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