Lighthouse MES - Compliance And Traceability In The Medical Devices Industry

Medical devices is a category covering anything from blood sample and drug dosage containers to syringes, surgical gloves and heart valves. It is a fragmented industry sector with many companies working in specialist, niche markets, yet they all have factors in common.

• The industry is heavily regulated, requiring complete traceability of all aspects of the production process from raw materials through to production and delivery.
• A need for rigorous quality control, as there could be serious consequences for patients and medical practitioners should defective product make it through.

To meet the demands of both regulatory bodies and customers, manufacturers have in the past been forced to use mainly paper-based records that have proved time-consuming and cumbersome and not without considerable hidden costs.

At the same time, they are attempting to improve all aspects of their performance - for example OEE or first-time pass rate - towards world-class standards, but the data they need to use is, of course, locked away in paper records.

The obvious answer is to implement all production records electronically. However this must be done carefully, and to this end specific industry regulation - in the form of the Federal Drug Administration's (FDA) 21CFR Part11 - governs the issue of electronic records and electronic signatures to allow companies to move towards the adoption of paperless systems.

This case study looks specifically at the benefits for a manufacturer in the medical devices industry of installing a world-class web-based quality control system.

Process, Problems & Challenges

The replacement of a paper-based quality data collection system has resulted in many benefits for this particular company, which is typical of those making devices for the pharmaceutical industry in a fast-moving process environment.

The plant manufactures many millions of parts a year and data used to be collected manually from many stations around the manufacturing process. The company relied heavily on inspection to reveal problems but there was no real information to help understand the root causes.

Operators recorded quality checks on paper and had little feedback on the direction of quality parameters until the data had been analysed by the quality department. This enabled only the crudest form of process control and often led to more spoilage than was desired.

The Shopfloor-Online MES Solution

With the introduction of the Shopfloor-Online MES Factory Information System, operators now have access to graphical, easy-to-understand SPC (statistical process control) charts that clearly indicate what is happening in the process, enabling remedial action to be taken swiftly.

Visual displays that mimic the production process now make the operators instantly aware of processes that are going out of specification or out of statistical control, ensuring that process control changes can be implemented in a timely fashion to reduce wastage.

Being web based and accessed by a standard browser, Shopfloor-Online MES is relatively low-cost to deploy, easily accessible and extremely economical to support. With more than 20 client PCs the system is proving to be the ideal architecture to extend easily to other areas of the plant.

By purchasing automated measuring equipment for the shop floor the company has also been able to speed up data entry significantly and ensure that errors are not made at this stage.

The system also logs transactions occurring in the system, so complete traceability can be achieved should problems need to be investigated. The system supports electronic signatures as required by FDA 21CFR Part11 compliance and can be utilised in an FDA-regulated environment.

Operators also input raw material usage against specific batch numbers so it can be recorded for future reference. Should a raw material problem affect finished goods, batches produced using the raw material can easily be identified and recalled.

Shopfloor-Online - The Benefits

The main benefits achieved by our customer are:

• A completely paperless system
• Instantaneous feedback to operators when problems occur
• Time saved by operators recording checks
• Because the system is web based, any user needing to access information can do so from anywhere without having special software installed on their PC
• Complete traceability of raw materials and the batches produced from them
• Management is alerted quickly to problems, helping reduce spoilage significantly
• Information is readily available during customer audits
• Improved OEE
• Improved customer satisfaction
• A common reporting tool