internal-auditor.com www.internal-auditor.coma function of the Manufacturing and Industrial Resource Center |
| Page 1 of 2 | October, 1999 |
| This Month's
Feature: How to find "Objective Evidence" In any type of audit, be it an internal audit or an external audit, the auditor is seeking what is called "Objective Evidence". We use objective evidence to prove our documented quality system (DMS). But just what is "Objective Evidence", and how do we obtain it? The first step in knowing how to obtain objective evidence is learning to recognize it. To do this you must first know what objective evidence is. ISO 10011-1:1994 describes it this way: "Qualitative or quantitative information, records, or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement, or test and which can be verified." (ISO 10011-1:1994, 3.7 Objective Evidence) The key, for internal auditors is "...based on observation, measurement, or test and which can be verified." Our job, as internal auditors is to find those verifiable things that support "...the quality of an item or service or to the existence and implementation of a quality system element." What we are looking for is "Qualitative or quantitative information, records, or statements of fact..." We look for these through "...observation, measurement, or test." Generally speaking we use three tools to obtain objective evidence.
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Featured Book: Title: The Quality Audit Handbook:Author: J.P. Russell (editing director)Publisher: ASQNotes: This is an excellent overview of the auditing system. Although experienced auditors may find parts to be rather elementary, even the most experienced will glean some wisdom from its pages. This book is a "must-have" in any auditor's bookshelf (provided of course that it actually gets read).You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm. |
| Tips/Tricks/Laughter: Audits can be rather unnerving, especially to newer employees. Two ways to lessen the anxiety of audits (either internal or external) are through education and involvement. The more an employee knows about the upcoming audit (like what the auditor is looking for, what question may be asked, etc.), the less likely they are to be stressed during the audit. Also, the more involved they are, the more they can anticipate the audit. In both cases, there will be less stress, and the audit should go smoother. |
| Observations from the field: Build objective evidence in your quality system. One way to ensure you meet the intent of the standard is to actually place, in your procedures, what the objective evidence of compliance will be. This will accomplish two things: First, it gives you a frame of reference in your implementation. Also it provides all auditors, internal and external, guidance to determine if your practices are in fact compliant. One caveat though, don't get locked into stagnation. As your quality system matures, your objective evidence should also mature. Continuous improvement activities and management review (as required by 4.1) should look at the objective evidence and make changes as necessary. |
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You can be a part of internal-auditor.com. Your submissions help make this publication work. You can send all contributions to: Ruth Ellen, Ruth Ellen Carey Communications, 3698 Heathwood E., White Lake, MI 48383 USA. You can also email them to contribution@internal-auditor.com. If we use your contribution, we will either provide you with a free one-year subscription, or extend your subscription for one year. Good Auditing!
internal-auditor.com www.internal-auditor.coma function of the Manufacturing and Industrial Resource Center |
| Page 2 of 2 | October, 1999 |
| This Month's
Feature continued: Observation: During our audits, we observe things. Are the procedures being followed? Interviewing: Interviewing (this will be covered in later sessions) is a mixture of skill and art. Auditors, as interviewers, must be careful not to interject bias into the interview process. We ask questions, verify and record answers. Do employees know the procedure? Where are work instructions? How do employees know what to do? How are emergencies, and nonconforming product handled? These are just a few of the questions that must be answered. Examination: Examination is the sitting down and reviewing of records. We compare invoices, po's, etc. to see if the vendor is approved. We look at calibration records, inspection records, training records. We look at the recordkeeping procedure to determine if records are being kept as per procedure. It is not uncommon for this to become the largest time thief during an internal audit. But it yields great rewards. One thing I always examine is corrective actions. I check to see if corrective actions lead to changes in such documents as FMEAs, Quality (control) Plans, SPC requirements, inspection work instructions, etc. Continuous Improvement mandates that as we improve, or make corrections, or errors, our inspection and statistical processes should change accordingly. |
Internal Auditor Resources: The Manufacturing Extension Partnership is a good all-around resource for manufacturing. Their website is: The Registration Accreditation Board, or RAB is now offering certification of internal auditors. Their website is: |
| Questions and Answers: Q-Where can I get formal internal auditor training? A-Most consulting companies, and some registrars offer training for internal auditors. Internal-auditor.com may offer some form of training in the future. Your best bet may be to contact your local MEP center. Most of them offer courses in internal auditing without heavy pushing of additional sales . Keep in mind that formal training is not required, but usually recommended for effectiveness.Q-How do I get certified as an internal auditor? A-First of all, you do not need certification...only trained. If you desire certification, or if your employer requires it, visit: http://www.internal-auditor.com/ home page. We have more information and links there. |
| Element Understanding: 4.17 Internal Quality Audits [Part 1] "...to verify whether quality activities...comply with planned arrangements ..." Your "quality activities" are things you do which relate to the quality of your product/service. Your "planned arrangements" are those items that make up your quality system. This is the "do as you say". Objective evidence is used to show that your "do" complies with you "say". Of course your quality system must also comply with the standard. The key to any component to a quality system is consistency. The less variation, the greater stability. (Gee...kinda sounds like SPC talk.) A later session will discuss applying SPC rules to quality system management. |
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