Quality Assurance Management 2012

8/2/2019 Quality Assurance Management 2012

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Main Services:

Training and consultancy

Development and implementation ofmanagement systems ISO 9000; ISO14 000; ISO 22 000; OHSAS 18000;HACCP

Contact details:

NIVEN SEENEEVASSEN

722, la Marie road, Vacoas

Tel: 684 0842

Fax: 684 6957

Email: [email protected]

Website: www.sclmanagement.net
mailto:[email protected]:[email protected]:[email protected]:[email protected]


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AIM OF THE COURSE


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Course materials Modules

Interactive

Dispensed in working language

Duration: hrs


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On completion of this course, you will beable to: Understand the requirements of Quality Assurance

for SMEs

Acquire practical knowledge and skills to establish,implement and maintain a QMS

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Course Materials

7 Modules

Interactive

(Discussions/questioning/exercises/present

ation/assignments)

Workshops and Exercises

Dispensed in working language to ensure

100% employees understanding at all levels

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Mod 1 - Evolution of QMS

Mod 2 - QMS model

Mod 3 - Quality Management System

Mod 4 Management Responsibility

Mod 5 - Resource Management

Mod 6 - Product RealisationMod 7 - Measurement, Analysis, Improvement

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Evolution of Quality Management

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FirstExample of

Quality

3000

BC


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NEEDS of the customer EXPECTATION of the Customer

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NATO North American TreatyOrganisation

AQAP Allied Quality Assurance Publication

Quality Control / Quality Assurance

Prevention v/s Detection

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Quality Management System Model

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PlanWhat to do?How to do it?

DoDo what wasplanned

Check Did things happenaccording to plan?

ActHow to improvenext time?


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Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplier relationships

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Satisfaction Dissatisfaction

Considerable feedback and referral

Some feedback

Where are we now?

Delight Anger

Customer Indifference

Most of the time we do not know what they

think and this is dangerous

No feedback

Customer Satisfaction is not the opposite of dissatisfaction,

they are ends of a spectrum. You cannot measure one by the

presence or absence of other except in fairly extreme cases.


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Global High Performers- Quality LeadershipA passion for Quality- Work from first principles- study state of the

art approaches but make up own minds-pace setter in quality thinking

Make their own way to the top. Unlikely to be taken by surprise

Examples- Toyota, Komatsu, Minolta, Hewlett Packard, Motorola,

Short Bros. CMB, VSEL, Wedgwood, Kodak, GE, Hydropolymer,

Allied Signal, ABB, Xerox etcGood but nothing special-not leaders but good

Me too approach to quality- cautious, rather follow than to lead.

Can be better than average depending on effort. Do not have a

winning mentality. Survival likely but not guaranteed. Vulnerable

to aggressive moves by High Performers. Easily discouraged if no

case examples of other organisations in field.The rest-how can you tell?

May have ISO 9000:1994 but only because forced to. Probably

get all of the cost of ISO 9000 but very little of the benefit-

hanging on in there! No time for quality improvement because

too busy fire fighting- Survival at the mercy of others.


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Typical Organisation Global High Performer

Management by

functionLow

performance

process output

Management by

processHigh

performanceprocess output

How to get from here---------------to here?

P3: Involvement of People


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Triple Role

Quality Responsibilities

As a Supplier

Know whom are

users

Understand needs

of users

Avoid creating

problems for

users

Obtain feedback

from users

As a Processor As a Customer

Plan Process to meet

user needs

Control Process to

meet user needs

Improve process

based on user

feedback

Transmit needs to

suppliers

Provide feedback

to suppliers

Obtain feedback

from suppliers


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Identifying in processChronic Problems

The internal Customer Supplier processchain

Process Process ProcessInput Input Input

Output Output

In Process KPIs

Output KPIs


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Jurans Message

Form a Quality Council

Steer programme (2)

Tackle-top level projects (6)

Learn about improvement

Take project by project

process downwards

through the organisation

P5: System Approach to Management


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3. Examine existing method (Process Analysis) identify in process KPIs

4. Cause analysis-critical examination

5. Develop improved methods

6. Install improved methods

7. Maintain improved methods and monitor results- select new problem!

Seven Steps to Solving

Chronic Problems

1. Select Chronic problem.

2. Record existing method (Map the Process)

Output KPI


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Transforming Data into Information:

DATA INFORMATION

Effective decision are based on analysis of data andinformation

InformationLife blood of an organisation


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Supplier

Processor

Customer

CustomerSupplier

Triple role supply chain management


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Continual improvement ofthe quality management system

Customer(and otherinterestedparties)

Requirements

Customer(and other

interestedparties)

Satisfaction

Managementresponsibility

Resource

management

Productrealisation

Measurement,analysis andimprovement

OutputProduct

Key

Value adding activities

Information flow

Input


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Scope Normative Reference Terms and Definitions

Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement

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Commitment and involvement Stated objectives

Project planning

Set Steering Committee

Nominate:Quality Management Representative (QMR)Quality Coordinators (QCs)Workgroups

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QMS training development course

Internal Auditing course

Lead assessor courseCustomer Service

Problem solving course

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Policies & PrinciplesQuality Objectives

Quality Manual

Procedures & Work Instructions ManualForms and Records

Internal Quality Audit

Management Review/Ready for certification

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Quality Management System

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Identify processes

Sequence and interactions

Criteria and methods (effectiveness) Availability of resources and information

Monitor, measure and analyse processes

Implement actions to achieve planned results Control outsourced processes

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Quality PolicyQuality Objectives

Quality Manuals

ProceduresWork instructions/Checklist

Records

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Documented statements of a quality policy and

objectives

Scope of QMS Justify permissible exclusions (if any)

Establish documented procedures or their

references Interactions between processes


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Documented procedures required bystandards

Approval prior to issue

Review / update and re-approval

Identify current revision/ issue status

Current versions available at point of use

Legible and readily identifiable

Identification and control of externaldocument

Identification of obsolete documents toprevent unintended use

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Documented procedure required Remain legible Readily identifiable and retrievable

Documented procedure to define: Identification Storage Protection Retrieval Retention time Disposition

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Management Responsibility

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Communicate importance of meetingcustomer / regulatory / legal requirements

Establish quality policy and quality objectives

Conduct management reviews

Ensure availability of resources

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Top Management shall ensure that customer

needs and expectations are: Determined

Converted into requirements And fulfilled

With the aim of enhancingcustomer satisfaction

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Appropriate to the purpose of organisation

Meet requirements of QMS

Continually improve effectiveness of QMS

Framework to establish and review Quality

Objectives

Communicated and understood at all levels

Reviewed for continuing suitability


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Quality Objectives Established at relevant functions and levels Measurable and consistent with quality policy

QMS planning Resource requirements Documented Reviewed and identify changes

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Responsibility and authority Organisation chart

Management representative Develop and implement system Report to top management Promote awareness of customer requirements

Internal communication

Various levels

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Review input Quality policy and objectives

Results of audits / customer feedbacks

Process performance / product conformance

Corrective and preventive actions status / changes/ follow ups

Review output Improvement of product/services, processes

Resource needs

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Objective 1: Reduce customer complaints by 50%

Prepare an action plan for the above for yourdepartment..

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Resource Management

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Determine and provide needed resources in atimely manner

Aim is to:

Implement, maintain and improve the effectivenessof the QMS

Address and enhance customer satisfaction

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Assignment of personnel

Competent on the basis of :

applicable education

training

skills and

experience


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Determine competency

Provide and evaluate training effectiveness

Ensure employees are aware of relevance andimportance of their contribution to achieve

quality objectives

Records as evidence


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Determine, provide and maintain the facilities

to include:

Workspace and associated facilities Equipment, hardware and software

Supporting services

E.g. transport, communication facilities

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Identify and manage the human andphysical factors

How good is the work environment toachieve conformity to product and /orservices ?(Health and Safety)

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According to you what factors in your work

environment can affect conformity to product

requirement ?

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Product Realisation

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The organisation shall :

Determine Quality objectives & requirementsfor : product, project, contract

Establish processes, documents & resources

specific to product under study Identify verification, validation, monitoring,

inspection and test activities (set criteria forproduct acceptability)

Records evidencing conformity of processesand resulting product

Maintain a Quality Plan : documentation


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Determine requirements related to Product

Requirements specified by the customer

Unspecified but necessary for specified or intendeduse

Statutory or regulatory requirements

Customer communicationProduct informationContracts/ order handling (+ amendments)

Customer feedback mechanism, inclusive ofcomplaints

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Review of requirements related to product

Defined product requirements

Non-documented statements confirmed beforeacceptance

Ability to meet defined requirements

Records of review, follow-up & changes

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Planning- Review, verify and validate activities

- Manage interfaces b/w different groups

- Update planning outputs

Inputs- Information from similar designs

- Records

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Outputs- Meet input requirements

- Provide information for purchasing, production/service

-provision

- Contain or reference product acceptance criteria

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ReviewReview with planned arrangements & evaluate

ability of results to meet requirements

Identify problems & propose necessary

corrective actions Maintain records of results

Verification

Ensure outputs meet input requirements

Maintain records of results of verification &actions taken

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Validation Resulting product meet requirements for

specified application or intended use

Completed prior to delivery or implementation of

product Maintain records of results and actions taken

Control of changes

Identify changes

Review, verify and validate changes

Approve before implementation

Maintain records & actions taken

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Purchasing Process Purchased product conforms to specificrequirements Establish criteria to select, evaluate & re-evaluatesuppliers

Maintain records of evaluation & actions taken

Purchasing Information Describes product to be purchased

Ensure adequate specified purchase

requirements

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Verification of purchased productPurchased product meets specified

purchased requirements

Establish & Implement inspection or other

activities

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Control of production & service provision Planning

Define processes for release, delivery &applicable post-delivery activities

Information describing products

Availability of work instructions

Validation of processes

Demonstrate ability to achieve planned results

Define criteria for review and approval ofprocesses/ equipment

Maintain records

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Identification & Traceability Identify product status

Control & record unique identification of product

Customer Property

Identify, verify, protect

Maintain records

Preservation

Preserve conformity during internal processing &

delivery Includes identification, handling, packaging,

storage, production

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Control of Monitoring & Measuring Devices Identify equipment to determine calibration

status

Calibrate/verify at measured intervals

Maintain records

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Measurement, Analysis and Improvement

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7.1 General Planning7.2 Monitoring and Measurement7.3 Customer Satisfaction

7.4 Internal Audit7.5 Monitoring and Measurement of Processes7.6 Monitoring and Measurement of Product7.7 Control of Non-conforming Product

7.8 Analysis of Data7.9 Improvement7.10 Preventive & Corrective Actions

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Plan and implement measurement, analysisand improvement processes to:

Demonstrate conformity of product / service

Ensure conformity of QMS

Continually improve effectiveness of QMS

Determine appropriate methods, e.g. statisticaltechniques

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Customer Satisfaction

Internal Audit

Monitoring and Measurement of Processes

Monitoring and Measurement of Product

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Monitor information on customer perception(satisfaction/dissatisfaction)

Determine methodologies for obtaining and using

information

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Training of auditors

Conduct periodic internal audits todetermine: Conformance to requirements of

International Standards and the organisation

Effective implementation and maintenance ofsystem

Plan audit programme to be conducted byindependent personnel

Record results and report to TopManagement Take timely corrective actions & monitor

follow-up

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Apply suitable methods for measuring andmonitoring processes

Take corrections and corrective actions toensure conformity of product

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Carry out measurement and monitoring atappropriate stages to: Evidence of conformity against

acceptance criteria

Indicate authority responsible for releaseof product

Authorise the release of product anddelivery of service when planned

arrangements have been completed

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Procedure documented to include:

Identification and control of non-conformities

Responsibilities and authorities

Correction of non-conformities

Re-verification to demonstrateconformity to requirements

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Collect and analyse appropriate data todetermine suitability, effectiveness andimprovement of QMS, to include: Customer satisfaction

Conformity to product requirements

Characteristics and trends of processes &

products

Suppliers

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Continually improve QMS through:

Quality policy

Quality objectives

Audit results Analysis of data

Corrective and preventive actions

Management reviews

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Establish documented procedures to include: Review non-conformities and determine

causes

Evaluating need for actions

Determine and implement actions

Record results of actions

Review corrective actions

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Quality Assurance Management 2012

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