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Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Key Components of SOPs: Developing High Quality Documentation

High product quality and minimal liability all begin with well-established and well-documented business processes. Standard Operating Procedures (SOPs) are one of the cornerstones of business documentation. They direct employees on proper approaches to completing tasks, ensuring quality deliverables regardless of who performs the work. SOPs are highly beneficial to maintaining consistency across company practices.

sops-quality-control-documentationIn regulated industries, compliance and quality control are critical. Industries frequently audited to ensure compliance with regulations, such as medical device, pharmaceuticals, and process manufacturing, employ Standard Operating Procedures to avoid violations and their adverse consequences.

Well-written SOPs are a fundamental component of regulation adherence, quality control, employee training, and workplace performance. Utilizing SOPs reduces system variation, the primary reason for failed quality control. So, what do well-written SOPs look like?

The best SOPs are understandable by anyone using them and accurately reflect the process that ensures quality and minimizes risks. During the SOP development process, it's important to remember the user as well as the intention of the documentation. Remembering the four key components of any SOP keeps the writing process running smoothly:

4 Features of Effective SOPs

1. Clear

Making sure users understand the meaning of words and sentences eliminates confusion and missteps. Defining industry terms and using acronyms and abbreviations cautiously, improves clarity.

2. Concise

When sentences are short, direct, and only have one meaning, employees can quickly memorize the steps in the procedure, which positively impacts their consistency.

3. Descriptive

Using descriptive language in SOPs enhances understanding of the procedures. The manner in which an SOP is written heavily impacts content retention by employees.

4. Accurate

Keeping SOPs up to date with company processes as they evolve is important to ensuring that documentation matches the instruction given to employees. Effective training programs rely on accuracy.

For more about developing effective SOPs, download our free guide:

A Guide to Standard Operating Procedures

Get the Guide

Topics: Quality System documentation, regulated industries, SOPs

 EU MDR