ISO, QMS & CIR Awareness 2013

Objectives At 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 Terms QMS (Quality Management Systems) Process Customer 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 Satisfaction a measure of how products and services supplied by a company meet or surpass customer’s expectations. Continual Improvement an ongoing effort to improve products, services or processes.

Definition of Terms Monitoring CAPA Corrective Action being aware of the state of a system. (Checking, auditing) CAPA Corrective Action, Preventative Action Corrective Action procedure used to eliminate recurrence of a detected non conformity. Preventive Action a 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: Aims to enhance customer satisfaction through the effective application of the system including processes for continual business improvement and Needs to demonstrate its ability to provide services that constantly meet customer and applicable regulatory requirements.

Basis of ISO 9001:2008 Standard The PDCA Cycle The 8 Quality Management Principles The Process Based Model

The PDCA Cycle Plan Do Check Act establish the objectives and processes necessary to deliver results. Do implement the processes Check monitor and measure processes and products against policies, objectives and requirements for the service and report results. Act take actions to continually improve process performance.

8 Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships

The Process Based Model

Business Operations PDC Asia-Pacific

Group Activity

The Production Process PDC Asia-Pacific

The ISO Standards and Our QMS PDC Asia-Pacific

4.0 Quality Management Systems Company Quality Management System ISO Standard Quality Manual Control of Documents approval, review and update, clear revisions, retrieval, legibility and identifiability, and control. 3. Control of Records Company QM and Department Quality Manuals Approval stamps, review management, revision procedure, available (e-copy and hard copy), labels, control stamps and logs. All Monitoring logs and stamps, printing by the DC’s, etc..

5.0 Management Responsibility Company Quality Management System ISO Standard Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication 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 Policy PDC Asia-Pacific

PDC Asia Pacific is committed to: E – Exceed Clients Expectations Provide high quality product delivered on time, every time. X – Error Free Do things right the first time, every time. C - Compliance Comply to all client’s and regulatory requirements. E – Empower The Team Ensure involvement and quality communication. L – Learn Continually Continuously improve via a review of the continuing suitability of the QMS.

6.0 Resource Management Company Quality ISO Standard Management System Provision of Resources Human Resources Infrastructure Work Environment Recruitment, training and development Employment, tardiness, absenteeism monitoring Equipment; TEKLA licenses Admin policies

7.0 Product Realization Company Quality ISO Standard Management 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 Company Quality Management System ISO Standard 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 Audit PDC Asia-Pacific

What is IQA? Who Can Conduct 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 Process PDC Asia-Pacific

Why we issue? When to 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? Problems or non-conformances are identified. When points for improvements are determined.

Origin of CIR’s? Non Conformance (NC) Formal Customer Complaint 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’s next when CIR is complete? Corrective and preventive and follow up. Create Lesson Learnt presentation incorporating the lessons from the errors. Organize and implement improvement to the system. Closing/ Sign-off

What do I do? What Now

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 Certification to the Company. This gives us a seal that we are meeting the customer’s and regulatory requirements. It allows us to improve the quality of our products, services and systems. It makes us understand, document and communicate our company processes. Provides for consistency in our operations. It keeps the management and the team focused on quality. It allows us to improve our efficiency, reduce waste and save money. 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.

FIN Thank you very much!