Post on 11-Jul-2015
Guidance for Preparing Standard Operating Procedures
Sherri-Lynne Almeida, Dr.PH, MSN, M.Ed, RN, CEN, FAEN
IntroductionOverview
A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end result.
IntroductionPurpose
detail the work processes document the way activities are to be performed
facilitate consistent conformance support data quality
IntroductionPurpose
intended to be specific to the organization assist that organization to maintain their quality control
and quality assurance processes and ensure compliance
IntroductionBenefits
development and use of SOPs promotes quality through consistent implementation of a process or procedure within the organization
reduced work effort, along with improved data comparability, credibility, and legal defensibility
IntroductionWriting Style
concise, step-by-step, easy-to-read format information presented should be unambiguous and not
overly complicated active voice and present verb tense should be used should not be wordy, redundant, or overly lengthy
SOP ProcessPreparation
written by individuals knowledgeable with the activity and the organization's internal structure
written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised
SOP ProcessReview & Approval
reviewed by one or more individuals with appropriate experience
approved by the State Council
signed by the President
SOP ProcessFrequency of Revisions & Reviews
need to remain current procedures are changed, SOPs should be updated and re-
approved systematically reviewed on a periodic basis to ensure that
the policies and procedures remain current and appropriate, or to determine whether SOPs are even needed
review date should be added to each SOP that has been reviewed
Checklists Many activities use checklists to ensure that
steps are followed in order. SOPs should describe how the checklist is to be
prepared or on what it is to be based.
SOP General Format Should be organized to ensure ease and
efficiency in use and to be specific to the organization.
SOP General Format Title Page
Title that clearly identifies the procedure/activity Date of issue and/or revision Name of the association Signatures and signature dates of those
individuals who prepared
SOP General Format Table of Contents
Quick reference Denotes changes or revisions made only to
certain sections of a SOP
SOP General Format Text
Purpose of the work or process Define any specialized or unusual terms either in
a separate definition section or in the appropriate discussion section
Clearly worded The use of diagrams and flow charts help to break
up long sections of text
SOP General Format Types
May be written for any repetitive technical activity, as well as for any administrative procedure
Examples In states where Chapters exist, State Councils
will be composed of representatives from each Chapter within the State in accord with Bylaws and Procedures.
TENA SOPs
Examples Each State Council shall coordinate the
individual State Delegation to the ENA General Assembly in accord with Procedures.
Examples Each Chapter has the responsibility to provide
representation for active participation at the respective State Level in accord with Procedures.
Examples