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Slides 01 - Ems Lac, Ig, Issue 4.2, 10-23-08
Slides 01 - Ems Lac, Ig, Issue 4.2, 10-23-08
Management Systems
Lead Auditor Course
Welcome!
• Safety – be aware of emergency exits
• Restroom and Telephones – nearest locations
• Contact Number – for urgent messages
• Personal Property – keep possessions secure
• Phones and Pagers – Turn them off please to
avoid interruptions
• No laptops on during class please
• Recording Devices – not allowed in class
• Lunch and Breaks – please return on time
• Smoking – not permitted in the classroom
• Special Needs – please inform the instructor
3
Student Introductions
• Student name
• Company and product/service
• Your job position
• Any ISO experience
• Any auditing experience
• Your course expectations
• Something personal (hobbies, background, etc)
4
Learning Objectives
• Understand environmental management
definitions, concepts, and guidelines
• Understand the purpose of the
ISO 14000 series
• Understand the requirements of the
ISO 14001:2004 standard
• Understand aspects and impacts
• Develop and manage an audit program
• Initiate the audit and conduct opening meetings
5
Learning Objectives
• Understand auditor responsibilities
• Conduct on-site activities
• Collect information
• Communicate effectively during the audit
• Generate audit findings
• Prepare audit conclusions
• Conduct closing meetings
• Reporting audit results
• Conduct an audit follow-up
• Understand the registration process
6
Course Overview
This course includes:
• A detailed student manual
• 40 hours of class time (see Agenda Tab)
• Tutorial sessions
• Practical exercises:
Case studies
Role-plays
• Possible daily homework
• Continual evaluation
• Written Examination
7
Student Assessment
Max Needed
ACTIVITY
Points To Pass
Continual Assessment
The continual assessment includes:
• Participation in class and team activities
• Written assignments
• Attitude and personal attributes
• Attendance and punctuality
• Role playing
• Communication skills
• Feedback
9
Certificates
“Certificate of Successful Completion”:
• Accepted by RABQSA for
auditor certification
• Numbered
• Valid for 3 years for
RABQSA certification
• 4.0 CEUs
– OR –
“Certificate of Attendance”
10
RABQSA Auditor
Certification Program
• Attend accredited Lead Auditor course
• Pass continuous assessment
• Pass written exam
• Meet other criteria:
Education
Environmental industry experience
Audit experience
Course Complaints/Appeals
• Complaints may be sent in writing to
BSI or the RABQSA
• BSI will respond in writing
• Final arbitration of complaints by the RABQSA
15
Clarification Auditor
Auditor
Focus
Focus
Clarification
• The term “establish and maintain Auditor
Auditor
Focus
procedure(s)” when used in standards or Focus
Clarification
• The material being presented is paraphrased
from ISO14001:2004. It is recommended that
you follow along with your copy of the standard
to see the exact wording
• Fulfillment of a • Fulfillment of
requirement of the legal/statutory or other
standard mandated requirements
• Nonconformity can lead to • Legal noncompliance can
suspension or revocation lead to fines/incarceration
of a registration
• Voluntary • Mandatory
22
Environmental
Environmental Management
Management Environmental
Environmental
Systems
Systems Auditing
Auditing
ISO
ISO ISO
ISO ISO
ISO
14001:2004
14001:2004 14004:2004
14004:2004 19011:2002
19011:2002
Specification General Guidelines for
guidelines quality and/or
on principles, environmental
systems, and management
supporting systems auditing
techniques
Concepts of ISO 14001:2004
ISO 14001:2004
ISO 14001 is: ISO 14001 is not:
ISO 14001:2004
• Culmination of
significant history
• 61 “shalls”
• 5 major sections,
21 elements
• Nationalized by more than
80 countries
• Referenced by
supporting documents
Exercise 1
Prerequisite Review
Process Approach
AAprocess
processisisaasetsetof
ofinterrelated
interrelatedor
or
interacting
interactingactivities
activitiesthat
thatuses
usesresources
resources
to
totransform
transforminputs
inputsinto
intooutputs
outputs
The
The process
process approach
approach systematically
systematically
identifies
identifies and
and manages
manages thethe linkage,
linkage,
combination,
combination, andand interaction
interaction of
of aa system
system of
of
processes
processes within
within an
an organization
organization
ISO
ISO 14001
14001 isis based
based on
on aa process
process
approach
approach to
to environmental
environmental management
management
37
Process Approach
The process approach emphasizes the
importance of:
• Understanding and meeting requirements
• Looking at processes in terms of added value
• Obtaining results of process performance
• Continual improvement of processes
38
Process Approach
PROCEDURE
(Specified way to carry out an activity or
process – may be documented or not)
Plan-Do-Check-Act
Shewhart-Demings Cycle
• Activities • Deploy and
• Controls conform with plan
• Documentation
• Resources
• Objectives PLAN DO
Continual
Improvement
Your
Process
ACT CHECK
• Analyze/review • Measure and
• Decide/change monitor for
• Improve conformity and
effectiveness
effectiveness
40
PLAN DO
Continual
Improvement
Your
Process
ACT CHECK
4.5 Checking 4.5 Checking
4.6 Management
Review
41
Continual
Improvement
Environmental
Policy
Plan
Plan
Management
Review
Act
Act Do
Do
Check
Check Planning
Checking
Implementation
and
Operation
• Bibliography
47
1 Scope
This International Standard is applicable to any
organization that wishes to:
a) establish, implement, maintain and improve an
environmental management system
b) Assure itself of conformity with its stated
environmental policy
c) Demonstrate conformity with this International
Standard by:
1) making a self-determination and self-declaration
2) seeking confirmation of its conformance by parties having an
interest in the organization, such as customers
3) seeking confirmation of its self-declaration by a party external
to the organization
4) seeking certification/registration of its environmental
management system by an external organization
48
2 Normative References
No normative references are cited
Guidance
• Follow along with your copy of ISO
14001:2004 during the review of the
following material
4.3 Planning
Clause 4.3 includes:
4.3.1 Environmental Aspects
4.3.2 Legal and Other Requirements
4.3.3 Objectives, Targets, and Programs
61
Environmental Aspects
Common aspects can include:
Energy Facility
•Natural Gas • Buildings
•Electricity • Parking lots
•Fossil Fuel • Drainage
Materials Abnormal or Emergency
• Raw materials • Fire
• Processed materials • Weather
• Recycled materials • Flood
• Reused materials • Increase/decrease in
production
• Equipment malfunction
Grounds Keeping Custodial
• Fertilizer • Detergents
• Herbicides • Aerosol cleaners
• Plant clippings • Water
64
Environmental Impacts
Common impacts could include:
• Impact on flora or fauna
• Soil, water, or air contamination
• Ecological disruption
• Resource use and depletion
• Climate change
65
Environmental Aspects
Environmental aspects can be related to
operations, products, or services.
Input
Input Process
Process Output
Output
Raw
Raw Material
Material Manufacture
Manufacture Product
Product
Specification
Specification Service
Service Delivery
Delivery
Aspect
Aspect
Impact
67
Impact Impact
68
Aspects:
Spillage
Spillageof
of Emission
Emissionof
of Disposal
Disposalofof
materials
materials gaseous vapors
gaseous vapors paint cans
paint cans
Impacts:
Use
Useof ofland
land
Contamination
Contamination Contamination
Contamination Air
Airpollution
pollution (i.e., disposal
(i.e., disposal
of
ofsoil
soil of
ofwater
water ininlandfill)
landfill)
69
Examples
Activity, Product, Environmental Environmental
or Service Aspect Impact
Potential Contamination of
Handling of for spill soil or water
Hazardous Waste Volatile Organic
Air release
Compounds
Improper burn Air pollution
Vehicle
Maintenance Increased use of Depletion
fossil fuel of resources
Air filer use Hazardous waste
Product Painting Volatile Organic
Air pollution
Compounds
70
Determining Significance
• A number of methodologies can be used to determine
significance including those that consider:
Legal liability
Public concern
Environmental criteria
Environmental Objectives
Environmental Targets
OBJECTIVE TARGET
Reduce greenhouse Achieve 25% reduction in
gases produced in energy use per million parts
manufacturing produced within 3 years
(specify base year)
84
4.4.3 Communication
The organization must establish, implement, and
maintain procedures for the communication of
information relevant to the EMS for:
• Persons working for or on behalf of the organization
at various levels and functions
• Receiving, documenting and responding to external
interested parties
98
4.4.3 Communication
The organization make a decision on external
communication of its significant aspects and:
• Record this decision
• Establish and implement a method for external
communication of significant aspects if applicable
99
4.4.3 Communication
What evidence can demonstrate conformity to? Auditor
Auditor
Focus
Focus
4.4.3 Communication
• What evidence can demonstrate conformity? Auditor
Auditor
Focus
Focus
Documentation of relevant internal
communications (4.5.4)
Documentation of relevant external
communications (4.5.4)
Documentation of the plan to communicate and
evidence of the external communication of
significant aspects (based upon decision) (4.5.4)
• Why is this done?
To encourage involvement and awareness
across the organization of the EMS and support
for the program (4.2, 4.4.2)
To manage the external flow of information
related to the environment and compliance
efforts (4.2, 4.3.2, 4.5.2)
101
4.4.4 Documentation
Minimum documentation must include:
• The policy, objectives, and targets
• A description of the scope of the system
• A description of the main elements of the
system and their interaction and reference to
related documents
• All documents required by ISO 14001 including
specified records
• Any necessary documents, including records, to
ensure effective planning operation and control of
processes relating to significant aspects
102
Documentation
Notes on system documentation:
• A documented manual is not required
• Documented procedures are not required for
all elements
• Documentation can be in paper or
electronic form or any other format usable
by the organization
103
4.4.4 Documentation
• What evidence can demonstrate conformity? Auditor
Auditor
Detailed information that shows what the core elements of Focus
Focus
the EMS are (requirements of
ISO 14001) and their relationships to each other
(4.4.4, 4.4.5)
Detailed information that identifies system documents, how
they can be located and are related (policy, procedures,
records, etc)
(4.4.5, 4.5.4)
All documents specifically called out by
the standard
• Why is this done?
To ensure the system is adequately understood and
effectively and efficiently operated
(4.1, 4.4.2, 4.4.3)
104
• To identify
• To control critical EMS documentation
Operational Controls
Sample procedures can include:
• Those developed to guide regulatory
compliance for activities such as:
Transferring chemicals to or between tanks
Minimizing waste when painting
Hazardous waste management
Permitted operations (air emissions, waste
water, storm water, etc)
Spill control contingency countermeasures
plans (SPCCP)
Purchasing guidelines for hazardous materials
112
4.5 Checking
Clause 4.5 includes:
4.5.1 Monitoring and Measurement
4.5.2 Evaluation of Compliance
4.5.3 Nonconformity, Corrective Action and
Preventive Action
4.5.4 Control of Records
4.5.5 Internal Audit
120
EMS Regulations
ISO 19011:2002
ISO 19011:2002 provides guidance on:
• Auditing principles
• Managing audit programs
• Conducting internal and external audits
• Competence of auditors
Nonconformity Classifications
For this course we will use the following
definitions and classification for Nonconformities
Major The absence of, or total systemic
Nonconformity breakdown of a management system
element specified in the standard or the
EMS; any nonconformances where the
effect is judged to be seriously
detrimental to the environment; and any
serious noncompliance to legal and
other requirements applicable to
the organization
Minor A single system failure or lapse in
Nonconformity conformance with a procedure relating
to the applicable standard or EMS
156
Inputs
From
Process Outputs
(specific value To whom/
whom/
added activities) where
where
Inputs
40 CFR Part Outputs
112 – Oil Chemical Verified
Pollution Management reduction in oil
use,
Prevention,
Corporate Process fewer reportable
spill (oil) spills
requirements
4 Principles of Auditing
Ethical • Trust, integrity, confidentiality,
Conduct discretion
Fair • Audit findings and conclusions are
Presentation accurate and truthful
Due • Exercise care according to the
Professional confidence placed
Care in them by their clients
• Competence is essential
4 Principles of Auditing
Independence • Auditors are independent of the
activities being audited and are
free from bias or conflict
of interest
• Conclusions will be objective and
based only on audit evidence
Evidence- • Audit evidence is based on
Based samples of information
Approach
• Conclusions are verifiable
ISO 19011:2002, clause 4
168
Auditor Relationships
• 3rd Party Auditor (especially Registration auditors):
Abide by an applicable code of conduct
Cannot consult or help
• 1st and 2nd Party Auditor:
Management interface; facilitator
Interface with customer and external auditors if
used as a guide
May consult, assist
• All Auditors:
Should follow the principles of auditing
Managing an Audit Program
Authorize
ISO 19011, 5.1
Audit Program
Audit #4
Audit #1
The Audit
Program
Audit #2
Audit #3
The Audit
Audit based on environmental importance and
previous audit results
Audit
Less
Importance / Less Greater
previous weakness Importance / More
previous weakness
175
The audit
program
Audit
Less
Importance / Less Greater
previous weakness Importance / More
previous weakness
176
B es t
Auditor Responsibilities Prac
tice
Audit Schedule
B es t
Prac
• An audit schedule often serves as the tice
output of the audit program
• Audit schedules give details about the
audit, including:
Which processes
Which areas
Which clauses
How often and when
206
Audit Schedule
B es t
Prac
Audit schedule considerations include: tice
• Status of activity
• Importance of activity/product
• Results of past audits
• New methods/new technology
• Organizational changes
• Corrective action pending
• Complexity and size of the area
• Size of audit team
• Team planning and reporting time
207
Emergency Response P P P
Corrective Action P P
Chemical
P A P
management
Air management P P
Document Control P A
Production P P P P
Management Review A P
B es t
Prac
Waste Monitoring P tice
P = Planned A = Additional
Activity #2 - Conducting
Document Review
Initiating the Audit 6.1
6.1
Checklists B es t
Prac
tice
Checklists B es t
Prac
tice
Checklists B es t
Prac
tice
B es t
Checklist Example Prac
tice
Area Audited: Document Control
Look at Procedure DC-05
Compliance of procedure to policies
and ISO 14001 standard
Look for
Control of all document types,
including external documents
Look at Document Approvals
Approvals by authorized persons prior
to document issue
Look for
Evidence of approvals, e.g., signature
or electronic proof
226
B es t
Checklist Example Prac
tice
Audit Evidence
Audit Findings
Reviewing
Audit Conclusions
242
Requirement:
Nonconformity/Evidence:
262
Requirement:
Document Control procedure #DC-003, issue 1, revision B, dated 10/15/2006
requires that all documents be reviewed, revised and approved by authorized
personnel prior to release.
Nonconformity/Evidence:
There is no evidence that Materials and Processes procedure #MP-010, issue 2,
revision A, dated 02/23/2007 was approved by anyone listed on the “Authorized
Approval List” that was in effect at the time the procedure was created.
263
Requirement:
Paragraph 3.4 of the Metrology Operations Manual, revision C, dated 4/10/2007
requires that all paint booth manometers be calibrated every six months.
Nonconformity/Evidence:
The manometer on paint booth #4, located in the assembly paint area (building #45,
column 13B) had a calibration sticker indicating that the last calibration occurred on
9/12/2006. A review of the associated calibration records confirmed that the last
calibration occurred on 9/12/2006.
Exercise 11
Writing Nonconformity Statements
Closing Meeting
Team Leader prepares and works to an B es t
agenda and controls the meeting: Prac
tice
1. Attendees 7. Audit Summary
2. Thanks 8. Nonconformities
3. Objective / Scope 9. Agreement (sign)
4. Reporting system 10. Recommendation
5. Limitations 11. Clarification
6. Confidentiality 12. Depart
269
Weaknesses:
• Major system failures in corrective action program and identification of legal requirements
Corrective action must be addressed for each of the written nonconformity reports. Please outline tentative action
plans, responsibility, and implementation timing. Submit CAR forms back to the audit team leader.
NCR Ref Nos: D01 thru D24
Report Prepared by: __________________________ Date: _______________
Report Approved by: _________________________ Date: _______________
Audit Manager
Distribution: department managers as listed
276
Discussion
During the closing meeting what do you do if:
• Top Management doesn’t show?
• A nonconformity is contested?
• Someone wants to argue?
• A nonconformity was corrected and they want to
have it removed from the report?
Completing the Audit
Personal Attributes
Ethical Fair, truthful, sincere, honest, discreet 7.2
7.2
Open- Willing to consider alternative ideas
minded
Diplomatic Tactful in dealing with people
Observant Aware of surroundings and activities
Perceptive Instinctively aware of and
understand situations
Versatile Able to adjust to different situations
Tenacious Persistent, focused on achieving
objectives
Decisive Reaches timely conclusions
Self-reliant Functions independently
295
Accreditation Programs
National Government/Trade Associations
Accrediting
RABQSA
RABQSA RABQSA
RABQSA Authority
Training Independent
Independent Certification
Training
Organization Auditors
Auditors Bodies
Organization 3rd Party
Auditors
Lead
Lead Auditor
Auditor Registered
Training
Training Organizations
Internal Auditors
Customers
314
Registration Process
Seven steps of the registration process are:
1. Agree on audit objective, scope, and date
2. Select CB and submit application
3. Arrange for the documentation review
4. Consider a pre-assessment visit (optional)
5. Participate in the assessment visit:
• Stage I - Assessment of EMS design
• Stage II - Assessment of EMS implementation
6. Receive the registration certificate
7. Begin the ongoing surveillance audits
320
Questions/Final Thoughts
323