Dr Nigel H Croft Mexico City April 21st 2005 Keeping the QMS Alive Dr Nigel H Croft Mexico City April 21st 2005 (c) Copyright Nigel H Croft 2005

ISO 9001:2000 – a common starting point (c) Copyright Nigel H Croft 2005

What is a Management System? Hardware (equipment) Software (methods) Humanware (people) ISO 9000:2000 definition: “set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives” (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 ISO 9001:2000 Scope Clause 1.1 - “Specifies quality management system requirements for organization to: demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements enhance customer satisfaction” (c) Copyright Nigel H Croft 2005

Components of a management system Administrative Policy Objectives Deployment Doc control Internal audit Management review NC control Corr/Prev Actions Etc………….. Technical Knowledge of business Product specification Technical integrity of “product” Legal requirements Understanding of process etc (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Business performance Need to integrate QMS with: Vision Mission Strategic objectives Overall business performance Results (c) Copyright Nigel H Croft 2005

Return on Investment (“ROI”) Many organizations view QMS only as “cost”, not “investment” Need to maximize ROI, by ensuring efficiency, as well as effectiveness Doing things Faster Cheaper “Better” Safer In a more environmentally friendly way (c) Copyright Nigel H Croft 2005

ISO 9001:2000 as a starting point Different approaches to ISO 9001: “Minimalist” Separate from other Total Quality initiatives Integrated into the way the organization does business How to promote this? Process-driven Results-focused Aligned with overall organizational strategy and objectives Integrated with other management systems (c) Copyright Nigel H Croft 2005

The ISO Model CUSTOMER Requirements CUSTOMER Satisfaction Continual Improvement of the Quality Management System The ISO Model CUSTOMER Requirements CUSTOMER Satisfaction Management Responsibility Resource Management Measurement, Analysis, Improvement Product Realization Inputs Outputs Product (c) Copyright Nigel H Croft 2005

How to drive the QMS beyond “ISO 9001 compliance”?? (c) Copyright Nigel H Croft 2005

Typical motivation cycle Approx 18 months Motivation ISO 9001 Time (c) Copyright Nigel H Croft 2005

How to maintain the motivation?? By promoting new initiatives within the framework of the QMS Important not to confuse these as “substitutes” for the QMS, or a “new flavours of the month” Some useful “tools”…………… (c) Copyright Nigel H Croft 2005

“People-related” tools Seiri – “Sort, Systematize or simplify” Seiton – “Straighten, standardize” Seiso – “Shine” Seiketsu – “Sanitize” Shitsuke – “Sustain” Quality Improvement Teams (Inter-functional) QC Circles Suggestions plans (NOTE - All rely on the QMS for support and maintenance) (c) Copyright Nigel H Croft 2005

“System-related” tools Systematic Problem Solving “QC Story” Small-step continual improvement (“Kaizen”) Breakthrough Improvement (“ Reengineering”) where necessary! Statistical techniques 7 tools / 7 “new tools” Statistical Process Control 6-sigma Management by policy (“Hoshin Kanri”) Error-proofing (“Poka-yoke”) Quality Function Deployment Cost of quality (c) Copyright Nigel H Croft 2005

“Business-related” tools “Lean” initiatives (Toyota philosophy) Initiatives to reduce bureaucracy Balanced Scorecard (“BSC”) National Quality Awards / Excellence Models Benchmarking Just-in-time inventories (“KANBAN”) Theory of Constraints (Goldratt – “The Goal”) Total Productive Maintenance (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 But remember……… “A fool with a tool is still a fool” (c) Copyright Nigel H Croft 2005

Implementation of new initiatives Impossible to do all at once! Need to prioritize “Organizational profile” What is important for your organization? Top management direction & support required Long-term plan needed Allocation of adequate resources Financial Human Marash – “Fusion Management” QSU Publishing (c) Copyright Nigel H Croft 2005

Keeping the Motivation Approx 18 months Motivation ISO 9001 Initiative “A” Initiative “B” Initiative “C” Time (c) Copyright Nigel H Croft 2005

Looking beyond “conformance” to “performance” (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 EFFECTIVENESS Dictionary definition: “producing or capable of producing a desired effect” ISO 9000:2000 definition: “extent to which planned activities are realized and planned results achieved” (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 EFFICIENCY Dictionary definition: “Acting or producing effectively with a minimum of waste, expense, or unnecessary effort.” “Exhibiting a high ratio of output to input” ISO 9000:2000 definition: “Relationship between the result achieved and the resources used” (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Cause and Effect “INTENDED PRODUCT” PROCESS “UNINTENDED PRODUCT” (WASTE) INEFFICIENCY (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 ISO 9001:2000 Specifies QMS requirements for an organization: to demonstrate ability to consistently provide conforming product to enhance customer satisfaction Requires continual improvement of the system effectiveness understand the role of ISO 9001 standard: Product / service quality oriented Confidence to own management Confidence to customers ‘Established requirements’ Customer satisfaction (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 ISO 9004:2000 Goes beyond requirements of ISO 9001 Provides guidance (“should”, not “shall”) on: Effectiveness and efficiency Performance improvement Focuses on benefits for all Interested Parties (“IP’s”) Ask participants to think about who are the IP's in their own organization (people in the organization, suppliers, owners, society) (c) Copyright Nigel H Croft 2005

The ISO Model Interested Parties Requirements Interested parties Continual Improvement of the Quality Management System The ISO Model Interested Parties Requirements Interested parties Satisfaction Management Responsibility Resource Management Measurement, Analysis, Improvement Product Realization Inputs Outputs Product (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Interested Parties Customers & end users Suppliers & partners Owners & investors People in the organization Society (community & the public) (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Relationship ISO 9001/ISO 9004 ISO 9004 perspective: Performance Improvement; QMS efficiency ISO 9004 ISO 9004 is not just ‘more of the same’ (Seen from the front:) Covers more activities, not just directly related to product conformity e.g. Support services, health & safety, social, environmental & financial considerations (Seen diagonally:) Also covers topics within ISO 9001 (product related), but from a management viewpoint > different perspective! ISO 9004 gives guidance on a wider range of objectives of a QMS than does ISO 9001, particularly for the continual improvement of an organization's overall performance & efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. It is not intended for certification or for contractual purposes. ISO 9001 ISO 9001 perspective: Quality of “product”; QMS effectiveness (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Relationship ISO 9001/ISO 9004 “Consistent pair”of stand-alone standards Common format & structure Harmonized terminology (ISO 9000:2000) Both based on 8 “Quality Management Principles” Emphasized more in ISO 9004 Organizations at different needs levels ISO 9001 - certified ISO 9001 - customer requirement Certified, now what? > Return on ISO 9001 QMS > ISO 9004 towards performance improvement Possible to advance from ISO 9001 to ISO 9004 within same basic structure. Each standard can be used alone. (c) Copyright Nigel H Croft 2005

Quality Management Principle “Comprehensive & fundamental rule, for leading & operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other Interested Parties.” Intended for top management in setting Quality policy & objectives Managing: “ Leading & operating an organization “ Focus on both customers & IP's. Basis for ISO 9004:2000 QMS- Guidance for Performance Improvement (c) Copyright Nigel H Croft 2005

Quality Management Principles Customer-focused organization Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship (c) Copyright Nigel H Croft 2005

Linking the QMS to business performance (c) Copyright Nigel H Croft 2005

Keys to business success Define and deploy the Vision, Mission and Strategic Objectives Understand the overall business processes Apply PDCA throughout the organization (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Plan What to do? (“Objective”) How to do it? (“Procedure”) Do Do what was planned Check Did things happen according to plan? Act How to improve next time? DELEGATE NOTES: (c) Copyright Nigel H Croft 2005

Plan (Strategic level): What do we want to achieve? Vision Mission Objectives How can we achieve it? Business plan Strategies Resources Dr Deming – “It’s pointless to establish an objective without defining a method to achieve it” (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Do: Get everyone involved, committed, and motivated (“Leadership”!) Carry out “the plan” Deploy throughout the organization Break down the objectives to the appropriate functions and levels (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Check: Is this what we expected? Are the results OK? Can they be improved? Look for trends (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Act Correct what went wrong (Correction) Plan to do it right next time (Corrective action) Learn to make things “error-proof” (Preventive action) Think – how can we do this…….. More consistently? Faster? Cheaper? Better? Safer? More environmentally friendly? (Improvement) (c) Copyright Nigel H Croft 2005

The strategic view “Where do we want to be in the long term?” “Understand, manage and improve” Understand the business Define policy and objectives Deploy policy throughout organization Routine management Continual (small-step) improvements Breakthrough improvements (c) Copyright Nigel H Croft 2005

Understand the business Why are we here? Who is (who are) our customer(s)? What is our product? What are our processes? How do they fit together? What is important (risk analysis)? (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Manage the business Use the “Plan-Do-Check-Act” cycle at all levels, functions and processes in the organization from the Board Room to the shop floor from R&D through customer support (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Improve the business Focus on the customer, but don’t forget other stakeholders Focus on the key processes Keep an eye on the competitor Innovate Think ahead (future trends; technologies; economic climate etc) (c) Copyright Nigel H Croft 2005

“The forgetful organization” Improvements “SAWTOOTH” EFFECT Improve FORGET Improve FORGET Improve FORGET Time (c) Copyright Nigel H Croft 2005

“The learning organization” Improvements “LADDER” EFFECT “KAIZEN” (Continual improvement) Maintain (routine) Improve Standardize Time (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Conclusions We need to keep people motivated with new ideas within the overall framework of the QMS. Look for efficiency, in addition to effectiveness Has to be top-management driven Will help to achieve business objectives Will drive improvement There are many ways to do this Careful not to try to do everything at once Need to customize Need to prioritize (c) Copyright Nigel H Croft 2005

(c) Copyright Nigel H Croft 2005 Muchas Gracias! (c) Copyright Nigel H Croft 2005