Internal Quality System Auditor Training Workshop

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					Introduction to Integrated
  Management Systems

                       REV # 091302-BSI
Contents :
Section One
•   Introductions
•   Overview of Business Systems
•    Process Mapping
•   Systems integration
•   Objectives and Targets
•   Analyzing Risk
Course Objectives :
•   Provide understanding of integrated
•   Business systems and their application
•   System Interrelationships
•   Background to assist participants in
    building integrated systems
Turn to the person next to you and
interview that person for the following:
1. Name
2. Company they work for
3. Current company registration to?
4. Why are they on this course?
5. What are the objectives they wish to achieve
   by taking this course?
6. Prepare to introduce this person to the group
7. 5 minutes max
Course Outline
1. Course presentation is through lecture and
2. Participation is key to learning, questions are
3. Hours are 8:30 a.m. to 4:30 p.m
4. There are two 15 minute coffee breaks and a
   one hour lunch
5. Times for each module can be adjusted to
   maximize learning
Business Systems Overview
•   Business management systems are
    established and implemented to facilitate
    control and consistency
•   Consist of multiple functions/disciplines
•   Methods of implementation vary
Business Systems Overview
Design Considerations:
•   What is required for successful business
•   Market - Deliverables - Support - Profit
•   Regulatory, shareholder requirements
•   Process costs and optimization
•   Personnel requirements
•   Measurement requirements
Impacts of Systems
Systems are implemented to manage:
•   Production & Quality
•   Health, Safety & Personnel
•   Finance
•   Environment
•   Information
Impacts of Systems
•   Systems control business functions and
•   They are pervasive throughout an
•   International standards are models for
    system design
•   Standards -> Design -> Systems -> Control
Impacts of Systems
Business management systems have
several impacts, for example:

Positives                  Negatives

Streamline                 Bureaucracy
Identify problems          Create problems
Establish controls         Remove entrepreneurship
Establish accountability   Major cost area
Workshop One
Establishing Impacts
•   Working in assigned groups, review the
    business scenario in your group and
    identify quality and environmental impacts
•   Time: 45 minutes with 15 minute
    presentation and feedback
•   What is a business system?
•   A business system can be based upon a
•   recognized international standard.
•   Examples of these standards are:
    •   ISO 9001
    •   TS 16949
    •   ISO 14001
    •   OHSAS 18001
                                        ISO 9001:2000
                                       ISO 14001:1996
                                       ISO 18001:1999
                                     ISO/TS 16949:2002
•   A significant misconception of standards is
    that a company must structure business
    around the requirement of a standard… this
    is simply not the case
•   Especially for integrated systems, create a
    system reflecting the business, then
    determine how the standard(s) fit in
•   The focus of the standards is on business
    flow of the organization, and to fit the
    requirements into the organization
Focus of Management Systems
•   Purpose is to assist in defining business
•   Provide framework for performance
•   Establish accountability
•   Define how processes are accomplished
•   Provide tools for meaningful measurement
    of performance
•   Establish boundaries for controlled growth
System Documentation
To create a business system,
documentation is required.
Questions to consider:
•   Documentation requires words on paper?
•   Have a written instruction for everything
    you do?
•   Structure of system to follow reference
•   Records to demonstrate evidence of every
    process performed?
System Documentation
•   Documentation needs to reflect actual
    business flow
•   Structure and content should be user
•   Utilize the K.I.S.S. method
•   Complexity of documentation is dependent
    on complexity of organization, training
    levels of personnel etc.
•   Make use of existing documentation
•   Watch out for redundancies
Typical System Documentation

                         Level 1        Quality (Policy) Manual

                    Level 2                   Procedures

                                                     Job or Work
          Level 3                                      instructions

                                                             External Docs.
Level 4

Process Flow
•   A method of defining the business flow of
    activities within an organization
•   Also known as mind mapping, flow charting
•   Can also be used as a procedure
•   Graphic representation of flow of business
    generally, or be detailed right down to the
    representation of a specific activity
Process Flow
Work Registry                                                    AJA Clerk
                                                                                          Flowcharting is the
receiv es MAF f rom                                              receiv es CF2302 f rom
                             1                          1a
customer                                                         customer
                                                                                          essential first
rev iews f or correct
assignment & specif ications             2

                                                                          Procedure xxx
                                                                                          • Examine the typical
Specif ications required ?                        Yes        3            Engineering

PLE                                                                       Procedure xxx   • Chart it using
assembles Job Package                    4                                Estimating
                                                                                            standard symbols
rev iews Work Package
                                                                                          • Verify the flow
                                                                                          • Identify the critical
Work Package complete &
accurate ?                                                                                  control points

                                      Job Issue
Linking Process Flowcharts to
                       METHOD STEPS

                                                        The flowchart is
    1          2        3      4          5      6
                                                         linked to the SOP
                                                          Indicate the actions
           OPERATING PROCEDURE                             taken at each step.
           RESOURCES   KEY POINTS     Q POINTS            Identify the resources
    1                                                      and people involved.
                                                          Clearly identify the
                                                           critical control
    3                                                      points…
                                                             Q       Quality
                                                             S       Safety
                                                             E       Environmental
Process Flow
When flow charting processes, consider the
highest level steps first, then break down those
steps into sub-processes as required. For
 Customer                                  Perf orm   Present to
               Fill order   requriements
                            to personnel   process

Each box depicted in the above flowchart can
be further broken down into sub-processes. If
necessary, procedures or work instructions for
each process step can be created to further
explain how to perform that step.
Process Flow
•   Once a “model” of the business flow has
    been constructed, use this model to define
    the balance of the documented system
•   It is a useful tool to identify weaknesses or
    redundancies within processes
•   Keep flowcharts current
Workshop Two
Process Mapping
•   In your respective groups, using the
    assigned scenario, plan out and create a
    process flow chart of the described
•   Time: 45 minutes with additional 15 minutes
Integration - Why Bother?
 Customer complaints where root cause is
inter-functional mis-communication
 Internal audits that focus purely on intra-
functional issues
 Increased time and effort being spent
serving internal customers
 Personnel, safety, legal or environmental
requirements that are not complied with
 “Turf wars” due to overlap or gaps
Integration - Are We Ready?
Maturity required includes:
- Direction from Top Management
- Acceptance by functional heads such as
Quality, Health & Safety, Environment,
Information Systems, Finance
- Ability to focus on the process first,
ownership second
- Ability to organize and accomplish cross
functional internal audits
Integration - Are We Ready? (Cont.)
- Consistent framework for setting and
reviewing goals across functions
Day One Review
•   Overview of Management systems
•   Impacts of systems
•   Focus of Management Systems
•   Documentation
•   Process Mapping
•   Integration - Are we Ready?
Business Impacts
Consider how management systems
-impact business:
•   Sales
•   Costs
•   Products
•   Customers
•   Product or Service Design
Business Impacts - Sales
How is customer information obtained?
• In-person
• Fax/Phone
• Internet
How are customer requirements reviewed for:
• Accuracy
• Production & process impacts
• Health & Safety issues
• Environmental issues
Business Impacts
Sales impacts on many functions, for
•   Price - Finance
•   Delivery Time - Production
•   Customer Technical Requirements - Quality
•   End use safety requirements - H & S
•   Customer recycling requirements -
•   Government regulations
Business Impact/Risk overlap
 Risks are managed through process control
 Process control will involve several
 Standards are written to manage risk by
functional discipline
 By definition then, there is overlap
 Opportunity to optimize system
 Overlap example - Training of personnel
Workshop Three
Impacts of Business related issues
•   In your assigned group, using the assigned
    scenario, review the impacts/risks present
    and determine which standard(s) are
•   Indicated the clause(s) of the appropriate
    standard in your presentation
•   Time: 45 minutes plus 20 minutes group
Process Impacts
Impacts on Products / Services:
•   Design of creation process impacts product
•   Design of product key to the “ilities” -
    manufacturability, durability, quality,
    maintainability, dependability, serviceability
•   Health & Safety of users and of builders
•   Life cycle analysis
•   Disposition at end of life cycle
Process Impacts
Consider the PDCA cycle:
•   First, we must “Think” therefore PLAN
•   Then we DO what we have planned
•   We must control / CHECK or measure how
    we have done
•   Then we ACT accordingly by taking
    corrective action if required
Process Impacts
“Standard” PDCA is consistent with APQP Five
1. Plan and Define Program
2. Product Design and Development
3. Process Design and Development
4. Product and Process Validation
5. Feedback Assessment and Corrective Action
Process Impacts
Process Impacts
The design process affects all key
  business risks/impacts:
•   Environment
•   Quality
•   Health & safety
•   Information
•   Finance
When designing a product or service, or
  the manner in which it is to be made,
      is critical to the business.
Process Impacts
Impacts on Product Manufacture:
•   Procurement of materials
•   Procurement of qualified personnel
•   Ensuring safe work practices for employees
    and stakeholders
•   Life cycle designed into product
•   Product disposal at end of life cycle defined
Process Impacts
Impacts on service provision:
When a service is being performed, consider
the following impacts:
• Pollution as a result of service performed
• Health and safety of service providers
   (food/beverage servers)
• How the service is to be defined
• What training is required to perform service
• What records are required
Process Impacts
Life cycle analysis
Life cycle analysis includes issues around:
• How long is the item expected to last?
• What levels of pollution will the life of the
   product permit?
• How will the item be disposed of at the end
   of the cycle?
• What kind of safety factors are built into the
   cycle estimates
Workshop Four
Impacts of Process related issues
•   In your assigned group, using the output
    from Workshops 1 and 3, look for the
    processes that are key to generating the
•   List the processes and the key process
    areas where mitigation of the risk is most
•   Time for this workshop is 35 minutes plus
    10 minutes for group feedback in plenum
Management System Support
Having an effective business system
  means integrating support methods.
  Examples are:
•   Performance Review
•   Complaint Management
•   Customer satisfaction/perception
•   Accident/spill/emergency management
•   Nonconformance management
•   Regulatory affairs
•   Documentation and Records Management
System Support Examples (Cont.)

•   Information Technology infrastructure and
•   Internal audits
•   Statistics
•   Communication
•   Training and development
Management System Support
Performance or Management review
  process includes:
•   Analysis of business performance
    - Quality
    - Environment
    - People
    - Finance
    - Process performance
    - External issues
    - Audits - Internal; customer; third party
Management System Support
Training covers areas such as:
•   Competence of personnel
•   Records
•   Requirements to fill a position
•   Indoctrination process
•   Cross training matrix
Management System Support
All systems require records. We have records
to demonstrate conformance to specified
requirements. Records can consist of:
• Nonconformance reports
• Corrective actions
• Training
• Document control
• Purchasing
• Process records
• Sales
Management System Support
Corrective Action:
- Initiated to resolve an issue
- Reactive not proactive
- Isolate occurrence or “contain”
- Identify immediate, mid and long term action
- Determine cause
- Eliminate cause
- Follow up for effectiveness
- Monitor
Management System Support
Preventive Action:
- Initiated to avoid a Corrective Action
- Proactive to trends, statistics and analysis
- Management tool for Continual Improvement
- Steps are the same as for Corrective Action
Management System Support
Can be in electronic or paper, but not
Typically includes:
• Procedures          •   Work instructions
• Records             •   Forms
• Invoices            •   Manuals
• Drawings
Management System Support
Internal audits:
- provide management with report on health of
- are a tool when the “Numbers” indicate
investigation is necessary
- provide opportunity for
cross functional
Management System Support
Data Analysis:
Used to measure several things:
• Performance
• Degree of Legal Compliance
• Degree of conformance
• Sampling plans
• Customer satisfaction
• Opinion polls
Management System Support
- Critical as long as there are humans
- Awareness of the critical operating
- Discussion of current situation/results
- Celebrate victories
- Brainstorm defeats
Workshop Five
Impacts of system related issues
• review the outputs from Workshops One,
  Three and Four.
• determine those support activities that will
  be necessary to deliver
• identify the standards and elements that are
• Time: 30 minutes plus 10 minutes group
Workshop Six
Overall analysis of requirements
•   Discuss the last three workshops
•   Look at the standards, the impacts of a
    business system and the appropriate
    internal controls
•   Design a model for an integrated system for
    the Scenario Company
•   Choose a spokesperson to present this
    conclusion to the class
•   Time: 30 minutes with 10 minutes group
Measurable Objectives & Targets
What are objectives and targets?
•   Objectives and targets are the output from
    strategic planning of the organization
•   The impact of setting objectives crosses all
    reference standards and all business

Measurable Objectives & Targets
What are objectives and targets?
•   Objectives and targets are layered - set at
    relevant functions or levels of an
•   Corporate Objectives and Targets will be
    linked to those set for individuals of all
•   Objectives and Targets are the
    way to determine if strategy/
    policy is working                    ?
Measurable Objectives & Targets
Typical considerations in setting
  Objectives and Targets:
•   Financial performance required
•   Customer demands
•   Self-assessment results
•   Benchmarking results
•   Current product / process information
•   Future products
•   Competitor progress
•   Support process capability
•   Communication and deployment
Measurable Objectives & Targets
•   When setting objectives and targets,
    consider that higher level objectives must
    be supportable by other functional areas
•   Objectives set for the machine shop must
    also provide support to objectives set by
    relevant Managers
•   Objectives and targets need to be re-
    assessed at regular intervals to determine
    continuing suitability, and revised if
Measurable Objectives & Targets
Some examples of measurable
objectives and targets:
•   Increase market share x%
•   Increase productivity (by % or volume)
•   Reduce scrap to y%
•   Eliminate lost time accidents
•   Establish more frequent H&S audits
•   Reduce atmospheric pollution by 45%
•   Improve risk analysis procedure
•   Provide training to staff reducing accidents
    by x%
International Standards and Business Impacts
Support Processes
Measurable Targets
Workshop 7
Establishing Objectives & Targets
•   In your assigned group, review the assigned
    scenario and establish relevant objectives
    and targets
•   There is no minimum or maximum number,
    set what your group feels applies to the
•   Prepare a presentation of your objectives
    and targets for group presentation
•   Time: 30 minutes to prepare and 15
    minutes group feedback
Workshop 8
Measuring Objectives & Targets
•   In your assigned group, review the assigned
    scenario and the objectives and targets that
    have been set
•   Prepare a presentation of the
    measurements you have established for the
    objectives and targets,and prepare for
    group presentation
•   Time: 30 minutes to prepare and 15
    minutes group feedback
Policy Statements
Many standards, and good business practices,
require policy statements to be established.
Policy statements can appear in many flavors,
for example:
• Quality policy
• Environmental policy
• Health & Safety policy
• Mission statement
• Vision statement
Policy Statements
Consider One Integrated Statement
  addressing all requirements
Things to consider:
• Matching stated requirements in the
   reference standard
• Redundancies
• Best fit for the organization
• Too many words, not enough meaning
Policy Statements
•   Policy statements need to address
    - business concerns of the organization
    - the requirements of the reference
•   Needs to be understandable/relevant at
    every function and level
•   Provides a framework to set and review
    objectives and targets
Workshop 9
Setting policy statements
•   Review the policy statement in the assigned
•   Determine its appropriateness for the
    business and the standards
•   Record and suggestions on improvement
    and how these would be “sold”
•   Time: 30 minutes to prepare and 15
    minutes group feedback
System efficiencies
When looking to integrate management
systems, one should consider the
•   Elimination of redundancies
•   Streamlining of requirements to be more
•   Modeling system after business
    requirements, not standards
•   Reduce bureaucracy to a minimum
System efficiencies
Give thought to:
•   One form for all occasions
•   Procedures or work instructions that
    address specific activities/processes, not
    requirements of the standard
•   Minimize the use of text in work instructions
•   Consider flowcharts, pictures or other
Analyzing Risk

•   Business is risk
•   Successful business is controlled risk risks
•   Organizations and management need to be
    aware of risks
•   There are tools that can be used to perform
    an analysis of risk and measure or rank
    risks identified
Analyzing Risk
Some examples of general risk:
•   Hazardous chemical spill
•   Shipping nonconforming product
•   Release of pollution
•   Accidental injury
•   Product failure
•   Improper service delivery
Analyzing Risk
Here are some specific examples of
identified risks:
•   Hazardous chemical spill
    •   Tank containment failure
•   Release of pollution
    •   Stack scrubber failure
•   Accidental death
    •   Falling from scaffolding
Analyzing Risk
Here are some specific examples of
identified risks:
•   Accidental dismemberment
    •   Placement of limb into active machine
•   Product failure
    •   Improper manufacture or testing of product
        before release to customer
•   Improper service delivery
    •   Poor training of food server resulting in
        customer dissatisfaction
Analyzing Risk
Risks must be considered in both normal and
abnormal conditions
Failure Mode Effect Analysis is a good tool to
use in the design or review of a process
Workshop 10
Analyzing Risk
•   In your group, review the risks generated at
    Workshop One
•   Review the work from the other Workshops,
    in particular, the processes
•   Prepare a 5 minute presentation of any risks
    now perceived differently
•   Use forms provided in your course binder
•   Time: 30 minutes to prepare and 15
    minutes group feedback
Measuring Risk
There are a number of methods to measure or
rank risks.
The purpose is to identify the risk, then rank
the risk. Rank can be established by a simple
Impact       x     Controls      =      Rank

Create a numerical ranking system from 1 to 10
for example. Rank the impact of an identified
risk, the controls in place for that risk. Multiply
the impact by control to establish the rank
Measuring Risk
•   Ranking of risks permits management
•   Highest risk dealt with first for root cause
    and mitigation
•   Depending upon the organization and
    related industry, risks can range from a few
    (less than 100) to several thousand
•   Measurement system permits ranking
Workshop 11
Measuring Risk
•   In your group, review the assigned scenario
    and rank the risks identified in workshop 10
•   Prepare a five-minute presentation of risk
    ranking for group presentation
•   Use forms provided in your course binder
•   Time: 30 minutes to prepare and 15
    minutes group feedback
- Objectives and Targets
- Policy Statements
- Risk assessment
- Risk Measurement
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   Thank you for attending this course.