Transcript Document

The world leader in serving science
Managing Change in
an
ISO/IEC 17025
Environment
Kelly Huckabone, MLT, ASQ, CQIA
Paper Highlights
 auditing the effectiveness of
change; and
 reviewing reasons for
implementing change.
Purpose of the presentation is to
discuss:
 the cycles of change and how
people adapt
 how to implement change in an
ISO/IEC 17025 environment;
 implementing change in a
manner which would not
jeopardize the Management
System;
 using a Project Management
Approach while building of the
Quality Management Principles
when evoking change;
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Definitions of Change
A deviation from a currently established baseline
Continual improvement
CHANGE
More work
Becoming different in essence
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The one thing we know about Change…
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Where there’s
smoke…
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there’s usually …
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but …
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Stages of Change
 People usually accept change in 5 stages:
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Shock or denial
Anger
Bargaining
Depression (not in the clinical sense)
Acceptance
• For a major life change (professional and personal), it usually takes
18 months to go through the 5 stages.
• Some people get stuck in one of the stages for years and have a
challenging time climbing out of the downward spiral.
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Change in the Quality Systems
 Change can evoke fear in people if the change is not clearly
communicated and implemented in a planned and systematic
fashion.
 In an ISO/IEC 17025 environment (because of it’s technical
nature), if the change is not implemented correctly, it can
jeopardize the integrity of the Management System.
 A mature Quality System can support change much more
effectively than a system in the early stages of development
(e.g., recent Accreditation).
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Implementation Model
 We used a combined Project
Management approach building
on the some of the Quality
Management principles.
 Project Management Cycle
 Quality Management Principles:
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•
•
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Concept
Finish
Project Life Cycle
C-D-E-F
Customer Orientation
Leadership
Involvement
Process Management
System Management
Continual Improvement
Fact-Based Decisions
Close Supplier Relationships
Develop
Execute (implement)
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The world leader in serving science
Phase 1 – Concept
(Mission)
Concept Phase
 The concept phase of this project was very clear:
• 17025 Accredited Laboratories have to self-declare compliance by
January 2007 (if not yet assessed to the new 17025:2005 standard)
• The compliance is to be audited at the next reassessment (Spring
2007)
• We decided it would be beneficial to implement the changes 6
months in advance of the requirement to allow staff time to adjust to
the changes and collect “evidence” of compliance
MISSION: To combine 2 separate Quality Management Systems
into one and align it to ISO/IEC 17025:2005 while trying to
implement standardization where possible.
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Project Model
Metrology Quality
System
9001
Quality Manual
+
+
ISG Quality System
=
New 17025:2005 Manual
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The world leader in serving science
Phase 2 Development
Development Phase
 The development phase of any project requires the most amount
of analysis
 New elements and changes to the 17025:2005 Standard
reviewed
 Current quality manuals reviewed and a Gap Analysis document
completed identifying areas of change
 Detailed Project Implementation Plan (PIP) completed which
outlined tasks, responsibilities and time frames
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Development Phase
 PIP served as “foundation” of project and was routinely used to
track progress and stay on task
 Development phase involved numerous team meetings with
involvement of personnel from all levels to deal with issues,
confirm management commitment, verify alignment with the PIP,
and assign responsibilities.
 Development phase used to “plant the seeds of change” with
affected staff putting a positive slant on the upcoming change
 All QM principles utilized in the Development Phase of the
project.
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EXAMPLE OF PIP
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Phase 3 Implementation
Implementation Phase
 The Implementation phase is the most challenging part of any project
 Implementation took approximately 5 months
 2 – way Communication is vital when implementing a significant change
Everyone was given the opportunity to feed into design. Even our
auditors and assessors were kept in the loop!
 Emphasis was placed on the positive changes the new Quality System
would bring to day to day tasks to ensure “buy in” by all employees (Top
management support, continual improvement, improved training
program, easier accessibility to procedures, etc).
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Implementation Phase
 Tasks:
 Tasks (continued):
• Integration of the 2 Quality
Systems (Metrology and ISG)
• Standardization of processes
(audits, exec review, complaints,
etc)
• Development of new procedures
for alignment to new standard
(Customer Feedback, QC
Analysis, Quality Objectives,
Training
• Reference to existing 9001 tools
and processes
• Updated Quality Policy
• Development of new forms to
create new procedures
• Senior Management approval of
procedures
• Updated job descriptions
• Staff signing of job descriptions
• All staff received training to the
changes
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Effectiveness of Implementation
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The outcome of the training sessions were verified during the
internal audit process
Specific questions were developed to provide evidence that
employees understood the changes:
1. Ask employees to explain how the new quality manual works.
2. Ask employees to name 2 changes that are part of the new
17025:2005 Standard (Customer Feedback, more top management
support, job responsibilities, QC analysis).
3. Ask employees the difference between 9001 and 17025.
Summary statement: Ideally, the performance indices and targets are
established during the development phase, monitored during the
implementation phase as necessary, then analyzed & reviewed
during the termination phase and results used for making informed
decisions.
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Effectiveness of Implementation
 A small customer feedback survey was initiated. The results will
be used in strategic planning and continual improvement
opportunities.
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Integrity of the Management System
 The integrity of the Management System can be jeopardized if
the changes are not planned and implemented in a systematic
approach.
 Signs of a Quality Management System not supporting change:
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Increase in the number of errors (Complaints and Errors)
Weak internal audits with a large number of Non conformances
Negative employee attitudes
Poor communication
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Change
 All interested parties including employees must understand that
the change will have a positive effect for them and customers
 Without change, there will be no improvement in customer
satisfaction (ISO 9001:2000 1.1(b))
 Random change is chaotic by nature and rarely leads to
improvement
 Change should arise from informed decisions:
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Requirement to ensure compliance
Significant process improvement
Corrective action resulting from a non conformance
Defined strategic objectives
Review and analysis of defined performance criteria
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People and Change
 Many employees resist change (may be related to past
management credibility problems and “fad of the month”
syndrome)
 Keys to overcoming resistance to change (Rely on the Quality
Management Principles) – involvement, open and honest
dialogue, good planning)
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Phase 4 - Termination
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Termination Phase
 Termination phase is the last phase and usually shortest of any
project. It is commonly referred to as “close-out”
 This phase includes determination of the effectiveness of
implementation
 A project is deemed successful in the objectives (project
deliverables) were met.
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Was our Project Successful?
 We need to go back to our objective:
MISSION: To combine 2 separate Quality Management Systems
into one and align it to ISO/IEC 17025:2005 while trying to
implement standardization where possible.
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We launched our new Quality Manual on July 1st/ 2006
We completed internal training and audits were executed during
October and November 2006
During our internal audits, there were no non conformances
related to the questions validating the effectiveness of the
implementation
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True Test
 The true test was our reassessment audits which werescheduled
for April 2007. I am happy to report that we received our renewal
of our scopes.
 Feedback from staff working under the umbrella of the new
standard has been very positive. This is related to clear
communication, easy to follow training material and procedures
as well as the implementations of changes that will improve daily
operations.
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Lessons Learned
 After any project, an independent review/audit of the
implementation process should be completed with input from the
project team.
 Critical area such as resources, budget, timeline, and change in
scope should be discussed during conception and development
stages.
 This review is commonly known as a “lessons learned analysis”.
This is a useful document for future projects.
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Lessons Learned
It is advisable to obtain external training when a new version of
a Standard is released
If information is solicited from too many individuals, it becomes
difficult to manage (consider representative cross-functional
workgroups rather than one-on-one with each individual)
Training and communication are critical
Assessing the effectiveness of the implementation is required
and using the internal audit is an ideal solution
If you are implementing required change and see an opportunity
for improvement, explore it
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Managing Change Effectively
 Change is chaotic by it’s nature.
 People need time to adjust to any change. They need the
opportunity to get involved.
 If you need to implement change either using a breakthrough
approach or a Kaizen approach, the most critical aspect will be
communication, training, and understanding the impact of the
change.
 Request feedback from some of your senior staff regarding the
change, they will usually be honest with you.
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Ride the Wave of Change
Buckle up and enjoy the wave of change,
Rome wasn’t built in a day!
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Questions?
The world leader in serving science