God, grant me the serenity to accept the things I cannot change, The courage to change the things I can, And the wisdom to know the difference. (Serenity Prayer, Reinhold Niebuhr)
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001 (Wikipedia).
A quality audit is a systematic and independent examination 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 (ANSI/ISO/ASQC A8402-1-1994).
An audit may be classified as internal or external, depending on the interrelationships that exist among the participants.
- A first party audit is performed within the organization by auditors who are employed by the organization to measure its strengths and weaknesses against its own procedures and methods and/or external standards adopted by the auditee organization (voluntary) or imposted (mandatory).
- A second-party audit is an external audit performed at a supplier by a customer or a contracted (consulting) organization on behalf of a customer (i.e. supplier audit). (Westcott 2006).
- A third-party audit is performed on a supplier or regulated entity by an external party other than a customer, usually compensated for the audit. (Westcott, 2006).
Types of audits
- A product quality audit is an in-depth examination of a particular product or service to evaluate whether it conforms to product specifications, performance standards and customer requirements (Westcott 2006).
- A process quality audit examines a single process or activity to verify that the inputs, actions and outputs are in accordance with requirements established by procedures, work instructions, or process specifications (Westcott 2006).
- A quality system audit is "a documented activity performed to verify, by examination and evaluations of objective evidence, that applicable elements of the quality system are appropriate and have been developed, documented, and effectively implemented in accordance and in conjunction with specified requirements (ASQ Certification Department).
Other types of 'audits'
- Management by Walking Around (MBWA)
- Management reviews - key performance indicators, trends and system problems may be reviewed in a scheduled basis.
- Skip-Level Meetings - when a member of senior management meets with persons two or more organizational levels below, without in-between management present.
- Analysis of Customer Feedback including complaints, orders cancelled, warranty returns, product recalls, lost customers.
- Analysis of Employee Feedback and trends including turnover, retention, grievances, lost time, promotions/demotions/transfers and recognition and rewards.
Items Used in Audits
- Accepted auditing protocols - auditor standards, codes of conduct
- Applicable standards and guidelines (external and internal)
- Organization's policies, procedures, work instructions, workmanship standards, forms
- Process maps
- Sampling techniques
- Copies of prior external assessments
- Copies of prior internal audits
- Quality system records