Considering these benefits that can be attained with the use of sops it is good to avail them at the actual location of the employees. Language and terminology Most laboratory staff in low-resource settings are not native English or French speakers and are often not expert in the particular domain of care or research; therefore, their literacy level may be lower than anticipated.
As these are not available in writing a laboratory standard operating procedure settings, one could reconsider some of the QMS requirements.
Training and implementation During the prestudy phase, the feedback of the study site team helped to refine and adapt the SOPs to the local setting. This language barrier is often not overcome by simple translation into the local language, as words in different languages are not always identical in meaning and function [ 20 ].
In particular, a QMS cannot hinge solely on written instructions in an environment with a strong oral culture. When relevant, safety precautions and waste management should be included as separate sections. By contrast, job aids were perceived to be very useful in day-to-day research practice.
Engage local staff to develop the SOPs Think about the language of the SOP English, French, local language Take extra care in adhering to requirements of legibility, readability, and comprehensibility Take cultural differences into account: Group training can be effective, if it allows time for discussion, questions, and answers.
Training of involved laboratory staff Training takes place after approval and before distribution and implementation of the SOP. Job aids should be posted in a place that is clearly visible from the work space [ 1 ] e.
Furthermore, even if quality systems have become a dominant feature in industrial societies, this is not always the case elsewhere. For clarity and simplicity, we opted for these five sections only, rather than for the full list of 17 sections recommended by CLSI Table 2 ; we also considered that these five sections were the most relevant at the time for all concerned SOPs also for those SOPs outside the laboratory domain.
Assessing comprehensibility of SOPs through pretesting To enhance its comprehensibility, each SOP should be pretested and adapted before finalization.
In addition, presbyopia i. A training period should be foreseen [ 2 ], and continuous support should be available. Due to the difficult internet and telephone communication with the remote site, some procedural changes could pass unnoticed.
The SOP master file contains the current and previous versions of the SOP and serves as the source for generating working copies of current SOPs as well as a historic record, which is useful for audit and inspection purposes.
Box 1 lists the basic principles of SOP writing. Feedback from the study site: Graphics are promoted if they are clear, simple, precise, and depicted at appropriate size and resolution.
SOPs should be developed on-site to produce best practices in accordance with the available resources [ 27 ]. Graphics preferably drawings should be added to aid comprehension. Adequate budget and staff should be allocated to pretest the draft SOPs and to implement them once finalized.
Writing, review and approval of SOPs: The European Commission guideline explains the concept of user testing, discusses the testing of multiple language versions, and describes a method for pretesting package leaflets [ 11 ].
Key learning points When writing SOPs, think about: Make sure SOPs are distributed in a timely fashion and are accessible to all staff involved Provide training on SOPs for all users and other implicated staff Plan periodic revisions and updating of SOPs in use Provide continuous support and regular site visits Conclusion The development of a set of SOPs is essential for the good conduct of a clinical study, such as the NIDIAG study on neurological disorders.
These can be used to enable you to easily and more conveniently come up with SOPs for your organization or institution. In addition, producing a high-quality translation is labor intensive [ 21 ]. They are designed for direct use at the testing site and are meant to supplement but not replace SOPs [ 1 ].
Web-based translation machines may be inaccurate: This guideline mentions document verification as part of the review process see belowwhich can be considered as a form of pretesting [ 2 ].
They will be helpful in many workplaces which require strict procedures or adherence to a set of instructions to see to it that certain outcomes are attained They will also serve as a good reference to employees who are required to follow a given set of procedures.
This will increase their accessibility and it also act as a sign that your organization or company is committed in ensuring only the right steps or procedure are followed in doing a given activity. The number, length, and complexity of SOPs can also be a barrier to writing and implementation, as well as the language issues.
Timely review of SOPs proved to be challenging in our study because of unforeseen events e.Writing Guide for Standard Operating Procedures. Table of Contents.
elements, including governance, standard operating procedures, training and exercises, and usage of interoperable communications, play a vital role. Operational Procedure and Guidelines for Limited and Full Activation. We prepared 37 Standard Operating Procedure (SOP) Templates & Examples which can be easily downloaded and used in your organization.
Standard Operating Procedures (SOPs) Standard operating procedures (SOPs) incorporating safety and health considerations must be developed and followed when laboratory work involves the use of hazardous chemicals, especially “particularly hazardous substances.”SOPs are written instructions that detail the steps to be.
Chapter 8: Writing Standard Operating Procedures. The OSHA/MIOSHA Laboratory Standard requires that written SOPs are developed for all laboratory work that involves hazardous chemicals or physical hazards.
Standard Operating Procedure Title: Writing, Issuing and Retrieving Standard Operating Procedures Revision: E Effective Date: 16MAY compliance with GMP laboratory requirements.
The standard font is Arial Headings with X.0 should be classified as Heading 1. Headings with X.X should be. Nov 03, · The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices Writing, review and approval of SOPs: Who does what?
An SOP should be written by a person who knows the procedure Most laboratory staff in low-resource .Download