1 reply to this topic

[mtelander]

Does anyone have any examples they would be willing to share of their format for their manufacturing process narrative? We are a contract dietary supplement manufacturer and to my process we have every other controlled document for our process except an actual written narrative 

[johnct]

Hello, 

 

I would start with the process flow chart and describe the processes step by step with each step numbered 1-2-3....You can use SOP format or simple bullet points depending on the Quality scheme you follow. Whatever format your current documents have can be adapted for this. I include the narrative in my HACCP plan in paragraphs per each step, I also have it on a separate document part of process validation.

 

Depending on your process flow each number can correspond to: 1-raw material acceptance criteria - 2- incoming material and testing - 3- storage - 4- production prep - 5-weigh? - 6- mix? -(you need to add the  processes) - 7-CCPs? (x-ray/metal detection/filter/screen etc...) 8-finished product testing- 9-packaging/labeling - 10-storage

 

Depending on your steps you can choose how in depth you want the document to be. 

 

Good luck