The world leader in serving science Managing Change in an ISO/IEC 17025 Environment Kelly Huckabone, MLT, ASQ, CQIA.

The world leader in serving science

Managing Change in an

ISO/IEC 17025 Environment

Kelly Huckabone, MLT, ASQ, CQIA

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Paper Highlights

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;

auditing the effectiveness of change; and

reviewing reasons for implementing change.

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Definitions of Change

CHANGE

Becoming different in essence

A deviation from a currently established baseline

Continual improvement

More work

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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:• 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:• Customer Orientation

• Leadership

• Involvement

• Process Management

• System Management

• Continual Improvement

• Fact-Based Decisions

• Close Supplier Relationships

Project Life CycleC-D-E-F Develop

Execute (implement)

Concept

Finish

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Phase 1 – Concept(Mission)

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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

New 17025:2005 Manual

9001 Quality Manual

+

=

Metrology Quality System

+

ISG Quality System

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Phase 2 - Development

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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

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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:• 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

Tasks (continued):• 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

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:• 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:• 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.

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 criticalAssessing the effectiveness of the implementation is required

and using the internal audit is an ideal solutionIf 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?