ISO 9001 QMS

contract manufacturing quality audit

Contract Manufacturing Quality Auditing

ISO 9001:2015 has made it clear, through clause 8.4, that the organizations shall control their externally provided processes, products. The organizations shall ensure that externally provided processes, products and services confirm to requirements, consistently deliver conforming products or services to its customers. This means each organization has an obligation to ensure its contract manufacturers are in full compliance with their requirements. Only with this assurance can the organization actually confirm that each batch conforms to its specifications, allowing it to approve and release the product for use or distribution.

An on-site contract manufacturing audit is strongly recommended to ensure contract manufacturers produce, package, label, test and ship product in compliance with your requirements.

Many companies rely on outside expert consultants to perform their supplier audits, however, if a firm decides to manage this with its internal staff, then some keys steps should be followed. In performing the audit, the following things should be taken into consideration:

    • Volume or amount of manufacturing to be performed
    • Mature or new company producing target intermediates or products
    • Previous experience with company delivering products with high quality in a timely manner
    • Applicable regulatory and statutory standards
    • Good regulatory history and other government authorities
    • Low incidence of customer complaints
    • Formal corrective actions program
    • Responsiveness to past issues, concerns and problems
    • Personnel competence who have comprehensive knowledge of technical matters and requirements
    • Low incidence of material reviews, out-of-specification (OOS) investigations, non-conformances for the lots
    • Analytical results for lots consistently verified by a second laboratory

It is important to properly prepare for the audit by requesting key documents and information to be reviewed prior to the on-site audit. This will provide the auditors with a good sense of the manufacturer’s regulatory history and current state of compliance. The following items should be requested and reviewed:

    • Organizational charts for the overall facility, and also the manufacturing, quality and analytical departments in each separate facility.
    • Master document index
    • Specific SOPs, including
    • Employee training/qualification
    • Equipment calibration, maintenance and cleaning
    • Specifications for raw materials and finished products
    • Testing of raw materials and finished products
    • Material reviews/non-conformance investigations
    • Quality control plan or process control plan
    • Manufacturing and quality records
    • Quality department roles and responsibilities
    • Preservation
    • Work environment and infrastructure maintenance program
    • Handling customer complaints
    • Change control
    • Copies of finished product specifications for the highest volume products manufactured at the site along with the raw material specifications

MNA has a team of auditors who are experience in conducting contract manufacturing audits based on the contract agreement and ISO 9001 standard. We will ensure quality agreements extremely important throughout the audits.

Talk to us and we would be happy to answer your questions and provide quotation.