BBR Audit December 4 TO 8, 2000

OBSERVATIONS AND RESPONSES
WHOLE BLOOD - Quality Control Department - C.02.014
1. Despite a satisfactory response to observation #2 of last year's audit, SOP INF-INS-020 and CLI-INS-037 had not changed as planned.
Response: After checking, we confirm that SOP INF-INS-020 was changed and implemented as of October 30, 2000. The requested change appears in the appendix on pages 9 to 12.
In conformity
SOP CLI-INS-037 will be changed.
In conformity: 25-01-2001

WHOLE BLOOD - Production test - C.02.011
2. On a total of 12 DSCMS checked, 3 holders had removed pages 5-1 and 5-2 from Section 5, whereas the notice of change stated only to replace the list of unacceptable drugs. Furthermore, the notice of change was returned to HQ Côte-Vertu without anyone following up on the 2 pages that were appended by the 3 holders.
Response: Pages 5-1 and 5-2 of Section 5 of the DSCMS have been sent to the three holders.
In conformity: 22-12-2000
A notice was sent to all other holders so that a check on the presence of these pages can be done.
In conformity: 22-01-2001
Accordingly, to avoid all confusion, subsequent notices of change affecting Section 5 will specify the pages to be replaced.
In conformity: 11-12-2000
The follow-up of returned documents will be done systematically for every return.
In conformity

WHOLE BLOOD - Production test - C.02.011
3. The expiry date was not documented on the box of No. 57 "Rad-Sure" labels (batch 186B03U15) after opening.
Response: The personnel concerned will be given further training on SOP LGP-INS-001 Irradiation of blood products. The training will be documented.
In conformity: 29-01-2001

WHOLE BLOOD - Production test - C.02.011
4. The weekly maintenance on the irradiator was not detailed in SOP LGP-INS-001v8.
Response: SOP LGP-INS-001 will be changed to better detail the weekly maintenance.
In conformity: 15-02-2001

WHOLE BLOOD - Files - C.02.020
5. On the irradiator weekly maintenance form (LGP-ENR-008v2):
1) Maintenance was not regularly documented;
2) Some of the changes did not conform to GMP; and
3) The form was not filled out in a standard manner.
Response: Points 1 and 3: The personnel concerned will be given further training on Form LGP-ENR-008v2 Irradiator maintenance. The training will be documented.
In conformity: 29-01-2001
Point 2: The personnel concerned will be given further training on the Documentation module in the GMP/GTP course.
In conformity: 28-02-2001

WHOLE BLOOD - Equipment - C.02.005
6. The IVAC series 4200 vital signs monitor (CO-10-052) was used in the Québec City clinic even though the calibration done by the Biomedical Equipment Department had not been adequately completed.
Response: The personnel concerned will be given further training. The training will be documented.
In conformity: 15-02-2001

WHOLE BLOOD - Equipment - C.02.005
7. The barcode scanners in the Donor Record Management Department were not checked in compliance with the frequency stated in SOP INF-INS-013.
Response: The personnel concerned will be given further training. The training will be documented.
In conformity: 26-01-2001

WHOLE BLOOD - Production test - C.02.011
8. An outdated copy of Guideline "Quality control for copper sulfate" (D94-044) was being used in the warehouse.
Response: The outdated copy of Guideline "Quality control for copper sulfate" (D94-044) has been withdrawn from the warehouse. Since mid-November, a follow-up has been done systematically of all returned documents.
In conformity

WHOLE BLOOD - Production test - C.02.011
9. SOP LGP-SPE-10 did not always describe the maximum acceptable number of bags per box. Furthermore, this SOP did not always indicate when box ISC E38 should be used.
Response: SOP LGP-SPE-010 Packing methods for blood products will be changed to include the missing information.
In conformity: 15-02-2001

WHOLE BLOOD - Production test - C.02.011
10. Some operations involving copper sulfate solution, such as receiving, quarantine and calibrating were not covered by a procedure.
Response: A procedure describing certain operations involving copper sulfate solution, such as receiving, quarantine and calibrating will be drafted.
In conformity: 15-02-2001

WHOLE BLOOD - Production test - C.02.011
11. When packing bags at the clinic, the procedure whereby the driver checks the RDs was not covered by an SOP. Furthermore, one driver documented this step before having completed it.
Response: We are evaluating the relevance of having the RDs checked by the driver. An analysis is currently underway. The results are scheduled for mid-February 2001. A request for training the person mentioned in the audit in GMP was sent on 28-12-2000.
In conformity: 15-02-2001

WHOLE BLOOD - Files - C.02.020
12. In the training files of the Processing Department, some of the "Skills checklist" (F300012-Ver.1) forms were not dated, initialed or signed by the trainer.
Response: The trainer in question has undergone retraining. The training has been documented. Also, an explanatory note has been sent to all trainers.
In conformity: 8-01-2001

WHOLE BLOOD - Files - C.02.020
13. Although the annual review of the apheresis files was done correctly, the signature of the department head was missing on several of the "Donor evaluation by apheresis" forms (SCP-ENR-083, version 3).
Response: A request for GMP training for department heads and supervisors was sent on 15-12-2000.
In conformity: 25-01-2001

WHOLE BLOOD - Production test - C.02.011
14. SOP "Inventory and control of collection bags" (CLI-INS-026 v3) did not reflect the new steps in the operations following implementation of the SAP system.
Response: SOP "Inventory and control of collection bags" (CLI-INS-026v3) will be changed to take into account the newly implemented steps in the operations.
In conformity: 15-02-2001

WHOLE BLOOD - Equipment - C.02.005
15. The variability limit of the test concerning the number of oscillations of the platelet incubator (model PC4200, ID Q13-305) was not entered on the results sheet.
Response: Form ENR-LA-169 will be changed to include the acceptable variability limit for the oscillations of model PC4200.
In conformity: 15-02-2001

WHOLE BLOOD - Production test - C.02.011
16. Step 7.3 in SOP ASQ-INS-014 did not adequately describe the cleaning procedure for the Hemocue according to the manufacturer's recommendation.
Response: SOP ASQ-INS-014 will be changed to adequately describe the cleaning procedure according to the manufacturer's recommendation.
In conformity: 15-03-2001