Presentation on theme: "Managing Change in an ISO/IEC Environment"— Presentation transcript:
1 Managing Change in an ISO/IEC 17025 Environment Kelly Huckabone, MLT, ASQ, CQIA
2 Paper Highlights Purpose of the presentation is to discuss: the cycles of change and how people adapthow to implement change in an ISO/IEC 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; andreviewing reasons for implementing change.
3 Definitions of Change CHANGE A deviation from a currently established baselineContinual improvementCHANGEMore workBecoming different in essence
8 Stages of Change People usually accept change in 5 stages: Shock or denialAngerBargainingDepression (not in the clinical sense)AcceptanceFor 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.
9 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 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).
10 Implementation Model Concept Project Life Cycle C-D-E-F Finish Develop We used a combined Project Management approach building on the some of the Quality Management principles.Project Management CycleQuality Management Principles:Customer OrientationLeadershipInvolvementProcess ManagementSystem ManagementContinual ImprovementFact-Based DecisionsClose Supplier RelationshipsConceptProject Life CycleC-D-E-FFinishDevelopExecute (implement)
12 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 complianceMISSION: To combine 2 separate Quality Management Systems into one and align it to ISO/IEC 17025:2005 while trying to implement standardization where possible.
15 Development PhaseThe development phase of any project requires the most amount of analysisNew elements and changes to the 17025:2005 Standard reviewedCurrent quality manuals reviewed and a Gap Analysis document completed identifying areas of changeDetailed Project Implementation Plan (PIP) completed which outlined tasks, responsibilities and time frames
16 Development PhasePIP served as “foundation” of project and was routinely used to track progress and stay on taskDevelopment 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 changeAll QM principles utilized in the Development Phase of the project.
19 Implementation PhaseThe Implementation phase is the most challenging part of any projectImplementation took approximately 5 months2 – way Communication is vital when implementing a significant changeEveryone 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).
20 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, TrainingReference to existing 9001 tools and processesTasks (continued):Updated Quality PolicyDevelopment of new forms to create new proceduresSenior Management approval of proceduresUpdated job descriptionsStaff signing of job descriptionsAll staff received training to the changes
21 Effectiveness of Implementation The outcome of the training sessions were verified during the internal audit processSpecific 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 andSummary 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.
22 Effectiveness of Implementation A small customer feedback survey was initiated. The results will be used in strategic planning and continual improvement opportunities.
23 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 conformancesNegative employee attitudesPoor communication
24 ChangeAll interested parties including employees must understand that the change will have a positive effect for them and customersWithout change, there will be no improvement in customer satisfaction (ISO 9001: (b))Random change is chaotic by nature and rarely leads to improvementChange should arise from informed decisions:Requirement to ensure complianceSignificant process improvementCorrective action resulting from a non conformanceDefined strategic objectivesReview and analysis of defined performance criteria
25 People and ChangeMany 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)
27 Termination PhaseTermination 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 implementationA project is deemed successful in the objectives (project deliverables) were met.
28 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/ 2006We completed internal training and audits were executed during October and November 2006During our internal audits, there were no non conformances related to the questions validating the effectiveness of the implementation
29 True TestThe true test was our reassessment audits which werescheduled for April 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.
30 Lessons LearnedAfter 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.
31 Lessons LearnedIt is advisable to obtain external training when a new version of a Standard is releasedIf 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
32 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.
33 Buckle up and enjoy the wave of change, Rome wasn’t built in a day! Ride the Wave of ChangeBuckle up and enjoy the wave of change,Rome wasn’t built in a day!