presentation iso 9001 - final for centom

8/3/2019 Presentation ISO 9001 - Final for Centom

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Quality ManagementConsultants ver 1.0 1

A Presentation byQuality Management Consultants,

(An ISO 9001:2000 Certified Organization)

Kolkata

on ISO 9001 : 2008

E-mail ID: [email protected]




ISO 9001 - 2008

HAS ADOPTED PROCESS APPROACH

FOCUS ON

CUSTOMER SATISFACTION

MEASUREMENTS AND MEASUREMENT ANALYSIS - RESOURCE MANAGEMENT

CONTINUAL IMROVEMENT




ISO 9001 - 2008

QMS : REQUIREMENTS

COMPATIBLE WITH

ISO 9004 - 2000

QMS : GUIDANCE

FOR PERFORMANCE IMPROVEMENT




ISO 9001 - 2008 COMPATIBLEWITH OTHER MANAGEMENT

SYSTEM STANDARDS

e.g EMS, OHS, FINANCIAL




5 RS IN ANY ORGANISATION1. REJECTS

2. REWORKS

3. RETURNS

4. RECALLS

5. REGRETS




REJECTS : NOT CONFINED TO PRODUCTS ALONE; A WRONGLYWRITTEN INFORMATION SENT FROM ONE DEPT TO ANOTHER ENDS UPAT SOME STAGE IN A WASTE PAPER BASKET AS A REJECT.

REWORKS : NOT CONFINED TO PRODUCTS ALONE; A LETTER TYPED WRONGLY ENDS

UP AS A REWORK.

RETURNS : NOT CONFINED TO A NON-CONFORMING PRODUCT RETURNED FROM

A CUSTOMER; A CONSIGNMENT ADDRESSED WRONGLY ENDS UP AS A RETURN.

RECALLS : NOT CONFINED TO A WRONG PRODUCT SENT TO A CUSTOMERAND RECALLED ON REALIZATION OF THE ERROR; A PERSON POSTED

WRONGLY IN THE ORGANISATION SETUP ENDS UP AS A RECALL.

REGRETS : NOT CONFINED TO A REGRET LETTER SENT TO ACUSTOMER FOR A DELAY IN DELIVERY OF THE PRODUCT; IT INCLUDESMANY REGRETS EXCHANGED BETWEEN PEOPLE WITHIN THE ORGNWHO END UP DOING THINGS WONG EVERY MINUTE, EACH TIME.




PLAN DO

ACT CHECK

STANDARDISE DO

CHECKACT




THE STANDARD IS STRUCTURED INTO 5 SECTIONS

4. QUALITY MANAGEMENT SYSTEM

5. MANAGEMENT RESPONSIBILITY

6. RESOURCE MANAGEMENT

7. PRODUCT REALIZATION

8. MEASUREMENT, ANALYSIS ANDIMPROVEMENT




The eight Quality Management principles :

Customer focus :

Organizations depend on their customers( Internal & External ) and

therefore should understand current and future customer needs, should

meet customer requirements and

strive to exceed customer expectations.




Leadership :

Leaders establish unity of purpose, direction, and theinternal environment of the

organization. They create theenvironment in which people canbecome fully involved in

achieving the organization’sobjectives.




Involvement of people :

People at all levels are the essenceof an organization and their fullinvolvement enables their abilities

to be used for the organization’sbenefit,



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Process approach:

A desired result is achieved more

efficiently when related resourcesand activities are managed as aprocess.

Power Control, Distribution Control, Fuel Coordination

Input Activities Output



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System approach:

A desired result is achieved more

efficiently when related resources andactivities are managed as a process.

Day to day MTD / YTD

Record / Log book Keeping

Keeping Latest position of distributionnetwork

Etc.



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Continual improvement : A permanent

objective of the organization is continualimprovement.Enable the employees to fulfill their commitment to quality by influencing

the programme of continual improvement. Possible actions:

Communication. Education and training. Corrective action task force, corrective actions

groups. Preventive Attitude Error cause removal schemes. Team. Problem solving.

SPC. Recognition of performance. Suggestion programmes. Self inspection programmes. So on




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Factual approach to decisionmaking : Effective decisions arebased on the logical or intuitiveanalysis of data and information.




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Mutually beneficial supplierrelationships:

The ability of the organization andits suppliers to create value isenhanced by mutually beneficialrelationships

USE OF STATISTICAL TECHNIQUES




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USE OF STATISTICAL TECHNIQUES :

PHASE TYPE OF STATISTICAL TECHNIQUES THAT CAN BE USED

CONTRACT REVIEW PROCESS CAPABILITY ANALYSIS; RELIABILITY ANALYSIS

DESIGN INPUT PROCESS CAPABILITY ANALYSIS; RELIABILITY ANALYSIS

STATISTICAL TOLERANCING

DESIGN OUTPUT HYPOTHESIS TESTING; PROCESS CAPABILITY ANALYSIS;

RELIABILITY ANALYSIS; STATISTICAL TOLERANCING

REGRESSION ANALYSIS SIMULATION

DESIGN VERIFICATION HYPOTHESIS TESTING; PROCESS CAPABILITY ANALYSIS;

RELIABILITY ANALYSIS; REGRESSION ANALYSIS; SIMULATION

EVALUATION OF HYPOTHESIS TESTING; PROCESS CAPABILITY ANALYSIS

SUB-CONTRACTORS

PROCESS CONTROL S.P.C. CHARTS; REGRESSION ANALYSIS; D.O.E.; PROCESS

CAPABILITY ANALYSIS

INSPECTION AND TESTING SAMPLING; RELIABILITY ANALYSIS

CALIBRATION MEASUREMENT ANALYSIS; PROCESS CAPABILITY ANALYSIS;

SPC CHARTS HYPOTHESIS TESTING

CORRECTIVE AND D.O.E.; REGRESSION ANALYSIS; SPC CHARTS

PREVENTIVE ACTIONS




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3. TERMS AND

DEFINITIONS TERM “ORGANISATION” REPLACES

TERM “SUPPLIER”

“SUPPLIER” NOW USED TO DENOTE “SUB CONTRACTOR”

“PRODUCT” ALSO MEANS SERVICE




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4. QUALITY

MANAGEMENTSYSTEM

4 1 GENERAL




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IDENTIFICATION OF PROCESSES NEEDED FOR THE

QUALITY MANAGEMENT SYSTEM AND THEIR APPLICATION THROUGHOUT THE ORGANISATION

DETERMINE THE SEQUENCE AND INTERACTION OF THESEPROCESS.

DETERMINE CRITERIA AND METHODS NEEDED FOR OPERATION AND CONTROL AND MONITORING OF THESE

PROCESSES

AVAILABILITY OF RESOURCES AND INFORMATIONS FOR

ABOVE MEASURE, MONITOR AND ANALYSE PROCESSESIMPLEMENT ACTION NECESSARY FOR ACHIEVING

PLANNED RESULTS AND CONTINUAL IMPROVEMENT OFTHESE PROCESS.

4.1 GENERALREQUIREMENTS




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4.2 DOCUMENTATION REQUIREMENTSQUALITY MANAGEMENT SYSTEM DOCUMENTATION ISEXPECTEDTO INCLUDE :

- DOCUMENTED STATEMENTS OF QUALITY POLICY ANDQUALITY OBJECTIVES

- QUALITY MANUAL

- DOCUMENTED PROCEDURES REQUIRED BY THESTANDARD.- DOCUMENTS NEEDED BY THE ORGANISATION TO

ENSURE THE EFFECTIVE PLANNING, OPERATION ANDCONTROL OF ITS PROCESSES.

- RECORDS SPECIFIED BY THE STANDARD.




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4.2 DOCUMENTATION REQUIREMENTS

THE ORGANISATION IS EXPECTED TO ESTABLISH ANDMAINTAIN A QUALITY MANUAL WHICH COVERS :

- THE SCOPE OF THE Q.M. SYSTEM INCLUDINGEXCLUSIONS (SECTION 7) IF ANY

AND THE JUSTIFICATION FOR THE EXCLUSIONS.- DOCUMENTED PROCEDURES ESTABLISHED FOR

THE QUALITY MANAGEMENT SYSTEM OR REFERENCE TOTHEM.

- DESCRIPTION OF THE INTERACTION BETWEEN THE

PROCESSES OF THE QUALITY MANAGEMENT SYSTEM.




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CONTROL OF DOCUMENTS

Requirement on maintenance of master list or equivalentdocument

control procedure identifying the current revisionstatus of documents

shall be established and made readily available tobe deleted. But this is covered through ensuring that

relevant versions of applicable documents are available atpoints of use.

- It should be ensured that documents remain legible,are readily identifiable, readily retrievable.

- Documents of external origin are to be given anidentification and their distribution needs to be

controlled.




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CONTROL OF RECORDS

Contractual requirements on makingavailable the records to the

customer or his representative as

given in the older version seem to be missing. But these are expected

to be taken care of under

“Determination of the requirementsrelated to the product” (7.2.1)




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5. MANAGEMENT

RESPONSIBILITY




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5.1. MANAGEMENT COMMITMENT

Top management has to demonstrate its commitment to

the Development and Implementation of the qualitymanagement system and continual improvement of itseffectiveness by.

A. Communicating to the Organisation the importance of meeting customer and legal regulatory requirements

B. Establishing the quality policy and quality objective

C. Performing management reviews.D. Ensuring availability of resources.



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5.2. CUSTOMER FOCUS

Top Management to ensure that customer’s requirementsare determined and fulfilled with the aim of enhancingcustomer satisfaction.

Customer – a person or organization who receive aproduct.

5.3. QUALITY POLICY

The Policy should include

=> Commitment to meeting requirements and continual

improvement of the Quality Management System.

=> Should be reviewed for continuing suitability.

Other requirements are as per the older version of theStandard.



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QUALITY POLICY

Centom Constructions is a fast growing Company in

the field of extra high voltage electrical contractingis committed to :

Ensuring effective & efficient structure to satisfy itscustomers needs & expectations with respect toquality & safety.

Continually improve the processes, productivity & reducing negative impact on environment.

Maintaining high level of employee moral throughtraining & involvement.

Establishing measurable objectives & performanceindicator at relevant functions and levels.

Ensuring that various processes are monitored andreviewed for continuing suitability.



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5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

• Quality Objectives are needed to beestablished at relevant functions shall include

those needed to meet product requirements

• Quality objectives are expected to bemeasurable, be consistent with the Quality Policy

and commitment to continual improvement.




Quality Objectives and Targets

Sl.

No.Quality Objectives Department

Target

2009 - 2010

Target

2010 - 2011

Frequency of

Measurement

1. Business volume.Project 12 Core

+ 10% wrt2009 -10

Quarterly

2. Securing order forprojects Marketing 6 Nos. 3 (New) Quarterly

3. Response to queries /complaints.

Marketing /site office

24 workinghours

24 workinghours

Quarterly

4. Compliance toCustomer’s Schedule.

Site office80% of

agreed time85% Quarterly

5. Logging of CustomerComplaints.

Do 100% 100% Quarterly

6. Accident Do 00 00 Quarterly



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5.4.2 QMS Planning

TOP MANAGEMENT IS EXPECTED TOENSURE :

Planning of QMS to meet requirements of products as well as Q Objectives.

Integrity of QMS to be maintained whilePlanning and implementing changes to

QMS.



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5.5.3 INTERNAL COMMUNICATION

The Top Management of the Organization isexpected to ensure that there is appropriatecommunication between the various levels and

functions regarding the effectiveness of theQ.M.S.



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5.6 Management Review

5.6.1 GeneralTo be conducted by TOP Management.

Assessment of Opportunities for

improvement Need for changes to QMS, Q policy,

Q objectives To be included

Input Out Put requirements are madeexplicit.



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5.6.2 REVIEW INPUT

REVIEW INPUTS TO INCLUDE :

Audit Findings

Customer feedback

Process performance, product conformance.

Status of corrective preventive actions.

Follow up actions from earlier managementreviews.

Planned changes affecting the Q.M.SRecommendations for improvement.



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5.6.3 REVIEW OUTPUT

REVIEW OUTPUTS ARE EXPECTED TOBE ACTION ORIENTED AND INCLUDE

Improvement of effectiveness of the Q.M.S and its

processesImprovement of Product

Resource needs

Other requirements are as per the older versionof the Standard.



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6 RESOURCE

MANAGEMENT



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6.1. PROVISION OF RESOURCES

The organization is expected to identify and

provide resources needed to implement, maintainand continually improve effectiveness of theQ.M.S and to enhance customer satisfaction bymeeting customer requirements.

6.2. HUMAN RESOURCES6.2.1 General

Personnel performing work affecting conformityto product requirement are competent on the

basis of appropriate education, skill, training andexperience. Centom Construction providecontinual O.J.T for development of employees.



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6.2.2 COMPETENCY, AWARENESS AND TRAINING

The Organization is expected to

=> Identify Competency needs for persons carryingout activities affecting product quality.

=> Provide training or other actions to satisfy theseneeds.

=> Evaluate the effectiveness of action taken

=> Ensure that the personnel are aware of the

relevance and importance of their activities , and

how they contribute towards achieving the qualityobjectives.

=> Maintain records of education, training skills andexperience.



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6.3 INFRASTRUCTURE The Organization is expected to identify, provide,maintain facilities needed to achieve the conformityof product requirement.=> Buildings,workspace and associated utilities.=> Process equipment, both hardware and software.

=> Supporting services (such as transportation &

communication / or information system).

6.4 WORK ENVIRONMENT

The organization is expected to define and managethe work environment needed to achieve conformityto product requirements.



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7 PRODUCT

REALISATION



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7.1 PLANNING OF PRODUCT REALIZATION

The organization to plan and develop product realization

processes, consistent with other processes of QMS.Following to be defined:-

Q-objectives and Product requirements

Need to establish Processes,documents; provide

resource specific to product

Verification, validation,monitoring, inspection test

and test activities, acceptance criteria for the product.

Quality records needed

Out put of planning to be in suitable form



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7.2 CUSTOMER-RELATED PROCESSES

7.2.1 Determination of requirements related to the

product

The organization is expected to identify customer

requirements covering

a. Product requirements specified by the customer,

including the requirements for post delivery activities.b. Requirements not specified by the customer but

necessary for specified or known and intended use.

c. Regulatory and legal requirements on the product

d. Additional requirements defined by the organization.

7 2 2 Review of Requirements related to the



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7.2.2 Review of Requirements related to theProduct

Prior to a commitment to supply the product to

the customer(offers, order acceptance) theorganization is expected to ensure that

a. Product requirements are defined.

b. Contract requirements differing from those

previously expressed are resolved.c. Organization has the ability to meet therequirements

* Results and action arising out of review arerecorded

* Where customer provides no written downrequirements

customer requirements are confirmed beforeacceptance.

* When product requirements are changed, amend



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7.2.3 Customer Communication

The Organization is expected to define

and implement

arrangements for customer

communication w.r.t.

a. Product information.

b. Enquiry, order handling including

amendments.

c. Customer feedback, complaints.



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7.3 DESIGN AND DEVELOPMENT

7.3.1 Design and Development Planning

D.D.P is expected to includea. Stages of the design development process

b. Required review, verification, validationactivities.

c. Responsibilities and authorities for variousactivities.

Manage interfaces between different involvedgroups.

The plan is expected to be reviewed and updatedas the design development progresses.

7 3 2 Design and Development Inputs



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7.3.2 Design and Development Inputs.

The inputs are expected to include -

a. Functional , performance requirements

b. Regulatory legal requirements.c. Information from previous similar design.

7.3.3 Design and Development Outputs

Apart from all the requirements laid down inthe older

version of the Standard.

Additional requirement reads as :-

=> The Design development output is expected toprovide

information for purchasing, production andservice

provision.

7 3 4 Design and Development Review



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7.3.4 Design and Development Review

Ability of design results to fulfill the requirements added as anobjective of the review.

Review is also aimed at identifying any problems and proposesuitable actions against the problems.

7.3.5 Design and Development Verification

Design and development work in progress and final stage have to be verified by alternative method / second person /

procedure. 7.3.6 Design and Development validation

Where practicable validation to be completed prior to thedelivery or implementation of the product.

Records of validation to be maintained.

7 3 7 C t l f D i d D l t



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7.3.7 Control of Design and DevelopmentChanges

The organization is expected to evaluate theeffect of

the changes on components, parts and already

delivered products. These changes areexpected

to be verified, validated and approved beforeimplementation.

Records of the review of changes and anynecessary actions are to be maintained.



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7.4 PURCHASING Criteria for selection, evaluation and re-evaluation

of suppliers’ need to be established. Records of the results of evaluation and any necessary actions arising from the evaluation need to be maintained.

Verification arrangements and method of product release to be made a part of purchasing data extended to verification of the product by

customer of the organisation at the suppliers’ premises.

7 5 PRODUCTION AND SERVICE



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7.5 PRODUCTION AND SERVICEPROVISION

7.5.1 Control of production and service provision The organization is expected to plan and carry outproduction and service operations under controlledconditions.

=> Availability of information that describes the

characteristics of the product.

=> Availability of work instructions.

=> Use of suitable equipment.

=> Availability of and usage of suitable monitoring

and measuring devices .



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7.5.1 Control of production and serviceprovision (contd..)

=> Implementation of suitable monitoring

measurement

=> Implementation of release, delivery and

post delivery activities

7 5 2 V lid ti f P f



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7.5.2 Validation of Processes forproduction and service provision

Where results of processes cannot be verified

by subsequent monitoring or measurement,processes to be validated to demonstrateability to achieve planned results.

Establishing of arrangements include:

Define criteria for review and approval

Approval of equipment and personnelqualification

Use of specific methods and procedures Requirements for records

Revalidation



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7.5.3 Identification and Traceability

1. Product identification from receiving end

upto the use including process.2. Traceability

7.5.4 Customer Property=> Customer supplied product is termed as

customer property

=> Scope to include intellectual property - information provided in confidence .



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7.5.5 Preservation of Product

=> The organization is expected to preserve theproduct and or service during internal processingand final delivery to intended destination.

=> This control is expected to include

identification,handling, packaging, storage andprotection.

=> All these controls are to be applied to parts,components of a product and elements of aservice.



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7.6 Control of Monitoring and MeasuringEquipment

=> Calibration of instruments, traceability of measurement and confidence on measured data.

=> The scope has been made explicit by including

monitoring devices also.



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8. MEASUREMENT,ANALYSIS

AND IMPROVEMENT



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8.1 PLANNING

The organization is expected to plan andimplement a system for monitoring,measuring and analysing of various activitiesto assure conformance of products /QMS. It

is also expected of define and implement asystem to achieve continual improvement of effectiveness of QMS. To do this theorganization is expected to define and useapplicable methods including statisticaltechniques.

8 2 MONITORING AND MEASUREMENT



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8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

The organization is expected to monitor information

on customer perception of fulfillment of

requirements.

Methods for obtaining and using this information tobe defined.



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8.2.2. INTERNAL AUDIT

• Results of previous audits to be considered while planning

audit schedule.• The audit criteria, scope, frequency and methods to be

defined.

• Selection of auditors and conduct of audits expected to

ensure objectivity and impartiality of the audit process.

the audit process.

• Responsibilities and requirements for planning and

conducting audits and for reporting results and maintaining

records to be defined.

• Words “without undue delay” replaces “timely” forelimination the non-conformities and their causes.

Other requirements are as per the earlier version of the

Standard.



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8.2.3 MONITORING AND MEASUREMENT OF

PROCESSES

The organization is expected to evolve andimplement a system for measuring andmonitoring the processes. The system should

be such that through the system theorganization should be able to confirm thecontinuing ability of each process to satisfy itsintended purpose. Correction and corrective

action to be taken.

8.2.4 MEASUREMENT AND MONITORING OF



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PRODUCT

=> The large clause 4.10 of the earlier version of thestandard is replaced by this short compact clause.

=> The organization is expected to measure and monitorthe characteristics of the product to verify that requirementsof the product are met. This should be carried out atappropriate stages of the product realization process.

=> Evidence of conformance with the acceptance criteriaused should be recorded.

=> Records to indicate the authority responsible forrelease of product.

=> Product release and service delivery are not to be

executed until all planned activities have been satisfactorilycompleted. Unless otherwise approved by relevantauthority and where applicable by the customer.



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8.3 CONTROL OF NONCONFIRMIINGPRODUCT

=> When non conforming product and or serviceis detected after delivery, or use has started, theorganisation is expected to take actions

appropriate to the consequences of the N.C.

=> No non-conforming product should go to theprocess or customer.

=> Identification of non-conforming product / service.



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8.4 ANALYSIS OF DATA

The organization is expected to collect and analyze

the data to evaluate the suitability and effectivenessof the Q.M.S. This activity should also identify scopefor improvement. Data generated from within andother relevant sources.

The data could be analyzed to get information on=> Customer satisfaction

=> Conformity to product requirements

=> Characteristics and trends of processes and

product incl. opportunities for preventive action.=> Suppliers.

8.5 IMPROVEMENT



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8.5 IMPROVEMENT

8.5.1 Planning for Continual

Improvement The organization is expected to have aformal system for continual improvementof the Q.M.S, through the use of Qualitypolicy, Quality Objectives, Audit results,Data

Analysis, Management Reviews,

Corrective and preventive actions.

8.5.2 Corrective Actions



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8.5.2 Corrective Actions Centom Constructions takes action to eliminate thecauses of non-conformities in order to prevent

recurrence. Corrective actions are appropriate to theeffects of non-conformities encountered.

A documented procedure (QSP/8.5.2) is establishedto define requirements for :

Reviewing non-conformities including customer’ complaints.

Determining the cause of non-conformities.

Evaluating the need for action to ensure that non-conformities do not recur.

Determining and implementing actions needed.

Records of results of actions taken.

Reviewing corrective action taken.

8.5.3 Preventive Actions



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8.5.3 Preventive Actions Centom Constructions determine actions to eliminatecause of potential non-conformities in order to

prevent occurrence. Preventive action shall beappropriate to the effect of potential problems. Adocumented procedure (QSP/8.5.3) is established todetermine requirements for,

Determining potential non-conformities and theircauses.

Evaluating the need for action to prevent occurrenceof non-conformities.

Determining and implementing actions needed. Records of results of actions taken.

Reviewing preventive action taken.



Thank You