SOP #:
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Effective Date: 8/16/00
Revision Date: _____________
Approval signatures:
Laboratory Director ________________________________ Approval Date: _____________
Medical Director ___________________________________ Approval Date: _____________
■ Policy
■ Procedure
XX:XX.XX: DOCUMENT PREPARATION, IMPLEMENTATION, AND REVIEW
PURPOSE: This policy describes the preparation, implementation, and review of documents,
including Standard Operating Procedures (SOPs) and the accompanying forms, for the XX
Laboratory (XX). All SOPs and forms are prepared in a standardized format and are identified by a
numbering system as described in this policy. Following this policy will assure that all SOPs are
uniform and complete, that staff members have been adequately informed and trained to perform
new or revised procedures, and that policies and procedures are adequately reviewed and updated
by the Laboratory Directors.
PRINCIPLE: SOP manuals contain both policies, which describe general operating principles and
processes, and procedures, which contain detailed instructions for performing various XX tasks. All
techniques performed on clinical products must be documented in procedures that are followed
strictly by XX staff members. New or revised policies or procedures and any accompanying forms are
reviewed and approved by the XX Director and Medical Director prior to implementation and are
reviewed annually. These documents and their review are mandated by accrediting and regulatory
agencies.
POLICY:
A. General Considerations
1. SOPs follow a standard format with the following characteristics:
 General formatting – Arial font, 10 or 12 pt., policy and procedure sections in outline format.
 1st page header – Hospital logo, Lab address/phone, SOP number, page number, date
documentation, approval signatures/dates, boxes indicating whether SOP is a policy and/or
procedure
 subsequent headers – abbreviated title, SOP number, page number
 All required sections – as described in sections C-E below
2. SOPs are maintained in a ring binder or suitable alternative. If multiple binders are necessary,
they are numbered (e.g., vol. __ of __).
3. Binders are kept in the XX and are not to be removed without permission of the Laboratory
Supervisor.
4. Each binder must contain a separate table of contents describing the contents of that binder. In
addition, the first of multiple volumes will contain a copy of the table of contents for each of the
additional volumes.
5. SOPs are indicated as a policy or procedure by marking the appropriate box in the SOP
header. An SOP can be classified as both a policy and procedure.
Document Preparation, Implementation, and Review
SOP #:
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6. The signed copies of all approved forms are maintained in a “Forms” binder that has a table of
contents listing each form and the SOPs in which it is used. It also contains extra blank copies
of the forms for use.
7. Completed examples of the forms used in each SOP are included in the attachments at the end
of the SOP.
B. Numbering System
1. Each XX policy or procedure is assigned a unique three-part number identifying the SOP type,
SOP number, and version number. For example – GE:001.01
a. The first part of the identification number (GE:001.01) is a two letter prefix based upon the
type of SOP as follows:
GE = General Policies and Procedures
PT = Processing and Testing Policies and Procedures
QA = Quality Assurance Policies and Procedures
b. The second part of the identification number (GE:001.01) is the specific SOP number and
consists of a three digit Arabic number. These numbers are assigned sequentially starting
with 001 for each of the SOP types defined above.
c. The third part of the identification number (GE:001.01) is the version number, which is a two
digit Arabic number defining the number of revisions that have been performed on a
procedure after implementation. A new procedure would have a version number of “.01”. All
subsequent revisions are numbered sequentially.
Example: A new processing procedure is assigned the next consecutive number in the
“Processing and Testing” category, which is 78. The procedure identification number would be
“PT:078.01”. The first revision of the procedure would be assigned the number “PT:078.02”.
The second revision would be assigned the number “PT:078.03”, etc.
2. Each XX form is assigned a unique two-part number identifying the form number and version
number. For example – 113.2
a. The first part of the identification number (113.2) is the specific form number and consists of a
three digit Arabic number. These numbers are assigned sequentially.
b. The second part of the identification number (113.2) is the version number, which is an Arabic
number defining the number of revisions that have been performed on a form after
implementation. A new form would have a version number of “.1”. All subsequent revisions
are numbered sequentially.
Example: A new form is assigned the next consecutive form number, which is 125. The form
identification number would be “125.1”. The first revision of the form would be assigned the
number “125.2”. The second revision would be assigned the number “125.3”, etc.
C. Format of Policies and Procedures
1. All SOP’s must adhere to a defined format, which includes a uniform appearance and inclusion of
all applicable sections depending on the type of SOP.
2. A procedure is a series of steps staff members must follow in a defined order to assure proper
performance. Each procedure includes the items listed below, with some optional sections
depending on the procedure.
3. A policy describes a definite course of action, thought process, or a code prescribing adherence to
correct etiquette or procedure.
4. Table 1, “Key parts of policies and procedures,” describes the required sections for policies and
procedures. If a section is optional for a specific SOP, “N/A” is entered next to the section
heading.
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Procedure
Policy
Table 1: Key parts of policies and procedures
Section
Description
Date
Documentation
A listing of dates (MMDDYY format) for the following items must be included:
 Effective date – date original version of procedure put into service; 1st page
 Revision date – date current version of procedure put into service; 1st page
 Approval date – signature and date of Director approvals; 1st page
X
X
Title
Include the SOP number followed by a title. Title should be unique and
sufficiently descriptive.
X
X
Purpose
A clear description of the aim or intent of the SOP, including specific clinical
situations which require that the SOP be followed.
X
X
Principle
A brief description of how the SOP achieves its purpose. Include any
biochemical reaction, if necessary.
Specimen
Requirements
Policy
x
x
(opt.)
(opt.)
x
Specify type of sample, quantity required, any storage and anticoagulant
requirements, and stability/expiration time.
State the policy. Be as concise or complete as needed.
Reagents/
Supplies/
Equipment
 include storage requirements and shelf life after preparation
 include acceptable chemical grade of reagents, manufacturer or supplier (if
required), and indications of unacceptable performance (e.g. precipitate,
color)
 identify reagents or devices that are for investigational use only (i.e., those
requiring an IND or IDE), including any unique labeling requirements
Materials
List any material required to follow the policy.
Quality Control
A clear description of any quality control activities in the procedure
 include acceptable and expected endpoints and action to be taken if stated
endpoints are not met
 describe the use of any reference control material, including when and how
frequently to run controls, acceptable ranges and corrective action when
controls are out of range
Procedural Notes
Describe any helpful hints or precautions, possible sources of error. List major
safety hazards and refer users to appropriate MSDS.
Procedure
 include detailed step-wise instructions, omitting long explanations and
technical background
 include specific instructions for use of equipment and special supplies
 provide acceptable recoveries for all intermediate steps and restate
acceptable endpoints
 describe any non-standard calculations required during performance of the
procedure with directions, equations and examples. NOTE: Standard
calculations are described in SOP XX, “Standard Calculations of the XX
Laboratory.”
Final Calculations
Describe any non-standard calculations that need to be done to report results
or prior to subsequent processing, but can wait until the procedure is
completed. Include directions, equations and examples.
Reporting Results
List special forms, worksheets and reports (include name & number) that are
to be filled out, with directions for completion. Alternatively, refer to SOP XX,
“Documentation and Reporting of Processing Results,” for a detailed
description.
(opt.)
X
x
x
(opt.)
x
(opt.)
x
(opt.)
X
x
(opt.)
x
(opt.)
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Procedure
Policy
Table 1: Key parts of policies and procedures
Section
Description
Records
Describe any worksheets, logs or records needed and the location of record
storage.
Attachments
List any forms, worksheets, reports used in the SOP and any other
attachments (e.g., flowcharts, tables, etc.). Completed examples are then
attached at the end of the SOP.
X
X
References
Cite journal articles, manufacturer product literature, equipment manuals,
textbooks, etc.
 Year of reference is required, when known
 Only the first three authors of a reference need be listed before using et al.
 For product literature, include the manufacturer’s name
 For other laboratories’ SOPs, include the name of laboratory and institution
 For regulatory & accrediting agency publications, include the agency name
X
X
Validation,
Training & Review
Documentation
The last page before attachments will contain documentation of SOP
validation, training and review signatures as follows:
 SOP validation information indicating date, type, person performing and
results
 method and date of staff training and signature of trainer
 signature and date of all staff training attendees
 initials and date of annual review by Laboratory Director and Medical
Director
X
X
x
(opt.)
D. Policy / Procedures An SOP can be classified as both a policy and a procedure. This is
indicated in the header on the title page and by inclusion of any/all appropriate sections needed to
sufficiently describe practice. For example, a policy/procedure may include all the required
sections of a procedure and a Policy section (usually right after the Principle section). Or, a
policy/procedure may include all sections of a policy and additional Quality Control and/ or
Procedure sections. In addition, steps to be followed in order to comply with a policy/procedure
may simply be contained within the policy statement without inclusion of a separate Procedure
section.
E. Forms All forms must contain the title of the form at the top of the page, and the form number,
revision date, page number (page x of y, if applicable), Hospital and XX identification in the footer.
F. Document Approval and Implementation (See Attachment 1 – Flow Chart)
1. Any member of the XX Staff can author an SOP.
2. The SOP draft is submitted to the XX Supervisor and Director for review along with all applicable
worksheets and forms.
3. SOP Validation: The XX Supervisor or Director decides on a validation plan and assigns a staff
member (other than the author) to validate the SOP. NOTE: SOP validation is separate from
process validation, which may be required to ensure that all requirements for product
specifications, functionality, safety, etc. are reproducibly met following performance of the SOP.
This is done according to SOP XX, “Process Validation”.
a. The purpose of SOP validation is to verify the completeness and accuracy of the SOP and any
accompanying forms, worksheets or reports.
b. SOP validation may consist of any or all of the following:
 reading SOP and discussion with the author
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 performing the procedure to verify achievement of predetermined results
 completing forms using case studies
c. Results of SOP validation must be documented on the last page of the SOP in the “SOP
Validation” section prior to SOP approval and training.
d. If SOP validation proves revisions are necessary, the changes must be incorporated and
approved by the XX Director prior to SOP implementation.
e. SOP validation documentation will be included with the final approved document in the SOP
manual, however, will not be included in the SOP page count.
4. Approval:
a. The final SOP, including validation results and any attachments (forms, worksheets, etc.), is
submitted to the XX Director and Medical Director for review and approval.
b. SOP approval is documented by the XX Director and Medical Director signing and dating on
the 1st page of the SOP.
c. Approval of a new form is documented by the XX Director writing “Approved”, signing and
dating on a blank copy of the form for inclusion in the Forms binder.
d. If any changes are required by the XX Director or Medical Director prior to approval, validation
of the SOP may need to be repeated at their discretion.
5. Training: All staff members must be trained on new or revised SOPs prior to SOP implementation
and the completion of training must be documented in the “Staff Training” section of the last page
of the SOP. See SOP XX, “Employee Orientation, Training, Continuing Education, and
Competency” for details on training.
6. Implementation: Once training is complete, the SOP and any accompanying forms are
implemented.
a. If the SOP is the first version, the Effective Date is entered on the 1st page.
b. If the SOP is a revision of an existing SOP, the Effective Date remains the same, and the
Revision Date is entered on the 1st page.
c. The SOP is then placed in the appropriate SOP manual and the signed copy of any new form
is placed into the Forms binder. If the new form is used in any other SOPs, completed
examples of the new form are also attached to those SOPs.
d. Any obsolete or superseded SOPs or forms are archived as described in Section H.
e. The table of contents of each SOP Manual and the Forms binder are updated.
G. Document Revision
1. Any member of the XX staff can suggest changes to a document; however, changes can only be
made by the XX Supervisor, Director, or Medical Director.
2. Minor changes to SOPs may be made at any time by hand-writing the change into the official hard
copy in the SOP manual. The changes must be legibly written in indelible black ink. The original
record must not be obliterated, using a single line to cross through the text to be modified. All
changes must be initialed and dated by the person making the change. Minor changes to forms
cannot be hand-written and must be made to the electronic document file.
3. Any change in prescribed laboratory practice, however slight, must be documented immediately
and communicated to XX staff.
4. As needed, changes are incorporated into the electronic document file and the document number
is updated (e.g., SOP PT:073.01 becomes PT:073.02, Form 117.1 becomes 117.2). The revised
document is then submitted to the XX Supervisor or Director for review.
5. Changes from the previous SOP version are listed on the back of the last page of the revised
SOP with the reason the change was made.
6. Validation, approval, staff training, and implementation for revised SOPs is performed as
described for initial SOP implementation in section F.
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H. Archival of Obsolete or Superseded Documents
1. Obsolete documents are those that are no longer used by the XX.
2. Superseded documents are prior versions of a current document following incorporation of
changes. Superseded documents have been replaced by a new version number.
3. The obsolete or superseded document is removed from the SOP manual and/or Forms binder
with any superseded or obsolete attachments. The date removed from service is marked
prominently across the header of the document and it is retained indefinitely.
4. Superseded forms attached to existing SOPs are replaced by a completed example of the
approved new version of the form, and completed examples of the superseded version are
removed and destroyed.
I. Annual Review Process
1. All SOPs must be reviewed annually, within the next calendar year, by the XX Director and
Medical Director. If there is a change in directorship, review by the new Director must occur in a
timely manner.
2. Annual review is documented in the “Annual Review” section at the end of each SOP by initials
and dates.
3. If it is determined that changes to the SOP are needed, this is handled as described in section G.
4. Each staff member is responsible for reviewing all SOP Manuals during their annual competency
review according to SOP XX, “Employee Orientation, Training, Continuing Education, and
Competency.”
RECORDS: Records of archived SOPs will be retained indefinitely as described in SOP XX, “Control
of Documents and Records”. SOP validation, staff training and annual review records for each
version of an SOP will be retained as the last page(s) of the SOP, either in the SOP Manual or in
archived records. Additional records of staff training are retained in the XX Training and Personnel
files.
MATERIALS: N/A
ATTACHMENTS:
1.
Flow Chart
REFERENCES:
1. Procedure Number B.2.9.3, “Preparation, Maintenance, and Review of Policies, Procedures and Manuals in the
Transfusion Service”, Transfusion Services, XX, 1999.
2. American Association of Blood Banks, Standards for Cellular Therapy Product Services, Second edition, 2007.
3. Foundation for the Accreditation of Cellular Therapy, Standards for Hematopoietic Progenitor Cell Collection,
Processing & Transplantation, Third edition, 2006.
4. “Clinical Laboratory Technical Procedure Manuals – Third Edition; Approved Guideline” NCCLS, GP2-A3, 1996.
Document Preparation, Implementation, and Review
SOP #:
SOP Validation
□ New SOP
□ Revised SOP
Reason for new SOP or changes: (List changes on back)
Validation Plan: (Check all that apply)
Read SOP
Read SOP and perform procedure using a mock sample (not a patient sample)
Read SOP and perform procedure using a patient sample
Complete forms using patient data in a case study analysis
Other:
Validation Plan Prepared By and Date:
Validation Performed By and Date:
Comments:
Validation Decision: (Check all that apply)
Acceptable
Acceptable with minor revision
Not Acceptable
Requires revalidation (note – attach new validation table)
Other:
Staff Training
SOP Review:
□ N/A
Technical Performance:
Conducted By:
Date:
Conducted By:
Date:
______________________________
__________
______________________________
____________
Quiz/ Competency Required?
□ Yes □ No
Staff Training Attendees: I have read and understand this SOP and I agree to consistently follow the procedure as described.
Signature:
Date:
Signature:
Date:
Annual Review
Laboratory Director
Date
Medical Director
Date