or other means then the procedure needs attention. Example; in the ISO system there is a requirement to perform and document “Preventative Actions” this is often confused with Corrective Action. If you use Kaizen as a means to proactively improve and or prevent a condition from occurring then the procedure for Corrective/preventative action should reference a schedule were the pending events are listed, the times they are to occur and most important the object (linkage) from the Top level X/TTI/Action plan. This is an example of a robust system that used to actually improve the way you do business. Many companies have implemented ISO systems using a template from a consultant that only makes the system compliant to the standard. This does not have value for the company and often only provides a document an auditor can use to audit from. These types of systems are symptomatic of reoccurring major or minor findings, duplication of work, reoccurring product defects and never really get down to the floor because they are not user friendly. This is usually a symptom of a false start. If a company has a mature system, (more than one cycle) one can look back at previous audit findings (external and internal) and tell whether or not the intent was to be complaint or continuously improve. The proof is in the auditable evidence. I have always found that you get what you “inspect” not what you “expect”. The level of importance from top management down is critical. If the top level management does not participate in 1
  • 2. Mark E. Lynch 6/2/2016 Management Reviews or Corrective Action, Root cause, or Mistake proofing then the methods will degrade in quality and ultimately result in being ineffective. Management Systems: The power of management system is now broadly recognized and there is a growing trend towards international standards like ISO 9000 series of standards for quality management system, ISO 14000 series of standards for environmental management system and OHSAS 18000 series of standards for occupational health and safety management system. Quality, safety and environment problems have a common root cause, which is variation. This variation can be reduced by an effective & efficient management system which takes care of all the three elements (quality, safety & environment). All the management systems have one basic approach - "process approach", the famous "PDCA" methodology can be the simplest or the DMAIC Model for more robust processes can be applied here. Plan - Establish the objectives and processes necessary to deliver results in accordance with customer requirements and organizations policies. Do - Implement the processes. Check - Monitor and measure processes and product against policies, objectives and requirements for the product and report the result. Act - Take actions to continually improve process performance. Define - Define the end points and document though flow charts the current process and highlight problems Measure - Measure the performance of the process and compare to established metrics Analyze - Analyze the process to identify the root causes and if possible the correlation between cause & effect Improve - Design a future state ensure process remains stable though the change Control - Establish measures of performance that can be tracked at the cell level make it visual The Integrated Management System: Now that quality, safety and environment are unavoidable elements in any organization. The most popular and accepted management systems for quality, safety and environment are ISO 9001:2000, ISO 14001:1996 & OHSAS 18001:1999. These are the broadest and most globally accepted. They are in my opinion the strongest foundation from which to begin. If you do not apply a proper approach for implementing these three systems in an organization, it can lead to complexity. This complexity can be poor quality, accidents / incidents, unfriendliness, unnecessary paper works, poor efficiency, confusions, duplication of work … etc. In order to avoid the above, all organization shall manage activities more holistically rather than the traditional approach of peripheral arrangement for each standard - ISO 9001, ISO 14001 & OHSAS 18001. Different forms of establishing a starting point can be GAP analysis, Value Stream Mapping, Process flow charting, or group gatherings and brain storming. It is important to realize in the beginning that although management may set policy it is the employee that will execute. The more the employee contributes the better. 2
  • 3. Mark E. Lynch 6/2/2016 Coming in to the integration of these three management system, the organization should consider the following elements:  Holistic – everyone on the same page  Clear – every employee can understand the plan  Simple – in presentation and execution  Value added – adds value the customer is willing to pay for  Effective and efficient – timeline that can be accomplished without disruption of the business  Common Sense – If it does not pass this test then we made an error. An appropriate model for this integrated management system can be: Policy: The organization can develop an integrated policy covering quality, safety and environment. This policy statement may be simple and may clearly express organization's vision and mission towards quality, safety and environment. However, it must be measurable. The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO14001:1996 OHSAS 18001:1999 1 5.1 & 5.3 4.2 4.2 Planning: The organization has to plan their integrated management system. The planning may cover identification of quality requirements, significant aspects / impacts, significant hazards / risks, identification of legal and regulatory requirements, setting of objectives / targets / program (s), development of structure & responsibilities, development of documentation (manual, procedures, work instructions … etc), emergency preparedness & response … etc. This planning stage can be classified as following.  Identifications of needs, requirements & analysis of critical issues (1) Top Level X  Selection of significant issues (2) Top Level TTI  Setting of objectives, targets & program(s) (3) Action plans  Identification of resources (4) Skill set assessment  Identification of organizational structure, roles, responsibilities and authorities (5) Policies  Planning of operational processes (6) Process Flow Charts  Emergency preparedness & response (7) Planning, Drill, Practice, Improve 3
  • 4. Mark E. Lynch 6/2/2016 The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999 1 5.2, 5.4.2, 7.2.1 & 7.2.2 4.3.1 & 4.3.2 4.3.1 & 4.3.2 2 5.2, 5.4.2, 7.2.1 & 7.2.2 4.3.1 & 4.3.2 4.3.1 & 4.3.2 3 5.4.1 4.3.3 & 4.3.4 4.3.3 & 4.3.4 4 5.4.2 4.3 4.3 5 5.5.2 & 5.5.3 4.4.1 4.4.1 6 7.1 4.4.6 4.4.6 7 8.3 4.4.7 4.4.7 Implementation & Operation: Now the organization has to implement and run the planned integrated management system. This can be done through development and appropriate communication of the integrated management system (distribution of documentation, meetings, trainings … etc). This implementation & operation stage can be classified as following.  Operational control (1) Visual Management, KANBAN  Management of human resources (2) Skill set assessment  Management of other resources (3) JIT  Documentation and its control (4) Standard Work  Communication (5) Visual Management  Relationship with suppliers and contractors (6) JIT, KANBAN The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999 1 7.2 - 7.5 4.4.6 4.4.6 2 6.2.2 4.4.2 & 4.4.6 4.4.2 & 4.4.6 3 6.3 & 6.4 4.4.6 & 4.4.4 4.4.6 & 4.4.4 4 4.2 4.4.5 & 4.5.3 4.4.5 & 4.5.3 5 5.5.4 4.4.3 4.4.3 6 7.2.3 4.4.5 4.4.5 Performance Assessment: Organization has to monitor and measure the integrated management system to see its effectiveness and efficiency. This monitoring and measurement may look in to policy, objectives / targets / program (s), product, process, non-conformities … etc. This may cover quality, safety and environment. Internal audit is also a mode of monitoring and measurement. The data received from the monitoring and measurement should be analyzed for finding out the trend, effectiveness, efficiency … etc. 4
  • 5. Mark E. Lynch 6/2/2016 This performance assessment stage can be classified as following.  Monitoring & measurement (1) Bowling Charts  Analyzing and handling non-conformities (2) 3 in one Pareto Charts, root cause identification  System audits (3) to include 5S or 6S (the sixth S is Safety) The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999 1 8.2 4.5.1 4.5.1 2 8.3 & 8.4 4.5.2 4.5.2 3 8.2.2 4.5.4 4.5.4 Improvement: Based on the analysis of data which is accomplished by monitoring and measurement, the organization may initiate corrective / preventive actions there by achieving the continual improvement. This improvement stage can be classified as following.  Corrective action (1) Mistake Proofing  Preventive action (2) Kaizen  Continual improvement (3) Kaizen The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999 1 8.5.2 4.5.2 4.5.2 2 8.5.3 4.5.2 4.5.2 3 5.4.2 & 8.5 - - Management Review: The top management of the organization should monitor the performance of the integrated management system in defined intervals. The linking of clauses for the three standards can be as follows. ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999 1 5.6 4.6 4.6 This document is intended to provide with an understanding of the way I approach Quality/Safety/Environmental compliance. I do not accomplish this in a vacuum or alone, I am not a hero but rather an integral part of a large team, I am a leader, coach, mentor, facilitator, change agent. The entire business approach includes: Market needs, Customer expectations, Competition, Supply/Distribution chains. I strive to eliminate rework and reduce variation at every opportunity. The entire Value chain is considered. 5
  • 6. Mark E. Lynch 6/2/2016 Your comments and suggestions are always welcome, please provide feedback or to ask specific questions Email; melynch@suddenlink.net 6
  • 7. Mark E. Lynch 6/2/2016 Your comments and suggestions are always welcome, please provide feedback or to ask specific questions Email; melynch@suddenlink.net 6