Case Study


Nutraceutical Process – Standard Operating Procedures Development 

The Challenge – Documentation

Client: Food Manufacturer
Objective: Standard Operating Procedure Development

The process (spanning hundreds of yards) began in an open warehouse environment, moved via conveyor into various powder bulk handling/filling/sealing rooms, quality inspection, labeling, and cartoning packout, until it arrived in robotic palletizing and stretch wrapping modules, before going into finished goods storage racks. 

Although the client’s operators and maintenance staff were very helpful, it was difficult to get inside the equipment to capture issues/corrective actions because the packaging line was continuously running production.  It was difficult to schedule reviews and get feedback from the entire team to maintain the client’s schedule because input was required from operators, maintenance, operations, and engineering.  

protein powder SOPs

Our Solution

Sterling Engineering structured the SOP documentation for the entire process into 22 different process modules so that document naming, file sizes, and version control were manageable. A process map depicting the overall process in CAD was developed, with a bill of material identifying the 22 process modules on the map.   

Sterling’s team was embedded in the production environment to learn the process and observe the operators during normal production and the maintenance team during machine downtime events.  As we inventoried the observed SOPs, we would meet with the operations and engineering team members to reconcile what was observed and what should be the actual best practice SOP.  Operator safety, sanitation, and GMP (good manufacturing practices) were all considered to guide the vetting process.  The files were shared with the entire project team via a cloud SharePoint site, addressing security and document control concerns. 

After the base outline of the SOP was developed, Sterling’s team captured detailed production environment data, including photos, videos, machine disassembly and reassembly, failure modes, recovery procedures, changeovers, etc. We took the opportunity to capture this data during pre/post-shift break times, machine changeovers, and process downtime events (scheduled PM and unscheduled events). 

Sterling Engineering used a stage gates process to review the 22 process module documents with the client as they evolved.  At each of the 3 design review gates (concept review, light-line review, and hard-line review), the client’s team could redline the documents until each was developed into the final deliverable.  

The client introduced these SOP documents into the training repository under their respective document number and version level.  Because of this modularity and document version control, the client will use their continuous improvement process to increase their OEE (Overall Equipment Efficiency) for the process and update each corresponding module document as the process is improved.   

The Results

Project Duration

160 Weeks

Project Size


Project Team

2 Technical Writers
1 Program Manager

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