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Re: Responses to the BBR Audit of Sudbury Centre 18 - 22 June 2001


Re: Responses to the BBR Audit of Sudbury Centre 18 - 22 June 2001

The following are the actions undertaken by the Sudbury Centre and Head Office in response to the observations contained in the Bureau of Biologics and Radiopharmaceuticals Exit Notice.

Manufacturing control / Contrôle de la fabrication - C.02.011

There was no procedure in place detailing follow-up action to be taken when blood component quality control testing results were outside acceptable limits.

Non-conforming quality control results are addressed in the following recently approved Quality Control SOPs:

  • 08 230, Supervisory Review of Component Quality Control Results
  • 08 242, Investigation of Non-Conforming Component Quality Control Test Results

The targeted implementation date for these SOPs is 2001-10-26.

Personnel / Personnel - C.02.006

It was noted that during the evening shift in Component Production there was no supervisor on site that provided:

  1. adequate authority; and
  2. technical expertise.

An operational assessment will be performed by 2001-10-01 to determine the most cost-effective solution to this supervisory requirement. A recommendation will be put forward to the Assistant Vice President of Operations for approval.

Manufacturing control / Contrôle de la fabrication - C.02.012

Regarding recalls:

  1. there was no procedure which defined the roles and responsibilities of staff within the Centre for the recall of supplies provided by either CBS Head Office of other external suppliers; and
  2. there was no final report prepared showing reconciliation.

SOPs for the conduct of recalls have been submitted to the BBR. In the interim period, a Centre Operating Procedure will be implemented by 2001-09-04 to define the roles and responsibilities of staff within the Centre for the recall of supplies provided by either CBS Head Office or other external suppliers. The COP will include instructions for reconciliation.

Equipment / Equipement - C.02.005

There was no evidence to demonstrate:

  1. that the Emergency Back-up Power Generator had been maintained according to the specifications detailed in the Operator's Manual;
  2. which circuits were powered by the back-up generator; and
  3. that the emergency power capability in the Centre Service Interruption Recovery Plans data was accurate.

  1. COP CTR014 Auxiliary Power Test Procedure will be revised by 2001-09-04 to ensure the generator is maintained according to Operator Manual Specifications.
  2. Circuits powered by the back up generator are identified by a specific label on the outlet cover plate indicating it is on emergency power.
  3. Power drawn information will be verified and updated in the Service Interruption Recovery Plan by 2001-09-04.

Manufacturing control / Contrôle de la fabrication - C.02.011

There was indication that some documentation was signed without proper review and understanding of the information/data recorded on the forms.

An assessment of the current review system will be conducted and a plan will be developed by 2001-09-04 to ensure that a meaningful review is conducted with an appropriate understanding of the information/data.

Equipment / Equipement - C.02.005

The following was noted concerning the Instacool MP1100 Thermogenesis Plasma Freezer (Unit#210, ser.# MC10007-RFB):

  1. the preventative maintenance was not performed as detailed in the Operations and Maintenance Manual (Rev. C June 16, 1999);
  2. the installation and initial calibration was not complete nor reviewed prior to use;
  3. equipment qualification was not complete; and
  4. there was no document demonstrating certification of the service technician.

  1. A Centre Operating Procedure will be implemented by 2001-09-04 to ensure that preventative maintenance is performed according to the Operations and Maintenance manual.
  2. The installation and initial calibration was completed before initial use but documentation was incomplete. The record will be completed and reviewed by 2001-07-16.
  3. The Instacool will be requalified, using the protocol established by Head Office, prior to the implementation of Concurrent Plasma scheduled for implementation 2001-09-04.
  4. Documentation demonstrating the certification of the service technician will be obtained by 2001-07-16.

Equipment / Equipement - C.02.005

The following was noted concerning the Gammacell 1000 Elite irradiator:

  1. the review of the form, "Irradiated Blood Components Record" was not timely;
  2. a copy of the equipment certification used to perform the preventative maintenance was not available; and
  3. the local supplement identified in SOP 25 055, Irradiator Maintenance (All models), was not available.

  1. The irradiation record will be reviewed weekly by a senior technologist beginning 2001-07-06.
  2. A copy of the equipment certification used to perform the preventative maintenance will be obtained by 2001-07-16.
  3. A local supplement will be implemented by 2001-09-04.

Manufacturing control / Contrôle de la fabrication - C.02.011

The documentation for Product Complaints and Adverse Transfusion Reactions were not in accordance with the requirements stated in the Centre Operating Procedures.

The documentation for Adverse Transfusion Reactions has been reviewed and appropriately corrected as per COP MD040 Adverse Transfusion Reactions.

Appropriate Laboratory staff will be retrained on COP QA019 Product Complaints by 2001-09-04.

Equipment / Equipement - C.02.005

There was evidence to demonstrate that the Freezer (Unit #201 Ser. # D3A-271) had not been properly maintained.

A new Centre Operation Procedure will be implemented by 2001-09-04 and will include a maintenance plan for the freezer.

Equipment / Equipement - C.02.005

In some instances, there were no records demonstrating external service provider's certification nor were there any records of the calibration of the instrumentation used by the technicians.

A Centre Operating Procedure will be implemented by 2001-09-04 to ensure that certification records for external service providers are received and that records of calibration for the instrumentation used is on file.

Quality control department / Service du contrôle de la qualité - C.02.015

The following were noted with regards to Lot Acceptance of anti-sera:

  1. no evidence to show that it was conducted on all anti-sera; and
  2. the testing performed on ABO anti-sera was incomplete.

  1. A procedure for lot acceptance and release for all reagents will be implemented by 2001-09-04.
  2. Form L862-1 Antisera Specificity/Avidity Testing will be revised by 2001-09-04 to ensure that testing is appropriate based on the end use of the anti-sera.

Manufacturing control / Contrôle de la fabrication - C.02.011

The following were noted regarding audits conducted by the Quality Systems Department:

  1. there was no procedure for the follow-up action to be taken with regards to observations made during audits; and
  2. there was no evidence to demonstrate that follow-up action had been taken, in a timely manner, to address audit observations made during the audit of the off-site storage facility.

COP QA 003 Internal Audits will be revised by 2001-09-04 to incorporate the follow up of observations and to include a time frame for follow up.

Manufacturing control / Contrôle de la fabrication - C.02.011

With regards to the storerooms:

  1. the Temperature Sensitive Product List (CTR004-2) was uncontrolled; and
  2. the maximum temperature for Pentaspan is 25 degrees Celsius, yet the storage room where the product was stored permitted temperatures above this limit (30 degrees Celsius)

Resolved during inspection.

Manufacturing control / Contrôle de la fabrication - C.02.011

The management of back-up magnetic Media Room was inadequate in that:

  1. SOP 07 220, System Back-up was not followed;
  2. SOP 07 112, Managing Magnetic Media Room was not followed;
  3. magnetic tapes were re-labelled with incorrect in-service dates; and
  4. expired tapes were available for use (LDMS).

  1. Effective immediately, a copy of the back up log will be sent to the off site storage location along with the back up Media Room. Staff will be retrained on SOP 07 220 by 2001-09-04.
  2. Effective immediately, a Media Room log will be created and maintained to document tapes that are in service. Staff will be retrained on SOP 07 112 by 2001-09-04.
  3. Effective immediately, the magnetic tapes in question will be corrected to reflect the correct in-service date. Staff will be retrained on SOP 07 112, " Managing Magnetic Media Room", by 2001-09-04 to ensure that magnetic tapes are not relabelled after initially being put in use.
  4. Tapes used for LDMS were mislabelled at the time of the audit. Expiry dates on the tapes in question were corrected immediately. Staff will be advised to record correct expiry dates.

Equipment / Equipement - C.02.005

The environmental validation performed on the Blood Component Issuing System (BCIS) and the Confidential Unit Exclusion (CUE) system were incorrectly documented.

Resolved during inspection.

Equipment / Equipement - C.02.005

There were several instances where the refrigerators and or freezers were incorrectly labelled regarding their contents.

Content labels have been corrected. A Centre Operating Procedure will be implemented by 2001-09-04 to ensure that labelling is accurate.