| Title: Material Supplier Approval | |||||
| Guidance Number: 072 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Introduction
This document provides guidance in the process for identifying suppliers to be audited and the process for conducting and documenting such audits and approving suppliers.
1. Approval of a New Supplier, New Materials from an Already Approved Supplier, or a New Supplier Manufacturing Site, actions to be taken, include and are not limited to, the following:
- Assess the need for a Supplier Audit using risk assessment methodology;
- Conduct full raw material testing of at least three representative raw material lots;
- Conduct pilot laboratory use testing;
- Perform plant trials;
- Evaluate Packaging Materials; and
- Evaluate product stability.
The number of raw material lots to be used in a pilot study or used in a plant trial should be determined by the Site Quality Principle on a case-by-case basis.
The batches or lots manufactured for plant trials may be used for trade if agreed before hand by the Site Quality Team and produced under conditions that comply with applicable regulatory and site requirements.
2. Requirement for Supplier Audit prior to purchase can be waived, if necessary, on a case-by-case basis by the Site Quality Team after review with the Quality Principle provided that all other requirements of item 1 and site requirements are satisfied. Each case should be reviewed with consideration to the following:
- Supplier history with the site,
- Local regulatory history,
- Length of time Supplier has been manufacturing the material in question, and
- Quality impact the material has on the product.
The Site Quality Team should document the rationale for waiving the Supplier Audit. This does not apply to API suppliers. All API suppliers must be audited.
The responsible Quality Principle should be contacted if this requirement cannot be met.
3. Findings Observed During the Supplier Audit should be classified as the following:
- Area of Special Concern (ASC) -item observed is extremely serious. Immediate corrective action by Auditee is required;
- Major Observation -item observed is serious, or a significant number of minor observations have occurred in the same area or system. Prompt corrective action by Auditee is required; or
- Minor Observation -item observed is not yet serious but could become a problem if not corrected in a timely manner. Auditee Management follow-up is required to assure that a systemic problem does not exist.
4. In the Event the Supplier Audit Rating is Conditionally Acceptable, the site should not initiate new business until all ASCs and major observations are satisfactorily addressed by the supplier and verified during a follow-up audit or review and acceptance of the supplier’s corrective action plan by the Site Quality Team.
5. Supplier Audit Reports should be drafted by the Site Quality Team or Director/Team Leader of Quality Audit Team for approval and issued within 30 working days after the audit.
6. The Supplier Audit Report should be written in a way that the body of the report is free from proprietary, speculative, or potentially controversial comments, and stating only actual facts observed during the audit.
7. The Supplier Audit Report should include, but not be limited to, the following information:
- Supplier name, address, type of operation, name of product or services supplied and principal contact;
- Date of audit and date of last audit, if applicable;
- Purpose of audit;
- Site auditor and audit participants;
- Audit findings;
- Supplier Audit Rating; and
- Executive Summary (for the site use only).
8. An Executive Summary Containing Proprietary Information should be included in each Supplier Audit Report to inform the site recipients of the audit results. This Executive Summary should not be included with the copy of the Supplier Audit Report that is sent to the audited supplier location representative. The Supplier Audit Report should be considered site’s-proprietary information.
9. The Supplier Audit Executive Summary should include, but not be limited to, the following:
- Purpose of the audit;
- Information regarding the supplier, such as:
- History of the supplier;
- Any regulatory inspection received;
- Any certification received (e.g., ISO); and
- A brief synopsis of the type of operation;
- Summary (number) of the ASC, major, and minor findings;
- ASC and major findings;
- Information regarding the use of materials;
- Information comparing the audited supplier location to its competitor (if
applicable); - Current audit rating (if available); and
- Next recommended audit. 10. Responses to Findings Noted in the Supplier Audit Report should be reviewed and tracked as determined by the Site Quality Team. Status report of ASC findings should be distributed to those receiving the Supplier Audit Report except for the audited supplier location representative.
11. When a Production Material Supplier Audit is Conducted by Quality Assurance Upon Request by the Site Quality Team or Director/Team Leader of Quality Audit Team, a copy of the Supplier Audit Report, including the Supplier Audit Rating, should be provided to the Director/Team Leader of Quality Audit Team. This supplier information should be included in the Supplier Audit Master List.
12. A Supplier Audit Master List should be maintained and made available electronically by Quality Audit Team. This master list should include supplier names, locations, and the audit ratings of all the production material suppliers audited by members of the Production Sites and Quality Audit Team.
Distribution of the master list should include, and not be limited to the following:
- Site Procurement Team who order materials,
- Site Materials Management Team who receive materials, and
- Site Quality Team who evaluate materials.
13. A Site Approved Supplier List that includes all suppliers of production materials used at the Site should be maintained by each Site Quality Team.
14. When Notified by the Supplier of Changes in Manufacturing Locations or Processes:
- The Site Procurement Team receiving such notification should notify the Site Quality Team of the changes;
- The Site Quality Team should review the changes and notify the Site Procurement Team whether or not the changes are acceptable; and
- The Site Procurement Team should then notify the supplier of the Site Quality Team’s decision. The supplier should not send material from the new location or new process until the Site Quality Team has accepted the proposed change(s).
- The Site Quality Team should determine whether to approve, conditionally approve, or not approve a supplier, based on recommendations from the QA and on review of the items listed in item 1 above. The decision and rationale should be documented.