An external audit (second party audit), is an audit of another organizational quality program not under the direct control or within the organizational structure of the auditing organization. External auditing is usually performed by the customer upon its suppliers (or potential suppliers) to determine whether or not the supplier can meet existing or proposed contractual requirements. The supplier quality system is a very important part of contractual requirements since it is directly (manufacturing, engineering, purchasing, quality control, etc.) and indirectly (marketing, inside and outside sales, etc.) responsible for the design, production, control and continued supportability of the product. Although external audits (second party audits) are usually conducted by customers on their suppliers, it is sometimes beneficial for the customer to contract with an independent quality auditor. This action helps to promote an image of fairness and objectivity on the part of the customer.
Guidelines for an external audit to ensure quality assurance specify the policies and procedures associated with assessing and verifying the reported data. External audit report guidelines examine the underlying systems. Quality management professionals execute compliance or operational audits to help companies manage risk and control quality.
Requirements for External Audits:
- AATB B1.521 Inspections/Audits of Other Facilities
- FDA 21CFR1271.150 Current Good Tissue Practice requirements © Compliance with applicable requirements (1) Manufacturing arrangements (iii)
Benefits of an External Audit Using Sparta Systems' Solution:
Sparta Systems' solution enables companies to improve quality, reduce costs and identify operational and compliance risks by providing the necessary automation tools to conduct effective external audits (second party audits) to ensure that findings are reported and addressed in a timely and effective manner. It enables your organization to take a best practices approach to compliance and risk management via an external audit report and supports your external audit program using an enterprise quality management system.
View a sample Supplier Audit Checklist
An Effective Tool for Managing Any Type of Audit Including:
Computer Related System Validation Audits
Contractor Compliance Assessment
Method Validation Audits