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TERMINOLOGIES
*Fitness for use Conformance to specification Delighting the customer Towards zero defects Free from defects Degree of excellence Right fist time all the time
Outline
Definition of quality and other related terms Historical development of quality management Functions affecting quality Achieving quality assurance
Historical Development of QM
The development of quality annulment can be defined in four stages: 1) Quality inspection stage (QI)-1920s 2) Quality control stage (QC) - 1950s; 3) Quality assurance stage (QA) - 1970s; 4) Total quality management (QM) stage
QUALITY CLASSIFICATION
Product quality may be classified into two categories; Quality of design Quality of conformance
TERMINOLOGIES
QUALITY POLICY Overall intentions and direction of an organization related to quality as formally expressed by top management QUALITY OBJECTIVES
Something sought, or aimed for, related to quality
Definitions (1)
Audit A systematic and independent examination to determine whether quality activities and related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives
Auditing Standard
IS0 19011 : 2002 Guidelines on Quality and / or Environmental Systems Auditing
Outline
Definition of a quality audit Types of audit Purpose and objectives of internal audits Creating an environment for successful audits Benefits of an effective audit process
Definitions (2)
Quality Audit Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
Types of audit
3 types Process audits Product audits System audits
Process audits
Evaluation of the content and effectiveness of specific processes and work activities To confirm the process parameters and improve capability of the process To ensure the realization of process quality characteristics To ensure improvement of process control during service provision
Product audits
-To identify opportunities for improvement to establish the quality level of units before final inspection and testing -To establish the capability of the inspection function -To determine the usefulness of inspection/tests
Products audits
Investigation of products conformance to specified characteristics -To obtain additional neutral assessment of products level of quality -To obtain additional assurance that specified quality requirements are met
System audits
Evaluation all the elements of the quaity system in order to: Verify usefulness, suitability and effectiveness Verify adequate documentation Verify compliance with requirements Determine weak points
Purpose of audits
Registration / certification audit Verify that the organization's QMS meet the requirements of ISO 9001 : 2000 Internal audit Identify opportunities for improvement Maintain ISO 9001 certification
Outline
Responsibilities for planning and scheduling Drawing of a schedule Selecting auditors Audit cycle
Selecting Auditors
Identify independent auditors Train them to form a pool of auditors Assign them the audit task
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1
2 3 4
Departmental section
Auditors
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
Personnel
Engineering
Modification
5
6 7 8
Sales
Management Review
Management review meeting (at least annually) Management issues the internal audit schedule After audits Management analyses results of the audit
Notification
Timetable allows auditee to: Organize who will attend Make himself available or assign a guide Organize resources (guide, meeting room etc) Timetable should be sent to auditee well in advance
Notification
Checklist preparation
Ensure the following comes out Quality system is understood and implemented Procedures are conformed to Procedures are effective
Remember
Audit preparation and planning Carrying out the audit Reporting audit and follow up 50% 30% 20%
Checklist preparation
Audit questions Use open ended questions which prevent the auditee from answering YES or NO Do not use leading questions Open questions start with How, Who, When, what, Which, Why On your checklist indicate against each question the section of the standard manual or procedure
Personal attributes
God outward impression Ethical Open minded Alert, observant Perceptive Well spoken and reasoning, diplomatic Emotionally stable Calm Self confident Persistent, insistent, through , curious
Outline
Auditor qualifications Phases of an audit The opening meeting Rules for auditors Objectives evidence Ending difficult situations Raising non-conformities Closing meetings
Auditor qualifications
The qualification on an auditor is founded on a solid Education Training Experience
Opening Meeting
Always arrive on time Keep it brief Auditee and others to be present Cover the following - Introductions - Confirm purpose - Confirm Scope and Basic of audit - Confirm timetable (plan)
Audit lozenge
Drawing..
Ask one question a time Wait for answers from the auditee Book and observe the answer, person
Objective Evidence
Collect all the details Exact observation What was seen / heard Where When Who Why / Creteria
Objective Evidence
ESTABLISH RECORD EXTRACT CLARIFY the facts the evidence for compliance for significant
Auditors Meeting
Compilation of findings / observation Recording of non conformities Preparation o summary report Formulation of opinions to be presented at Closing meeting
Raising non-conformities
Any considered deviation to be discussed with auditee Say what clause it is against Ensure it is understood Record the objectives evidence Commit observation to paper Have the auditee / guide sign for it
Correction action to eliminate a detected non-conformity (ISO 9000:2000 cause (3,6,5) Analysis of cause Corrective action: action to eliminate the cause of a detected non conformity or other undesirable situation (ISO 9000:2000 cause 3,6,5)
Outline
Response to non conformity Reviewing responses Objective of the QMS Informed judgment
Reviewing responses!
Documentation and objective evidence for corrections causes and corrective action: Effective corrective action should eliminate the cause; Corrective action should not be confused with preventive action Preventive action to eliminate the cause of a potential nonconformity or other undesirable situation (ISO 9000:2000 cause 3,6,4,)
QMS Objective?
Improvement - Quality improvement (3.2.12)= part of quality management focused on increasing the equality to (NOTE the requirements can be related to any aspect such as effectiveness) Continual improvement (3,2,13) = recruiting quality to increase the quality to . Requirements
Improvement - Further requirements specify the need for continual improvements to the quality management system not just sporadic quality campaigns - The term continual improvement is stated 10 times in the standard (5,8 important) - The term improvement is stated 27 times in the standard
Informed Judgment
Conclusion drawn (positive and negative) findings Number of major nonconformities raised Number of nonconformities raised during audit of documentation Number of nonconformities raised during audit of implementation Number of nonconformities related to the effectiveness of the QMS Number of non conformities raised against the clause of the standard Number of nonconformist raised to each Number of nonconformities raised in each department or area of responsibility
QMS Objectives?
Effectiveness: - Extent to which planned activities are realized and planned results achieved (ISO 9000:2000 defn) . Effectiveness - ISO 9001 specifies requirements for a quality management system that can be used for internal application by organization, or for certification or for contractual purposes. - It locuses on the effectiveness of the quality management system in meeting customer requirements - The term effectiveness of is state 10 times in the standard (5,3 important) - The term effectiveness is stated 16 times in the standard (8,5 important
Informed judgment
QMS Effectiveness Conclusion drawn (positive and Negative) findings - Major / minor conformities - Working to their processes and procedure - Strength and weakness of sections / department - Strength and weaknesses of the quality system QMS effectiveness input: - Any failure, internal and external - Internal audit results - Trends - Corrective and preventive actions
Reporting of Audits
Auditors not responsible for carrying out corrective action but should facilitate timely action by: Issuing audit report immediately (within 24 hrs) Ensuring that CARs are clear with reference to finding and specific objective evidence
Reporting of Audits
Report should cover the following headings Date of audit Scope and purpose of audit Basis of the audit Audit tem Findings - Summary of the non conformities - Observations noted - Opportunities for improvement - Examples of outstanding performance / improvement since last audit Summary Attachment (including copies of CARs) The audit report including any nonconformity report/corrective action notices are issued to the auditee or MR
Outline
Responsibilities for reporting Format for reports Analysis of audits Records and administration follow-up of audits
Reporting of Audits
A standard Proforma for the reporting of audit is usually used Ensure that positive as well as negative findings are summarized
Reporting of Audits
ISO 19011:2002 includes recommendations for report content
Analysis of Audits
MR will analyze audit reports to identify areas of common deficiency within QMS This will initiate changes to the audit schedule A full analysis of audit reports is presented to management review meeting
Following up
Can be done in two ways By the auditors at an agreed time By the MR after collection of all reports
Car no
Date audited
Assigned to