Transcript ISO, QMS & CIR AWARENESS Objectives At the end of the training session, the team is expected to: • Be aware, know, and understand.

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)
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
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:
1.
Aims to enhance customer satisfaction through the effective application of
the system including processes for continual business improvement and
2.
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
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
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 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
ISO Standard
Company Quality
Management System
1. Quality Manual
1. Company QM and Department
Quality Manuals
2. Control of Documents
- approval, review and update,
clear revisions, retrieval, legibility
and identifiability, and control.
2. Approval stamps, review
management, revision procedure,
available (e-copy and hard copy),
labels, control stamps and logs.
3. Control of Records
3. All Monitoring logs and stamps,
printing by the DC’s, etc..
5.0 Management Responsibility
ISO Standard
Company Quality
Management System
1.
Management Commitment
-SMT support to QMS
2.
Customer Focus
-BDM, Client Intimacy Strategy,
3.
Quality Policy
Client Surveys
4.
Planning
-EXCEL
5.
Responsibility, Authority and
-Strategic Planning
Communication
-Org Structure, Communication Lines
Management Review
-Review of systems and changes/
6.
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
Management System
ISO Standard
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
Company Quality
Management System
ISO Standard
•
Planning of Product Realization
•
•
Customer-related processes
•
Design Development
•
Client QA
•
Purchasing
•
Checklist, Forms etc.
•
Production and Service Provision
•
Project Status Reports
•
Control of Monitoring and
•
Project targets and KPI
Measuring equipment
•
Added value
Quality Objectives and the whole
Production cycle
8.0 Measurement, Analysis and
Improvement
Company Quality
Management System
ISO Standard
•
Monitoring and measurement
•
QMS Monitoring
•
Control of Nonconforming
•
Internal Quality Audit
product
•
Project Audit
•
Analysis of Data
•
KPI
•
Improvement
•
CIR’s, Corrective and
Preventative Actions
The Internal Audit
PDC 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 Process
PDC 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 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.
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
Question and Answer
listen.
Lessons from the geese.
FIN
Thank you very much!