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QMS 2000 Slide Brief)
QMS 2000 Slide Brief)
To commit on quality, one has to make his intention to know about the quality
QUALITY IS FREE
... Philips Crosby
Cost of Quality
Internal Failure cost Scrap Rework Retest Downtime Yield loss Re-inspection Disposition
Cost of Quality
External failure cost Customer complaint processing. Reworking of returned items. Warranty costs. Lost opportunity costs.
Cost of Quality
Appraisal cost Incoming material inspection. In-process and final, inspection and test. Maintenance and calibration of inspection and test equipment.
Cost of Quality
Prevention cost Quality planning Incoming material inspection Quality system audits Training Supplier assessments New product design reviews Process control
25 20 15
Total Cost
Internal failure cost 10 5 External failure cost Appraisal cost Prevention cost
10
11
12
13
14
15
DISADVANTAGES OF CUSTOMER EVALUATION Expensive for customer , especially if supplier is located overseas Subjective nature of each assessment Experts , drawing conclusion on their companys own experience , may have different perception of effectiveness of quality system Time & money spent by organization , in preparation of such evaluation visit
Requirement(3.1.2)
need or expectation that is stated , generally implied or obligatory
Grade(3.1.3)
category or rank given to the different quality requirements for products, processes or systems having the same functional use
Quality(3.1.1)
degree to which a set of inherent characteristics fulfils requirements
Capability(3.1.5)
ability of an organization,system or process to realize a product that will fulfill the requirements for the product
Characteristic(3.5.1)
Distinguishing feature
Customer Satisfaction(3.1.4)
customers perception of the degree to which the customers requirements have been fulfilled
Top management(3.2.7) person or group of people who directs & controls an Org. at the highest level Quality policy(3.2.4) overall intentions & direction of an organization related to quality formally expressed by top mgt Quality objective(3.2.5) something sought,or aimed at,related to quality
Management system(3.2.2) system to establish policy & objectives & to achieve those objectives Quality management(3.2.8) coordinated activities to direct & control an organization with regard to quality
Quality management system (3.2.3) mgt.system to direct & control an organization with regard to quality
Continual improvement(3.2.13) recurring activity to increase the ability to fulfill requirements Quality control (3.2.10) part of quality mgt. focused on fulfilling quality requirements Quality Assurance Quality improvement (3.2.11) (3.2.12) part of quality mgt part of quality mgt. focused on providing focused on increasing confidence that quality the ability to fulfill Reqts. will be fulfilled quality reqt.
Quality planning(3.2.9) part of quality mgt.focused on setting quality objectives & specifying necessary operational processes & resources to fulfill the quality objectives
Defect(3.6.3) non-fulfillment of a requirement related to an intended or specified use Preventive action(3.6.4) action to eliminate the cause of a potential nonconformity or other undesirable potential Corrective actions(3.6.5) action to eliminate the cause of a detected nonconformity or other undesirable situation
Requirement(3.1.2) Conformity(3.6.1) fulfillment of a requirement Deviation permit(3.6.12) permission to depart from the originally specified requirements of a product prior to realization Concession(3.6.11) permission to use or release a product that does not conform to specified requirements
Scrap(3.6.10) action on a non conforming product to preclude its originally intended use Correction(3.6.6) action to eliminate a detected nonconformity
Repair(3.6.9) action on a nonconforming product to make it acceptable for the intended use
Re grade(3.6.8) alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial ones
4. 5. 6 7.
4.
PROCESSES FOCUS ON SATISFYING THE CUSTOMER 6. PROCESSES TRANSFORM INPUTS INTO OUTPUTS THROUGH THE USE OF RESOURCES
PROCESSES ARE DRIVEN BY PHYSICAL FORCES SOME OF WHICH MAY BE ACTIVATED BY HUMANS 8. 9. PROCESSES EXIST, THEY ARE DYNAMIC PROCESSES CAUSE THINGS HAPPEN
8. 9.
PROCEDURES EXIST, THEY ARE STATIC PROCEDURES CAUSE PEOPLE TO TAKE ACTIONS AND DECISIONS
Act
Take actions to continually improve process performance
Plan
How to improve next time? Establish the objectives & processes necessary to deliver results in accordance with customer requirements & the org. policies;
Check
Monitor & measure processes & product against policies, Objectives & requirements for the product & report the results
Do
Implement the processes
E X T E R N A L C U S T O M E R
A P C D Input E
PROCESS E
Output E
Input A
PROCESS A
Output A A P C D Input C
PROCESS C
A P C Input D
PROCESS D
D Output D A P C D
E X T E R N A L C U S T O M E R
Input B
PROCESS B
A P C Output B D
Output C
A P C D
C
Contin Proces System Approach To Managemen Involvement Factual Approach To Decision L Mutually Beneficial Supplier
U S T O M E R
Management responsibility
Resource Management
Satisfaction
Requirements
Quality Manual
Level 1 (Overall System Description) Quality Management System Description , Quality Policy & Objectives
Internal & External Use Ext knows about organizations control system
Level 2 Internal Use (Who,What,When, Where,Why) Dept / Section Heads Description of activities/ Process About day-to-day operation Quality Management Actions
Level 3 Internal Use (How) Operators & Technicians Dos & Do not do Instructions / Steps Action guidelines Level 4 Internal Use (Evidence/ Results/ Support Ref) To demonstrate system Forms , Standardized Reports, Data & compliance Data Analysis Information
4.2.3 CONTROL OF DOCUMENTS 4.2.4 CONTROL OF QUALITY RECORDS 8.2.2 INTERNAL AUDIT 8.3 CONTROL OF NON-CONFORMITY 8.5.2 CORRECTIVE ACTION 8.5.3 PREVENTIVE ACTION
6.2.2(e) Education, training, skills & experience 7.1 (d) Realization processes and resulting product meet requirements 7.2.2 7.3.2 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.5.2 7.5.3 7.5.4 Results of the review of requirements relating to the product and actions arising from the review Design & development inputs! Results of design and development reviews and any necessary actions. Results of design and development verification and any necessary actions. Results of design and development validation and any necessary actions. Results of the review of changes and necessary actions. Results of supplier evaluations and actions arising from the evaluations. As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement. The unique identification of the product, where traceability is a requirement. Customer property that is lost, damaged or otherwise found to be unsuitable for use.
MANDATORY RECORDS REQUIRED BY ISO 9001-2000 7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. 7.6 7.6 8.2.2 8.2.4 8.3 8.5.2 8.5.3 Validity of previous results when measuring equipments is found not to conform with its requirements Results of calibration and verification of measuring equipment Internal audit results Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product. Nature of the product non conformities and any subsequent action taken including concessions obtained. Results of corrective actions. Results of Preventive actions.
AUDITING
Definition:
Quality auditing is systematic, independent and documented process for obtaining audit evidences and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
AUDITING
AUDIT PURPOSE:
To determine whether organization is following
systems or not To check compliance to specified standard To determine effectiveness of quality system To identify & prioritize areas for improvement To check readiness for compliance audit
AUDITING
AUDITING PROCESS STAGES:
Planning Implementation Reporting Follow up
AUDITING
WHAT AUDITOR LOOKS FOR:
Existing Implementation Results
Compliance
Of System
Effectiveness Performance