TITLE: STANDARD OPERATING PROCEDURE (SOP)

PREPARED BY: GROUP 2

CONTENTS:
WHAT IS STANDARD OPERATING PROCEDURE?
WHY IT IS ESSENTIAL?
BENEFITS
SOP WRITING STYLE
POINTS TO BE KEPT IN MIND WHILE WRITING SOP
INSIDE THE SOP
STEPS OF SOP

STANDARD OPERATING PROCEDURES
-Set of written instructions that is followed routinely or repetitively. Created culture where
Quality objectives are Transparent, well understood, and undoubtedly these goals can be achieved by
certain sets of Procedures called as Standard Operating Procedures. SOPs describe both technical and
fundamental programmatic operational elements of an organization that would be managed under a
work plan or a Quality Assurance (QA) Project Plan also associated with the term Good Manufacturing
Practices or GMP.

Standard Operating Procedures (SOPs) help maximum safety and operational efficiency for these kinds
of organizations:

Pharmaceutical organizations
Government organizations
Emergency response operations
Clinical research organizations
Power producing organizations

IS SOP NECESSARY?
-The details in an SOP standardize the process and provide step-by-step how-to instructions that
enable anyone within your operation to perform the task in a consistent manner. The SOP document
serves as an instructional resource that allows employees to act without asking for directions,
reassurance, or guidance. The step-by-step written procedure can also help hold employees accountable
because employee expectations are documented and their actions can be measured against the SOP.
Communicating procedures that anyone in the operation can follow with consistent results will ensure
your operation continually provides high quality products and services.

SOPs OBJECTIVES
To describe the responsibilities of the coordinating center for managing and monitoring the
participating sites.
To provide guidelines for accurate and timely data collection, resolution of data clarifications
(queries).
To detail the regularly recurring work processes that are to be conducted or followed within an
organization.
To facilitate consistent conformance to technical and quality system requirements and to
support data quality.


WHY IS IT ESSENTIAL?
-Because a Standard Operating Procedure is an integral part of successful quality system. It
plans the effectiveness and efficacy (or efficiency). It is a regulatory requirement. It ensures that
production operations are performed consistently to maintain quality control of processes and
products. And lastly, it ensures that processes are continuously uninterrupted and are completed on a
prescribed schedule.

BENEFITS OF STANDARD OPERATING PROCEDURES
-Standard Operating Procedure provides information to perform job properly. It provides people
with all safety, health, environmental and operational information necessary to perform job properly,
consistency (very important in any of the field), it gives information in order to achieve pre-determined
specification and quality end-result. Also, it minimizes variation and promotes quality. Steps can be
reviewed in accident investigations. And lastly, serves as a training document for users.

STANDARD OPERATING PROCEDURES WRITING STYLES
Here are tips and things that should be remembered when writing an SOP:

SOPs shall be written in a concise, step by step, easy to read and follow format.
Information should not be complicated. The active voice and present verb tense should be used.
Should be simple and short.
Routine procedures that are short and require few decisions can be written using simple steps
format.
Long procedures consisting of more than 10 steps, with few decisions should be written
along with graphical format or hierarchical steps.
Procedures that require many decisions should be written along with flow chart.
Requirement for document identification and control, accountability and traceability
responsibility must be included with every SOP; this can be achieved by providing
consistent format.
Do not introduce acronyms without explaining what it means.
Dont use the word may, if possible as it implies that the user can do something
under conditions. Instead be positive and tell them what to do.


INSIDE THE STANDARD OPERATING PROCEDURES
Companys Name and Pagination
The company name and pagination (e.g. page 4 of 7) must appear on every page.

Title
The title should be descriptive. The title should use directive language to declare what is being
done to what.

Identification
Procedures must be easily identified by giving unique number and version number. This
identification number of the SOP supports accountability of the document throughout the facility and
over time as it changes.



Review and approval
All SOPs shall have space for signature of initiator (the person who has written the SOP)
Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance Head of the
organization).
Initiator (the person who has written the SOP) ,
Reviewer (The persons who has reviewed the SOP), and
Approver (Quality Assurance Head of the organization).



Purpose
The purpose or objective of the procedure should restate and expand well written title. Expand
or qualify the directive language used in the title (e.g. to describe the operation procedure of
compression machine).



Scope
The scope should provide limits to the use of procedure. The scope shall be written in such a way
that it answers following questions.
Are there certain samples that are appropriate to test by this method?
Do these operations apply only to certain equipment or certain departments?
Is there a limit to the capacity, volume, or throughput of the procedure?
State to what areas this procedure does apply and does not apply?



Procedure
Describe the procedure in a step by step, chronological manner. Use active verbs and direct
statements.
(e.g. To describe the operation procedure of compression machine.)





Responsibility

Who is responsible for performing the work described?
Who is responsible for implementing the procedure?







STANDARD OPERATING PROCEDURE PROCESSES









SOP PREPARATION

-The organization should have a procedure in place for determining what procedures or
processes need to be documented. SOPs should be written by an individual who performs the tasks
routinely or someone who is directly responsible for the performance of the task.
There are also steps you should know when preparing Standard Operating Procedures, namely,
Format of your SOP, How youll possibly write your SOP, and Ensuring success and accuracy of your
Standard Operating Procedure.


SOP REVIEW AND APPROVAL

-SOPs should be reviewed by one or more individuals with appropriate training and experience
with the process especially helpful if draft SOPs are actually tested by individuals other than the original
writer before the SOPs are finalized. Once the first draft is complete the author will send the document
to the appropriate team(s) for review. Comments should be returned to the author within a maximum
of 10 working days. If substantial comments are provided, the author may send out the document for a
second round of review if this considered appropriate. And if all comments have been incorporated
appropriately, the author will send the document to the QM for review. The QM will review the
document and provide comments within 5 working days. All comments should be addressed prior to
sending it for approval.


SOP PROCESS
1. Sop
Preparation
2. SOP
Review and
Approval
3. Frequency
of Revisions
and Reviews
4.
Implementi
ng SOP
5.
Management
of SOP

FREQUENCY OF REVISIONS AND REVIEWS

-SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs
should be updated and re-approved. If desired, modify only the pertinent section of an SOP and
indicate the change date/revision number for that section in the Table of Contents and the document
control notation. SOPs should be also systematically reviewed on a periodic basis (i.e every 1-2 years), to
ensure that the policies and procedures remain current and appropriate, or to determine whether the
SOPs are even needed. The aim of SOPs is to document the standard procedures in an organization:
therefore SOPs need to remain current in order to be useful. IntelliSOP keeps track of SOP due dates and
every user is able to see when an SOP will expire. The system marks every SOP to show it will soon
expire and puts them into a special dashboard for administrators to review them and prepare the next
versions.



IMPLEMENTING SOP

-Tell employees how to follow the procedures, don't ask. Let them know that you or other
managers will be monitoring their ability to implement the procedures. Give them incentives for tackling
the new procedures by reminding them that the new procedures will improve their ability to do their
job.
Ask for feedback on the new procedures. Often, procedures are implemented to improve an
aspect of operation. No one is more familiar with the pros and cons of the procedure than those who
use it directly. Get their feedback to ensure the procedure is effective.

Evaluate the target audience for these operating procedures. If the procedures apply to a small
group of people, a group meeting works best; if they apply to the entire company and it's a large
company, a mass email or newsletter might get the word out faster.


MANAGEMENT OF SOP

-Organization shall have SOP on Preparation, approval, revision and control of standard
Operating Procedure for better control and management of SOPs. Generally, administrative aspects of
the SOP system such as distribution and filing are well managed. On the other hand, overall system
management, frequently characterized by the lack of a system owner, is generally poor. If a system
owner exists at all, his or her responsibilities are limited. Standard operating procedures management is
commonly used across all industries to help companies operate safely and more efficiently. Properly
managing SOPs for manufacturing companies that are ISO or QS/TS certified is mandatory. Within the
pharmaceutical, medical device, biotechnology, or other industries regulated by the FDA, SOPs must be
managed with strict change control processes to assure proper compliance with current good clinical
practices (cGCP), good manufacturing practices, (cGMP) and good laboratory practices (cGLP). Whether
or not an industry imposes specific requirements, SOP management is to be done in a controlled
manner should be implemented as a standard business practice.














Standard Operating Procedure
(Written Report)




SUBMITTED BY: GROUP II SUBMITTED TO:
Denver Audre Gorumba Engr. Julius Angelo Luzada
Francisco Miguel Palaa
Jorraine Razal
Jenzen Aglit
Gio Marasigan
Jennexa Aliermo
Paolo Lorenzo De Jesus
Jolo Barrientos
Ian Calibuyot