2 Background Quality management standards require many things, including Corrective and Preventive ActionsInternal AuditsManagement reviewsISO 9001:2008 “The Organization shall continually improve the effectiveness of the quality management system through the use of…audit results, analysis of data, corrective and preventive actions, and management review.”The SBS Quality database was created to ease the complexity of compliance to quality management standardsISO 9001AS9100ISO/TS 19649ISO 13485
8 Benefits Efficient and cost effective Reports and analysis Simple, low cost solutionNo additional software to purchaseNo annual maintenance feesConcurrent user licensing – not CPU basedMinimal training is requiredSaves time and improves efficiencyReports and analysisManagers get immediate answersHow many CA/PA Requests are open and why?How long are CA/PA Requests open?reminders for open actionsDevelop agendas for meetingsUtilizes a proven method of Corrective ActionOrganize and track actions from management review meetings
9 Database Set-up and Configuration Add Employee informationSet user passwords and access levelsCustomize set-up parameters
10 Easy Installation Download the demo database Save or copy the Quality DB.mde or Quality DB.accde file to a designated folder on your Network File ServerOnce purchased, register the demo database (enter the Product Code)Ensure all Workstations haveMicrosoft Access or the free Runtime version of Microsoft AccessRead and write privileges to the designated folder on the Network File ServerNote: The above graphic is for stand alone Access databases - SQL configurations are different
11 Login Screen The login process limits access to the database features The Demo version includes dummy data and employeesAdmin is the default login for demo versions (unregistered)Admin has full Database privilegesFor the demo database,Employee: AdminPassword: adminAll other employees password = pw
12 Setting up the Database Add Employees (owners)Enter Company specific informationCompany contact informationSitesDepartmentsCAR/PAR CategoriesRoot Cause categoriesDefect categoriesCustomer ListSupplier ListsParts ListDocument names
13 Add / Edit Employees and Assign Privileges Used for automatic sEmployees are your CAR, PAR, NC owners and action ownersEnter a password to log in to the databaseAccess Level defines standard privilegesSpecific privileges may also be selected
14 Set-Up Parameters Organized into one form with multiple tabs Many tabs contain information used to build drop-down lists on various forms for exampleParts, Customers, Suppliers, etc.
17 Set-Up Parameters – Document Details Document #s appear on key formsto trace forms to your document control system
18 Corrective Action Requests Background: The 8D problem solving processCreate a CARReview reportsMeasure effectiveness
19 Types of Corrective Action Requests InternalOriginated from within the companyExternalOriginated from outside source like a regulatory body or potential CustomerCustomer complaintDefective product shipped to CustomerLate deliveryInternal AuditInternal audit findingsSafetyResults of Safety auditSafety incident investigationOSHA complianceSupplierVendor or supplier failing to perform to specificationLate deliveries, defective parts
20 The 8D Problem Solving Process PlanD1Build a teamD2Define the problemD3Contain the problemD4Define and verify the root cause(s)D5Determine and verify the permanent corrective actionsD6Implement and verify the permanent solutionD7Prevent recurrenceD8Congratulate the team!
23 Tab #1: CAR Details - (8D steps 1 & 2) CAR TypeInternalExternalCustomer ComplaintsSafety – for OSHA complianceInternal AuditSupplier CAR – issued to supplierCategoryUser defined functional areas or departmentsStatusAutomatically set based on the dates enteredDatesDetermine the status of the CARDetails(Part #, PO, etc.)Define the CAR teamDetailed Problem description
25 Establish containment actions with specific owners Tab #2: ContainmentContain the problemTake immediate and possibly temporary actions to prevent the problem from happening todayFor example, Stop shipping and 100% inspect for the defectDefinition: ECD = Estimated Completion Date or due dateEstablish containment actions with specific owners
26 Tab #3: Root Cause Analysis Determine the Root Cause (s)Document the 5 Why’sThe problem may have multiple root causesPrimary root causeEscape Root causeContributing root causeCorrective actions must be aligned to each root causeAsk why?, why?, why?, why?, why? to determine effective corrective actionsDocument multiple root causes for a single CAR including Primary, Escape, and contributing root causes
27 Corrective Actions Record multiple Corrective Actions for each CAR Management or designate may verify each action to ensure theyEffectively address each root causeEnsure the problem will not re-occurEach Action has anOwnerECD – Estimated Completion dateFirst ECD – original ECD (does not change)Current ECD – may be changedStatus – see corrective Action Life CycleDate completeComment – used to explain current statusValidation or acceptance criteriaValidation name and dateOnce reviewed and approved, the Corrective Action plan is considered “Approved” when a date is entered in the “CA Plan Approved” field
28 Tab #4: Corrective Actions and Validation Establish corrective actions with specific ownersEstablish Validation criteria and document closure
30 Verification and Validation Documented by approving the corrective action planShould require management review and approvalUpon completion, each action must be validatedValidation / Acceptance CriteriaDefines pass / fail criteriaFor example:99% of all parts measure < 15mmDocument XX version 02 released on 4-May-2006Training records updated and reviewedActual Valuethe observed or actual valueRecord who validated the action, when, and definitively state that the action was effective (or not)
32 Tab #5: Preventive Actions Document any preventive actions to prevent similar occurrences
33 Tab #6: Comments and Files Add comments including customer feedbackTab #6: Comments and Filesthe electronic CAR report directly to Management or CustomersLink electronic files such as pictures, customer s, etc.
34 Professional ReportsPrint or the CAR report directly to the Customer
35 Handy Features Forms may be Directory Sorted Filtered Searched Export dataSpell checkDirectoryLists a summary
36 Apply filters to reports CAR ReportsA full set of reports, charts, graphs and analysisApply filters to reports
37 PARs use the same process and similar forms as CARs Preventive ActionsFor want of a nail, the shoe was lost, For want of the shoe, the horse was lost, For want of the horse, the rider was lost, For want of the rider, the battle was lost, For want of the battle, the kingdom was lost, And all for the want of a horseshoe nail!PARs use the same process and similar forms as CARs
51 Management Reviews Quality Management System Reviews Document meeting minutesTrack and manage actionsDrive Continual Improvement at the management level
52 Quality Management System (QMS) Reviews Document a QMS MeetingWho attendedWhat was the agenda?What was discussed?ISO9001:2008 establishes the basic agendaWhat were the resulting actions taken?Are the actions complete?QMS review organized in 4 tabsQMS DetailsData ReviewActions and ValidationComments and files
57 Simple Survey Features Easily create custom surveysSimple, intuitive interfacePrint out or a professional looking survey directly from the programAsk different types of questionsTrue or False / Yes or NoRating (on a scale of one to ten)Text response (let the customer provide feedback in his own words)Create an efficient quality record
58 Simple Survey Features Customer SatisfactionDirectly quantify customer satisfactionMonitor Customer perceptionsAnalyze trends with grafts and reportsVendor qualification surveysMeasure vendor suitabilityMonitor vendor improvementEmployee opinion pollsMeasure job satisfactionSolicit continual improvement ideasMeasure and track long term results print
60 Creating Surveys Enter general survey information Create a survey Category (i.e. Customer Service, General, Engineering Support, etc.)Create a question and establish the order in which it will appear on the surveySelect the question type.Yes/no and true/false questions are rated as either 0 or 10Text response questions have no scoreRating types receive a number rating from 1 to 10 with 1 being the lowest or worst level.If the question was yes/no or true/false, you must determine if a positive answer (yes or true ) carries the maximum score.Check the check box labeled "PositiveIsTen" if a positive answer receives the maximum score.Leave the "PositiveIsTen" check box unchecked if a positive answer should receive the minimum score.Each question may be weighted differently (not all questions were created equal).The "Weight" field is used to score each question where Score = Rating * weight.The user must determine appropriate waiting factors.
63 Best in class software solution SBS Quality DatabaseBest in class software solution
64 Summary The SBS Quality Database is a cost effective tool to Ensure effective training compliance with Quality standardsISO 9001:2008AS 9100TS 16949ISO 13485ISO 14001Manage Corrective and Preventive ActionsManage Management Review meetingsMonitor Customer perceptionsMaintain paperless quality recordsAnalyze performance and develop improvement strategiesSave time and effort
65 About SBS Sunday Business Systems Sunday Business Systems is engaged in software sales and consulting services.Applies Lean Manufacturing principles to Quality Management SystemsSells affordable and efficient software solutions to help implement ISO9001:2008 compliant systemsDocument ControlCorrective and Preventive ActionsAudit ManagementEmployee TrainingControl of calibrated equipmentVendor ManagementSPCCommunication / Continual improvementProvides Training and instructionWill customize the software for specific Customer needsWe build a custom solution for your specific business processesSundayBusinessSystems
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