1 | The first internal audit in 2023 has the following problems:
The content of the audit in accordance with the terms of the IVDR is not specified in the internal audit record.
There were a total of 6 findings in the internal audit, and the effectiveness of corrective actions was not evaluated.
| 1. Add the content of the IVDR regulations to the internal audit checklist
2. The effectiveness evaluation content of corrective measures is added to the non-conformance report.
| 1. Supplement the IVDR regulations for internal auditors
2. Redesign of the non-conformance report form
3. Supplemental corrective measures control procedures training and publicity
| 1. The number is C BG/DR 018-02 internal audit checklist
2. Report of non-conformities numbered C BG/DR 018-03
3. IVDR regulations and corrective measures training sign-in form and training summary form
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2 | The maintenance records of the cutting machine (equipment number: 1301000073) are inconsistent with the requirements of the maintenance procedures
| Revise the maintenance procedures of the cutting machine to make the content of the record consistent with the requirements of the regulations
| 1. Department managers conduct training on SOP and related records for new employees before taking up their posts, so that employees can understand the content and relationship of documents and records
2. Check the consistency of the maintenance procedures of all equipment and the maintenance records of the equipment, correct the problems found in the verification, ensure that the content of the two is consistent, and check the consistency of the procedures and records every month
| 1. Standard Operating Procedures for Equipment Maintenance No. SJSC-GMP-04-0017-R53
2. Consistency check record form and training record
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3 | Some components of the biochemical analyzer CS400 are subcontracted to Changchun Fengtong Logistics Co., Ltd. for assembly, but there is no identification of this part of the outsourcing process in the production flow chart
| Issuing technical file changes, revising the CS-400 assembly process flow diagram to identify the outsourcing process in the flow chart
| 1. Revise the "Instrument Production Process Control Procedures" and add management requirements such as production process outsourcing review and document change identification
2. Training the revised "Instrument Production Process Control Procedures" for relevant departments
3. The technical department horizontally checks whether there are similar problems in other models
| 1. CS400 assembly process flow diagram numbered as 0000026014
2. "Instrument Production Process Control Procedure" numbered G CX/DR-010
3. Training materials for production process control procedures
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4 | AFP test kits were sampled during the design development process and during the procurement process. One of the materials has changed, but the organization can't provide documentation of the change control process
The catalog number of the AFP antigen listed in the bill of materials of the AFP kit does not match the catalog number of the AFP antigen studied during the design process
| Documentation of raw material part number change verification records in the R&D process documentation
| 1. System management:
1.1 The project manager/transformation team leader shall organize the preparation of the stage review one month before the project stage review; Organize the pre-review, and the quality system post confirms the completeness and compliance of the project system documents, gives evaluation opinions, and fills in the "review opinion form". The project manager/transformation team leader forms a review record and makes improvements according to the pre-review opinions, and organizes the project stage review meeting
1.2 After the review meeting, the project manager/conversion team leader will archive the project stage data within 2 tasks
1.3 After the review form and project stage data are approved, the quality system post will review the design change notice
2. Personnel management:
The training of the "Research Institute Project Review Management Measures" requires the project leader to complete the design and development document archiving work in a timely manner in accordance with the provisions of the "Research Institute Project Review Management Measures", and reward and punish in accordance with the company's relevant systems
| 1. The number is FG-AFG-SJG-001 alpha-fetoprotein assay kit (chemiluminescence immunoassay method), design change verification plan and other documents
2. Training on project review management system and product change management system
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