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1. INTRODUCTION
1.1 Purpose
The purpose of this document is to provide guidance regarding the identification of a
quality record and the documentation practices required for their proper creation
and maintenance.
1.2 Scope
These procedures apply to all documents related to the training of personnel and /
or the design, testing (clinical and non-clinical), quality control, quality assurance,
production, tracking, storage, service and distribution of ZOLL, medical devices.
These procedures explain the manner in which data and / or information is
recorded, transcribed, reviewed, transmitted and archived by ZOLL, personnel.
(See also 90A0001, Documentation Control.)
2. RESPONSIBILITIES
2.1 All ZOLL, personnel are responsible for recording and storing training, design,
clinical research, quality control, quality assurance, manufacturing, component and
device tracking, storage, service and distribution information, as it is generated, in
accordance with this document.
2.2 Each employee is responsible for ensuring the quality records he/she produces are
accurate and complete.
2.3 Each department manager is responsible for ensuring their subordinates are
adequately trained in the proper completion and maintenance of quality records.
Department managers are responsible for ensuring quality records are maintained
in accordance with the Quality Records Matrix (see Appendix A).
2.4 Quality Assurance is responsible for assisting in the identification of document or
electronic files that are required in order to demonstrate: (1) conformance to
specified internal or external requirements and (2) the effective operation of the
quality system.
3. APPLICABLE DOCUMENTS
21 CFR Part 11 Electronic Records and Electronic Signatures
21 CFR Part 803 Medical Device Reporting (MDR)
21 CFR Part 806 Medical Devices: Reports of Corrections and Removals
21 CFR Part 820 Quality System Regulation
93/42/EEC Council Directive Concerning Medical Devices
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MEDDEV 2.12/1 March 2012 - rev.7 Commission of the European Communities Guidelines
on a Medical Device Vigilance System
90A0001 Documentation Control
90A0023 Change Requests and Change Orders
90A0127 Electronic Records Back-up and Archival
4. DEFINITIONS
4.1 Quality Record-- A document or electronic file that is maintained to demonstrate:
(1) conformance to specified internal or external requirements and (2) the effective
operation of the quality system. Quality Records can include databases relevant to
the above.
4.2 Documents identified as Quality Records include the following and their specified
subparts (see relevant SOPs):
Management Reviews (CONFIDENTIAL)
Quality System Record
Corrective Action Requests
Supplier Evaluations (CONFIDENTIAL)
Inspection and Nonconformance Reports
Dock to Stock List
Audit Reports (CONFIDENTIAL)
Design Review Records
Design History Files (DHF)
Device Master Records (DMR)
Technical Files
Device History Records (DHR)
Purchase Orders
Equipment Maintenance Records
Calibration Records
Material Review Board Records
Approved Supplier Lists
Employee Training Records
Complaint Report Forms
Functional Test Reports
System Problem Reports
Change Requests & Change Orders
Medical Device Tracking Missing Data Log
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5. PROCEDURE
5.1 General
5.1.1 Record all information directly, promptly and legibly using permanent ink,
preferably BLACK ink. (Do not use felt-tipped pens.)
5.1.2 All documentation must be dated with the date on which the entry was
made. DO NOT BACK-DATE AN ENTRY.
5.1.3 Data should be recorded using clear concise language, initialed, then dated
in such a manner as to avoid any doubt as to when or by whom the entry
was made.
5.1.4 Data entry should be recorded by the individual performing the activity
5.1.4.1 If a signature or date was omitted and employee is available, the
employee who performed the work should sign with the current
date and record a reason for the omission including the date on
which the work was performed.
5.1.4.2 If a signature or date was omitted and employee is unable or
unavailable, the employee’s Manager/Supervisor will have
signature authority. Manager/Supervisor shall sign with the
current date & structure “Manager Name signing for Employee
name”.
5.2 Signatures on Quality Records:
5.2.1 Quality Records may be signed using either handwritten signatures or
electronic signatures. All electronic signatures must be compliant to 21
CFR Part 11.
5.2.2 All signatures, both handwritten and electronic, are legally binding. Upon
request, one may be required to provide additional testimony that a specific
electronic signature is the legally binding equivalent of the signer’s
handwritten signature.
5.2.3 Repetitious entries in a column may be completed by entering the data on
the first and last row of the column and drawing an arrow from the first
row to the last. See Example 1.
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Example 1:
5.3 Time and Dates
5.3.1 Record all times in standard 12 hour format, such as 1:00 pm
5.3.2 Dates should be recorded as month day year, unless otherwise specified by
a written procedure, instruction, or regulation for a specific form or label.
Any reasonably apparent format or structure is acceptable. See Example 2
for commonly used formats.
Example 2:
2-9-15, 02-09-15, 02-09-2015, 2/9/15, 02/09/15, February 9, 2015
5.3.3 To avoid confusion, communication intended for Europe should use the
format Year Month Day only, unless otherwise mandated by regulation for
completion of a specific form or label.
5.4 Responding to Requested Information
5.4.1 When filling out forms and other documents that request information,
respond to all requests. Do not leave blank spaces. The following should
be used:
5.4.2 If the request does not apply, enter “N/A”, Not Applicable, in the blank
space.
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5.4.3 If the information requested is unavailable but may be obtained later, enter
“N/I”, No Information, in the blank space
5.4.4 If the information requested is not known and not obtainable, enter “UNK”,
Unknown, in the blank space
5.4.5 If the information requested is not obtained, or an activity is not carried
out, enter “N/D”, Not Done, in the blank space. An explanation of why the
data was not obtained should be noted.
5.4.6 Entire blank pages or the unused portion of a page can be marked
diagonally with a line, reason for unused space and date and initials.
5.5 Error Correction:
5.5.1 Any change to a quality record should include a justification for the change
(if not readily apparent) then be initialed and dated. See Example 3
Example 3:
5.5.2 To correct an incorrect entry:
5.5.2.1 Draw a single line through the incorrect entry. Clearly enter the
correct information adjacent to the error then initial and date the
corrected entry. See Example 4
Example 4:
5.5.2.2 DO NOT use a liquid correcting fluid (e.g., White-out). See
Example 5
Example 5:
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5.5.2.3 DO NOT obliterate the original entry by crossing through it more
than once. See Example 6
Example 6:
5.5.2.4 DO NOT write over previously entered information. See
Example 7.
Example 7:
5.5.3 To correct an incorrectly checked box:
5.5.3.1 Circle the correct box and the associated words, draw a line
through the incorrectly checked box and the associated words,
then initial and date the correction, See Example 8.
5.5.3.2 DO NOT individually circle the box or associated wording as seen
in Examples 9.
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Example 8: Correct- Line out and circle associated words and box.
Example 9: Incorrect- Individually lined out and circled words.
5.6 Alterations of Forms
5.6.1 Alterations of Controlled Forms, Standard Operating Procedures, Test
Methods must be justified, approved and documented according to
90A0023- Change Request and Change Orders.
5.7 Storage: (General)
5.7.1 Quality Records are stored at the ZOLL facility (121 Gamma Drive,
Pittsburgh, PA 15238) in such a manner as to maintain accessibility and
prevent deterioration by environmental influences and loss. Records may
be stored off-site in secured, environmentally protected facilities in
accordance with 90A0001 – Documentation Control. Quality Records
intended for offsite storage shall be boxed, clearly labeled, and stored in a
designated area. Records stored off-site shall be readily retrievable for
review and duplication by the FDA.
5.7.2 Where possible, paper files will be stored in metal file cabinets to prevent
deterioration or loss.
5.7.3 Electronic records will be backed up on a regular basis, according to
90A0127- Electronic Records Back-up and Archival. Back-ups will be
stored in a safe location, preferably off-site.
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5.7.4 Quality Records are available for review and duplication by ZOLL
employees.
5.7.5 Outside auditors (e.g., employees of the Food and Drug Administration)
may also receive copies of these documents, provided they are NOT marked
“CONFIDENTIAL”. All requests should be processed through the Quality
Assurance department and a complete record maintained of all duplication.
5.8 Record Location:
5.8.1 All Quality Records are typically maintained by the group responsible for
the development of that record. Refer to the Quality Record Matrix
(Appendix A) for the specific location of each record.
5.9 Length of Storage:
5.9.1 Quality Records shall be maintained for a minimum of 12 years from the
date of record creation, with the exception of employee training records,
which shall be maintained for 12 years from the date of termination of
employment.
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Appendix A – Quality Records Matrix
This matrix is the key to identifying and locating Quality Records. It includes the Quality Record
name, a description of the record, the method of indexing, file location, responsible group,
minimum length of storage and the document’s disposition upon expiration.
Quality
Record
Description Method of
index
File location /
responsibility
Minimum
length of
storage
Disposition
Management
Review Record
Corporate Quality
Council meeting
minutes.
Date QA 12 years Destroy
Quality System
Record
Index of procedures
required by 21 CFR
820, but not product
specific.
Numerical
order
Document
Control
12 years Destroy
Corrective Action
Requests
Records of all
internal corrective
action requests.
Numerical
order
QA & Document
Control
12 years Destroy
Supplier
Corrective Action
Requests
Records of all
external corrective
action requests.
Numerical
order
Supplier Quality
& Document
Control
12 years Destroy
Inspection and
Nonconformance
Reports
File of all inspection
and nonconforming
material reports.
Numerical
order
QA & Document
Control
12 years Destroy
Dock to Stock
List
List of parts
qualifying for the
Dock to Stock
Program.
Date QA & Document
Control
12 years Destroy
Audit Reports Records of internal
and audits.
Numerical
order
QA & Document
Control
12 years Destroy
Supplier
Evaluations
Records of external
supplier audits and
evaluations
Numerical
order
Supplier Quality
& Document
Control
12 years Destroy
Design Review
Records
Records and minutes
of all design reviews.
Numerical
order
QA & Document
Control
12 years Destroy
Design History
Files
Compilation of
records which
describes the design
history of a finished
device.
Index Document
Control
12 years Destroy
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Quality
Record
Description Method of
index
File location /
responsibility
Minimum
length of
storage
Disposition
Device Master
Record
Compilation of
records containing
the procedures and
specifications for a
finished device.
Index Mfg Eng &
Document
Control
12 years Destroy
Technical File Compilation of
product information
required by the
Medical Device
Directive
93/42/EEC.
Technical File
Category
Document
Control
12 years Destroy
Device History
Record
Compilation of
records containing
the production and
service history of a
finished device.
Top level:
Serial or lot #
Lower level:
Numerical
order of Work
Order
QA & Document
Control
12 years Destroy
Purchase Orders Copies of all purchase
orders.
Alphabetical
by Vendor
Name
Procurement &
Document
Control
12 years Destroy
Equip.
Maintenance
Records of all
equipment
maintenance.
Equipment ID
and in the
equipment
database
Mfg Eng &
Document
Control
12 years Destroy
Calibration
Records
Records of all
equipment
calibrations
Equipment
manufacturer,
ID, and
Calibration
database
Mfg Eng &
Document
Control
12 years Destroy
Material Review
Board Records
Copies of all records
of Material Review
Board decisions.
Numerical
Order
QA & Document
Control
12 years Destroy
Approved
Suppliers List
List of all suppliers
currently approved
for use.
Database /
ERP System
Procurement 12 years Destroy
Employee
Training Records
General Employee
and Job Specific
Training Records.
Alphabetical
by employee
name.
ZOLL on-line
training platform
or designated
functional
trainers.
12 years
from date of
termination
of
employment
Destroy
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Quality
Record
Description Method of
index
File location /
responsibility
Minimum
length of
storage
Disposition
Complaint Report
Forms
Records of all product
complaints received
from the field.
Numerical
Order*
RA & Document
Control
12 years Destroy
Adverse Event
Reports
Records that are
associated with an
adverse event that
occurred in the field.
Numerical
Order Grouped
by Year
*Complaint
Report Forms
associated
with Adverse
Events will be
filed with the
Adverse
Events
RA & Document
Control
12 years Destroy
System Problem
Reports
Records of all
discrepancies
detected primarily
during design
verification &
validation.
Numerical
Order
Document
Control
12 years Destroy
Change Orders Records of all
changes made to
approved
documentation
Numerical
Order
Document.
Control
12 years Destroy
Medical Device
Tracking Missing
Data Log
Log listing the aware
date of the missing
data, the date(s) of
the missing data, the
description of the
missing data, and the
reason the data is
missing and why data
could not be collected.
Numerical
Order
QA & Document
Control
12 years Destroy
