This living paper developed and maintained by Kim Niles, is meant to change as you send us your comments, additions, definitions, case studies, or stories, etc.  Please use the on-line form below for submissions or contact any of our officers.  You will be featured in the reference section as appropriate unless requested otherwise.     

 

The following audit guidelines are very similar to those advocated by the American Society for Quality as most auditing functions are officially carried out by the company Quality department in accordance with internal and customer requirements.

Recorded audit related text date back more than 3000 years to Sumeria. Egyptians used "overseers" to build the pyramids. Greeks and Romans used "auditors" during war. Auditors filled out medieval ship logs.

Audits are independent, unbiased, fact-finding exercises that provide information to management in order to reduce the risks of decisions being made by management. Other reasons include finding opportunities for improvement, verifying compliance to regulations, and to provide visible management support for programs.

The ASQ Quality Auditing Index states that Quality audits are used to determine the following about organizations and their processes:

1. The sustainability of documentation as it applies to systems, products, services, processes, and overall management practices
2. The conformity of the operations to established documentation
3. The effectiveness of the documentation and its implementation to achieve intended results

Audits are planned, independent, and documented assessment to determine whether agreed-upon requirements are being met.

The ASQ glossary lists an audit as:  The inspection and examination of a process or quality system to ensure compliance to requirements. An audit can apply to an entire organization or may be specific to a function, process or production step.

Another definition of what an Audit is by Terry M and Nazril I.

Participants include the client (outside or inside), the auditor (performing the audit), and the auditee (being audited).

• Internal: Inside the company. Example, on the manufacturing department by the finance department.

• External: Outside the company

• First-Party: Within the same company on itself.

• Second-Party: External on a supplier by a customer.

• Second-Party Surveys: Assessment or evaluation of facilities, resources, economic stability, technical capability, personnel, production capabilities, past performance, systems and documentation in place, etc.

• Third-Party: On a supplier or entity by a an external participant other than the customer.

• Product: Examination of a particular product for conformance against specification.

• Process: Examination of a process for conformance against established limits.

• Systems: Examination of systems development, documentation, and operation relative to requirements.

• Horizontal: One system across several departments (example: training)

• Vertical: Across several systems (example: non-conformances or calibration of equipment used by many types of systems)

Ethics are important to maintain the integrity of the audit and performance uniformity from auditor to auditor. Honesty, impartiality, safety, sincerity, dignity, modesty, trustworthiness, loyalty, friendliness, courtesy, kindness, and understanding are all traits that should be maintained.

The auditor must recognize and avoid conflicts of interest and or un-ethical situations.  See ASQ Code of Ethics.  at http://www.asq.org/about-asq/who-we-are/ethics.html. 

Establishment of reporting relationships, authority or standards to measure against, operational boundaries, procedures, priorities and schedules, reporting mechanisms, mechanisms for continuous improvement.

• Define the purpose of the audit

• Define the scope (what type of audit, where, etc.)

• Determine the resources to be used

• Identify authorization for the audit

• Identify the standards to be measured against

• Develop an understanding of the product, processes, or systems to be audited

• Contact persons to be audited

• Evaluate all pertinent documents (work instructions, operating procedures, guidelines, etc.)

• Evaluate previous audit reports

• Evaluate corrective actions and closure

• Evaluate complaints and or other measurements of performance.

• Write checklists of needs (data needed, clearance, etc.)

• Write a list of questions that might be asked.

Audit plans are useful to send out in advance of the audit in order to minimize problems. Plans should include the following:

• Date of audit

• Place of audit

• Contact information for all team members and auditees

• Scope and purpose of the audit

• Standards being measured against

• Duration of the audit

• Report issuance date

• Prepare twice as long as the audit will take place.

• Develop process flow charts

• Look for inconsistencies or variation in everything

• Let the auditee do the talking and the auditor only guide the discussion

• Listen well

• Follow discrepancies to the source (develop audit trails)

• Review documents that specify requirements such as procedures, detail instructions, work instructions, workmanship standards, policy manuals, blueprints, drawings, project plans, specifications, strategic plans, certificates of compliance forms, industry practices and methods, forms, schedules, trade practices, service standards, software operation manuals, routing cards, preventative maintenance plans, inspection plans, purchase order forms.

• Planning, see audit preparation steps above

• Conduct an opening meeting to establish final audit logistics

• Conduct the audit writing down specific details of all non-conformances regardless of severity only after they have been discussed (corroborated) with the auditee at the time of discovery.

• Conduct a closing meeting to present the facts of the audit with the auditee

• Write an official audit report with corrective actions required

• Perform a follow-up review of the auditee's response or resolution of corrective actions

• Close the audit once all corrective actions are closed with permanency.

• ASQ Quality Auditing books for sale.
• Institute of Internal Auditors—Organization focused on internal auditing, governance, IT audit, education, and security. IIA is the world's leader in certification, education, research, and technological guidance for the profession and the Institute serves as the profession's watchdog and resource on significant auditing issues around the globe.

• J-E-T-S Quality Consultants—This site contains the out-of-print ASQ Quality Surveillance Guidelines developed by the Energy and Environmental Division along with articles, Department of Energy Assessment Guides and other auditing resources.

• FDA guide to how they inspect companies.  Adobe version 1999 http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF

   

 

We've removed the form but you are still encouraged to email your questions, comments, stories, definitions, links, etc. to Kim Niles. 

 

 

History of updates:

• Added FDA QCIT link October 22, 2007

• Format cleanup, additional site links, and ethics link update thanks to member Jocelyn C. Wolf with OCR   09/07/07

• Original release September 18, 2002

• Jocelyn C. Wolf ▪ ASQ SD Member and QA Manager
• Personal Experience of Kim Niles
• Review and comments by Hank Posters
• ASQ Code of Ethics
• ASQ glossary listing of "Audit"
• Definition of Audit by Terry M and Nazril I.
• ASQ Quality Information Center Reprint Articles on Auditing for sale
• ASQ Quality Auditing books for sale
• ASQ Quality Auditing links 
• Institute of Internal Auditors,  
• J-E-T-S Quality Consultants
• ASQ Quality Auditing Index

Other related articles on our site:

• "Audit Decision Making" - by Pete Maizitis

Other related tool links on our site:

• "Process Auditing Slides" by Ron Sedlock (see May 2006 ed news)
• "Color Blindness Tests" by Toledo-Bend.  (see April 2006).  This link also has links to other types of on-line color blindness tests.  
• "Free Tool: 5S Evaluation" by Unknown  (see Oct 2006 ed news)

• CpK at http://www.asqsandiego.org/articles/cpk.htm
• Statistical Distributions at http://www.asqsandiego.org/articles/distributions.htm
• Auditing at http://www.asqsandiego.org/articles/auditing.htm
• Deming at http://www.asqsandiego.org/articles/deming.htm
• Lost Work Advice at http://www.asqsandiego.org/articles/lostworkadvice.htm