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10 Steps to Qualituy A good practice Clemens Spoorenberg 10 Steps to Qualituy A good practice Clemens Spoorenberg

Topics • Implementing a Quality Management System (ISO 9001: 2000) • Do’s and don’ts Topics • Implementing a Quality Management System (ISO 9001: 2000) • Do’s and don’ts

The objective An objective without a plan is a dream A plan without an The objective An objective without a plan is a dream A plan without an objective is a nightmare

The objectives 1. Give clear insight in process flows 2. Harmonize existing process organization The objectives 1. Give clear insight in process flows 2. Harmonize existing process organization 3. Tune interfaces within the process organization 4. Describe tasks, authorities and responsibilities 5. Optimize process efficiency 6. Stimulate “quality mindedness”

Step 0 Step 0

The objective: 10 steps to quality Activities ▼ Results The objective: 10 steps to quality Activities ▼ Results

Step 1 Analyze Ø Organizational analyses by the external consultant Ø Interviews with all Step 1 Analyze Ø Organizational analyses by the external consultant Ø Interviews with all Management Team (MT)-members Ø Presentation of results to MT Ø Processes identified Ø Blue print for process model (=relations between processes) Ø Structure for QMS (= chapters and paragraphs) Ø Specific points of attention /threats for the project identified Ø Communication plan for implementation QMS determined

Step 2 Define quality policy, organizational and responsibility structure Ø Getting the MT members Step 2 Define quality policy, organizational and responsibility structure Ø Getting the MT members (Board) on one page (noses in the same direction) Ø Discussing organizational structure Ø Adjusting process model and structure for QMS Ø TAR-session (Tasks-Authorities. Responsibilities) ▼ Ø Objectives clear for MT members and supported by them Ø Organizational chart and TAR-structure described (relation between processes and organization) Ø Process Owners appointed

Step 2 TAR-structure Step 2 TAR-structure

Step 3 Step 3

Step 3 Determine and implement primary processes Ø Form workgroups consisting of Process owner, Step 3 Determine and implement primary processes Ø Form workgroups consisting of Process owner, primary responsible functions, quality manager and consultant Ø Starting point for describing is not the current situation but “soll” situation which can be achieved within 3 to 6 months Ø Describe processes in workgroup per process, identify bottlenecks Ø Document procedures, review by workgroup members Ø Process owner starts implementation of changes ▼ Ø Procedures documented Ø Standard documents/ forms/ checklists identified

Step 4 Step 4

Step 4 Publish Quality Management System Ø Publish the authorized procedures Ø Communicate to Step 4 Publish Quality Management System Ø Publish the authorized procedures Ø Communicate to the users/organization how to find and use the QMS ▼ Ø QMS “live” on intranet

Step 5 Step 5

Step 5 Implement secondary processes Ø Same as step 3: form workgroups… only for Step 5 Implement secondary processes Ø Same as step 3: form workgroups… only for secondary processes: ü Planning & Control (performance indicators)/ Management review ü Quality checks: organization of internal audits, corrective and preventive measures ü Document control; control of quality records ü HRM ü Finance & Administration & ICT ▼ Ø Secondary processes documented Ø Process owner starts implementation

Step 6 Step 6

Step 6 Evaluate and adjust processes Ø Process owner reports to Board on implementation Step 6 Evaluate and adjust processes Ø Process owner reports to Board on implementation progress Ø Bottle necks are monitored ▼ Ø Procedures are revised and updated where necessary

Step 7 Step 7

Step 7 Internal audit Ø Internal audit by another consultant Ø Objectively check implementation Step 7 Internal audit Ø Internal audit by another consultant Ø Objectively check implementation Ø Report internal audit findings Ø Report to MT-members (Board) Ø Determine corrective measures on audit findings ▼ Ø Weak spots identified Ø Corrective actions determined and implemented

Step 8 Optimize based on Internal audit results ØProcess owner implements changes ▼ ØProcedures/ Step 8 Optimize based on Internal audit results ØProcess owner implements changes ▼ ØProcedures/ Forms/ Checklists further documented

Step 9 Prepare certification (ISO 9001: 2000) Ø Invite several Certification institutes for quotations Step 9 Prepare certification (ISO 9001: 2000) Ø Invite several Certification institutes for quotations Ø Compare quotations and approach Ø Select Certification institute ▼ Ø Contract with Certification Institute (Lloyd’s Register Nederland BV) Ø Certification date planned (First document review, then implementation audit)

Step 10: Change management Plan, Do, Check, Act P A D C Step 10: Change management Plan, Do, Check, Act P A D C

Step 10: Control and improve the QMS Ø Internal audits Ø Objectives/Year plans Ø Step 10: Control and improve the QMS Ø Internal audits Ø Objectives/Year plans Ø Periodical management review Ø Periodical external audit (every 6 month) Ø Updating/optimizing procedures QMS

Do’s and Don’ts Ø Do: § Get professional help § Involve the complete management Do’s and Don’ts Ø Do: § Get professional help § Involve the complete management § Involve and inform your organization § Appoint process owner on management level Ø Don’t: § Don’t get caught in theoretical never ending discussions, start implementing and evaluate § Don’t put short term successes before realizing the project objectives § Don’t develop a perfect QMS, but a practical, realistic, acceptable QMS § Don’t …