Quality Management Systems

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Quality Management Systems

• Chapter 10

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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

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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

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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

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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

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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 90002000- Fundamentals and vocabulary
• ISO 90012000- Requirements
• ISO 90042000- Guidelines for performance
  improvements

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Sector-specific Standards

• Some industries require special set of ISO rules
  not operated the same as most
• Three other quality systems
• AS9100-
• ISO/TS 16949
• TL9000

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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 industrys needs

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ISO/TS 16949

• 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

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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

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TL 9000 continued-

• This standard focused on
• Hardware Specific Requirements and Measures
• Software Specific Requirements and Measures
• Services Specific Requirements and Measures

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ISO 9001 REQUIREMENTS

• The standard has 8 clauses
• Scope
• Normative Reference
• Terms and Definitions
• Quality Management Systems
• Management Responsibility
• Resource Management
• Product Realization
• Measurement Analysis and Improvement

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• Scope
• To provide a product that meets
• Customer Requirement
• Regulatory Requirements
• Customers Satisfaction

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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

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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

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

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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

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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 Productf) Control Of
Monitoring And Measuring Devices
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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
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IMPLEMENTATION

• Top Management Commitment
• Appoint the Management Representative
• Awareness
• Appoint an Implementation Team
• Training
• Time Schedule
• Select Element Owners
• Review the Present System
• Write the Documents
• 10) Install the New System

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

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

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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.

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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.

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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.

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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.

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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.

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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.

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AUDITOR

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

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TECHNIQUES

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

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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.

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• 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.

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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

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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.

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SELECTING A REGISTRAR

• Qualifications And Experience
• Certificate Recognition
• The Registration Process
• Time And Cost Constraints
• Auditor Qualifications

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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

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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.