Biggest Challenges – Too much time spent on non-value added work.

Control of Master Documents was costly  – Quality documents such as SOPs, Work Instructions, forms and product technical documents were stored on 4 file servers, one for each division. Revisions were done manually on each server and the quality team had to copy, change and re-publish documents as links in a document control excel sheet. All of this took a lot of time and created a high risk of manual errors. 

Quality Audits, such as GMP and SQF, were managed in excel spreadsheets and the results were manually consolidated into a powerpoint presentation for the leadership team.

Managing Non Conformities was inefficient    –Non- Conformances were logged in an excel spreadsheet, and manually consolidated into graphs into a management powerpoint presentation.

Managing Safety Incidents was manual –Safety related incidents were completed on a printed form, hand written and copied and filed on a server location and added to another tab on the excel spreadsheet for further manual inclusion into the powerpoint for management.

Batch Release Records are not centralized  –The positive release program of products to undergo 3rd party independent testing was managed in another excel document, and manually transferred into the management powerpoint presentation.

Reporting to Management was time consuming – The management reports were created by each of the quality department team members, responsible for each location. These individual power points were manually consolidated by the Technical Services Manager into a single powerpoint for management attention.

Solution

• • Our first priority was to implement SoftExpert Document Master control to create a single source of truth and an automated document creation and revision process. This meant a migration of all master documents, development of clear attributes for searching and creation of document types to control the review and approval process. A document Portal was created to automate the management reporting requirements, so the leadership team could use the data in the quality management reviews without additional manual intervention, costs and delays. This data is available on the mobile device.
• Using the SoftExpert business process management component, the non-conformance process was interactively designed and built, digital forms integrated and automated. The process flowed from the Technical Services team members, to the Technical Services manager, with the option to push the approval to senior management, if investments were needed outside of the delegations of authority. A non conformance reporting portal was configured, to create visibility to the management team.
• The SoftExpert digital Audit management solution was then implemented, configuring each requirement, defining the requirements audit criteria and overall Audit result criteria and rolling out training for the mobile application , which can be used when there is no network connectivity such as when “in the shed”. Audit result reporting was then configured in the SoftExpert integrated portals.
• Finally, the manual batch release process was designed and implemented, automating the forms and process for creating, recording and receiving the external certificates for each product . An automated email was integrated into the process that sends a pass or fail email to the impacted team members. This automation re-used the product information, such as batch number and best before date from the digital  form, eliminating manual work and risk of typing errors.

Results

The total value add productive time for the Technical Services team was increased by 18.9%. This project means that over a five year period, the team is able to do almost 10,000 hours of value-addwork that had previously been wasted with manual processes across these core business processes.

Other intangible results include:

• Reduce the need to buy more server space due to growing document/files needed to be stored.
• Central document system that can be accessed by all staff from multiple sites.