© 2003 – 2004 Practical Perspectives TM Getting Started A Brief Look at Using This Audit System ISO 9001:2000 Revision: 2/20/2004 © 2003 – 2004 Practical Perspectives PRACTICAL PERSPECTIVES Brought to you by:

© 2003 – 2004 Practical Perspectives The Audit Process Audit Schedule(s) Opening Meeting Materials Audit Summary and Audit Report Additional Questions A Completed Audit Report Management Summary Closing Meeting The Rest of the Story (Audit Procedure) © 2003 – 2004 Practical Perspectives

Examples and/or Explanations are in Blue An annual audit schedule based upon audit reports, which are in support of ISO 9001:2000. Basis for number of audits per year. Audit Schedule – Annual Plan (frequency and planned intervals of the audit program per ISO 9001:2000) Audits are spread out to balance the work load. May be subdivided by process(es) for audits covering more than one area (i.e., Production and Service Provision may involve multiple processes). © 2003 – 2004 Practical Perspectives

Examples and/or Explanations are in Blue An event-based schedule, using a team of auditors to audit the entire system. This schedule tends only to be used when a team is involved or when we are auditing a large portion of the system all at once. Examples and/or Explanations are in Blue Fill in the amount of time (hours & minutes) and the hours per day calculate automatically. Once you know how much time to designate for each, it’s just a matter of setting the time slots and getting the client (person requesting the audit) to tell you who the guide will be. © 2003 – 2004 Practical Perspectives

OPENING MEETING CHEAT SHEET Opening Meeting Materials (when we decide we need an opening meeting) When should we conduct an opening meeting? An opening meeting is typically done when the audit involves a large group, more than one area or process, and/or when an external party (customer, registrar, etc.) is involved, but can be done for any audit. It’s really up to you. Lets us keep track of who attended, so we can prove management was aware, when necessary. Opening Meeting Sign-In Date: ______________ NAME TITLE What an opening meeting should cover. OPENING MEETING CHEAT SHEET PRACTICAL PERSPECTIVES Greeting Thank them for the invitation & provide a brief introduction of audit team. Pass around attendance log Printed names & date. Defer questions to the end Questions may be answered in the information provided. Purpose of audit & scope Verify compliance with the ________ standard & conformance of effective practices to documented system. Note: This is where you normally describe the process (desktop review, audit, & report/conclusion), with the scope being to verify effectiveness of the system to the applicable standard. Audit process disclaimer Random sample. Verify availability of facilities & guides Set time for Closing Meeting Auditor Confidentiality Auditor code of ethics requires confidentiality. Open up for questions (applicable) © 2003 – 2004 Practical Perspectives

“I” is done at the beginning, “II” & “III” are done during the audit, and “IV” & “V” are done at the end. ONE GETS FILLED OUT FOR EVERY AUDIT (in essence, this is the cover sheet for each audit and is filled out along the way) On this page: Blue = tutorial Dark Red = example Title of the applicable audit report goes here. The auditor is either happy with what was seen or sad they found something. © 2003 – 2004 Practical Perspectives This section tends to get filled out from notes from the audit report and with area management near the end of the audit. The number corresponding to the finding on this summary or the individual audit report used. The examples shown are write-ups from “General Issues” (line II) and from section “2” of the “Training” audit report. Simply put, the “Line Number” represents the location where the finding came from, so we can have traceability to the issue at hand.

Examples and/or Explanations are in Blue Audit Reports (like this one) have been developed to cover all of the requirements, in a process-oriented manner. Each one includes a flowchart (an overview of the audit being performed) and lays out the series of events, including the evidence and conclusions reached. In other words, the flowchart is fulfilled simply by answering the questions. Audit Report – Training 5.3d, 5.5.1, 6.2.1 & 6.2.2 The numbers over each question relate to the flowchart and allow for traceability when a finding or improvement opportunity is identified. Questions include the clause(s) in ISO 9001:2000 so you can fall back on the standard if needed. © 2003 – 2004 Practical Perspectives The auditor is either happy with what was seen or sad they found something. Directions provide a starting point and suggested sample sizes. May be a definition, examples of what to look for, or scenarios to consider. Additional questions can and should be added where procedures call for requirements greater than those in ISO 9001:2000 (regulatory, customer, legal, those the organization imposes on itself, etc.).

A Completed Audit Report On this page: Blue = tutorial Dark Red = example Audit Report – Training 5.3d, 5.5.1, 6.2.1 & 6.2.2 © 2003 – 2004 Practical Perspectives It is possible to have J and L or more than one J or L on any given question, when the evidence tells you some of the item is done correctly (i.e., happy some are right, but sad to say it is not enough) or a question has more than one piece of evidence collected.

ONE GETS FILLED OUT FOR EVERY AUDIT (here is the completed summary for the completed audit report on the previous slide) On this page: Blue = tutorial Dark Red = example “IV” & “V” are done at the end. Don’t forget to score the audit. © 2003 – 2004 Practical Perspectives The Audit Report should be attached and this record filed per records control procedures. When everything is dealt with and verified as being effective, the audit coordinator closes out the audit.

CLOSING MEETING CHEAT SHEET Closing Meeting Materials (when we decide we need a closing meeting, especially if we already had an opening meeting) When should we conduct a closing meeting? A closing meeting is typically done when the audit involves a large group, more than one area or process, and/or when an external party (customer, registrar, etc.) is involved, but can be done for any audit. It’s really up to you. Lets us keep track of who attended, so we can prove management was aware, when necessary. Closing Meeting Sign-In Date: ______________ NAME TITLE What a closing meeting should cover. CLOSING MEETING CHEAT SHEET PRACTICAL PERSPECTIVES Greeting Thank them for the audit opportunity & the guides for participating in audit. Pass around attendance log Printed names & date. Defer questions to the end Questions may be answered in the information provided & allows those needing detail to stay while the others are free to leave. Purpose of audit & scope Verify compliance with the _________ standard & conformance of effective practices to documented system. Note: This is where you normally describe the process (desktop review, audit, & report/conclusion), with the scope being to verify effectiveness of the system to the applicable standard. Audit process disclaimer Random sample. Auditor Confidentiality Confidentiality due to auditor ethics. Report on results of audit Provide a conclusion Open up for questions Provide client with audit summary (applicable) © 2003 – 2004 Practical Perspectives Reporting on the results and providing a conclusion can be accomplished with the Management Summary! (see next slide)

Management Summary (page 1) Explanations are in Blue (can be used to report the results of audits over the year and/or as the summary for any audit involving multiple areas) Explanations are in Blue Instructions are embedded as comments in the MS Excel file “Management Summary” These are the totals from the Audit Summary for each audit. The “Accept. Rate” calculates automatically. Each finding, noted in the “Issue needing attention…” section of the Audit Summary for each audit is acknowledged as a Major (system-wide breakdown or missing ISO 9001:2000 requirement), Minor (issue needing to be resolved, but not a Major), or Comment (positive or negative feedback that could be acted on to make things better or to prevent potential problems). This is where you note the significant issues (typically in a bulleted fashion) and let management know whether the system is conforming with requirements based upon a score of 80%+ on each checklist and no Major nonconformances. © 2003 – 2004 Practical Perspectives

Management Summary (page 2) Explanations are in Blue (can be used to report the results of audits over the year and/or as the summary for any audit involving multiple areas) Explanations are in Blue Instructions are embedded as comments in the MS Excel file “Management Summary” OBSERVATIONS & ACTIONS TAKEN, WHERE KNOWN Reference to what is not being lived up to. Each finding, noted in the “Issue needing attention…” section of the Audit Summary for each audit is documented in this section to provide management with an overall ‘laundry list.’ The FINDING forms the basis upon which the MAJOR/MINOR/COMMENT conclusion is made on page one of this summary. REPORT & SECTION OR LINE # is how we tie the finding back to the actual audit. The OBSERVATIONS & ACTIONS TAKEN, WHERE KNOWN is where we quote the requirement(s) not lived up to (paraphrased as much as possible) and a summary of the evidence supporting the finding. The action taken, including evidence of effectiveness would also be helpful. © 2003 – 2004 Practical Perspectives

© 2003 – 2004 Practical Perspectives The Rest of the Story While this tutorial provides a nice overview, the procedure (including supporting notes) covers the process in detail! © 2003 – 2004 Practical Perspectives

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