ISO 9001:2008 Standard Awareness program Pearl confectionery (Pvt) Ltd

ISO 9001:2008 (QMS)Awareness program

Pearl confectionery (Pvt) LtdSyed Noor Mustafa ShahJr. Officer Compliance

Presentation Index:. Program Objective. Introduction to ISO . What is ISO 9001:2008 (QMS). Eight Principles of QMS. PDCA Cycle of QMS. Key Definition Of QMS. Corrective Action Request . List of procedures. Benefits of QMS. Brief of ISO 9001:2008 Requirements

Program Objective:

Awareness of ISO 9001:2008

Introduction To ISO:. International Organization for Standardization( English). ISO derived from Greek word ISOS means equal.. Founded on 23,Feb,1947 and headquartered in Switzerland, Geneva. Non-Governmental Organization. Network of the national standard bodies of 175 Countries. Around 175 countries member. Technical committees are formed to produce standards.

Introduction to ISO (Continued):. By 31 Dec, 2008- 17765 standards.. ISO 9001:2008 (for QMS) and ISO 14001:2004 (for EMS) are among the most well known and widely implemented ISO standards ever. Implemented by 1 million organization in 175 countries.. ISO standards are generic standards. ISO does not carry out certification and does not issue or approves certificates

What is ISO 9001:2008 . ISO 9001:2008 for quality management system (QMS) . QMS is about how to manage the quality aspects of all processes more effectively, taking into consideration customer Satisfaction and compliance of contractual requirements 9001 = code to denote QMS Family2008 = year of last revisionInitially Released in 1987 Second edition 1994 Third edition 2000 Fourth edition 2008In coming edition 2015

What is ISO 9001:2008 (Continued):ISO 9000 (QMS) Standards Family

. ISO 9000:2005 QMS- Fundamentals & Vocabulary. ISO 9001:2008 QMS- Requirements. ISO 9004:2000 QMS- Guidelines for performance Improvement

What is ISO 9001:2008 (Continued):Other Supporting Standards:

. ISO 10005:2005 QMS- Guidelines for Quality plan. ISO 10006:2003 QMS- Guidelines for quality management in projects. ISO 19011:2002 Guidelines for QMS &/or EMS Auditing

Eight Key principles Of QMS:Customer focusLeadershipInvolvement of peopleProcess approachSystem approach to managementContinual improvementFactual approach to decision makingMutual beneficial supplier relation ship

Eight Key principles Of QMS(Continued):Customer focus

. Organization Depends on their Customers . Determine Customer Need & Expectation . Meet Customer Requirements . Customer Satisfaction

Leadership

. Leaders must set the direction of the organization . Leaders must create and maintain internal environment that encourages people to achieve the organizations objectives

Eight Key principles Of QMS(Continued):Involvement of people . Must help people to develop and use their abilities . Must encourage the involvement of people at all level

Process approach . Any activity that takes inputs and converts them to outputs . The systematic identification and management of these activities and the interaction between activities . A desired result is more efficiently achieved when resources and activities are managed as a process

Eight Key principles Of QMS(Continued):System approach to managementIdentifying , understanding and managing a system of interrelated process for a given objective improves the organization effectivenessand efficiency

Continual improvementContinual improvement of the organization's overall performance should be a permanent objective of the organization

Eight Key principles Of QMS(Continued):Factual approach to decision making Effective decisions are based on the analysis of data and information

Mutual beneficial supplier relation ship

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

PDCA Cycle (Process improvement):

Plan : Define objectives Do : Implement the processCheck : Check the process and ResultAct: Take corrective Action, Preventive Action & Improves the process

ACTPLANCHECKDO

Key definitions of QMS 1 - Quality

. Fit to purpose . Degree to which a set of inherent characteristics fulfils requirements

2 - Quality Policy

. Overall intentions and directions of an organization related to its quality performance, as formally expressed by top management.

Key Definitions of QMS (Continued):3 - Quality Control (Q.C)

. A process employed to ensure a specified level of quality is there in a product or service

4 Quality Assurance (Q.A)

. A process of verifying or determining whether product or service meet or exceed customer expectation and QA is determined using (PDCA) cycle.

Key definition of QMS (Continued): Quality Assurance Quality Control

. Prevention Based . Detection Based. Process Oriented . Product Oriented . Phase Building Activity . End Phase Activity. Responsibility Of All . Responsibility of Inspection . QA is about Experience . QC is about Instrument . QA is Built in Product . QC is Inspected Production

Key Definitions of QMS (Continued):5 - Document: Information and its supporting medium. The medium can be paper, magnetic, electronic, photograph, etc.

Example:. Forms, Procedures . Inspection Sheets. ISO Standards

Key Definitions of QMS((Continued):6 - Record Document stating result achieved or providing evidence of activities performed.

Example: . Audit Report . Material Test Report . Daily Progress Report . Training Attendance Sheet

Key definition of QMS((Continued):7 - Process Set of inter related or interacting activities which transforms input into output.

Example:Weighing of ingredientsMixingCookingFlavor and Color additionFormingWrappingPacking

Process Activity

Key definition of QMS((Continued):8 - Procedure Specified way to carry out an activity or a process. Example: . Complaint Procedure . Production Procedure . Material Approval Procedure . Auditing Procedure

Key definition of QMS(Continued):9 Audit Examine carefully with intent of verification. So Quality Audit is systematic inspection to determine whether quality activity comply with QMS requirements & are implemented effectively or not.

Types of Audit First-Party Second-Party Third-Party

Key definition of QMS(Continued):First-Party:. Auditing your own organization using a planned schedule and trained internal auditors.

Second-Party:. Audit is initiated by one company on another for example customer

Third-Party:. Audit performed by independent organization or regulatory body, e.g. ISO 9001:2008 registrar. Example QMI, BSI, BvQi, UL, Loyds

The Purpose of an Audit is ...To collect objective evidence to permit an informed judgment about the status of the quality management systemObjective EvidenceRecords, statements of fact or other information, which are relevant to the audit criteria and verifiable ORInformation collect during an audit

Key definition of QMS(Continued):10 - Auditor

Person with the competence to conduct an audit.

Roles & Responsibilities: The Auditor is responsible for :. Audit execution with in the scope of audit.. Documenting audit finding and reporting it. Help auditee by suggesting corrective action

Key definition of QMS(Continued):11 - Auditee

Organization or dept. being audited

Roles & Responsibilities: The Auditee is responsible for :. Informing employees about the scope of audit. Showing professional and positive attitude . Providing all relevant resources to auditor. Providing root cause and corrective action for the CARs raised by auditor

Key definition of QMS(Continued): 12 - Conformance: Fulfillment of a requirement Example: . Purchase only Approved Material . QC Testing at Defined Stages . Use Calibrated Equipment for Testing . Use Approved Formats/ Documents

Key definition of QMS(Continued):13 - Non- Conformance (NC)Non- fulfillment of a requirement

Example:. Procedure is not updated. Record is not Available. Obsolete Specification, Drawing or Documents are used

Key definition of QMS(Continued):13.a Major NC: Any violation which shows a gap in system or an ultimate fall in quantity of the product. OR. System element is missing. System element is not implemented or is not effective

Example:In Store currant stock report and physical quantity of PF-01 was found not aligned i.e. stock shows 28.27. However, present 190 liters.

Key definition of QMS(Continued):13.b Minor NC:Partial lack in quality system which has no direction impact on product quality OR A single/isolated lapse in the systemExample:Attendance record was found not mentioned for training conducted on ISO 22000, dated 24/3/2014

Key definition of QMS(Continued):13.c Observation:The cause of a potential nonconformity or other undesirable situation which needs improvement

Example: Web cobs were found above chilling unit in wrapping area.

Key definition of QMS(Continued):14 Root Causes:A root cause is a factor that caused a nonconformance and should be permanently eliminated through process improvement.

Example:Ignored as the 3 different categories of staff is involved in housekeeping e.g. Maintenance helpers, Operators, and Housekeeping staff.

Key definition of QMS(Continued):15 - Corrective Action:Action to eliminate the cause of a detected non- conformity or other undesirable situation

Examples:. NC- Procedure is not updated after changes were made . CA- Production Manager to review the procedure per month

Key definition of QMS(Continued):16 - Preventive Action : Action to eliminate the cause of a potential non conformity or other undesirably potential situationExample:. Potential NC - Procedure is not available in some departments.. Preventive Action - Establish System of distribution sheet

Corrective Action Request PCL/FM 04:

LIST OF PROCEDURES:S.#ProcedureDocument Ref #DepartmentRevision Status1System Of Management ReviewPCL/PR 01Compliance12System Of Document ControlPCL/PR 02Compliance23System of Record ControlPCL/PR 03Compliance14System Of Training and developmentPCL/PR 04HR25System of Recruitment & SeparationPCL/PR 04-BHR06System Of Internal AuditingPCL/PR 05Compliance17System Of Corrective & Preventive ActionsPCL/PR 06Compliance18System Of General StorePCL/PR 07Engineering19System Of Calibration PCL/PR 08Engineering010System Of Handling Customer PCL/PR 09Local & Export 1

LIST OF PROCEDURES(Continued):S.#ProcedureDocument Ref #DepartmentRevision Status11System Of MaintenancePCL/PR 10Engineering012System Of Export Mkt & Order ReviewPCL/PR 11Export213System Of Supplier's EvaluationPCL/PR 12Purchase214System Of Export Order DeliveryPCL/PR 13Export215System Of Confectionery ProductionPCL/PR 14Production216System Of Main Store (Raw Materials)PCL/PR 15Store/MM117System Of Finished Goods StoragePCL/PR 16Warehouse118System Of Local PurchasePCL/PR 17Purchase119System Of Import PurchasePCL/PR 18Purchase120System Of InspectionPCL/PR 19QA&D2

LIST OF PROCEDURES(Continued):S.#ProcedureDocument Ref #DepartmentRevision Status21System Of Monitoring & AnalysisPCL/PR 20QA&D222System Of Local Order ReviewPCL/PR 21Local Sales123System Of Product DevelopmentPCL/PR 22Product Development024System Of Corporate Order ReviewPCL/PR 23Corporate025System of SamplingPCL/PR 24QA&D026System Of IT Control and SecurityPCL/PR 25I.T327System Of Material ManagementPCL/PR 26Store/MM028System of Work Environment & MeasurementsPCL/PR 27Engineering029System of Internal CommunicationPCL/PR 28Compliance030System of Research & DevelopmentPCL/PR 29QA&D131System Of Confectionery Production - ChocolatePCL/PR 30Chocolate0

Steps OF AUDIT ACTIVITES:

1 - Planning and scheduling audit2 - Conducting document review4 - Conducting audit5 - Prepare CARs6 - Conducting follow-up

3 - Preparing for on-site activities

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Benefits of QMS:Decrease in wasted time, materials, and efforts.

Establish leadership role within organization.

Increased recognition and satisfaction by customers.

Ability to maintain standards of quality and excellence. Roles and responsibilities are clearly defined via documented procedures

As variation is eliminated, efficiency improves.

As efficiency improves the cost of quality service is reduced.

Increased employee morale as they are asked to take control of their processes (empowerment).

Benefits of QMS(Continued):

Reduction in conflicts.

Transformation from a reactive organization to a pro-active, preventative organization

Improved communications.

Major transformation that would change the mind set.

Institutionalize a culture of excellence.

Performance evaluation (Continuous Improvement)

Brief of ISO 9001:2008 Requirements:Section 1 : Scope Talks about the standard and how it applies to the organizations

Section 2 : Normative Reference References another document that should be used along with ISO 9001:2008

Section 3 : Terms and Definitions Gives definition used in the standard

Section 4: General Requirements Gives requirements for the overall quality management system

Brief of ISO 9001:2008 Requirements(Continued):Section 5 : Management Responsibility gives requirement for top management and their role in the quality management system

Section 6: Resource Management Gives requirement for resources including personal, training, facility and work environment

Section 7 : Product Realization Gives requirement for a realization of product or service, including planning, customer related processes, design, purchasing and process control

Section 8 : Measurement, analysis and improvement Gives requirements on monitoring processes and improving those processes