Quality Assurance Self-Appraisals (QASA)
Introduction
This document provides guidance in the conduct of Quality Assurance Self-Appraisals (QASA) to verify and assure the effectiveness of on-going quality systems, practices, and programs and to identify potential procedural gaps or system weaknesses at Manufacturing Production and logistic Sites.
1. The Site Quality Team should prepare and maintain a master list of Site operations that may be subjects of the QASA program. Collectively, that list should cover all major regulatory-related operations at the Site. Illustrative examples for production Sites include, but are not limited to, the following:
| Manufacturing, | Shipping, |
| Packaging | Receiving |
| Labeling& Label Control | Solvent Recovery |
| Engineering | Quality Assurance |
| Purchasing | Validation |
| Quality Control Labs | Safety |
| Production Control Labs | Security |
| Human Resources | Medical Device Design Controls |
Illustrative examples of definable operations for Logistics Centres include, but are not limited to, the following:
- Receiving and Shipping,
- Returned Goods,
- Carrier Identification,
- Rejected Goods,
- Carrier Inspection,
- Safety
- Personnel Training,
- Security
- Product Status Controls,
- Visitor Controls,
- Public Warehouses,
- Inventory Controls, and
- Temperature Controls
- During Product
- Transport,
- Sanitation and Pest Controls.
The Site Quality Team should review the above lists at least annually, and adjust them to broaden the coverage, when necessary.
2. The QASA Action Plan should minimally define the following:
- Appraisal objectives;
- Planned meetings if any (e.g., pre-appraisal introductions, review of planning and timing; post-appraisal wrap-up, including Site Management if requested; discussion of findings, including planned prioritization);
- List and roles of intended participants;
- Documents to be reviewed (if known); and
- Expected date(s) and timing of appraisal events.
- Each QASA should be defined and limited in scope to assure timely completion.
3. The QASA Team Leader should hold a post-QASA team meeting, at which time the findings are reviewed. Corrective actions that need to be taken to address identified findings may be discussed and assigned priority. Any corrective actions taken during the appraisal are to be discussed. If a corrective action taken appears complete and satisfactory to the QASA Team Leader, the item should be omitted from the QASA Report.
4. The QASA Report should minimally include the following:
- Copy of the QASA Action Plan (updated, if changes were made);
- Summary of findings (with priorities, if needed), and assigned responsibilities; and
- Identification of findings follow-up plan (e.g., identify follow-up reports schedule, responsibility for follow-up reports, and recipients of follow-up reports).
5. Responsibilities of the QASA Team Member (s) include, but are not limited to, the following:
- Serve as point-of-contact with the Team Leader and the manager of the operations being appraised;
- Identify conference areas when needed for the Appraisal Team to meet and to use as a base of operations throughout the appraisal;
- Prepare a Corrective Action Plan upon receipt of the approved QASA Report that identifies findings, including their priority if needed, and indicates how each finding will be addressed;
- Assure findings are tracked and status reports are made available periodically, until all findings are completed; and
- Assure appraisal-related documents at the Site are subjected to the security Measures.