7/25/20151 Quality Management Systems (QMS) Overview

7/25/20152 Quality is Conformance with requirements User dependent Fitness for use DEFINITION OF QUALITY

7/25/20153 Management System Management system refers to what the organization does to manage its processes, or activities, so that its products or services meet the objectives it has set itself, such as: satisfying the customer's quality requirements, complying with regulations, or meeting environmental objectives.

7/25/20154 Management System Standards Management system standards provide a model to follow in setting up and operating a management system. This model incorporates the features on which experts in the field have reached a consensus as being the international state of the art. The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards

7/25/20155 P-D-C-A Plan – establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them). Do – implement your plans (do what you planned to). Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives). Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).

7/25/20156 QUALITY Good Quality does not necessarily mean High Quality Good quality means a predictable degree of uniformity and dependability at low cost suitable to its purpose

7/25/20157 QUALITY ASSURANCE part of quality management, focused on providing confidence that quality requirements will be fulfilled ISO 9000:2000

7/25/20158 QUALITY MANAGEMENT QA = quality and assurance Quality = fitness for use Assurance = Confidence Risk QA (defined) - Actions taken to provide confidence of fitness for use (or reduce risk of failure)

7/25/20159 QUALITY ASSURANCE STANDARDS 1945 NATO 6-49 DEF131a 1955 NATO AQAPs 1959 MIL-Q-9858A DC(SMMT) 1975 BS BS s TC 176 formed 1987 ISO 9000 EN ASQC Q ISO 9000 revisions ANSI/ASQC Q ISO 9001 revisions 2008 ISO 9001 update

7/25/ Quality Management Standards

7/25/ THE ISO 9000 FAMILY ISO 9000: 2005 Identifies the fundamentals and vocabulary for Quality Management Systems (QMS) ISO 9001:2008 Specifies requirements for a QMS where capability to provide product that meets customer and regulatory requirements needs to be demonstrated ISO 9004:2009 Provides guidance on QMS that contributes to the satisfaction of customers and other interested parties

7/25/ ISO 9000 : 2008 Eight quality management principles 1.Customer focus 2.Leadership 3.Involvement of people 4.Process approach 5.System approach to management 6.Continual improvement 7.Factual approach to decision making 8.Mutually beneficial supplier relationships

ISO 9001:2008 CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

7/25/ Inputs With What? (Materials / Equipment) How Many? (Measurement / Controls) How? (Methods/Procedures) WHO? Special Skills? / Competence? Outputs Process Linkages Objectives and Targets Business Process Source: AIAG ISO/TS 16949:2002 Implementation Guide PROCESS REQUIREMENTS

7/25/ SCOPE OF STANDARD 1.Scope +General +Application 2.Normative reference 3.Terms and definition e.g., Supplier Organization Customer

7/25/ QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4.1General requirements +Document, implement, maintain and continually improve +Identify and determine sequence and interaction of processes +Determine criteria and methods needed +Ensure availability of resources +Monitor, measure and analyze processes +Implement actions to achieve planned results

7/25/ QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4.2 Documentation requirements +Management system documentation +Quality Manual +Control of documents +Control of records

MANAGEMENT RESPONSIBILITY CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

7/25/ MANAGEMENT RESPONSIBILITY 5.1Management commitment 5.2Customer focus 5.3Quality policy +Must be documented +Must be used for setting objectives 5.4Planning +Document objectives- Must be Measurable +Quality management system planning

7/25/ What are some typical objectives for a company?

7/25/ MANAGEMENT RESPONSIBILITY 5.5Responsibility, authority and communication +Responsibility and authority +Management representative +Internal communication

7/25/ MANAGEMENT RESPONSIBILITY 5.6Management Review +General +Review input +Review output

RESOURCE MANAGEMENT CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

7/25/ RESOURCE MANAGEMENT 6.1Provision of resources 6.2Human resources +General +Competence, awareness and training 6.3Infrastructure 6.4Work environment

PRODUCT REALIZATION CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

7/25/ PRODUCT REALIZATION 7.1 Planning of product realization 7.2 Customer-related processes +Determination of requirements related to the product +Review of requirements related to the product +Customer communication

7/25/ PRODUCT REALIZATION 7.3 Design and development +Planning, inputs, outputs, systematic reviews, verification and validation, control of changes 7.4 Purchasing +Supplier evaluation and selection +Relevant purchasing information +Verification of purchased product - receiving, source

7/25/ PRODUCT REALIZATION 7.5 Production and service provision +Controlled conditions including product characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activities +Validation of processes when no other method +Identification and traceability of product and its status +Care of customer property +Preservation of product 6 Includes constituent parts

7/25/ PRODUCT REALIZATION 7.6 Control of monitoring and measuring devices +Calibrated or verified where necessary +Adjusted and re-adjusted as necessary +Identified to enable calibration status +Safeguarded from invalid adjustment +Protected from damage and deterioration

MEASUREMENT, ANALYSIS, AND IMPROVEMENT CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

7/25/ MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.1General 8.2Monitoring and measurement +Customer satisfaction +Internal audit +Monitoring and measurement of processes +Monitoring and measurement of product

7/25/ MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.3Control of nonconforming product 8.4Analysis of data 8.5Improvement +Continual improvement +Corrective action +Preventive action

7/25/ ISO 9001:2008 A Structured Approach to Quality Management

7/25/ Documented Systems

7/25/ QUALITY SYSTEM DOCUMENTATION STRUCTURE 1st Level Quality Manual 2nd Level Procedures 3rd Level Work Instructions Machine instructions Computer inputs Detailed work instructions 4th Level Technical Data International standards Computer operating manuals Detailed product specifications Policy and Objectives What the company wishes to achieve How the company implements its policy Structured to reflect process flow of events Detailed instructions How to complete a job or task

Example: High Level Process

Example: Lower Level Process

7/25/ DOCUMENTATION... may take other forms

7/25/ Identify the processes needed Determine the sequence and interaction Criteria and methods Availability of resources and information Monitor, measure and analyze processes Implement actions to achieve planned results and continual improvement DOCUMENTATION

7/25/ State policy and objectives Describe Products Plants and facilities Organization Inform employees Inform customers Aid auditors Refer to lower-level documents DOCUMENTATION

7/25/ Extent is dependent on: Size and type of organization Complexity and interaction of processes Competence of personnel DOCUMENTATION

7/25/ DOCUMENTATION Companies are expected to: Say what they do Do what they say Show that it works (effectiveness) Continually improve Ensure changes are authorized, controlled