Chapter 04.Performing an audit Session Plan Format: Student led training & open discussion Objectives: Understand the methods for gathering the information and audit evidence, and requirements of ISO 19011 & 17021 Understand the importance of observation during the audit and in particular observation of production and service provision processes Understand the importance of process focus during the audit and in particular the need to verify every time if the audited process is producing intended outputs Understand the concept of process mapping and its benefits in preparation for auditing a process OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 2 Performing an audit How do auditors find evidence ? • Reviewing the documentation (ex :documents, records, procedures, drawings, specifications etc) • Reviewing the analyzed data / information • Interviewing people at all levels • Observing practices and physical environment / conditions/ controls NOTE: Can/should the auditor cover all people, documents and records during the audit? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 3 Performing an audit What documents should be reviewed as part of Document review? ►System manuals ►System / Operational Procedures ►Work instructions ►Other documents ►Records Should all documents be reviewed ? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 4 Performing an audit Observations ► Keep observing the physical evidence: Facilities, equipment, instruments Infrastructure,conditions, controls records Observation – What to Look for Posted Procedures Structure & Organization Actual Operations Communications Postings Control Points Awareness Reminders Operating Logs Calibration Tags Instruments with Process Infrastructure Measurements Inspection Logs OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 5 Performing an audit Auditor Proverb: “Seeing is believing” Visit the field! See the 'real world'!!! production /service lines/activities, controls, inspections/ audits/ monitoring nonconforming product /service management; talk to people on the field - if you can hear them and understand !; watch the processes as and where they happen; check what is happening and maintenance systems; storage locations and conditions; product segregation; product handling, marking, verify against the stated/ documented version of events and processes… ask what the dials and meters are indicating about process monitoring and measures. packing; Operations such as data entry Keen observation is one of the keys to successful audit OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 6 Performing an audit Spell out 3 types of approach for Auditing Product based approach Process based approach System based approach What will be the different steps for each of these approaches ? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 7 Performing an audit Auditing using Process Approach 4. With What? (Materials/Equipment/People) 3. Inputs 1. 5. With Who? (Competence/Skills/Training) Bid/Tender Process (Activities) 7. How Effective? (Measurable Objective) OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 2. Outputs 6. How? (Methods/Procedures/Techniques) 8 Performing an audit Auditing using Process Approach 4. With What? (resources) 5. With Who? (Competence/Skills/Training) - Specific skill sets – product knowledge, commercial skills, etc - People - Information - Office Equipment 3. Inputs - Customer requirements - Legal requirements - Organisations requirements 1. - Bid/Tender Process (Activities) Identify customer needs Review feasibility Perform cost calculations Prepare offer document 7. How Effective? (Measurable Objective) - Success rate - Accuracy - Timliness OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 2. Outputs - Approved bid - Or a regret letter 6. How? (Methods/Procedures/Techniques) - Procedures, work instructions - Price lists, forms - Formulae for calculations 9 Performing an audit – Process Approach Planning for an audit using process approach • Understand the nature of products / services offered • Identify key / typical requirements of customer for products / services • Identify the key Customer oriented processes (COP), Support Oriented Processes (SOP) and Management Oriented processes (MOP) •Schedule the audit plan to include COP’s, MOPs & then SOPs in that order. OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 10 Performing an audit – Process Approach What are Customer Oriented Processes..? What are Support Oriented Processes What are Management Oriented Processes..? How do you monitor & measure any process ? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 11 Performing an audit Why Prepare a “Checklist” before an Audit? ► to assist memory ► to ensure covering all issues and control points ► to ensure depth & continuity of the audit ► help in time management ► organise note taking ► part of audit report OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 12 Performing an audit Checklist Format ► Leave space for notes ► Allow space for time control and recording Inquiries Evidence and Results Production Area (8.1) Interview Production ► Reference the requirements of audit criteria Manager about production planning. Plan, results. Observe equipment and settings ► Reference the control documents Employee interviews (5.2.2, 7.2) Are you aware of the quality policy? ► Reference verifying documents (records) How does the policy relate to what you do? What type of training have you had on QM? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 13 Performing an audit Checklists should: Checklists should NOT: Be specific for a given QMS. • Narrow the vision or limit Be prepared using QMS documentation. evaluation. • Obstruct communication. Be clear about evaluation criteria. Note documents to review. Identify records to sample (and sample size). • Be too strict or constraining. • Be a script of exact questions. • Restrict auditor’s inquiry. Identify key people to interview. • Be yes/no lists. Include some key questions for • Be completely generic. interviews. Note physical evidence you expect to see. OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 14 Performing an audit Follow Audit Trails As you audit you will find interesting opportunities for follow-up (audit trails). Pick promising audit trails: ►Follow it through ►Interact with team OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 15 Interview Top Management Obtain evidence of leadership and commitment Observe attendance and interest in opening, closing and feedback meetings Review documents: Quality policy Objectives Management reviews records Interview members of top management: Do they know “their” system? Do they monitor, analyse data, draw conclusions, define actions? Interview personnel at other levels: Do they understand what top management is trying to communicate? OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 16 Performing an audit Always take notes ►Explain the need to take notes to auditee ►Make your notes: OCT 2015 Comprehensive Accurate Precise Legible QMS Auditor / Lead Auditor course (A 17929) 17 Performing an audit Time management ► Time is always short ► Plan well ► Do not allow your audit to get side-tracked ► Do not dig too much (beware false audit trails) ► Do not focus on trivia ► Remember an audit is a sampling Can 3rd party auditors provide solutions as well..?.... OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 18 Performing an audit 3rd Party Auditors cannot give advice on how to correct non-conformities. (However, auditors must write very clear non-conformities.) This is the finding. It is up to you to decide how you want to correct this. Ref :ISO/IEC 17021 OCT 2015 QMS Auditor / Lead Auditor course (A 17929) 19