Thorough or sketchy? Does duplication of effort exist between sub-functions? Are any non-value added steps apparent? Does the overall process complement the expressed or implied quality objectiv es of the organization: short-term customer satisfaction, long-term repeat business, continued profitability and growth? The word "audit" in product audit is somewhat of a misnomer.
Actually, a product "audit" is a detailed inspection of a f inished product performed prior to delivering the product to the customer. It is a test of both attribute and vari-able data i. Results of product audits often provide interesting bi ts of information regarding the reliability and effectiveness of the overall quality system.
Product audits are usually accomplished for one or more of the following reasons:. During a compliance audit, the auditor examines the written procedures, work instructions, contractual obligations, etc. In essence, it i s a "say what you do — do what you say" type of audit. Specifically, the compliance audit centers on comparing and contrasting written source documentation usually the contract to ob jective evidence in an attempt to prove or disprove compliance with that source documentation.
A first party audit is usually performed by the company or a department within the company upon itself. It is an audit of those portions of the quality assurance program that are "retained under its direct control and within its organizational structure.
However, employees within the department itself may also conduct an assessment similar to a first party audit. In such an instance, this "audit" is generally referred to as a "self assessment. The purpose of a self assessment is to monit or and analyze key intradepartmental processes which, if left unattended, have the potential to degenerate and negatively affect product quality, safety and overall system integrity.
These monitoring and analyzing responsibilities lie directly with those m ost affected by departmental processes — the employees assigned to the respective departments under examination. If performed properly, first party audits and self assessments:. Unlike the first party audit, a second party audit is an audit of another organization al quality program not under the direct control or within the organizational structure o f the auditing organization. A company may also elect to perform an internal audit of its quality control systems on a periodic basis.
Members of the audit team are typically professionals who have extensive knowledge about auditing standards , procedures, and principles. In addition, auditors should have hands-on experience with examining, evaluating, and reporting on whether each aspect of a quality system is deficient or satisfactory. In a typical quality audit, the auditor first formulates a system audit plan.
Transfer of audit clerks:. It is useful for auditor to transfer the work of auditor to another clerk in case of emergency any audit clerk can go on leave. The auditor can ask another audit Clerk to count the work of the first clerk. Audit staff supervision:. It is beneficial for auditor.
He can supervise the activates of audit staff the can use the audit program as basis of supervision. Every part of audit work can be competed as per schedule. He can control the activities of audit staff through observation and direction when the audit work is going on. Need of audit staff:. It is helpful to determine the number of person needed to do the work. The staff requirement is essential for every auditor.
The shortage of staff means slow progress the exact number of senior and junior audit clerks can be determined. In this way an auditor is able to bundle the audit work properly. Other advantages:. The other advantages are workload distributed, completion of work on time, guidance from senior auditor, work completed on time, negligence control, junior auditor may trained.
In order to understand the program for internal audits, it is first important to know what an internal audit is. Quite simply, in an internal audit you will have a designated person look at a process, and compare the process outputs to the planned arrangements for that process, to make sure that they match.
First, an audit checklist is created to define the planned arrangements that will be checked, often from review of a procedure or the ISO standard requirements, and then the auditor will review the process outputs to see if the identified details are occurring.
The audit will include looking at the records of the process, interviews with employees, and witnessing the process being performed to ensure that what is happening with the process is what was planned to happen.
The auditor will look for the outputs to conform to the plan, but if they find that this is not the case, they will identify the problems found so that the process owner can find the root cause of the problem and apply corrective action to ensure it does not happen again. Each audit needs to have its criteria and scope identified, auditors need to be chosen to be objective and impartial, results need to be reported to management, and action needs to be taken to address any nonconformities identified.
For some details on creating checklists to perform internal audits, check out How to create a check list for an ISO internal audit for your QMS. The ISO requirements for the audit program ask that you plan, establish, implement, and maintain an audit program, meaning that you need to have an ongoing program in effect. The audit program relies heavily on a schedule of all audits, which can be as simple as a spreadsheet or calendar of the audits to be performed, but it is more than just an audit schedule — it is the entire procedure you will follow to maintain your internal audits.
The audit program also needs to consider the following information that is particular to the company being audited:.
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