IMPLEMENTING A MULTI- LOCATION EQMS SYSTEM – LESSONS LEARNED Aaron Schmick - Quality Systems Manager, Monosol

EQMS Users Group Meeting 2

MonoSol Business Segments

Consumer Products Worldwide Confidential 4

Late 1950’s – MonoSol acquired by Chris-Craft Industries. Began developing water-soluble films for the aerospace and solid surface markets, early developments of MonoDose segment 1999 − MonoDose launches in EU laundry detergent market − Entered the Global ADW market 2010 – Developed and installed Generation III Manufacturing Line 1953 − Founded as an automotive foam manufacturer 1990’s − Spearheaded the worldwide use of water soluble films in the agrochemical industry 2001 − Became independent from Chris Craft 2004 – MonoSol acquired AquaFilm 2012 − Acquired by Kuraray … – Developed and installed Generation II Manufacturing Line – Spins off pharmaceutical division, MonoSol RX; two separate businesses 2005 MonoSol History 2013

England MonoSol Manufacturing Locations

Business Segments

Plant 1 Portage, IN Plant 2 La Porte, IN Headquarters & R&D Merrillville, IN MonoSol Locations in the US

9 Duneland Cast film site USA

EQMS Implementation Confidential 10 MonoSol had a Document Control Software in place that was out of date and unsupported by the manufacture Project was started to implement a replacement 20 potential candidates were reviewed and compared and narrowed down to 4 – One of the 4 was the same manufacturer as the one currently in place. Demonstrations were conducted with the 4 potential candidates and EQMS was found to be the most user friendly and had the most useful additional modules. Two candidates were presented to Senior Management, EQMS and the software that was in place, for consideration with a push to change over to the Qualsys EQMS software. Approval was given quickly. Qualsys quickly took the lead as the project manager for implementation. The decision was unanimous to start with the Document Manager Module.

Document Control Confidential 11 Aggressive timeline was developed by Qualsys MonoSol had to determine an effective method of transferring from the current software to the new without losing any critical data such as revision dates and past approvals.

Document Control cont. Confidential 12 Difficulties With Implementation – A lot of upfront building needed, requiring much thought and consideration. Approval paths, permissions, escalation paths, layout of the files. – Launching 1 system for all sites to share, sites having different accessibility options. – Establishing review protocols, and frequency – Over thinking the permissions portion of the structure, caused difficulties in adding groups to document types later.

Document Control cont. Confidential 13 Greater Advantages with implementation – With the enforceable notification option we are able to track employee review and training. – Escalation paths help ensure approvals are completed in a timely manner. – Document review and expiration date notifications helpful to ensure completion. – Ease of launching a document revision by non-document control owner.

Audit Manager Confidential 14 Audit Manager was installed and set up to be initially utilized for ISO 9001 and RC14001 internal auditing. Additional usages are in discussions for many other areas – Forklift inspections, daily – Safety audits – Supplier Audits

Audit Manager cont. Confidential 15 Difficulties with implementation – Auditors new to electronic auditing, attached to pen and paper audits. – Auditor not utilizing the evidence attachment or auditee feature, also adhering to the checklist and not auditing the process thoroughly enough. – Training of auditors in multiple sites. – Some confusion on the closing of audits with and without findings, ability to delete an audit with no findings. – Some lack of flexibility in the set-up All or nothing with the text required fields Some audits lost due to auto log off, learning curve

Audit Manager cont. Confidential 16 Greater Advantages with implementation – Ease in creating new audits – Simple to launch a round of audits – The process of making adjustments to audit checklists and questions is simplistic. – Ability to audit remotely greatly increased. – Evidence attachment – Availability to review past audits much more simple.

Issue Manager Confidential 17 Issue Manager implemented to control our Customer Complaints and corrective actions. – CARs – RMAs – Credits – Replacements

Issue Manager cont. Confidential 18 Difficulties with implementation – Flexibility of some of the fields – Difficulty to track complaints by weight – Would not directly tie into our RMA numbering system causing us to continue using the current RMA database – No printable form for CARs or RMA for distribution to a customer or supplier. – CAR process has been temporarily dropped for reconsideration, and restructuring. – Accessibility (my additional modules)

Issue Manager cont. Confidential 19 Greater advantages with implementation – Tracking of issue by customer/site – Ability to tie all documents, evidence, and reports to the issue – Ease of monitoring to closure – Adaptability

Up Next Confidential 20 We are moving forward with implementation of the Training Module in our Hartlebury UK Facility. Investigate and implement the CAPA manager to potentially replace our current Access Database process Investigate and implement the Supplier Management Module with your purchasing dept.

21 Questions