2 Quality Quality is Conformance with requirements Quality is fitness for purposeQuality is fitness for useQuality is user dependentTo achieve consistency in output, it is quality of everything that we do, which can be improved.
3 QualityThe extent to which a set of inherent characteristics fulfills requirements/specifications
4 Need for Quality Every organization would like to improve in different ways i.e.Improving customer satisfactionIn means of operationsIncreasing market sharedriving down costsmanaging risk more effectively.
5 Core Principles of Quality Management Customer Focus.Leadership.Involvement of People.Process Approach.System Approach to Management.Continual Improvement.Factual Approach to decision Making.Mutually beneficial supplier relationships.
6 Quality Management System A quality management system gives you theFramework and guidelines you need to monitor and improve performance in any given areaManagement System to direct and controlan organization with regard to qualityAssess the processes and measure the same
7 ISO Quality management -key requirements QMS - Document processes necessary to ensure product or service is of high quality and conforms to customer requirements.Management Responsibility - Provide a vision. Show commitment. Focus on the customer. Define policy. Keep everyone informed.Resource Management - Assign the right person to the job. Create and maintain positive workspace.Product Realization - Clearly understand customer, product, legal and design requirements. Ensure specifications are followed. Check your suppliers.Measurement, Analysis & Improvement - Identify current and potential problems. Monitor and measure customer satisfaction. Perform internal audits. Fix problems.
8 ISO To address this need of the customers and also to ensure that organization would improve theirworking internally, system standards werereleased by ISO, in the year 1987 which have been revised once in 1994 and latest version standards have been released in 2000.ISO stands for “International Organization forStandardization”
9 ISO Core Standards ISO 9000:2000 Series, 1994 family of standards have been reduced to 4 core standards:ISO 9000: Fundamentals and VocabularyISO 9001:2000 – RequirementsISO 9004:2000 – Guidelines for performance improvementsISO 19011:2002 – Guidelines for Auditing Quality and/ or Environmental Management Systems AuditingISO 90003: Guidelines for the application of ISO 9001:2000 to computer software.
10 Process The ISO standards are structured around the Process Approach concept. Two of the eight qualitymanagement principles are key to understandingthis principle:Process Approach - Understand and organize company resources and activities to optimize how the organization performs.System Approach to Management - Determine sequence and interaction of processes and manage them as a total system. Processes must meet customer requirements.
11 Work ProcessMonitoring and Measurement opportunities before, during andafter the processMethodINPUT (Includes resources)PROCESSOutputProduct (Result of Process)
12 Documentation Management should define the documentation, including the relevantrecords, needed to establish, implement andmaintain the quality management systemand to support an effective and efficientoperation of the organization’s processes.
13 Typical Structure of Documentation The number and levels may be adjusted to meet the organization’s needs.Forms may be applicable at all levels of the hierarchy.Quality manual (Level A)Quality ManagementSystem Procedures(Level B)Work Instructions, Process maps and other documents for QMS (Level C)Forms and Records(Level D)
14 Documentation Quality Manual: The quality manual gives the management’s directions forQuality Management system, in which it will define thedepartments/ Areas to be covered in the process system.QMS - Procedures/ SOP:Control of DocumentsControl RecordsInternal AuditsControl of NonconformityCorrective ActionPreventive Action
15 ISO clause Clause4: Quality management system Clause5: Management responsibilityClause6: Resource ManagementClause7: Product realizationClause8: Measurement, analysis and improvement
16 Audit Systematic Approach Independent and well documented Process for getting evidenceEvaluating objectivelyCheck if the audit criteria is fulfilled
17 Quality System Audit An investigation of the intent and the implementation of selected aspects of the quality system of an organization.
18 Types of Audit Internal Audits External Audits Second party audits Third party audits
19 Audit Activities Initiating an Audit Conducting document review Preparing for onsite activitiesConducting onsite activitiesPreparing, approving and distributing the audit reportComplete the auditConducting the audit Follow-up.
20 Audit Plan Sample Template Audit objectiveAudit criteria and reference documentsAudit scope - CoverageArea and aspectsDates and places for audit activitiesAudit meeting TimesAllocation of resources for critical areas.
22 Types of Checklist Bulleted specific Question "Look AT" and "Look FOR" Model
23 Sample Template "Look AT" and "Look FOR" Model Function : HR Dept - Recruitment AreaActivity : Updating the skills of EmployeeLook AT : Employee Details Screen- (SPCG)Look FOR: Skill Type, Skill Rating, Employeejoining date, Frequency of updating the skill.Sample size : 10Time : 30 minRemarks:
24 Non conformance Not meeting customer requirements Not meeting our own defined processesNot meeting management commitments
25 Types of Non conformity Major Non conformityMinor Non ConformityObservation
26 Major Non conformityThe absence or total breakdown of a system to meet the ISO 9000 requirement.A bunch of number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.Any noncompliance that would result in the probable shipment of nonconforming product to the customer.A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose at customer placeAnything that can affect the quality system itself
27 Minor Non ConformityA failure in some part of the documented quality system relative to ISO 9000, orA single observed lapse in following one item of the company's quality system as an isolated case.
28 Observation An observation is essentially an OPINION. Some say you can ignore it while others expect the Observation to be addressed in some manner - such as through the corrective action system.