Quality management System

Internal Auditing
What is Internal Auditing ?
...an independent, objective assurance and consulting
activity designed to add value and improve an
organization's operations. It helps an organization
accomplish its objectives by bringing a systematic,
disciplined approach to evaluate and improve the
effectiveness of risk management, control and
governance processes.2
 Add Value to Quality Audits

• What is our mission ?

• Why we exist ?
„Organizations exist to create value or benefit to their
owners.”

• What is value ?
Value is provided through the development of products
and services and the use of resources to promote
those products and services.
• In the process of gathering data to understand and assess risk, internal auditors
develop significant insight into operations and opportunities for improvement
that can be extremely beneficial to their organization.
• This valuable information can be in the form of consultation, advice, written
communications or through other products--all of which should be properly
communicated to the appropriate management or operating personnel. 1
 How to add value to Internal Audits?
• gather data
• analyze and understand process
• process auditing against internal and external stanadards
• understand, assess and manage risk
• develop insight into the operations
• strenghten internal controls
• measure operational efectiveness
• reduce cost
• eliminate waste
• highlight oportunities for improvement
• provide trendline data to determine baseline and benchmark
performance improvement
 Types of value added audits:
1. Process auditing
• Steps:
Indentify business and process objectives
Flowchart critical procesess
Indentify critical process inputs and outputs
Evaluate process procedures, records and
documentation against ISO 9001:2000 or similar
quality criteria
Evaluate process metrics against business objectives
Analyze metrics to determine process stability and
then improvement over time.
 Types of value added audits:
2.Risc auditing
• Steps
-Identify business and process objectives.
-Identify operational and other risks.
-Define business or other controls.
-Assess and ensure the effectiveness of the
business process to satisfy objectives.
 Audit results ?
• Comunicate to involved parties and top management
Top management ?
Analyze
 Reviewed by: ISO Management
Approved by: Chief Executive Officer
COP 4.1 Customer-Oriented Process (COP) Model Representative
Signature/Date:
Signature/Date:
Rev: 12/15/03

Sales Manager . Engineering Manager . Contracting Officer . Production Manager . Quality Manager . Shipping Manager . Servicing Manager .

Market Analysis Bid / Quote

and Sales Submission

Order / Release
Processing

Product and/or New / Changed

Manufacturing Yes Product or Mfg
Process Design Process?

No

Post Delivery Yes

Servicing?

Warranty Work
Inspection and
No Production Delivery or Post Delivery
Test
Servicing

Customer
Invoicing and
Feedback and
Payment
Complaint
Processing
Processing
 DFC 4.1 - Sequence and Interaction of Key QMS Processes Reviewed by: ISO Management Representative Approved by: Chief Executive Officer
Signature/Date: Signature/Date:
Rev: 12/15/03

Top Management / ISO Mgt. Rep. Sales Manager Engineering Manager Materials Manager Production Manager Quality Manager Human Resources Ofcr Info Systems Manager

Conduct
Management
Reviews
Responsibility
Management

see OP 5.6

Establish &
Improve QMS
see QM Section 4.0
and QM Section 5.0

Provide
Management

Plan & Maintain

Resource

Resources
see QM Section 6.0 Plan & Maintain Qualify & Train Documents/Data
Facilities Workforce see OP 4.2.3
see OP 6.3 see OP 6.2.2 and OP 4.2.4
(Closely Aligned with our “Customer Oriented Process”, see COP 4.1

Identify and Review

Product Requirements
see QM Section 7.2.1 and OP 7.2.2 Assure Plan & Control Develop Product
Supplier Quality Production Quality Plans
see OP 7.4.1 see OP 7.5.1 see OP 7.1
Product Realization Processes

Manage Customer No Design? Purchase and Verify Needed Materials & Services
Communications see OP 7.4.2, QM Section 7.4.3 and OP 8.2.4
(Inquiries and Feedback,
including Complaints)
Yes
Design/Validate Production Processes
see QM Section 7.2.3 see OP 7.5.2

Establish & Maintain Product Identification and Traceability

see OP 7.5.3

Plan & Control Control Customer Property Control

Design and Preserve Product Monitoring &
(Purchased Product, In-Process Material & Finished Goods) Measuring
see OP 7.3 Devices
see OP 7.5.4 and OP 7.5.5
see OP 7.6

Conduct Monitor & Measure Monitor Production Monitor Product

Internal Customer Processes Quality
Audits Satisfaction (Receiving, In-Process &
(Operator Monitoring)
Final Inspection)
see OP 8.2.2 see OP 8.2.1
see OP 8.1
Measurement, Analysis

see OP 8.2.3
and OP 8.2.4
and Improvement

Control Nonconforming Product Analyze

see OP 8.3 Analyze Document &
Analyze Internal Analyze Customer Analyze Product Analyze Supplier
Competency Records
Audit Data Satisfaction Data Performance Data Performance Data
Analyze Production Analyze Quality Data Management
Process Data (QA/QC) Data Systems Data
see QM Section 8.4

Initiate Corrective, Preventive and Improvement Actions

see OP 8.5
 Reviewed by: ISO Management Representative Approved by: Chief Executive Officer
DFC 5.6 - Management Review Process Signature/Date: Signature/Date:
Rev: 12/15/03

ISO Management Representative Top Management (includes CEO, CFO, COO and HRO) .

Assess Overall QMS Monitor Objectives

Overall Responsibility for Administering the Management Review Process: ISO Management Representative

Effectiveness and Operations

Status Reports on Actions from Previous Management Reviews

Identification of any Strategic or Operational Changes that could affect the QMS
Plan and Schedule Significant Identification of any Policy Issues Requiring Review
Analyze Results and
Management Review Yes Impact on NO
Trends
Meeting QMS? Status Reports on Progress towards meeting specific improvement objectives:
Customer Satisfaction (COO/Sales Manager per OP 8.2.1)

Supplier Performance (COO/Materials Manager per OP 7.4.1)

Prepare Overall QMS Effectiveness, including evidence of repeat audit findings (ISO Management Representative per OP 8.2.2) or other repeat problems (ISO
Issue Management Management Representative per OP 8.5)
Management Review
Review Agenda
Inputs Overall Operational Efficiency, including an evaluation of the cost of poor quality (CFO)

Manufacturing Process effectiveness and efficiency, including performance against customer specified (or other) targets for productivity, process capability
and cost (COO/Engineering Manager per OP 7.3)

Overall Product Performance, including an analysis of actual and potential field-failures and their impact on quality, safety or the environment (COO/
Engineering Manager per OP 7.3)
Issue Management Review Inputs and Overall Effectiveness of Production Process Controls, including:
Review Minutes Develop Outputs performance against production schedules (COO/Production Manager per OP 7.5.1),
equipment/facilities maintenance plans (COO/Production Manager per OP 6.3), and
product preservation goals/targets (COO/Production Manager per OP 7.5.5)

Overall Product Quality, including performance against customer specified (or other) targets related to product quality (COO/Quality Manager per OP 8.2.4)
Actions to Improve Effectiveness of the QMS
Monitor and its Processes Overall effectiveness of training completed, including skills training, on-the-job training and employee awareness, and effectiveness of employee motivation
programs/systems (HRO per OP 6.2.2)
Implementation of Actions to Improve Products Analysis of QMS Self-Assessment Results, IsoQual Form 8.5-3, against Malcolm Baldrige based criteria contained in Annex A of ISO 9004:2000
Actions Resulting
from Management Actions to Provide Needed Resources Presentation of New or Changed Objectives
Review New or Revised Improvement Objectives Recommendations for Improvement and Plans (including resources) for Implementation
per OP 8.2.2 and OP 8.5

Assess Process for

Effectiveness

per PAW 5.6

 DFC 6.2.2 - Competence, Awareness and Training System Rev 1-1-03
Top Management Responsible Manager Human Resources Officer Materials Manager

Recommend
Identify Competency
Source(s) for Obtain Required
Needs during Outsource? Yes
Meeting Emergent Services
Strategic Planning
Competency Needs
per SOP 7.4.2
Overall Responsibility for Managing the Competence, Awareness and Training System: Human Resources Officer

Planning Meeting Minutes Memorandum

NO

Review Evaluate Supplier

Develop Staffing
Qualifications and Performance
Plan and Document
Identify Training per SOP 7.4.1
Job Requirements
Needs
Staffing Plan and New or
IsoQual Form 6.2.2-2 Revised Position Description

Training Yes
New
Needed? Employee?

Yes
NO

Provide/Coordinate
Annually, New Employee
Orientation
Re-Evaluate IsoQual Form 6.2.2-1
Qualifications,
Provide/Coordinate
Evaluate
Required Training
Performance,
IsoQual Form 6.2.2-2

and Evaluate
Effectiveness of Assess Process for
Training Completed Effectiveness
IsoQual Form 6.2.2-2 per PAW 6.2.2

Initiate appropriate Corrective/Preventive Action and

Recommend appropriate Action by Top Management, as needed

per SOP 8.5 and SOP 5.6