Process & standards

The inspection of the manufacturing site(s) of a male circumcision device (MCD) is conducted to assess compliance of the manufacturer’s quality management system (QMS) and manufacturing practices with international standards, such as the quality management standard ISO 13485:2003 and ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes, and other relevant international standards and guidelines produced by the former Global Harmonization Task Force and the International Medical Device Regulators Forum.

However, WHO inspection of the manufacturing site will focus on the suitability of the implemented processes and procedures for the reliable supply of MCDs to WHO Member States. Therefore, customer-related issues that may be covered only in general terms in ISO 13485 are inspected in detail.

Importantly, the inspection will also verify the content of the product dossier through review of reports and raw data on site, and interviews with the personnel involved. If serious or critical nonconformities of public health concern are identified in connection with an inspection, WHO reserves the right to use, publish, issue, share with with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (in each case, pursuant to WHO provisions, including provisions regarding the protection of any commercially-sensitive confidential information of the manufacturer) any outcomes, reports and/or results – whether in draft or final form, and whether positive or negative – arising from or relating to the prequalification assessment process, including without limitation any WHO Notices of Concern, WHO Notices of Suspension, WHO information notices for users and/or manufacturer-issued field safety notices. (See Guidance Documents below for more information on the requirements of inspection, reports, nonconformities and Notices of Concern.)

Initial inspection as part of full prequalification assessment

An initial inspection is performed in two stages:

• Stage 1 inspection, usually a desk audit, will evaluate the documentation related to the QMS to ensure readiness for the stage 2 inspection. General information about the documented quality management system (including the quality manual and manufacturing processes, organigram, workflows, critical suppliers and floor plan) will be reviewed during the stage 1 inspection to establish the readiness of the manufacturer’s quality management system and to prepare for an on-site visit. Any issues of concern will be communicated to the manufacturer. A satisfactory stage 1 inspection is a precondition for proceeding to the stage 2 inspection. T
• Stage 2 inspection will comprehensively evaluate the effective implementation of the QMS and production processes through an on-site inspection(s). The inspection team is composed of WHO staff, external experts (inspectors) appointed by WHO as well as, potentially, interpretors and observers. The inspectors involved in the onsite(s) inspection should have appropriate qualifications and expertise in the relevant fields, must comply with the confidentiality and conflict of interest rules of WHO, and will act as temporary advisers to WHO. Representatives of the national regulatory authorities (NRAs) and other WHO employees may accompany the inspection team to the manufacturing site(s) as observers or for training purposes.

Report on the inspection of the manufacturing site(s)

A preliminary non-conformance report detailing issues of concern (if any) will be provided to the manufacturer on the final day of the inspection. A final inspection report, including the graded nonconformities will be issued to the manufacturer after the inspection of the manufacturing site(s). All nonconformities must be corrected by the manufacturer through suitable corrective actions addressing the root cause of each nonconformity. The manufacturer will have the opportunity to submit up to two corrective action plans. Depending on the nature and number of nonconformities objective evidence of the effective implementation of proposed corrective actions may be required. WHO will assess the information provided and decide whether the corrective action plan can be accepted. Conformity with prequalification requirements will be established based on assessment of such information. In some instances, the number and criticality of nonconformities may require that the effective implementation of proposed corrective actions needs to be verified in a follow up inspection, before the nonconformities can be closed off.

A summary of the findings of the inspection of the manufacturing site(s) will be included in the WHO prequalification public report, if the product successfully meets the WHO prequalification requirements. In certain cases, WHO may agree, in its sole discretion, to permit the manufacturer to correct specific nonconformities after prequalification, provided that the manufacturer commits in writing to address them by an agreed upon deadline. Such a "commitment to prequalification" will be reflected in the WHO prequalification public report and will be verified during the reinspection.

Waiver of site visit

A site visit may be waived under exceptional circumstances such as recent inspection by a WHO recognized inspection agency and the full report and other requested documentation being made freely available to WHO inspection staff for review.