Professional Documents
Culture Documents
IMS Internal Auditors Briefing
IMS Internal Auditors Briefing
IMS Internal Auditors Briefing
Implementation and operation Design and Development Product Realisation Purchasing Order to Delivery Production Management of resources and infrastructure Calibration Control of documents and records Communication Customer complaint
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Audits are normally designed to achieve one or more objectives as follows: Determine the conformity or non-conformity of the clauses of the management system prescribed requirements Determine the effectiveness of the quality system in place to satisfy the prescribed objectives Determine compliance to legal requirements
Identify the needs of improvement Therefore, 1. Your remarks must be exact, based on value added facts people may see your remarks pertinent, although strict and strong it should bring value to organisation 2. People must understand how to handle your remarks 3. Adding value
Objectives of an audit
Aim of an audit
Understand the requirements of ISO 14001:2004, ISO 9001:2008 and ISO 19011: 2002 Acquire practical knowledge, skills, attitudes and habits necessary to become an internal auditor To gain the necessary competence to work in an audit team and how to manage an audit programme
Objectives
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Introduction to ISO 14001: 2004 Introduction to ISO 9001: 2008 ISO 19011: 2002 Preparing and Conducting an audit
Course Structure
Environmental aspects
Continual Improvement
Checking & Corrective Action Implementation & Operation Planning
Policy, Resources, Emergency Preparedness, Responsibility & Authority, Training & Awareness, Communication, Documentation & Record Management, Internal audit
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YOUR ROLE: Policy goals must be achievable - If too ambitious may not be met - If too conservative may be open to criticism Auditors should scrutinise policy statement and checked for discrepancies
Mixing Process
IMPACTS: INPUT Depletion of resources
Mixing
Semi-Finished Product
HOW TO IDENTIFY: Through process flow diagrams, walking inspections and checklists
OUTPUT
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Two types: Internal and External Communication Internal Communication: Address information exchange between levels of staff ( Dashboard, HoD meetings, Management Review, Steering Committee, Briefings) External Communication: Cover complaints and replies to enquiries, report performance to pressure groups
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External documents (e.g. legal permits, etc) must also be controlled and ensure they are distributed to correct people.
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Procedure for periodic compliance evaluation: All relevant legal requirements Other standards subscribed to Records of evaluation to be kept
Main sections of the audit procedure: Audit scope; Frequency; Methodology; Responsibilities; Reporting
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Audit Process ISO 19011: 2002 Guidelines for quality and/or environmental management systems auditing
Summary of Audit Procedure Step 1 Prepare Audit Programme Set of one or more audits planned for a specific timeframe and directed towards a specific purpose An audit programme will include all activities necessary for planning, organising and conducting the audits. To be approved by Top Management.
1. Planning and Scheduling audit; 2. Assuring the competence of auditors and audit team leaders 3. Selecting appropriate audit teams and assigning their roles and responsibilities 4. Conducting audits 5. Conducting audit follow-up, if applicable 6. Monitoring and performance and effectiveness of audit programme 7. Reporting to Top Management on the overall achievements of the audit programme
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Planning of Audit
Objective of QMS
Overall objective is to enhance customer satisfaction by meeting their requirements
Emphasis should be put on the following key themes:
All QMS processes must be planned, implemented, measured and improved ISO 9001 requirements focus on controlling QMS processes, not product QMS controls must emphasize prevention of nonconformities rather than detection. QMS processes must be customer focused. Process personnel must be aware of and strive to meet internal and external customer requirements. Continually improve the effectiveness of the QMS.
CUSTOMERS REQUIREMENTS
INPUT
Product
OUTPUT
Value-Adding activities
Information Flow
CUSTOMERS SATISFACTION
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Do: Implement & communicate Set responsibilities Write procedures Establish controls Training Check: Monitor compliance Audit & Inspection Sample & measure Report non conformities
Achieving Compliance
System Linkages
Risk Assessment
Legislation
Goal: One stop shop document for each process and task.
Business Controls
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4.4.3: Documentation requirements, 4.5.4: Handling non conformities, 4.6.2: Corrective & preventive action
Control of documents & data Control of records Control of non conformities CAPA
Goal: Common procedures for these systems and clear priority on CAPA for the business as a whole
Goal: Common vision, goals and priorities for the business as a whole
Core Systems
Management Responsibilities
Saves time Must focus on processes (not system elements) Use auditors & specialists to achieve competency Carefully define the scope of the audit & criteria
Equipment Infrastructure
Process
Goal: Common vision, goals and priorities for the business as a whole
How Many?
Performance Indicators
How?
IMS Audit
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Perception: Fear:
Too Hard:
Lack of Control:
Nice try Mike but Ive just spent the last 5 years trying to get everyone to follow the Q/E/H&S procedures we need to maintain the focus not dilute it!
Write a policy for the IMS Define the system write a well structured manual to act as your instruction book Make sure you have well developed process understanding Install common system elements
Implementing an IMS
Encourages risk management across the business Gives a competitive edge more holistic approach to business management Stakeholder satisfaction systemic approach to risk, governance across the business Common goals across the business You should not integrate to save a few on Certifications costs!
Benefits of an IMS
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So in conclusion
PAS 99 Simple framework to use Genuinely drives a risk based approach to management Simplifies systems Can lead to internal savings
But Translate your system Ensure common processes Ensure correct competencies are sustained
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