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Managing Change in an ISO/IEC 17025 Environment. Kelly Huckabone, MLT, ASQ, CQIA. 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;
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Managing Change in an ISO/IEC 17025 Environment Kelly Huckabone, MLT, ASQ, CQIA
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. Paper Highlights
Definitions of Change A deviation from a currently established baseline Continual improvement CHANGE More work Becoming different in essence
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.
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).
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 Implementation Model Concept Project Life Cycle C-D-E-F Finish Develop Execute (implement)
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.
Project Model Metrology Quality System + ISG Quality System 9001 Quality Manual + = New 17025:2005 Manual
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
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.
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).
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 Implementation Phase
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: • Ask employees to explain how the new quality manual works. • 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). • 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.
Effectiveness of Implementation • A small customer feedback survey was initiated. The results will be used in strategic planning and continual improvement opportunities.
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
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
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)
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.
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
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.
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.
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
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.
Ride the Wave of Change Buckle up and enjoy the wave of change, Rome wasn’t built in a day!
