Quality Management and Quality Tools: Audit

As defined in ISO 19011:2011- guidelines for auditing management system,

An audit is a “systemic, independent and documented process for obtaining audit evidence records, statements of fact or other information which are relevant and variable, and evaluating it objectively to determine the extent to which the audit criteria (set of policies, procedures or requirements) are fulfilled”.

There are several audit methods and types which are employed to achieve the audit process.

An audit may be classified depending on the interrelationship among participants.

Internal audit- is performed by employees of an organization. Internal audits are often referred as 1^st party audits.
External audit- is performed by an outside agent. It is refereed as either 2^nd party or 3^rd party.

Types of audit- Three discrete types of audit are-

Product/ services audit
Process audit
System audit

Some audit is named according to their purpose or scope of a department or function. The purpose of audit remains same everywhere that is the assessment of area performance or efficiency.

Some audit categories may be summed up as-

1. Process audit-

It evaluates an operation and method against predetermined instructions or standards to measure conformance to standards and the effectiveness of the instructions. In a nutshell, it is a verification inspection that processes are working within established limits.

Such an audit may –

a. Check conformance to define requirements such as accuracy, temperature, pressure, time, etc.

b. Examine the main resources (equipment, materials, people), the environment, the methods (procedures, instructions) followed, and the measures collected to determine process performance.

c. Check the adequacy and effectiveness of the process controls established by standard operating procedures, work instructions, flowcharts, manufacturer instructions and training process specifications.

2. Product/Service audit-

An examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements, that is, specifications, performance standard and customer requirements.

3. System audit-

“An audit conducted on a management system”

It involves all documented activity performed to verify, by examination and evaluation of objective evidences, that applicable elements of the system are appropriate and effective and have been developed, documented, and implemented in accordance and in conjugation with specified requirements.

a. A quality management system audit evaluates an existing quality program to determine its conformance to company policies. Contract, service agreements, commitments and local regulatory requirements.

b. An environmental system audit examines an environmental management system

c. A food safety system audit examines a food safety management system and

d. Safety system audit examines the safety management system.

Other types are-

Dock audit-

Dock audit is similar to a product audit only. Dock audit is done on the processed product which is ready to dispatch. The audit verifies that the product meets customer specific requirements. This audit includes dimensional, packaging methods, count accuracy, bar code labeling requirement, etc.

Layout audit/ Inspection-

Layout inspection is a complete measurement of all part dimensions shown on the design record. A layout inspection may be required by some customers for all products annually unless other frequency is established in a customer approved control plan.

Layered audit -

Layers” stands for various levels of management in the considered process wherein the LPA is implemented. It is a tried and tested form of assessment for various departments to identify if processes are implemented as agreed, and if the desired results are achieved. For more details refer to-

CQI-8 “layered Process audit”

IATF 16949:2016 clause 8.5.6.1.1- “temporary change of process control”.