Quality Audits

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Quality audits are a form of Quality Control, they are inspections. They are planned and documented assessments of the system, process, or material. They compare actual performance against planned arrangements.

The purpose of the audit is to improve the effectiveness of the Quality Management System. They are not an evaluation of the people! There primary purpose is to drive quality improvement.

Types of Quality Audits

System Audits - A system audit is a review of the entire quality system used by a company. It is a review of how quality standards are implemented, measured and met by the company.

It is a verification of the procedures used to measure the quality of the product, how issues are recorded, and how the company ensures that any failed product is not passed on to customers.

It's a review of all of the processes that make up the entire system.

Process audits - A process audit verifies that a documented process meets quality requirements and that the process is being followed.

Audited processes include manufacturing processes as well as other business processes related to the quality system.

Process audits examine one or more pieces of the system.

Product Audits - A product audit physically verifies that product meets design specifications and any other quality requirements.

Product audits require measuring physical dimensions and typically testing. A product audit also involves checking the calibration status of measurement and test equipment to verify that the product truly meets design requirements.

Quality Audit Checklist

Internal Audit – Internal audits ensure that a company is meeting its own procedures, quality standards and any contractual requirements. Internal audits are typically by auditors who work for the company being reviewed.

They are also sometimes hired by a company to audit its own functions. Auditors must always be independent of the function that they are auditing.

They are performed by your own people on yourself.

External Audit – External audits are performed by auditors separate from the company being audited. They are typically performed by a potential customer prior to contract award to ensure that a company meets certain quality standards.

External audits performed by a company that has a contract with the audited firm are often referred to as second party audits. The second party quality audit is performed by the company holding the audit.

External audits are also conducted during the performance of a contract as a part of continued surveillance. 

For example - your customer performs an audit on you, or on your supplier.

Third Party Audit – External audits performed by an organization that has no contract, or potential contract, with the company it is auditing is called a third party audit. A third party audit is often done to attain or maintain certification to a recognized quality standard.

With third party audits there is no customer-supplier relationship - the audit is performed by an unbiased third party (ISO registration authority)

Audit Results

The results of a quality audit are audit observations and/or audit findings. Almost all quality audits result in these because the perfect Quality Management System has yet to be created.

  • An audit observation is a statement of a potential problem that may result in noncompliance in the future.
  • An audit finding is a statement of fact about an actual noncompliance with a given requirement.

Corrective action should be taken for observations and findings although findings are certainly the priority.

Benefits of Audits

  • Understand current performance,
  • Determine if customer requirements are being complied with,
  • Determine if internal processes are being complied with,
  • Identify areas where quality improvement is needed,
  • Keep management informed of current performance,
  • Ensure that new, or changed processes, are implemented effectively,
  • Provide an objective no-biased point of view.

Quality Audit Phases

There Are Four Key Phases To An Audit:

  1. Planning: planning is the responsibility of the lead auditor. During planning the a) purpose and scope of the audit is defined b) relevant procedures and specifications are reviewed c) audit checklists are prepared d) the organization to be audited is contacted to work out plans for the audit
  2. Performing: during the actual performance of the audit a) an opening meeting with the auditee team is conducted b) the audit is performed through interviews and observation c) issues are discussed as they arise d) the auditing team meets daily to create the days summary report e) an out briefing is conducted daily to keep the auditee informed of progress and conclusions f) a closing meeting is conducted at the end of the audit and the lead auditor states the audit teams observations and findings.
  3. Reporting: the lead auditor is responsible for creating the quality audit report and sending it to the client. The report a) details the audit and its observations and findings b) is well written so that the auditee can easily recreate any observations and findings c) requests formal corrective action for any audit findings.
  4. Follow-up & Closure: the auditee is responsible for resolving all audit findings and submitting their corrective action report to the lead auditor. A follow-up audit may be schedule by the lead auditor to substantiate effective corrective action implementation. If the lead auditor agrees that the corrective action was effective, the audit is formally closed.

Remember, the primary purpose of quality auditing is continuous quality improvement!

From Quality Audits to Quality Control

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