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Overview of Quality Management Systems and ISO 9001
228-January-2008
Why is ISO 9001 so popular?The scope of the Standard specifies requirements
intended to:
► demonstrate organization’s ability to consistently provide product meeting customer & applicable regulatory requirements
► enhance customer’s satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements
328-January-2008
New Structure & Focus
Why is ISO 9001 so popular?
►Significantly less emphasis on procedures and records.
►Significantly more emphasis on management involvement and a system that works to achieve the goals of your business.
428-January-2008
The ISO 9000 “Family”► ISO 9000:2005 Quality management - Fundamentals and vocabulary
► ISO 9001:2000 Quality management systems - Requirements
► ISO 9004:2000 Quality management systems - Guidelines for performance improvements
► ISO 10006:2003 Quality management - Guidelines for quality management in projects
► ISO 10007:2003 Quality management systems - Guidelines for configuration management
► ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
► ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing
528-January-2008
Relationship with ISO 9004
► ISO 9001 & ISO 9004 - consistent pair
► Designed to complement each other
► Different scope - same structure
► ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness
► ISO 9004 aims on improving performance and efficiency
628-January-2008
The Use of ISO 9004 as a Management Tool
► ISO 9004 includes all of ISO 9001 plus additional items to consider for improvement ideas.
► ISO 9004 should be regularly used throughout the organization to lead beyond the basics of ISO 9001 and improve the QMS.
► There is a possibility that we may offer ISO 9004 “certification” for clients seeking to achieve results beyond ISO 9001
728-January-2008
New Structure & Focus
►The ISO 9001 Standard is modelled for Quality Management with 5 Major clauses:
Quality Management System (QMS)
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis & Improvement
828-January-2008
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProduct
Continual Improvement of theQuality Management System
RequIrements
SatIsfactIon
InputOutput
System Approach of ISO 9k2k
The Deming Cycle
1028-January-2008
The Deming Cycle for improvement is the cornerstone of all Management Systems
1128-January-2008
1. PLAN: Design or revise business process components to improve results
2. DO: Implement the plan and measure its performance
3. CHECK / STUDY: Assess the measurements and report the results to decision makers
4. ACT: Decide on changes needed to improve the process
1228-January-2008
Every organization’s management systems are comprised of various processes, each with their own set of metrics, goals, targets and initiatives.
The key is to align each process’ PDCA cycle with the overall strategic effort of the organization.
1328-January-2008
As your Management Systems mature, effective use of the Deming Cycle will ensure continual improvement
1428-January-2008
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProduct
Continual Improvement of theQuality Management System
RequIrements
SatIsfactIon
InputOutput
System Approach of ISO 9k2k
1528-January-2008
WASTE
VARIATION
SELL IT!PERFORMANCE
RISK
THE VALUE ADDED AUDITING APPROACH
PROCESS AUDITS
8 Management Principles
1728-January-2008
New Structure & Focus
► The intent of ISO 9001 is based on the 8 Management System Principles described in ISO 9004:
customer focus
leadership
involvement of people
process approach
system approach
continual improvement
factual approach to decision making
mutually beneficial supplier relationships
Customer Focus
1928-January-2008
Customer Focus
Customer Focus
“Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.”
2028-January-2008
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProduct
Continual Improvement of theQuality Management System
RequIrements
SatIsfactIon
InputOutput
System Approach of ISO 9k2k
2128-January-2008
Customer Focus
►Information on Customer perception as to whether the organization has met their requirements must be collected, reviewed and appropriately acted upon (8.2.1).
►The methods of doing this are not prescribed by the standard but should be objective, representative of the customer base, and ADD VALUE.
2228-January-2008
Customer Focus
► The most common methods of collecting Customer Satisfaction data are customer surveys and customer report cards (when provided).
► Other methods include measuring repeat orders, market share, industry benchmarking, capturing info. from sales visits, focus groups, and hiring consulting firms.
► A good system will use multiple methods and compare data from multiple sources to comprehensively understand customer perceptions and balance out any potential biases.
2328-January-2008
Customer Focus
Additionally, the organization must demonstrate that effective arrangements for communicating with customers are in place in relation to:
2428-January-2008
Customer FocusProduct Information (7.2.3-a):
How well do you communicate your product information to your customers?
Consider the experiences of using your favorite store Catalogue, or browsing Amazon.com or ebay...
Were you satisfied with these experiences?
How do you know what your customers think about your ability to communicate information that they are looking for?
2528-January-2008
Customer Focus
Enquiries, contracts, and order handling, including changes (7.2.3-b):
Now consider the “buying experience” with these same companies and ask the same questions…
How do you think your customers feel about the ordering experience with your company? What about your quoting and order amendment processes?
2628-January-2008
Customer Focus
Customer feedback, including complaints (7.2.3-c)
Consider that a customer can be more loyal when you handle their problems to their satisfaction (or delight) vs. them never having a problem at all.
Your want to know whether your customers are satisfied with how you handle their feedback (even positive) and complaints.
Process and System Approach
2828-January-2008
Process Approach“A desired result is
achieved more efficiently when activities and related resources are managed as
a process.”
The Process Approach
2928-January-2008
System Approach“Identifying, understanding and
managing interrelated processes as a system contributes to the
organization’s effectiveness and efficiency in achieving its
objectives.”
The System Approach to Management
3028-January-2008
ISO 9000 – 2.4 The Process Approach
Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process.
For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach”.
3128-January-2008
ISO 9000 – 2.8.1 Evaluating processes within the quality management system
When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated.
a) Is the process identified and appropriately defined?
b) Are responsibilities assigned?
c) Are the procedures implemented and maintained?
d) Is the process effective in achieving the required results?
The collective answers to the above questions can determine the result of the evaluation.
Process InteractionsInputs and Outputs
3328-January-2008
ProcessActivities
+Resources
InputsInputs OutputsOutputs
ControlsControls(procedures, inspections, training, etc.(procedures, inspections, training, etc.) )
3428-January-2008
Management Systems – must define the sequence and interactions of processes
ProcessA
ProcessD
ProcessB
ProcessC
InputOutputControls
3528-January-2008
Customerrequirements
CustomerSatisfaction
ProcessA
ProcessD
ProcessB
ProcessC
A Quality Management System is focussed on meeting customer requirements.
3628-January-2008
Regulatoryrequirements
RegulatoryCompliance
ProcessA
ProcessD
ProcessB
ProcessC
Other Management Systems (Environmental, Safety, SOX, etc.) are mainly focussed on meeting regulatory requirements.
The Process Approach can be used for all Management Systems!
3728-January-2008
Investment Profitability
ProcessA
ProcessD
ProcessB
ProcessC
Ultimately every Management System must be seen by Top Management as an effective method for ensuring financial performance (even though it’s not a requirement).
3828-January-2008
Compatibility with other management systems
Standard is intended to be compatible with other systems
It is aligned with ISO 14001 and 18001 to enhance compatibility
Standard does not include requirements for other management systems such as EMS, OHSM, or financial management
Integration of management systems is possible
3928-January-2008
The ultimate goal of any organization is to fully integrate all
customer
shareholder
regulatory
and any other requirements? (discuss)
into ONE Business Management System.
4028-January-2008
Ideal scenario:Our clients’ Quality, Health & Safety and Environmental Management Systems operate within their Business Management System
Their BMS =
•QMS+
•FMS+
•OHSM+
•EMS+
•ERP+
•HR
BMSQMS
OHSMS
EMS
4128-January-2008
All too common scenario that we need to help change:
Their QMS, OHSMS and EMS are seen as the “ISO systems” and operate mostly outside of their BMS. Management does not see the value of these. “It’s something that we have to do for ISO” BMS
QMS
OHSMS
EMS
4228-January-2008
This example clearly defines the sequence of processes but does it clearly define their interactions?
How should process interactions be defined?
ProcessA
ProcessD
ProcessB
ProcessC
Sequence versus Interactions
4328-January-2008
► Interaction should be defined using inputs and outputs
►Graphical representations such as process maps / flowcharts are perhaps the most easily understandable methods of describing interaction between processes, however not a specific requirement.
► Interaction can be described with words if desired
►At a minimum, the processes of the organization need to be identified as per 4.1a and their interaction needs to be clearly defined in the manual as per 4.2.2c.
Interaction of Processes
4428-January-2008
Common methods used to define process interactions:
1. Flowcharting
2. SIPOC diagrams (Six Sigma method)
3. Process Turtles (ISO 9001 method)
4. Value Stream Mapping (Lean Manufacturing method)
NOTE: How many times have your processes been defined in how many ways? Are all process definitions linked and do they complement each other (no redundancy)?
4528-January-2008
Process: Outputs:
Tools/Equipment: Personnel/Competency:
Inputs:
How/Methods/Controls Measurements:
4628-January-2008
With What?
CAD/ CAM systems Test equipment Warranty database Call center
With Who? Eng. Manager CAD Technicians Mech/ Elec Engineers Administrative assistance Service Technicians
PROCESS
Engineering
I NPUTS Lessons learned Service/ Warranty Customer needs Marketing data Charter
OUTPUTS Robust design, durability, reliability, maintainability
BOM/ purchasing data Specifications
Product standards
How? CAD systems and Database Engineering procedures 5-stage design process Test and build standards Warranty/ claim data
How Eff ective?
Status of projects – >90% First time capability >96% Eng. Warranty claims < 5%
of total Budget – within 10%
CUSTOMERS I nternal / External
Mfg. Consumer
SUPPLI ERS
Customer Consumer Marketing
Charter review and approval
PROCESS FLOW
Process I nteractions
Purchasing Marketing/ Sales Service I nsp / Test department
CAD drawings, approval Simulation, lif e cycle Prototype Supplier evaluation/ capability
5 Stage design plan Kick-off meeting multi-
f unctional
Pre-production run Capability Ppk/ Cpk Mfg. Feedback meeting Lessons learned
4728-January-2008
4828-January-2008
Most importantly, does Top Management use their process definitions to
effectively manage their business (not just for audits)?
4928-January-2008
Every process has an owner.
The process outputs are their job description!
The process measures are their performance review!
5028-January-2008
Evidence to find and communicate:
Organization charts are process based and show clear process ownership
Business metrics are process based and ensure transparent accountability for process performance
Facility floor plans can be linked to processes
Business plans and budgets align with their process definitions.
Management reviews of “process performance” include ALL processes at some frequency
5128-January-2008
Quality Manual
ISO 9001, clause 4.2.2 requires:
►The organization shall establish and maintain a quality manual that includes
A) the scope of the quality management system, including any details of and justification for any exclusions
B) the documented procedures established for the QMS, or reference to them
C) a description of the interaction between the processes of the QMS
5228-January-2008
Quality Manual
► A QM that simply regurgitates the ISO clauses is not acceptable!
► A QM that includes a process map showing sequence only is not acceptable!
► The QM must define the process interactions (outputs & inputs)!
5328-January-2008
Quality Manual – potential uses
► To manage the business as a key input to organizational planning, resource allocation, goal setting, problem solving, etc.
► The training material for employee orientation, especially managers!
► A communication tool for external parties (customers, corporate management, board of directors, regulatory bodies, etc.)
Process Measurementand Objective Deployment
5528-January-2008
Factual Approach to Decision Making
Factual Approach to Decision Making
“Effective decisions are based on the analysis of data and information.”
5628-January-2008
Analysis of Data & Measurement
Food for Thought:
►Consider all the records and data that you collect and store in your company...
►How are each of these used for analysis, training, and improvement purposes?
► If you can’t answer this question for nearly every record you spend time and money collecting then why do you do it?
5728-January-2008
Analysis of Data & Measurement
8.4 - The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
► customer satisfaction (see 8.2.1),
► conformity to product requirements (see 7.2.1),
► characteristics and trends of processes and products including opportunities for preventive action, and
► suppliers.
5828-January-2008
Continual Improvement
Continual Improvement
“Continual improvement of the organization’s overall performance should be a permanent objective of the organization.”
5928-January-2008
Continual Improvement
►The organization shall implement actions necessary to achieve planned results and continual improvement of the QMS processes (4.1-f).
►Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness (5.1).
6028-January-2008
ISO 9000 – 2.11 Quality management systems and other management system focuses
The quality management system is that part of the organization's management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate.
6128-January-2008
ISO 9000 - 2.8.2 Auditing the quality management system
Audit findings are used to assess the effectiveness of the quality management system
and to identify opportunities for improvement.
6228-January-2008
WASTE
VARIATION
SELL IT!PERFORMANCEPERFORMANCE
RISK
THE VALUE ADDED AUDITING APPROACH
PROCESS AUDIT
6328-January-2008
PROCEDURE*(“Specified way to carry out an activity or a
process” - may be documented or not)
PRODUCT(“Result of a
process”)
MONITORING AND MEASUREMENT OPPORTUNITIES
(Before, during and after the process)
OutputInput PROCESS(“Set of interrelated
or interacting activities”)
EFFECTIVENESSOF PROCESS =Ability to achievedesired results(Focus of ISO
9001:2000)
EFFECTIVENESSOF PROCESS =Ability to achievedesired results(Focus of ISO
9001:2000)
EFFICIENCY OF PROCESS =
Results achieved vs resources used
(Focus of ISO 9004:2000)
EFFICIENCY OF PROCESS =
Results achieved vs resources used
(Focus of ISO 9004:2000)
(Includes Resources)
* Note – This is the definition of “procedure” given in ISO 9000:2000. This does not necessarily mean one of the 6 “documented procedures” required by ISO 9001:2000
Process Monitoring and Measurement
6428-January-2008
Processes must be monitored and measured -
Measurement categories that need to be considered are:
Quality: Does the process consistently produce desired outputs?
Delivery: Does the process consistently deliver the outputs on time?
Efficiency: Does the process produce and deliver the outputs using the least amount of resources necessary
Others such as Cost, Safety, Regulatory Compliance, etc.
Too often only one of these categories is applied and that misleads management into thinking that everything is alright.
6528-January-2008
How does a company implement their BUSINESS PLAN?
The process approach is one of the best methods to implement a business plan
6628-January-2008
Policy
Management
System (Business)
Objectives
Process Objectives
•Project / Product / Sub-process objectives
Top Management
Process Owners
Operators
Top Management
Eff
ectiv
e P
lann
ing
and
Com
mun
icat
ion
Effective policy deployment through measurement is required by all ISO 9001 based standards.
6728-January-2008
Production Planning & Scheduling
Process
PurchasingProcess
MaintenanceProcess
Warehouse Process/Inventory
Management
OrderReview Process
OTD
We try to focus our audits on:
The linkage of the measures and objectives to customer satisfaction and business results
The planning and resource allocation activities that are necessary to achieve any improvement objective
The leadership and communications activities that engage the entire organization in this process
The effective use of the PDCA cycle in every process that is focused on company objectives
6828-January-2008
Policy – Defect free product, on time to the customer at a reasonable price and continually improving all processes in accordance with the requirements.
► Organizational objective – 98% on time to customer promise date
► Process objectives established to meet organizational goal
Order review processes – all orders processed within 2 days of receipt
Warehouse process – 100% compliance with FIFO, 18 inventory turns
Maintenance Process – 97% uptime, no past due scheduled items
Purchasing process – 95% of tier 1 suppliers on time and within window
Production Scheduling – all shop routers completed within 1 day of receipt and all orders scheduled to be completed 2 days prior to required ship date
Management Communicationand Employee Awareness
7028-January-2008
Leadership & Involvement of People
Leadership and Involvement of People
“Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.”
“People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.”
7128-January-2008
Leadership & Involvement of People
►Top Management shall ensure that appropriate communication processes are established within the organization… (5.5.3)
►Specific requirements for communicating information regarding the effectiveness of the QMS and the importance of meeting customer and regulatory requirements (5.5.3 & 5.1-a).
7228-January-2008
Leadership & Involvement of People
►The organization shall ensure that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (6.2.2-d).
7328-January-2008
Imagine the power of an organization that has truly achieved Unity of Purpose?
7428-January-2008
On Time Delivery
0
20
40
60
80
100
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Actual
Goal
Is this enough information to ensure that everyone clearly understands what must be done to achieve the improvement goal?
7528-January-2008
Too often management only communicates partial information. To understand the complete path to improvement everyone needs to know the following:
Where are we now (measure) and where do we want to be (goal)?
Why are we here (causes of failure)?
What are we doing to improve (plan)?
How am I personally involved?
7628-January-2008
On Time Delivery
0
20
40
60
80
100
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Actual
Goal
0
20
40
60
80
100
1stQtr
2ndQtr
3rdQtr
4thQtr
Causes of Late Deliveries
machine down
part shortage
labor shortage
Tasks Resp. Due % Contribution Status
Increase PM frequencies on key machines
Joe K. 2/23/08 50 75% complete, Need more resources
Increase buffer inventories of critical parts
Janice Q. 4/1/08 30 50% complete, no issues
Plan for Improvement
7728-January-2008
EFFECTIVE Communication Too often management only communicates in one way (think -
quarterly all employee meeting)
Does this communication effectively reach everyone (think - kids in the back of the room)?
To truly achieve unity of purpose shouldn’t there be multiple communication methods happening all the time?
Will management have to adjust their communication methods and frequencies or do they normally achieve perfection on the first try?
Can management communication be considered a process with clear outputs (employee understanding, satisfaction, unity of purpose, etc.) and measures?
Summary
7928-January-2008
What is the role of an auditor?
Especially 3rd party “pros”
8028-January-2008
►To make sure that an organization is doing the right things, the right ways, all the time.
►To find evidence that what the organization does is conforming, effective and efficient.
►To add value by:
Identifying potential problems before they happen
Helping to solve existing problems, and
Identifying opportunities for improvement.
8128-January-2008
Hierarchy of Quality
QualityManagement
Quality Assurance
Quality Control
Advanced Auditing covers QA and QM more effectively
Basic “conformance” auditing covers QC level
8228-January-2008
It’s not about the paperwork…
It’s all about if it works!
Course Summary
8328-January-2008
The majority of the efforts needed to demonstrate
conformance to ISO 9001
lie with Top Management.
Course Summary
8428-January-2008
Run properly, by management, your QMS
will help you achieve your business goals.
Course Summary
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