THE DYNAMICS OF A QUALITY AUDIT

What is a quality audit and what is the purpose of a quality audit? Is a quality audit similar to a financial audit? Is an audit the same as a surveillance or inspection?

A Quality Audit is a periodic, independent, and documented examination and verification of activities, records, processes, and other elements of a quality system to determine their conformity with the requirements of a quality standard such as ISO 9000.

There are very many definitions of a quality audit but all point to the same thing. As an agent of simplicity, I will define Quality Audit as a systematic, independent and documented process of being certain that what is done in practice is in agreement with set policies, procedures and processes.

It is systematic in the sense that it is carried out using a planned, ordered procedure. It is methodical, regular and orderly. It is independent in the sense it must stand on its own without due or undue influence. It is documented in the sense that there must be records.

The purpose of a quality audit is to assess or examine a product, the process used to produce a particular product or line of products or the system supporting the product to be produced. A quality audit is also used to determine whether or not the subject of the audit is operating in compliance with governing source documentation such as corporate and regulatory directives, federal and state environmental protection laws and regulations, etc.

TYPES OF QUALITY AUDIT

SYSTEM AUDIT

This addresses the who, what, where, when and how of the quality system used to produce its product. It is characterized by its emphasis on the macro nature of the quality management system. A quality system audit is defined as a "systematic and independent examination used to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives." (ISO 10011-1 (1990)).

PROCESS AUDIT

This compares and contrasts the manner in which the end product is produced to the written procedures, work instructions, workman-ship standards, etc., used to guide the manufacturing process responsible for building the product in the first place. It has Appraisal and Analytical modes. The Appraisal modes seeks to find out if personnel adhere to instructions, procedures and standards while the Analysis mode questions/validates the work procedure used to support the processes under audit.

PRODUCT AUDIT

Product audits are usually accomplished for one or more of the following reasons: to estimate the outgoing quality level of the product or group of products; to ascertain if the outgoing product meets a predetermined standard level of quality for a product or product line; to estimate the level of quality originally submitted for inspection; to measure the ability of the quality control inspection function to make quality decisions, and; to determine the suitability of internal process controls. It is mostly associated with but not limited to contract manufacture.

COMPLIANCE AUDIT

This is basically a "say what you and do what yo say" audit. Written procedures, work instructions and contractual obligations are examined to ensure they agree with set standards.

KEY INDICATORS OF QUALITY

I have developed my own way of assessing a facility to know the degree of auditing work required. There are key indicators I look at to arrive at the conclusion of whether to do a painstaking audit or not. I will share them

1. Review previous audit reports: this will give you an idea of how committed Management is towards Continuous Quality Improvement. If recommendations of previous audits have not been implemented, what's the need carrying out another one that may end up not being implemented?

2. Review consumer/customer complaint register: No product is perfect. Our major objective is to keep complaints within tolerable limits not eliminate them entirely. Consumers are bound to have complaints so every producer must deploy suitable mechanisms to get these complaints and act on them if vital. A review of this information will point the way forward for an Auditor.

3. Inspect Toilets and Cloak Rooms: If these areas are not neat and tidy, the facility has a cleaning problem. You don't judge the neatness of a home by the appearance of the living room or parlour. The kitchen or toilet is best. What is the point of keeping food processing area neat and clean when personnel will use dirty toilets and cloak rooms?

4. Look for cobwebs: cobwebs exist only where there are spiders. A good fumigation program will kill all spiders. If there are spiders then expect to see other rodents and pests. The presence of cobweb is an indicator of no or bad fumigation/pest control.

5. Training Records: training records show an Auditor where there are defaults so he can lay emphasis on those areas in order to correct them. If a particular training is being given all the time then a system/operational review is necessary.

That all the above are in order does not mean that a quality audit should not be thoroughly done. The above are simple indicators  Quality Auditor can look at to know the extent of work required. If the above are in order it's an indication that the facility is working towards quality improvement.

It must be stated clearly that Quality Audits are never adversarial or confrontational but advisory and correctional. Quality Audits should be formal, planned, and organized. It must be conductedin an impartial objective manner following an agreed scope and procedure. Audits are used to gather facts and determine the degree to which requirements are being met.