ISO, QMS & CIR AWARENESS 2013

ObjectivesAt the end of the training session, the team is expected to:

• Be aware, know, and understand ISO 9001:2008 and its requirements.

• Get familiar with and embrace the company QMS

• Appreciate the policies, processes and procedures in place.

• Learn the systematic process of Issuing CIR’s

Definition of TermsQMS (Quality Management Systems)the set of procedures for determining and implementing the intention of an organization as regards quality.

Process an activity supported by resources and management for enabling the transformation of inputs into outputs. (control to these processes are called procedures)

Customer internal or external. The team or the client.

Customer Satisfactiona measure of how products and services supplied by a company meet or surpass customer’s expectations.

Continual Improvementan ongoing effort to improve products, services or processes.

Definition of TermsMonitoring being aware of the state of a system. (Checking, auditing)

CAPACorrective Action, Preventative Action

Corrective Actionprocedure used to eliminate recurrence of a detected non conformity.

Preventive Actiona procedure used to eliminate the cause of a potential non conformity.

Non-conformity or Non conformance Either a mistake made within the organization’s application of the processes or a mistake found in the drawings sent to the Shop

CIR (Continuous Improvement Request)a document that is populated to identify any action that can be taken to show an improvement over any existing procedure, process, practice or any other way of improving business and the QMS

What is ISO?• International Organization for Standardization

• It was established in 1947 and is currently an association of 157 National Standard Bodies (from different countries).

What is ISO 9001:2008?From ISO 9000 –

is a family of standards for quality management systems, maintained by ISO and is administered by accreditation and certification bodies.

It is a standard designed to specify requirement for a QMS where an organization: 1. Aims to enhance customer satisfaction through the effective application of

the system including processes for continual business improvement and2. Needs to demonstrate its ability to provide services that constantly meet

customer and applicable regulatory requirements.

Basis of ISO 9001:2008 StandardThe PDCA Cycle

The 8 Quality Management Principles

The Process Based Model

The PDCA CyclePlanestablish the objectives and processes necessary to deliver results.

Doimplement the processes

Checkmonitor and measure processes and products against policies, objectives and requirements for the service and report results.

Acttake actions to continually improve process performance.

8 Quality Management Principles

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach

6. Continual Improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

The Process Based Model

Business OperationsPDC Asia-Pacific

Group Activity

The Production ProcessPDC Asia-Pacific

The ISO Standards and Our QMSPDC Asia-Pacific

4.0 Quality Management Systems

ISO Standard Company QualityManagement System

1. Quality Manual

2. Control of Documents- approval, review and update, clear revisions, retrieval, legibility and identifiability, and control.

3. Control of Records

1. Company QM and Department Quality Manuals

2. Approval stamps, review management, revision procedure, available (e-copy and hard copy), labels, control stamps and logs.

3. All Monitoring logs and stamps, printing by the DC’s, etc..

5.0 Management Responsibility

ISO Standard Company QualityManagement System

1. Management Commitment

2. Customer Focus

3. Quality Policy

4. Planning

5. Responsibility, Authority and

Communication

6. Management Review

- SMT support to QMS

- BDM, Client Intimacy Strategy,

Client Surveys

- EXCEL

- Strategic Planning

- Org Structure, Communication Lines

- Review of systems and changes/

improvement

One Minute Question

Quality PolicyPDC Asia-Pacific

PDC Asia Pacific is committed to:

E – Exceed Clients ExpectationsProvide high quality product delivered on time, every time.

X – Error FreeDo things right the first time, every time.

C - ComplianceComply to all client’s and regulatory requirements.

E – Empower The TeamEnsure involvement and quality communication.

L – Learn ContinuallyContinuously improve via a review of the continuing suitability of the QMS.

6.0 Resource Management

ISO Standard Company QualityManagement System

1. Provision of Resources

2. Human Resources

3. Infrastructure

4. Work Environment

• Recruitment, training and

development

• Employment, tardiness,

absenteeism monitoring

• Equipment; TEKLA licenses

• Admin policies

7.0 Product Realization

ISO Standard Company QualityManagement System

• Planning of Product Realization

• Customer-related processes

• Design Development

• Purchasing

• Production and Service

Provision

• Control of Monitoring and

Measuring equipment

• Quality Objectives and the whole

Production cycle

• Client QA

• Checklist, Forms etc.

• Project Status Reports

• Project targets and KPI

• Added value

8.0 Measurement, Analysis and Improvement

ISO Standard Company QualityManagement System

• Monitoring and measurement

• Control of Nonconforming

product

• Analysis of Data

• Improvement

• QMS Monitoring

• Internal Quality Audit

• Project Audit

• KPI

• CIR’s, Corrective and

Preventative Actions

The Internal AuditPDC Asia-Pacific

What is IQA?Internal Quality Audit

A systematic, independent and documented process for obtaining evidences (of conformity ) and evaluating it objectively to determine the extent to which policies, procedures and requirements are fulfilled.

It is conducted for Management Review and other internal purposes

Who Can Conduct IQA?Internal Quality Audit Team

Lead Auditor and Associate Auditors that are qualified and certified to be doing internal audits per the requirement of ISO 19011.

The CIR ProcessPDC Asia-Pacific

Why we issue?• For continuous improvement.

• To better analyze the cause so we can apply an adequate and appropriate

corrective action.

• To keep a record of Corrective and Preventive Action for possible future use.

• To make the process owner aware of the mistake and the corrective action

which is part of an education process for him/her.

When to issue?

1. Problems or non-conformances are identified.

2. When points for improvements are determined.

Origin of CIR’s?Non Conformance (NC)

This can be categorized depending on the gravity of the error either Major, Minor or Points for Improvement. This can be achieved by internal or external aspect. Either an error found on the product or a lapse in the application of certain process in the QMS.

Formal Customer Complaint

Any complaint, written or verbal passed on from a customer or customer’s representative concerning customer dissatisfaction or unmet expectation of products or services provided by the company.

Quality Improvement Request (QIR)

A suggested improvement concerning quality of our services or product or management systems. This is not originated from a non-conformance but is a potential point for improvement.

System Audit Findings

These are the result of the collective audit findings thru internal and external audit.

How to Issue

- Determine the need for a CIR.

- Gather all information about the error or points for improvement.

- Seek assistance from the QA Department*

- Follow the steps @ QMI-009 – CIR Issuing Procedure.

What NowWhat do I do?

The Leader - is expected to lead by example.

Listens…

Drives the team to a common goal

Represents the group

Develops leaders

The Team - Is a real team player.

listens.

speaks up.

is a leader himself.

The Impact of ISO Certificationto the Company.

1. This gives us a seal that we are meeting the customer’s and regulatory requirements.

2. It allows us to improve the quality of our products, services and systems.

3. It makes us understand, document and communicate our company processes.

4. Provides for consistency in our operations.

5. It keeps the management and the team focused on quality.

6. It allows us to improve our efficiency, reduce waste and save money.

7. This is an affirmation that our Quality is guaranteed by an international body.

I speak you listen, you speak, I listen.Question and Answer

Lessons from the geese.

FINThank you very much!