Quality Management Systems - Page 2 of 2

Quality Audits and Corrective Action Systems

Quality Audits

Any organization needs a mechanism by which it can check whether or not its operations are complying with all standards defined to meet its charter and objectives.  This is the purpose of quality audits: to ensure that the company has documented standards or specifications on how to do things and that these standards are complied with at all times. 

Simply put, a quality audit consists of  preparing a list of items (procedures, equipment set-ups, quality records, measurements, etc.)  to check and going to the areas responsible for these items for an actual check or audit of these items. The audit may be performed by a person (the auditor) or a group of persons (the audit team). 

Using the audit plan or checklist as basis, the auditor proceeds by asking questions, reviewing documents, checking records against specs, making measurements,  etc. to ensure that all the audit items have adequate documentation and are implemented in accordance with the documentation. There are three types of audits: 1) first-party or self audits; 2) second-party audits; and 3) third-party audits. 

First-party audits, also known as internal or self audits, pertain to audits wherein the auditors themselves are employees of the company being audited.  Some companies let people directly audit the areas they are responsible for, while some companies ask people to audit areas that are not under their jurisdiction. Self-audit teams are usually composed of three or four people.

Second-party audits involve a direct customer of the company being audited as the auditor. Needless to say, a second-party auditor has a direct interest in how well the auditee adheres to the standard, even if he or she is not an employee of the auditee.

Third-party audits pertain to audits wherein the auditor is an independent, third-party entity not related in any way to the company and the company's customers.  Third-party auditors are usually hired by the company to conduct audits that will help the company get certified to a certain quality standard, such as the ISO 9000.  

Gap Analysis and Corrective Action System

The world is not perfect, so there will always be room for improvement within the company.  Gap analysis is the comparison of what actually goes on within a company to what is required of the company. At a high level, it pertains to the comparison of the existing quality system and its current implementation to the requirements of external standards.  At a different albeit equally important level, gap analysis is the comparison of the company's actual practices with its quality system requirements.  The objective of gap analysis is to identify as many discrepancies as possible in order to systematically address them through a corrective action system. 

Gap analysis and corrective action pertaining to quality system conformance to external requirements are often addressed by a special team composed of personnel who have the expertise and authority on the element being analyzed. Simply put, this team will review the company's quality system against the conformance model it was or will be certified to, as well as applicable government regulatory and statutory requirements.  Any gaps will then be addressed by instituting process changes and making the necessary documentation revisions.

Just as there is a need to do gap analysis at quality system level, there is a need to do gap analysis at product/process conformance level.  Thus, a company's quality system must include a gap analysis (GA) mechanism and corrective action (CA) system for product/process conformance discrepancies. No matter how mature a company's operations are, there will be glitches along the way.  An effective corrective action system will minimize, if not preclude, the recurrence of such glitches in the future.

At a minimum, the GA/CA system of the company must have a standard procedure for: 1) highlighting detected discrepancies and initiating a GA/CA request; 2) documenting the gap analysis results; 3) identifying and documenting containment and corrective actions; 4) proper disposition of affected products, if any.  

<Back to Page 1 - The Basics of Quality Management Systems>

See Also:  Quality Audits;  Corrective Action System; Monitors and Controls; Document Control;

The ISO9000 Standard; Metrology and Calibration