Quality Management Systems Chapter 10

Introduction ISO- International Organization for Standardization Founded in 1946, in Geneva, Switzerland Main function is to promote the development of standardization of goods and services, to better accommodate a world wide market. ANSI- American National Standards Institute ANSI represents U.S. in the ISO

ISO Registration Companies can become registered as an ISO company This involves the registrar giving an assessment of the operations a company, and then making periodic surveillance audits Primary Reason: To give your customer the comfort of knowing that you have a quality plan in place, and it is being monitored by an objective third party

Internal Reasons for Becoming ISO Registered 100 Italian manufacturing firms were surveyed to find out what improved after certification. – Internal quality: less scrap, rework, nonconformities – Production reliability: less breakdowns, less time with emergencies, downtime – Time performance: time to market, punctual deliveries  Externally: less nonconformities

Negatives Prevention and appraisal costs increased – Only one negative shown in 100 surveys. – Positives outweigh negatives – Takes time to implement, but worth it in the long run

ISO 9000 The ISO 9000 series of standards is generic It is designed to adapt to fit any industry type Three standards of the 9000 series: – ISO 9000:2000- Fundamentals and vocabulary – ISO 9001:2000- Requirements – ISO 9004:2000- Guidelines for performance improvements

Sector-specific Standards Some industries require special set of ISO rules; not operated the same as most Three other quality systems: – AS9100- – ISO/TS – TL9000

AS9100 This standard is specifically for the aerospace industry Attempt at unifying the requirements of NASA, DOD, and FAA At the same time satisfying the industry’s needs

ISO/TS Standard specifically for automotive suppliers Merges supplier quality requirements of U.S. with German, French, and Italian automakers Goal- provide continuous improvement, defect prevention, reduce variation and waste Is assumed that this standard will show 85% improvement rate in first 5 years

TL9000 Telecommunications Industry Consolidate various quality systems requirements Defines design, development, production, delivery, installation and maintenance of telecommunications Customers receive benefits, worldwide competition, benchmarks, improvement initiatives

TL 9000 continued- This standard focused on: – Hardware Specific Requirements and Measures – Software Specific Requirements and Measures – Services Specific Requirements and Measures

ISO 9001 REQUIREMENTS The standard has 8 clauses 1)Scope 2)Normative Reference 3)Terms and Definitions 4)Quality Management Systems 5)Management Responsibility 6)Resource Management 7)Product Realization 8)Measurement Analysis and Improvement

1.Scope To provide a product that meets a) Customer Requirement b)Regulatory Requirements c)Customers Satisfaction

2. Normative Reference: Fundamentals and vocabulary 3. Terms and Definitions: Supplier  Organization  Customers 4. Quality Management System: a) General Requirements b) Documentation * General Documentation * Quality Manual * Control of Documents * Control of Records

5) Management Responsibility: a) Management commitment b) Customer Focus c) Quality policy d)Planning * Quality Objectives * Quality Management System Planning e) Responsibility, Authority, And Communication * Responsibility and Authority * Management Representative * Internal Communication f) Management Review * General Management * Review Input * Review Output

6) Resource Management : a) Provision of Resources b) Human Resources * General * Competence, Awareness and Training c) Infrastructure d) Work Environment

7) Product Realization a) Planning of product Realization b) Customer Related Processes * Determination Of Requirement Related to the Product * Review Of Requirement Related to the Product *Customer Communication c) Design And Development * Design And Development Planning * Design And Development Inputs * Design And Development Outputs * Design And Development Review * Design And Development Verification * Design And Development Validation * Control of Design And Development Changes

d) Purchasing * Purchasing Process * Purchasing Information * Verification Of Purchased Product e)Production And service Provision * Control Of Production And service Provision * Validation Of Processes For Production And service Provision *Identification And Traceability * Customer Property * Preservation of Product f) Control Of Monitoring And Measuring Devices

8) Measurement, Analysis, And Improvement a) General b) Monitoring And Measurement * Customer Satisfaction * Internal Audit * Monitoring And Measurement Of Processes * Monitoring And Measurement of Product and Service c) Control Of Nonconforming Product d) Analysis Of Data e) Improvement * continual improvement * corrective Action * preventive Action

IMPLEMENTATION 1)Top Management Commitment 2) Appoint the Management Representative 3) Awareness 4) Appoint an Implementation Team 5) Training 6) Time Schedule 7) Select Element Owners 8)Review the Present System 9)Write the Documents 10) Install the New System

11) Internal Audit 12) Management Review 13) Preassessment 14) Registration

DOCUMENTATION policy procedures Work instructions or practices Records or proof States Policy and Objectives for each of the pertinent ISO elements Departmental Procedures & responsibilities Forms, Work Instructions & Equipment Instructions Business supporting documents

POLICY: This is a document that defines what will be done and why. A quality policy manual should be written so it is clear, precise, practical, and easy to understand.

PROCEDURE: The procedures define 1) who should perform specific tasks 2) when the task should be done 3) Where documentation will be made showing that the task was performed.

WORK INSTRUCTIONS: Work instructions are usually department, machine, task, or product oriented and spell out how a job will be done. The writing of a work instruction is best carried out by the employee who performs the task.

RECORDS: Records are a way of documenting that the polices, procedures, and work instructions have been followed. Records provide data for corrective action and a way of recalling products.

DOCUMENT DEVELOPMENT: To begin creating the documentation system, the implementation team should gather all the existing policies, procedures, work instructions, and forms that are presently in use. When the documents have been completed, they should be formatted in a manner that will allow for simple and effective document control.

WRITING THE DOCUMENTS When writing the document it should be simple rather than complex. Use flow chart and check sheets where ever possible wherever possible rather than lengthy verbiage.

INTERNAL AUDITS Objectives: 1) Determine that actual performance conforms to the documented QMS. 2) Initiate corrective action activities in response deficiencies. 3) Follow up on noncompliance items from previous audits. 4) Provide continued improvement in the system through feedback to management. 5) Cause the auditee to think about the process, thereby encouraging possible improvement.

AUDITOR: A qualified individual who have received training in auditing principles and procedures should perform audits.

TECHNIQUES: During the audit the auditor should employee three methods: 1) Examination of documents 2) Observation of activates 3) Interviews

Examination of Documents: The auditor should examine the documents in a systematic manner 1) Documents are identified with a title, revision date, and responsible owner. 2) Documents are readily available to users 3) A master list by departments or function for procedures, work instructions, and records is appropriately located. 4) There are no obsolete documents at workstations. 5) Changes follow a prescribed procedure.

Observation Activity: It requires an aptitude for details. Interviews: 1) Place the auditee in a nonthreathing environment 2) Encourage employees to talk about the process. 3) Focus on the system not on the auditee. 4) Discuss the major issues informally with the auditee first. 5) Use the appropriate type of questions.

PROCEDURE: Before the audit takes place an audit plan and check list should be prepared. The audit itself has three parts 1) The preaudit meeting 2) The audit 3) A closing meeting

REGISTRATION It is the assessment and audit of a quality system by a third party, known as a registrar. Two parts: 1) Selecting a registrar. 2) The registration process.

SELECTING A REGISTRAR Qualifications And Experience Certificate Recognition The Registration Process Time And Cost Constraints Auditor Qualifications

REGISTRATION PROCESS The process has six basic steps: 1) Application for registration. 2) Document review. 3) Preassessment 4) Assessment 5) Registration 6) Follow-up surveillance

CLOSING COMMENTS The standards are written for contractual compliance to the standard. Before entering into a contract for registration, management must be able to justify the cost versus the potential gains in continued or increased business.