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BBR Audit January 31 to February 9, 2001 at Héma-Québec Montréal

BBR Audit January 31 to February 9, 2001 at Héma-Québec Montréal

OBSERVATIONS AND RESPONSES (translation)
WHOLE BLOOD - Quality Control Department - C.02.011
1. After discovering an error in a product code, a trainer used a trainee's PIN to make the correction in the Progesa system.
Response: Given the significance of this observation, a directive will be sent to all Progesa users explaining how to use the PIN according to good manufacturing practices. The training will be documented.
In conformity: 15-03-2001

WHOLE BLOOD - Equipment - C.02.005
2. Transaction histories in Progesa (mobile clinic) were not recovered before the laptop computers were updated.
Response: The procedures for recovering histories will be presented in the comprehensive Progesa work plan.
In conformity: 09-03-2001

WHOLE BLOOD - Production test - C.02.011
3. Despite a satisfactory response to observation #4 of last year's inspection, SOP INF-INS-040 (Updating laptop computers) was never implemented. Consequently, there is cu
rrently no approved procedure for updating laptop computers.
Response: Version 2 of SOP INF-INS-040 was submitted to the BBR on 30-01-2001.
In conformity: 30-01-2001

WHOLE BLOOD - Storage - C.02.004
4. Storage areas for recovered plasmas designated "in conformity" and "not in conformity" were not adequately separated.
Response: The ASQ-FCT-030 operating manual will be revised.
In conformity: 16-03-2001
Until the operating manual is implemented, a reminder will be sent to users of this storage area about the importance of restricting access to products designated "not in conformity."
In conformity: 28-02-2001

WHOLE BLOOD - Raw materials analysis- C.02.009
5. For an autologous donor who had a corneal graft, the box "donor accepted" was checkmarked before medical approval had been obtained.
Response: A memorandum reminding nursing personnel to follow the procedure was sent February 15, 2001, accompanied by an acknowledgement slip.
In conformity: 28-02-2001

WHOLE BLOOD - Production test - C.02.011
6. In a designated donation record, the donor's consent form was signed only at the second donation.
Response: A memorandum reminding nursing personnel to follow the procedure was sent February 15, 2001, accompanied by an acknowledgement slip.
In addition, the procedure governing designated donations (SCP-INS-012) will be modified in order to clarify this point for the nursing personnel.
In conformity: 01-06-2001

WHOLE BLOOD - Quality Control Department - C.02.015
7. For an LGP-M-00-063 non-conformity, no deviation was noted during the acceptance of recovered plasmas even though the storage temperature had reached 9°F.
Response: Presently, the Quality and Standards Department is working to overhaul the system for managing non-conformities. The concept of deviation will also be clarified during this revision. Personnel will then be trained in quality systems, and this training will be documented.
In conformity: 01-06-2001

WHOLE BLOOD - Quality Control Department - C.02.015
8. The LCQ-ENR-010.1M quality control work sheets (pages 1-17), as well as all other documents related to the quality control of blood components, have not been checked by a supervisor since August 2000.
Response: The work sheets and other documents related to quality control were checked and signed by a supervisor (department manager, director or assistant director). Reports from the 2nd and 3rd quarters of 2000-2001 were distributed to the departments concerned.
In conformity: 20-02-2001

WHOLE BLOOD - Equipment - C.02.005
9. There was no system in place to ensure the equipment was calibrated within a reasonable timeframe. For example:
1. The #13 secondary weights (ASQ-098-094 and ASQ-098-111) were not calibrated in December 2000, and
2. Non-conformity VIR-00-011 indicated that the equipment was being used even though the calibration date had expired in December 2000.
Response:
9.1: The equipment calibration management system for calibrating equipment will be revised and corrected by the Biomedical Equipment Department to ensure that all equipment is calibrated within the stipulated deadlines.
In conformity: 31-03-2001
9.2: It is incumbent upon the user to check the conformity of instruments. To ensure effective follow-up, a check will be added to the Virology/Blood Bank Department work sheets.
In conformity: 28-02-2001

WHOLE BLOOD - Production test - C.02.011
10. In Clinics Preparation, a previous version of CLI-INS-008 entitled "Maintenance of hemoglobinometers/dishes" was found in the SOP manual alongside the current version.
Response: During the audit, the previous version was immediately removed, and the current version is now being used.
In conformity: During audit

WHOLE BLOOD - Records - C.02.020
11. In several departments, some forms were found to be incomplete.
Response: A second series of courses on GMPs will be given to all Héma-Québec employees from May 2001 to December 2001.
In conformity: May 2001
A complete revision of forms is in progress, and is proceeding according to the schedule set for the annual SOP revision.
In conformity: March 2002

WHOLE BLOOD - Personnel - C.02.006
12. With the exception of Blood Clinics, no department has an ongoing training program in place.
Response: Héma-Québec is currently reviewing its training system. The SOPs will be submitted no later that April 1, 2001.
In conformity: 01-04-2001

WHOLE BLOOD - Equipment - C.02.005
13. Despite repeated alarms over several months from the RC 37A refrigerator, no permanent measure has been taken to control temperature variations.
Response: Héma-Québec is currently evaluating a permanent solution to resolve the problem of repeated alarms from the RC 37A refrigerator.
In conformity: 31-03-2001

WHOLE BLOOD - Equipment - C.02.005
14. The SOP governing verification of the Ortho scanner was not followed up regarding the number of times a scan can be repeated following a verification failure.
Response: The SOPs governing verification and calibration of Ortho and Bio-Rad (Sanofi) equipment and the user manuals will be examined in parallel to determine recommendations in cases of failure, and appropriate corrective measures will be taken.
In conformity: 29-06-2001
In the meantime, a memorandum was sent on 01-03-2001 to remind technicians of the difference between the two brands with respect to repeats following a failure.
In conformity: 01-03-2001

WHOLE BLOOD - Production test - C.02.011
15. The SOP CON-INS-006 does not allow the cell washer to continue in manual mode after the automatic mode has been interrupted.
Response: The procedure will be modified to allow functioning in the manual mode, as described in the manual for the COBE 2991 cell washer.
In conformity: 01-06 2001

WHOLE BLOOD - File - C.02.020
16. The training form for certain Progesa programs was not up to date. The program code for sending results is now "ctpretou.d" and not "ctpenres.d," as documented.
Response: The personnel concerned will have updated training on the ctpretou.d program. This training will be documented.
In conformity: 01-04-2001

WHOLE BLOOD - Quality Control Department - C.02.015
17. The LCQ-SPE-001 specification entitled "Schedule for verification of components prepared from whole blood" and LCQ-ENR-010.1M quality control work sheets (pages 1-17) were not up to date.
Response: The LCQ-SPE-001 specification, as well as the related forms, are currently being revised. The revised specification will be submitted to the BBR by 15-03-2001.
In conformity: 15-03-2001

WHOLE BLOOD - Production test - C.02.011
18. The batch numbers of "RAD-SURE" labels were not correctly transcribed onto the validation labels.
Response: An operating guide will be written to define the specification of the alphanumeric sequence for batches of "RAD-SURE" labels.
In conformity: 13-03-2001

WHOLE BLOOD - Equipment - C.02.005
19. Several irradiator maintenance forms were not reviewed for more than 12 months.
Response: The irradiator maintenance form (LGP-ENR-008) will be modified to facilitate monthly review.
In conformity: 15-03-2001

WHOLE BLOOD - Equipment - C.02.005
20. Weekly visual inspection of the generator was not done for three consecutive weeks. Furthermore, SOP TEC-INS-012 did not reflect the tasks normally carried out during this weekly inspection.
Response: The weekly inspection is now being carried out as per procedure. The SOP will be modified for submission to the BBR.
In conformity: 01-06-2001

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