At a high level, quality audits are conducted to obtain objective evidence of operational compliance. There are several different types of audits that can be conducted to validate conformity. Audits can be performed internally, externally by a supplier, or by an independent third party. Audits can encompass processes, systems or products, but in all cases, they are measured against a defined set of standards.
The following is a list of 10 commonly performed quality audit types:
Internal Quality System Audit
This type of audit is an examination of the tool used to measure quality itself. An internal quality audit seeks to evaluate an organization’s Electronic Quality Management System (EQMS). The quality documentation and processes managed by the software solution are reviewed to ensure maximum efficiency and high-quality product outcomes. The software manual is audited to ensure all critical areas of the solution are covered and all key employees readily have access to the document. Work instructions are audited to ensure conformity to standard operating procedures and to confirm quality processes are meeting targets.
Supplier audits allow an organization to collaborate in real-time directly with its suppliers. By auditing the supply chain, companies can control the quality of its suppliers and sub-tier suppliers and introduce accountability for poor performers. Key performance indicators (KPIs) quickly identify areas for improvement. With this level of transparency, suppliers are able to view purchase order activity such as receipt and inspection history in order to collaborate on nonconformances and corrective actions.
Production Team Audit
Production team members usually get an examination (audit) when Operator Acceptance or Certified Operator programs are in place, or when skills management re-qualifications are required. Auditors evaluate changes to processes, evidence of training, past activity for escapes, nonconformance, and conformity inspections of operator accepted product as part of the re-qualification.
A safety audit looks at the plans and procedures designed to protect the safety of company employees. This type of audit can include a review of equipment operation or an examination of organizational procedures to ensure routine safety. Successful safety policies prevent injuries and accidents from occurring and improve overall employee well-being.
A facilities audit addresses quality concerns of a corporation’s assets. Components of a facilities audit can include a review of building systems such as HVAC, manufacturing equipment or technology. Processes associated with these facilities are reviewed to ensure safety and identify improvements that could affect quality outcomes.
Environmental audits are designed to help companies create a safer work environment by helping to identify areas of workplace risk with an actionable plan to meet OSHA and other standards. An audit is conducted to ensure employees are adhering to regulatory standards and using appropriate personal protective equipment.
Risk Assessment Audit
A risk assessment is a process that identifies potential workplace hazards, then categorizes each risk so preventative measures can be put into place. An audit of this type helps companies put an effective risk mitigation strategy into action. When all risks have been identified, preventative measures can be prioritized, preventing adverse workplace and economic consequences.
Design Control Audit
Design control audits are conducted within highly regulated industries to ensure that manufacturers follow a formalized process that results in an end-product that meets acceptable quality and safety standards and adequately serves user needs. The design plan and design inputs and outputs are reviewed for proper acceptance criteria and a risk analysis is performed.
Regulatory audits are conducted to verify compliance with a specific set of regulations or standards. Quality practices are examined, and the data collection process is systematically reviewed to identify possible areas of nonconformance. Examples of regulatory agencies include FAA, DARPA, DCMA, ISO, AS9100 as well as many others.
Method Validation Audit
A method validation audit is used by the FDA or other regulatory authorities to ensure that the analytical test methods used in the manufacturing process are standardized, reproducible and documented. This methodology is applied to testing that requires consistency and accuracy, usually in cases of products manufactured for human use.
An Electronic Quality Management System (EQMS) is key in helping a company build an effective audit management strategy. The system provides the flexibility to manage customer specific audit processes. An EQMS supports internal and external audits and allows auditors to get their job done more efficiently. With an effective audit management strategy in place, companies can examine their audit process and better predict where improvements can be made.
Quality assurance solutions such as TIPQA from TIP Technologies, should be used to manage regulatory compliance. Using a combination of these solutions, customers have effectively demonstrated compliance to regulatory standards including, but not limited to ISO / AS / QS / IPC Standards / Mil Spec Requirements. Contact us today at (262) 544-1211 to learn how TIP Technologies can support your auditing process, or request a demo of our quality solutions.