Thanks to EFACS E/8, Mi3 Limited can support the complexities of medical manufacturing, utilise effective MRP and conform to ISO 13485.
Mi3 Limited designs, develops and manufactures products such as medical tubing sets for the disposable medical device and pharmaceutical industries. Founded in 2006, the company employs over 70 people and is based in Blackburn.
Before implementing EFACS E/8, the company used a bespoke Microsoft Access-based ERP system called MARSS (Manufacturing and Resource Scheduling System). An Excel spreadsheet provided stock management with Sage being used for accounts.
According to Operations Manager Tim Ravenscroft, "MARSS was fine for a few years but as we went towards 10 users, we started having unhandled system exceptions. We ended up running compact and repair jobs on the database twice a day."
The stock control spreadsheet came under pressure as it tracked over 1,000 allocated storage spaces and thousands of components.
"It isn't suitable to be managing your stock through a spreadsheet, particularly with the complexities of kitting in a medical environment."
Jumping Hurdles
A big hurdle for replacing MARSS concerned the handling of sterile components. If you want 500 sterile items from a box of 10,000 for an order, you move the box to a clean room. You then extract 500 and return 9,500 to stock.
This isn't a good way of doing things with standard ERP. All the 10,000 components would be allocated to the order. That risks unnecessary over-ordering for subsequent orders as 9,500 of the components taken to the clean room would not be shown in stock until returned later. Full parts traceability during manufacture was also another requirement. Finally, ISO 13485 is the quality management standard for the design and manufacture of medical devices.
"The issue you have when manufacturing to ISO 13485 is that your systems must be validated," says Ravenscroft. "I wanted to manage stock and the supply chain more effectively too."
It was decided to deploy a fully-integrated ERP platform on a new server. Mi3 evaluated several options until an EFACS E/8 presentation proved compelling. The integral Customisation Toolkit meant core functionality could be added or modified easily.
"I was quickly sold on Exel. We wanted a system to manage our growth over the next 15 years. I was confident that Exel would provide that."
Training Focus
A "very aggressive" six-month timetable was set for a big-bang change. The Operations Manager, Materials Manager and Engineering Manager received some technical training. Other staff in various departments benefited from Exel's classroom training.
Top-level overviews from Exel were followed by departmental workshops to determine current working practices while mapping the old system onto the new. Where necessary, customisation changes were made and documented.
Ravenscroft extracted the MARSS data for uploading to the EFACS E/8 database. Mi3 and Exel worked closely together to achieve the transfer.
"The training, support and on-site workshop support was managed by Exel," says Ravenscroft. "I have never come across a supplier where every person had the same positive approach. There was a genuine desire to share knowledge."
Thanks to these efforts, the project went live in May 2015.
"We improved upon the old system immeasurably. We would not have been able to do that without Exel's support and the functionality of EFACS E/8."
ISO 13485 Compliance
The new system offered a number of positive changes. For example, stock details are now held in EFACS E/8 while role-based permissions limit functionality to the requirements of an individual's role. Reporting was improved over MARSS including 'On Time In Full' monitoring.
"Then there was the simple pleasure of being able to run MRP and getting recommended orders," says Ravenscroft. "A sales order comes in, the EFACS E/8 system takes it, creates works orders, allows us to analyse the stock and assess how efficiently we can build and deliver."
EFACS E/8 has been expertly customised to handle sterile stock moves. Although products change location, a number for traceability remains attached while reports identify over-kitting. Orders and components are easily traced.
"We added an element to EFACS E/8 which allows us to manage sterile products and comply with ISO 13485."
A future phase will include improved project management, document control and workflow. The Quality module will be implemented, barcode label production integrated and more use made of business intelligence.
"EFACS E/8 has given me everything I need to run operations effectively," says Ravenscroft.
