Essential Quality Audits: Types, Objectives, and Benefits

The Essence of a Quality Audit

A quality audit is an in-depth critical analysis of the activities within a unit or system, conducted to determine their effectiveness and adherence to established standards.

Types of Quality Audits

First-Party Audits: Internal Review

Conducted internally, first-party audits involve the organization reviewing its own processes. These are typically performed by internal auditors.

Second-Party Audits: Client & Supplier Focus

Second-party audits are conducted by an organization on its clients or suppliers. This involves assessing companies to whom products are sold or from whom supplies are procured.

Third-Party Audits: Certification & External Bodies

Third-party audits are performed by independent certification bodies. Examples include:

• MEXICAN QUALITY CERTIFIED (Calmec)
• DET NORSKE VERITAS MEXICO, SA DE CV
• SGS DE MEXICO, SA DE CV
• AUDIT PARTNER OF MEXICO, SC
• FACTUAL SERVICES, SC

When Are Quality Audits Conducted?

• At the Request of Management: Management may initiate an audit of a manufacturing center's quality management system as a crucial step in product approval processes.
• As Required by a Client: Clients often mandate audits of a supplier's quality system before or during the development of a product or service.
• For Certification Application: Organizations seeking certification for their quality system, conforming to an adopted model, must undergo an audit by a certification authority.
• Driven by the Quality System Itself: Depending on the adopted quality management model, internal audits are regularly conducted by internal staff to ensure ongoing compliance and improvement.

Quality audits can originate from the organization's own quality system requirements or be mandated by external parties, such as a certifying body, a client, or even the organization's own management.

Top Management's Role in Quality Audits

Regardless of the audit's origin, top management must provide the necessary resources to conduct these audits effectively. This includes facilitating the identification and improvement of areas that do not conform to the required quality model.

It is therefore management's responsibility to establish a robust internal audit program and ensure its proper implementation. Developing an audit program merely to satisfy external requirements from a client or entity is counterproductive. Such a misconception can lead the company to overlook the significant potential for improvement inherent in an audit program, viewing it instead as a formal imposition lacking real value or opportunities for enhancement.

What Quality Audits Determine

Quality audits are conducted to determine:

• Adequacy: The suitability of an organization's quality system against a specific reference norm or standard.
• Conformity: Whether the actions of an organization's staff align with the requirements of its quality program, as defined in documentation such as the quality manual, procedures manual, and procurement specifications.
• Effectiveness: The efficacy of various activities within the organization's quality system, including corrective and preventive actions taken. It is crucial to remember that quality assurance philosophy emphasizes prevention over problem detection. Therefore, greater importance must be attached to:
  • Identifying problems early.
  • Understanding the depth of the problem.
  • Discovering the root cause of the problem.

Benefits of Quality Audits

Quality audits provide the firm's management with objective, fact-based evidence. This empowers management to make informed decisions grounded in reality, rather than assumptions.