Industrial Projects, Basic Quality & ISO 9001 Briefing Orientation

JAL International Company LimitedIPD-QAQC/fgcalucin

IPD.M01 IPD.M01 –– Basic Quality and ISO Awareness BriefingBasic Quality and ISO Awareness BriefingFor Industrial Projects Division, Rev.00, 01Feb09For Industrial Projects Division, Rev.00, 01Feb09

Industrial Projects DivisionIndustrial Projects DivisionBasic Quality and ISO 9001Basic Quality and ISO 9001

Orientation BriefingOrientation Briefing

with Frank G. Calucinwith Frank G. Calucin



OBJECTIVESOBJECTIVES::

1.1. Understand Key Concepts of Basic Understand Key Concepts of Basic Quality relative to Industrial Projects Quality relative to Industrial Projects DivisionDivision

2.2. Awareness on ISO 9001:2000 StandardAwareness on ISO 9001:2000 Standard3.3. Understand the Relationship of Understand the Relationship of

Industrial Projects within the Industrial Projects within the OrganizationOrganization

4.4. Awareness on Customer SatisfactionAwareness on Customer Satisfaction











QUESTION:QUESTION:

What is your definition of What is your definition of Quality?Quality?



QUESTIONSQUESTIONS::

1.1. Why is Quality important to an Why is Quality important to an Organization?Organization?

2.2. Why do we have to ensure Why do we have to ensure Quality with our work?Quality with our work?

3.3. Why is Quality important to Why is Quality important to JAL?JAL?



QUALITYQUALITY

ISO 9000: 2000ISO 9000: 2000 defines defines QualityQuality as:as:

•• ““as a degree to which a set of as a degree to which a set of inherentinherentcharacteristics fulfils characteristics fulfils requirementsrequirements..””

•• Quality is about Quality is about satisfactionsatisfaction on the on the needsneeds and and requirementsrequirements of the customerof the customer

Quality is Categorized into Two CategoriesQuality is Categorized into Two Categories::

1.1. Measurable QualityMeasurable Quality2.2. NonNon--Measurable QualityMeasurable Quality



QALITY ASSURANCEQALITY ASSURANCE

ISO 9000: 2000ISO 9000: 2000 defines Quality Assurance as:defines Quality Assurance as:

““part of part of quality managementquality management focused on focused on providing confidenceproviding confidence that quality that quality requirementsrequirementswill be fulfilledwill be fulfilled””

What really is Quality Assurance?What really is Quality Assurance?



QALITY CONTROLQALITY CONTROL

ISO 9000: 2000ISO 9000: 2000 defines defines Quality ControlQuality Control as:as:

““part of part of quality managementquality management focused on focused on fulfillingfulfilling quality quality requirementsrequirements””

What is What is youryour basis of Quality Control?basis of Quality Control?

How will you know that something you How will you know that something you require is acceptable to you?require is acceptable to you?



Three Aspects of Three Aspects of Quality Control at IPDQuality Control at IPD

••Receiving (Incoming) InspectionReceiving (Incoming) Inspection

••Process / WorkProcess / Work--InIn--Process InspectionProcess Inspection

••Final Inspection (PreFinal Inspection (Pre--Commissioning)Commissioning)



ISO 9000 and CustomerISO 9000 and Customer

In simplest term, ISO 9000 In simplest term, ISO 9000 means, satisfying the specific means, satisfying the specific

customercustomer’’s requirements requirement



What is ISO?What is ISO?

“ISO” is not an acronym for International Organization for Standardization, because if it were, it would then be as “IOS”

“ISO” was derived from the Greek word “ISOS”, meaning, “equal”

From the word “equal” to “standard”, the line of thinking that let to the choice of “ISO” as the name of the organization is easy to follow.



Origins of ISO 9000Origins of ISO 9000

The International Organization for Standardization The International Organization for Standardization (ISO), was founded in Geneva, Switzerland in 1947 to (ISO), was founded in Geneva, Switzerland in 1947 to develop a common set of standards in manufacturing, develop a common set of standards in manufacturing, trace and communications.trace and communications.

The ISO 9000 standards represent the common The ISO 9000 standards represent the common denominator of business quality that is accepted denominator of business quality that is accepted Internationally. In 1987 BS 5750 Quality System was Internationally. In 1987 BS 5750 Quality System was adopted by ISO to become the model for Quality adopted by ISO to become the model for Quality Assurance.Assurance.ISO 9000 certification demonstrates the capability of an ISO 9000 certification demonstrates the capability of an organization to control the processes that determine the organization to control the processes that determine the acceptability of the product or service being supplied.acceptability of the product or service being supplied.



CUSTOMERSCUSTOMERS

ISO 9000: 2000 interISO 9000: 2000 inter--relationship of customer relationship of customer with supplier:with supplier:

Customer Customer Organization Organization SupplierSupplier



CustomerCustomer SatisfactionSatisfaction

To provide the needs and To provide the needs and expectations of our customer expectations of our customer based on specified criteria and based on specified criteria and specificationsspecifications



Repeat BusinessRepeat Business

Only EXCELLENT service gets noticed. Remember Only EXCELLENT service gets noticed. Remember that repeat business is the lifethat repeat business is the life--blood of most blood of most businesses. Ask yourself, would you rather have:businesses. Ask yourself, would you rather have:

Customer Customer ““charge to experiencecharge to experience”” due to poor due to poor service and go to your competitor service and go to your competitor

ORORHave customers who comes back to you because of Have customers who comes back to you because of excellent serviceexcellent service



JAL Quality PolicyJAL Quality Policy












Basic Awareness in

ISO 9001:2000 Standard



INPUT

(Order Requirement)

OUTPUT

(Product)

The Business ProcessThe Business Process



ISO 9001: 2000 StandardISO 9001: 2000 Standard

4.0 QUALITY MANAGEMENT SYSTEM4.0 QUALITY MANAGEMENT SYSTEM

4.14.1 General RequirementsGeneral Requirements4.24.2 Documentation RequirementsDocumentation Requirements

4.2.1 4.2.1 GeneralGeneral4.2.2 Quality Manual4.2.2 Quality Manual

4.2.34.2.3 Control of DocumentsControl of Documents4.2.4 Control of Records4.2.4 Control of Records




5.05.0 MANAGEMENT RESPONSIBILITYMANAGEMENT RESPONSIBILITY

5.15.1 Management CommitmentManagement Commitment5.25.2 Customer FocusCustomer Focus5.35.3 Quality PolicyQuality Policy5.45.4 PlanningPlanning5.55.5 Responsibility, Authority andResponsibility, Authority and

CommunicationCommunication5.65.6 Management ReviewManagement Review




6.06.0 RESOURCE MANAGEMENTRESOURCE MANAGEMENT

6.16.1 Provision of ResourcesProvision of Resources6.26.2 Human ResourcesHuman Resources

6.2.16.2.1 GeneralGeneral6.2.26.2.2 Competence, Awareness &Competence, Awareness &

TrainingTraining6.36.3 InfrastructureInfrastructure6.46.4 Work EnvironmentWork Environment




7.07.0 PRODUCT REALIZATIONPRODUCT REALIZATION

77.1.1 Planning of Product RealizationPlanning of Product Realization7.27.2 Customer Related ProcessesCustomer Related Processes7.37.3 Design and DevelopmentDesign and Development7.47.4 PurchasingPurchasing7.57.5 Production and Service ProvisionProduction and Service Provision7.67.6 Control of Monitoring andControl of Monitoring and

Measuring DevicesMeasuring Devices




8.08.0 MEASUREMENT, ANALYSIS & IMPROVEMENTMEASUREMENT, ANALYSIS & IMPROVEMENT

8.18.1 GeneralGeneral8.28.2 Monitoring and MeasurementMonitoring and Measurement8.3 Control of Nonconforming Product 8.3 Control of Nonconforming Product 8.48.4 Analysis of DataAnalysis of Data8.58.5 ImprovementImprovement



Control of DocumentsControl of Documents

20002000 Version: Version: Clause 4.2.3Clause 4.2.3

Written Procedure; Master List of documentsWritten Procedure; Master List of documentsISO Internal documents have ID and REV numbersISO Internal documents have ID and REV numbersISO External documents are controlled, maintained andISO External documents are controlled, maintained andupdatedupdatedDocuments are Issued in a controlled mannerDocuments are Issued in a controlled mannerEvidence of review and approval by authorized personnelEvidence of review and approval by authorized personnelRelevant documents are available where it is neededRelevant documents are available where it is neededDocuments such as FORM should be LEGIBLEDocuments such as FORM should be LEGIBLEObsolete or superseded documents are identifiedObsolete or superseded documents are identifiedChanges to document is identified and traceableChanges to document is identified and traceable



Control of RecordsControl of Records


Written Procedure; Quality Records Matrix ListWritten Procedure; Quality Records Matrix ListProvision of evidence (output) for specific process (input)Provision of evidence (output) for specific process (input)System for filing System for filing –– identification, indexing, accessing, identification, indexing, accessing, storagestorageRetention period Retention period –– not necessarily the same for all recordsnot necessarily the same for all recordsRecords are Records are LEGIBLELEGIBLE –– meaning reviewer can read itmeaning reviewer can read itDisposition Disposition –– what to do with the recordswhat to do with the recordsRecords maybe in the form of electronic media but requiresRecords maybe in the form of electronic media but requiresdocumented procedure defining the control process.documented procedure defining the control process.Use of pencil on quality record is not allowed.Use of pencil on quality record is not allowed.



PRF and POPRF and PO


General purchasing procedure for the preparation of General purchasing procedure for the preparation of purchasingurchasingrrequest equest fform (PRF), its review, canvassing/quotation/sourcingorm (PRF), its review, canvassing/quotation/sourcingout and preparation/approval of out and preparation/approval of ppurchase urchase oorder (PO).rder (PO).

PRF and PO are auditable against the accredited and approvedPRF and PO are auditable against the accredited and approvedsupplier master list.supplier master list.



Control of Service ProvisionControl of Service Provision

20002000 Version: Version: Clause 7.5.1/2Clause 7.5.1/2

Written Procedures, instructions, guidelines, checklists used tWritten Procedures, instructions, guidelines, checklists used toomake/build/produce the product understandable with the make/build/produce the product understandable with the workers.workers.

Methodology includes the use of applicable equipment,Methodology includes the use of applicable equipment,measuring devices, monitoring, inspection, measuring devices, monitoring, inspection, ““good and notgood and notgoodgood”” samples as basis for workmanship criteria, recordingsamples as basis for workmanship criteria, recordingwhat was produced and number of rejectswhat was produced and number of rejects

Workers should have evidence of qualification and record ofWorkers should have evidence of qualification and record ofcontinuous training.continuous training.



Identification & TraceabilityIdentification & Traceability


Written procedure or guideline on the methodologies involvedWritten procedure or guideline on the methodologies involvedin identifying materials, semiin identifying materials, semi--processed product and finishedprocessed product and finishedgoods. Identification also includes in quality records (and goods. Identification also includes in quality records (and shopshopdrawings), IMTE against master list of IMTE, productiondrawings), IMTE against master list of IMTE, productionequipment against PMP, etc.equipment against PMP, etc.

Methodology for identifying the inspection done for Methodology for identifying the inspection done for ALLALLprocesses must be defined in the form of guideline.processes must be defined in the form of guideline.



Customer PropertyCustomer Property


Written procedure or guideline for receiving customer suppliedWritten procedure or guideline for receiving customer suppliedmaterials such as drawings (ematerials such as drawings (e--mail, courier or fax). This shouldmail, courier or fax). This shouldinclude include auditableauditable verification done; what is done when if lost,verification done; what is done when if lost,damaged or unsuitable to use; and communication with thedamaged or unsuitable to use; and communication with thecustomer, reporting if the result of verification unsatisfactcustomer, reporting if the result of verification unsatisfactory.ory.

Record of what was received from the customer is also Record of what was received from the customer is also auditableauditable



Handling, Storage, Preservation, Handling, Storage, Preservation, Packing & DeliveryPacking & Delivery


General written procedures or guidelines for handling,General written procedures or guidelines for handling,storage, preservation, packing and delivery of materials,storage, preservation, packing and delivery of materials,semisemi--process product and final product.process product and final product.

Methodologies include Methodologies include receiving and issuancereceiving and issuance of materials,of materials,semisemi--processed product and finished goods; processed product and finished goods; handlinghandling,,storagestorage and and preservationpreservation of/for materials, semiof/for materials, semi--processedprocessedproduct and finished goods; product and finished goods; packingpacking either for local or longeither for local or longdistance delivery; and distance delivery; and deliverydelivery coordination.coordination.



Control of Monitoring Control of Monitoring and Measuring Devicesand Measuring Devices

20002000 Version: Version: Clause 7.6Clause 7.6

Written Procedure or guideline for monitoring the IMTEWritten Procedure or guideline for monitoring the IMTEused in production and inspection; updating of IMTEused in production and inspection; updating of IMTEmaster list; conducting of internal calibration;master list; conducting of internal calibration;maintenance of calibration records and calibration status;maintenance of calibration records and calibration status;and storage, handling and preservation of IMTE.and storage, handling and preservation of IMTE.

Written procedure or guideline on what to do if andWritten procedure or guideline on what to do if andwhen the IMTE used has expired calibration.when the IMTE used has expired calibration.

Written procedure or guideline for checking the softwareWritten procedure or guideline for checking the software



Customer SatisfactionCustomer Satisfaction


What is required here is to provide methodology forWhat is required here is to provide methodology forobtaining and determining the satisfaction level based onobtaining and determining the satisfaction level based onwhat was delivered against the requirement of thewhat was delivered against the requirement of thecustomercustomer

Evidence of customer satisfaction is Evidence of customer satisfaction is auditableauditable..



Internal Quality AuditInternal Quality Audit


Documented procedure stating the frequency of auditingDocumented procedure stating the frequency of auditingconsidering the importance of area being audited; auditconsidering the importance of area being audited; auditplanning; auditing process; recording the result of theplanning; auditing process; recording the result of theaudit; audit criteria, scope and methodology of auditingaudit; audit criteria, scope and methodology of auditingshall also be defined.shall also be defined.Methodology for issuing minor, major nonconformity,Methodology for issuing minor, major nonconformity,including including ““observationobservation”” shall be defined.shall be defined.Selection and independence of AuditorsSelection and independence of AuditorsAuditee not to prolong the corrective action is mandatoryAuditee not to prolong the corrective action is mandatoryVerification of CA/PA to end the cycle is auditable.Verification of CA/PA to end the cycle is auditable.



Monitoring and Measurement of Monitoring and Measurement of Processes/Services ProvidedProcesses/Services Provided

20002000 Version: Version: Clause 8.2.3/4Clause 8.2.3/4

Written procedures or guideline for conducting receiving, inWritten procedures or guideline for conducting receiving, in--process and final inspections for all processes requiring thiprocess and final inspections for all processes requiring thissactivity.activity.The The ““outputoutput”” or or ““inspection recordsinspection records”” like receiving inspectionlike receiving inspectionreports, inreports, in--process and final inspection reports in all stages ofprocess and final inspection reports in all stages ofproduction are all production are all auditableauditable..Evidence that all required inspections stated in the Evidence that all required inspections stated in the Quality PlanQuality Planis is auditableauditable..These records shall indicate who authorized the release.These records shall indicate who authorized the release.



Control of Nonconforming ProductControl of Nonconforming Product


Written procedure stating the methodology for Written procedure stating the methodology for ““controllingcontrolling”” thetheuse of use of ““nonconformingnonconforming”” raw/consumable materials, workraw/consumable materials, work--inin--process and completed work provided.process and completed work provided.The methodology shall state the responsible person forThe methodology shall state the responsible person forcontrolling the nonconforming itemscontrolling the nonconforming itemsIf the nonconformity item requires reIf the nonconformity item requires re--work, this shall bework, this shall bereported to the customer, if required by the contract, and shreported to the customer, if required by the contract, and shall all be rebe re--inspected. All inspected. All ““outputsoutputs”” are auditableare auditableThis procedure is interfaced with This procedure is interfaced with ““Corrective and PreventiveCorrective and PreventiveAction ProcedureAction Procedure”” and and ““Effective Handling of CustomerEffective Handling of CustomerComplaintComplaint””



Analysis of DataAnalysis of Data


Methodology for determining, collecting (gathering) andMethodology for determining, collecting (gathering) andanalyzinganalyzing the data relating to 1) customer satisfaction 2)the data relating to 1) customer satisfaction 2)inspection reports 3) corrective and preventive actioninspection reports 3) corrective and preventive actionrequests 4) trend analysis made based on the statistical datarequests 4) trend analysis made based on the statistical dataand 5) evaluation of suppliers shall be defined orand 5) evaluation of suppliers shall be defined orincorporated in other related procedures.incorporated in other related procedures.This activity is prelude to management review andThis activity is prelude to management review andauditableauditable



Continual ImprovementContinual Improvement


The process is incorporated in the management reviewThe process is incorporated in the management reviewprocedure.procedure.

To determine whether the organization is continuallyTo determine whether the organization is continuallyimproving its established QMS, the following shall beimproving its established QMS, the following shall beconsidered: quality policy; monitoring result of qualityconsidered: quality policy; monitoring result of qualityobjectives; result of data analysis; IQA result; CPAR objectives; result of data analysis; IQA result; CPAR resultresultand actions taken based on the result of MR. and actions taken based on the result of MR.



Corrective and Preventive ActionCorrective and Preventive Action


Documented procedure specifying the investigation, rootDocumented procedure specifying the investigation, rootcause analysis, proposing and providing the requiredcause analysis, proposing and providing the requiredcorrective action to prevent corrective action to prevent recurrencerecurrence of of existing deficiencyexisting deficiency; ; and preventive action to prevent and preventive action to prevent occurrenceoccurrence of of potential potential deficiencydeficiency

Corrective and Preventive Action Request, its monitoring,Corrective and Preventive Action Request, its monitoring,verification and verification and ““closingclosing”” are all are all auditableauditable