In my time writing in corporate positions, I quickly learned there is a constant need for document creation. Nowhere did I find this more pressing an issue than when working in a cGMP, ISO certified, FDA regulated manufacturing environment that relied completely on employees being trained on and strictly following established Operating Procedures.
The Problem With Poorly Written Procedures
Flawed procedural documentation is found to be a common root cause of costly and time consuming issues that affect manufacturing line downtime and product delivery timelines.
And when it comes to third party audits and regulatory compliance, the quality of an organization's operating procedures may be all that stands between them and reputation damaging legal issues.
The unfortunate fact is that whomever happens to be walking past a manager's office at a given moment is often the person roped into writing such documents, whether or not they had the requisite subject matter expertise or writing skills.
This common scenario creates a situation where poorly written documentation causes expensive problems, including:
- Increased errors
- Increased downtime
- Increased lot reworks
- Increased waste / MDOs
- Increased customer complaints
- Increased audit observations
Beyond cost and compliance, it also creates tensions between floor staff and management. It's not unusual for employees to be expected to follow a document written by someone who never even bothered to walk out on the floor to find out how their job is actually done.
Additionally, when there are disconnects between the language proficiency level of the individual writing the document and the document's audience, it can lead to procedural errors.
Operating Procedure Workshop Audience
I work with staff members tasked with writing, editing, reviewing or otherwise contributing to an organization's operating procedures. I coach them on proven methodologies for creating clear, effective and efficient operating procedures.
Operating Procedure Workshop Content
Topics addressed include:
- Analyzing and segmenting content
- Best practices for length and language
- Necessary specificity versus shooting yourself in the foot
- Tailoring content to the audience
- Version control
Operating Procedure Workshop Format
The workshop is a combination of presentation / discussion and hands-on sample work. If a workstation classroom is not available, the content can be delivered as a straight presentation / discussion.
Contact Michelle to discuss hosting an operating procedure best practices workshop at your location.