Presentation on theme: "Effectively applying ISO9001:2000 clauses 6 and 7."— Presentation transcript:
1Effectively applying ISO9001:2000 clauses 6 and 7. Version K.10.1-UK Oct 03The High Performance Organisation LtdISO9001:2000 Clause 6 and 7 workshop
2Outline of the day Process management for context Clauses that support process managementExamples of applicationClauses that can be processesExamples of processes
3What is a process management? Session oneWhat is a process management?Learning points:To understand what is meant by the term management systemTo be able to put process management in context
4System management Customer satisfaction Products & Economic Services EnvironmentalInputsOutcomes / resultsLawRegulationsSocietyChangeLearn‘system is a collection of processesthat delivers results’
5A typical system? Supporting ? ‘the system is the business’ UnderstandingthemarketBringing aboutchangeBusinessplanningMonitor &measureperformanceDesign/ enhanceservicesManagingaftersalesDeliverservicesWinningbusinessManagingpeopleManagingassetsManagingfinanceSupporting ?‘the system is the business’
6Process management Competence Budget Asset use H&S Culture Process as aseries of activitiesMeasure outcomes/ results againsttargetsInputsTeamworkMethodsEnvironmentInformationsharingLearn & improve toEnhance performance
7Continual improvement of the management system ISO 9001:2000 process modelContinual improvement of the management systemManagementresponsibilityCustomerCustomerResourcemanagementMeasurement,analysis andimprovementSatisfactionRequirementsinputoutputProductrealisationProduct
8Management system structure Clauses are seen at system level‘the what’A processA processWith detailed requirementsat process level andA procedureProcedures where required‘the how’TrainingGuidePhotograph
9The big picture ‘setting off in the right direction is critical’ Systems & processthinkingManagement systems developmentCorporate Social Responsibility / Corporate GovernanceBased onISO 9001:2000Management skills developmentLearning and change‘setting off in the right direction is critical’
10Clauses that support process management Session twoClauses that support process managementLearning points:To understand the requirements of clauses6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environmentTo identify processes activities that meet each clause requirements.To understand how the sub-clauses link together.
11Resources support core process activity 6.2 Human Resources6.3 Infrastructure6.4 Work Environment‘along with other resources!!’
12Provision of resources (6.1) Requirements: Provide the resources required to implement, maintain andcontinually improve the effectiveness of the management system, toenhance customer satisfaction.The organisation must provide the resources for:A management representative, to coordinateTraining, for people in understanding process managementTime, for people to be involved in developing & maintainingthe management system
13Human resources (6.2) Identify the competencies required for each role Requirements: Determine what competences are required by individualsin order to perform their assigned duties and provide training in order toachieve the competences required.Identify the competencies required for each roleConsider using job descriptions to include these competenciesDetermine the current competencies of staffConsider a formal appraisal process / competency matrixClose competency ‘gap’ with trainingCheck training has been effectiveKeep records of training
14Example process Refer to laminate of an example ‘Managing & Developing Our People’process shows how an organisation can complywith clause 6.2 human resources.
15Infrastructure (6.3)Requirements: Determine, provide and maintain the infrastructure requiredto meet product / customer requirements.Buildings and workspace must be suitable for the product being made or the service being providedEquipment (hardware & software) used in processes must be capable of doing what is being asked of itSupport services (such as transport) are appropriate
16Work environment (6.4)Requirements: Determine and manage the work environment requiredto meet product / customer requirements.Being aware of & complying with health & safety lawProviding adequate lighting, protective clothing, atmospheric conditions, etc., etc., etc.
17Exercise 1 For your organisation map either: A managing people process covering clause 6.2OrA managing physical assets process clause 6.3Showwhere the main elements of clauses are covered.
18Session three Clause 7 Learning points: To understand the requirements of clauses7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring devicesTo identify processes activities that meet each clause requirements.To understand how the sub-clauses link together.
19The ‘joined up’ clause 7 ‘what about exclusions’ Customer related processes & 7.2.2Design and development 7.3Control of measuring devices 7.6Product & service provision 7.5Purchasing 7.4Customer related processes 7.2.3‘what about exclusions’
20Planning & product realisation (7.1) Requirements: Identify and map the processes required to directly producethe product or deliver the service and to be consistent with other managementsystem processes.Identify & map the ‘Key’ processesEstablish the objectives for each process linked to:The product or serviceThe overall business objectiveDevelop support documents to support process activities, consider risksConsider what records should be maintained as evidence of meeting requirements
21Customer-related processes (7.2) Requirements: Determine what the customer requirements are and reviewthem to ensure they can be met. Any differences in perceived requirementsOr amendments to an order must be highlighted and agreed with the customer.Be clear ‘up-front’ what the customer wantsProduct or service specificationDelivery and after sales serviceStatutory or regulatory requirements of the productBe sure the organisation can deliver what the customer wantsAgree any difference or amendments with the customerProvide the customer with:Clear product informationOrganisation contact information for enquiries, etc.A complaints process
22Design and development (7.3) Requirements:Design and Development PlanningDesign and Development InputDesign and Development OutputDesign and Development ReviewDesign and Development VerificationDesign and Development Validation
23Example process Refer to laminate of an example ‘Designing New Products & Services’process shows how an organisation can complywith clause 7.3 design and development
24Purchasing (7.4) Select suppliers based on ability to supply Requirements: Clearly specify what you want to purchase, provide the supplierwith all the information they need to supply you correctly. Select suppliersbased on our purchasing needs and evaluate their performance, maintainingonly the best suppliers.Select suppliers based on ability to supplyEstablish supplier evaluation criteriaKeep records of supplier evaluationDescribe fully what you want to purchase, usually on a purchase orderReference any specific standards, product approval requirements, etc.Review order prior to communicating to the supplier
25Example process Refer to laminate of an example ‘Managing Purchasing & Suppliers’process shows how an organisation can complywith clause 7.4 purchasing
26Production & service provision (7.5) Requirements: Carry out operational process activities in a controlled mannerusing suitable information and equipment, ensuring that, where appropriate,product is identified and traceable, particularly customer property.Define the process & determine the controls required to reduce risks of failureProvide the right information:- product specification, procedures, work instructions, etc.Provide the right equipmentImplement monitoring & checking methodsEnsure the product or service is identified & can be traced using recordsLook after customers property & report problems to them
27Production & service provision (7.5) Requirements: Validate any processes where the output of the process cannotbe subsequently tested.Usually manufacturing processes such as weldingValidation / testing can be of the person carrying out the activity rather than the product itselfNeed to define validation / test criteriaNeed to keep records of validation / testsNeed to re-test / validate at defined intervals
28Control of monitoring & measuring devices (7.6) Requirements: Determine what monitoring and measuring is to be undertakenneeded to provide evidence of product conformity to specified requirements.Provide the most appropriate devices and maintain them to the appropriate levelto ensure they provide consistent results.Understand what needs to be monitored or measuredSelect most appropriate devices for taskCalibrate device to ensure it can be trustedMaintain device & re-calibrate at appropriate intervalsPrevent devices from being tampered withDetermine action to be taken if device fails calibrationMaintain calibration records
29Example process Refer to laminate of an example ‘Calibrating Measuring Equipment’Process to show how an organisation can complyWith clause 7.6control of monitoring & measuring devices
30Exercise 2 For your organisation map either a ‘Sales Order’ process or a ‘Design and Development process’Showwhere the main elements of clauses are covered
31Activities first, clauses second Session fourActivities first, clauses secondLearning points:To understand that process requirements depend upon the organisationTo understand that demonstration to meeting each clause will bedifferent for different organisations.
32Exercise 3 Given the following management systems, where would expect to find clauses:6.2 Human resources6.3 Infrastructure6.4 Work environment7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service realisation7.6 Control of measuring devices.