Arjyh Romero

Extracted from ISO/TS16949 Process Approach Internal Auditing Prepared by: Arjyh Romero Date: Nov. 5, 2007 Report No./Rev.: Confidential Report Contents Session 1 – Introduction to Auditing Session 2 – Audit Overview Session 3 – Process Approach Session 4 – Audit Core Tools Introduction to Auditing What is Audit: - A “Check and Balance” process to ensure activities are performed in an appropriate manner - Usually conducted on an independent basis. - Objective evidence is required (like “the action”, “the words they say”, etc..) Formal definition of an Audit: - A “Systematic, Independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled” Source: ISO- Introduction to Auditing Internal Audit: There shall be: * Planned intervals; annual plan of Audit * Audit Criteria, Scope, Frequency and methods shall be defined * Auditors shall not audit their own work (independence of Auditee) * Documented procedures * Action are taken without undue delay * Follow-up on actions taken and record results * Cover all shifts * Internal Auditor Qualifications (knowledge on ISO requirements) Introduction to Auditing Types of Audit: * Quality Management System Audit - The Organization shall audit it’s Quality Management system to verify compliance compliance with this Technical Specification and any additional Quality Management System requirements. * Manufacturing Process Audit - The Organization shall audit each Manufacturing Process to determine it’s effectiveness (Control Plan) * Product Audit - The Organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency. Introduction to Auditing Purpose of Conducting Audit: * Looking at the over-all process * Auditing for conformity * Auditing for effectiveness (achieving the set goal/target) * Approving Suppliers/Subcontractors * Assessing for certifications * Investigating problems * Ways of Improving Introduction to Auditing Common Internal Audit Failure: * Perceive audit as waste of time * Incompetent auditor selection process * Lack of proper system to train auditors * Inadequate process to evaluate ability to perform audit * Over-reliance on QC department * Poor auditor judgment leads to lack of confidence in internal audit result * See auditors as fault-finder or trouble-maker Audit Overview Typical Internal Audit Cycle: Planning the Audit Conducting the Audit Reporting the Audit Corrective Action and Follow-up Process What is a Process: - Set of interrelated or interacting activities which Transforms Inputs into Outputs. What is a Process Approach: - For an organization, there may be numerous inter-linked process. - The systematic identification and management of the various processes and the interactions between such processes may be referred to as “Process Approach” to management. Process Model of Process Based QMS Continual Improvement of the Quality Management System Customers (and other Interested Parties) Customers (and other Interested Parties) P Management Responsibility D Customer Requirements Measurement Analysis Improvement Resource Management Product Realization Product A Customer Satisfaction Output C Manufacturing – Transformation of raw materials to Product Product Realization – Transformation of Customer requirements to Customer Satisfaction. Process Functional Vs. Process Approach Customer Functionality Thinking Priority: to meet Functional objective Customer Process Thinking Priority: to meet Customer needs Process Auditors Perspective: * Each Customer Oriented Process in detail is complex and involve many sub-process performed by various functions of the organization * Some of these sub-process do NOT have direct interface with the customers * Depending on the nature and organization perspective, these process can be classified as Support and Management process. Process Types of Processes: Organization Management Process Input Customer Customer Oriented Process Output Support Process Process Types of Process Examples: Support Process Examples Management Process Examples Database Management Capacity Planning Maintenance Business Planning Internal Audit Project Management Management Review Supplier Management Training Material Planning Tooling Management Manpower Allocation Document Control Process What To Look For: 3 Aspects Improvement Effectiveness Conformance Process What To Look For: 1. Conformance What should be done What is actually done * Conformance is the basic principle * Compare the actual activity against the audit criteria Process What To Look For: 2. Effectiveness - Effectiveness of a process is shown by the result it achieved with the delivered output. - Hence, auditors shall look at indicators/measurable metrics to tell if customer requirements are met. Process Delivery Production Inspection/test Planning Metrics On Time Delivery (OTD) Yield, Utilization, Cycle Time, Cpk, PPM, DPMO Defect Rate, Pass Ratio Delay, Progress vs Plan Process What To Look For: 3. Improvement - Look for trends - Compare current results against past result Daily DPMO for Line:____- 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Process Process Analysis: * Every Process has these characteristics - Process Owner(s) - Process is defined and if appropriate, documented. - Process linkages/interface of the process are establish - is monitored to tell the performance and is improved if needed - has records to show as evidence Process Audit by Process Approach: How? (Method, Technique) Input With What? (Equipment, Material) With Who? (Skill, Training) Process Output What key criteria? (Measurement, Assessment) Other then Input and Output, Auditor should look at “Who Does What”, “With What”, “How it is Done” and “Key Criteria Measured”. Process Question Auditor Should Ask: * Who is the Process Owner? (P) * What is the Purpose of your Process? (P) * What are the inputs to to your Process? (D) * What are your Process Outputs? (D) * What type of Process are you Working on? (D) * What are the Important Process Parameters? (D) * What do you Measure about your Process? (C) * What do you do with this Measurements? (A) Note: Guide/Pattern in Developing a Checklist (follow the PDCA cycle) Process What Auditors Need to Look at?: * Auditor need to look at the process from different aspects and ask the essential questions. What is the Objective? Process Objective: the Means to measure the Process effectiveness What is the process Purpose, the intention Of the Process Input What are the inputs, Resources required Before the Process Can begin Process Output What is the end product, Service delivered upon Completion of the Process * How is it Monitored and Measured? * Is it Effective? Is it Efficient? * Do the result meets the Objective Conducting an Audit Audit Plan and Contents: * Audit Planning should include the following activities: - Identification of Process based on Quality Management System Documentation and any additional information provided by the organization - Analysis of the Process according to the criteria * Products and/or service provided to the customer * Risk to the Customer * Interfaces (Inputs/Outputs) * Possibilities to Group process for economical and effective audit - Prioritization of audit activities considering * Follow-up issues of prior audits (external/internal) * Customer complaints * Value (add) to audited organization - Finalization of Audit Plan including sequence/process steps, timing and interview partners. * Objectives of Audit; Audit Scope, Documents required, Persons you want to see and timetable of events. Conducting an Audit Collecting and Verifying Information Methods include: Question (Ask them what they do) •Interview •Observe activities •Review Documents Audit Triangle Observe Check (See what they actually do) (What the procedure says That they should do) Note: For a smooth flow of audit an Audit check is necessary Conducting an Audit Where to look for information: * Observe activities and surrounding work environment * Examine records - Inspection/Test reports, meeting minutes, result of measurement * Ask for documents - Objectives, Procedures, Plans, Instructions, Specifications, Drawings, etc.. Sampling: * Sampling cannot be statistically significant * Select examples such as: (product model, part number, etc.) * Follow Audit Trail, using the example to provide you with evidence of conformance to the Standard Process Key points for Interviewing: * Who do we audit? - the person responsible for the activity to be audited * How to begin? - ask the auditee to explain/describe the activity * When? - during normal working hours Key points for Interviewing: * Ask Open Questions (not answerable by “Yes” or “No”) - Encourage the Auditee to talk freely - Use What, Where, When, Why, How and Who? (how is the best question) * Probing Questions (Investigative Questions) - Follow-up questions or focusing on more precise details. * Closed Questions (answerable by “Yes” or “No”) - Used where you want a clear answer “Yes” or “No” and don’t forget the Please Show Me Audit Core Tools Relations of Core Tools Feasibility Review Contract Review APQP Phase 1 APQP Phase 2 APQP Phase 3 APQP Phase 4 Planning Product Development Process Development Validation MSA SPC PAP PAP APQP Phase 5 Mass Production Report Contents E N D