To redesign the Sales Picklist Process to comply with Quality Standard ICH Q7

 

Key Business Challenges and Project Objectives:

Our multinational client, a manufacturer of bulk Active Pharmaceutical Ingredients, made a strategic decision to migrate to a new electronic system. From their Warehouse perspective, this change would result in the current Sales Picklist Process being out of compliance with Quality Standard ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients. The process also did not fit with the standard process within the new electronic system and customisation was too expensive. Crystal Lean Solutions were invited to lead the Redesign Project in conjunction with the Warehouse team members over a 4-month period. The key objectives of the project included:

  • To resign the Sales Picklist Process to comply with ICH Q7 and to suit the new electronic system workflow
  • To Streamline to Sales Picklist Process

CLS Approach and Changes Implemented:

Using the DMAVD methodology, CLS first reviewed the current process with warehouse personnel, mapping the actual workflow and paperwork trail. Key steps under review included a) identifying customer requirements b) selecting appropriate materials c) labelling drums and d) supply of paperwork. The number of entries were counted, including both entries and reviews required. From reviewing the data and identifying unnecessary activities, the following changes were implemented, which complied with ICH Q7:

  • Eliminated excess labelling of drums
  • Reduced the number of certificates of analysis supplied from 2 to 1
  • Standardised location of customer requirements from 4 locations to just 1
  • Eliminated non value added entry boxes and minimised number of review signatures
  • Design flow of form aligned to the work flow

Results / Outcomes:

  • Standardised Sales Picklist process to meet new electronic system work flow
  • Reduced the number of entries by 41%
  • Redesigned Sales Picklist process to meet Quality requirements of ICH Q7
  • Project completed on time and on budget