Retention of other records

Question 1

Management review of effectiveness of the quality system

Answer 1

5 years

Question 2

Exception to policies, processes, and procedures

Answer 2

10 years

Question 3

Emergency operation plan tested at defined intervals

Answer 3

2 years

Question 4

Job descriptions

Answer 4

5 years

Question 5

Qualification of personnel performing critical tasks

Answer 5

5 years

Question 6

Training records of personnel

Answer 6

5 years

Question 7

Evaluation of competence of personnel

Answer 7

5 years

Question 8

Personnel records of each employee

Answer 8

5 years

Question 9

Records of names, signatures, initials or ID codes and inclusive dates of employment for personnel who perform or review critical tasks

Answer 9

10 years

Question 10

Equipment qualification

Answer 10

10 years after retirement of the equipment

Question 11

Unique ID of equipment

Answer 11

5 years

Question 12

Monitoring and maintenance of equipment

Answer 12

10 years after the retirement of equipment

Question 13

Temperature monitoring of refrigerators, freezers, and incubators

Answer 13

10 years

Question 14

Monitoring of liquid nitrogen levels or temp

Answer 14

10 years

Question 15

Implementation and modification of software, hardware, or databases

Answer 15

2 years after the retirement of the system

Question 16

Validation of system software, hardware, databases, user-defined tables, electronic data transfer, and/or electronic data report
Fulfillment of applicable life-cycle requirements
Numerical designation of system versions, if applicable, with inclusive dates of use
Monitoring of data integrity for critical data elements

Answer 16

2 years after the retirement of the system

Question 17

Evaluation and participation in selection of suppliers

Answer 17

5 years

Question 18

Agreements

Answer 18

5 years

Question 19

Agreement review

Answer 19

5 years

Question 20

Agreements concerning activities involving more than one facility

Answer 20

5 years

Question 21

Inspection of incoming critical materials and containers

Answer 21

10 years

Question 22

Incoming containers, solutions, and reagents meet FDA criteria

Answer 22

10 years

Question 23

Validation of new or changed processes and procedures

Answer 23

5 years

Question 24

Participation in PT program

Answer 24

5 years

Question 25

QC records and review of QC results for reagents, equipment and methods

Answer 25

10 years

Question 26

Records of storage temps and blood products

Answer 26

10 years

Question 27

Ambient temperature recorded every 4 hours

Answer 27

10 years

Question 28

Inspection before shipping

Answer 28

10 years

Question 29

Container qualification and process validation records

Answer 29

10 years

Question 30

Participation in development of policies, processes, and procedures regarding recipient consent for transfusion

Answer 30

5 years

Question 31

Review and approval of new and revised documents before use

Answer 31

5 years

Question 32

Biennial review of policies, process, and procedures

Answer 32

5 years

Question 33

Identification and appropriate archival of obsolete documents

Answer 33

5 years

Question 34

Description an devaluation of nonconforming blood, components, its, derivatives, critical material, and services

Answer 34

10 years

Question 35

Nature of nonconformances discovered after release and subsequent actions taken, including acceptance for use

Answer 35

10 years

Question 36

Disposition of nonconforming products

Answer 36

10 years

Question 37

Fatality reports

Answer 37

10 years

Question 38

Transfusion service evaluation and reporting of transmissible diseases

Answer 38

10 years

Question 39

Review of assessment results

Answer 39

5 years

Question 40

Peer-review assessment of blood utilization

Answer 40

5 years

Question 41

Implementation of changes to policies , processes, and procedures resulting from corrective and preventive action

Answer 41

5 years

Question 42

Corrective action

Answer 42

5 years

Question 43

Preventive action

Answer 43

5 years

Question 44

Monitoring of biological, chemical and radiation safety

Answer 44

5 years

Question 45

Appropriate discard of blood and components

Answer 45

10 years