PROQUIS Audit and Assessment tool Bill Best

1. PROQUIS Audit and Assessment tool Bill Best PRQE SALES1 PPT. Release 3.

2. The presentation will provide a brief overview of the Proquis software. It is not designed to cover everything We are going to concentrate on Auditing, Inspections & Assessments. Screens & terminology shown can be customised to your requirements.

3. What are the objectives • Risk - Identify and Reduce • Improvement – Discover and Act – make it happen. • Actions – checks and balances on CAPA • Monitoring – Were we effective • Educate – assist staff, suppliers and others to do the right thing.

4. How do you achieve the objectives • Competent trained auditors • Good meaningful questions • Efficient comprehensive plan of audits • An ability to analyse • Easily • Comprehensively • Regularly • Identify opportunities and problems (with minimum or no effort – too hard - it doesn’t happen).

5. PROQUIS Application Modules • Document Control • Audit Management • Audit Nomad • Personnel and Training • Customer Care • Equipment Management • Remote Access Portal • Process Information • Accident Tracking • Management Review • Supplier Control • Product Test Results

6. Return to menu Audit Management - 1 • Audit & Assessment system home page • Instant view of your outstanding audits • See which non-compliances are still not closed • Search for the audit you want to see, or add a new audit to the plan • Jump straight to analysis reports • Reminders and escalation of outstanding tasks

7. Return to menu Audit Management - 2 • Define audit and assessment plans for the year • Internal & Supplier audits / assessments • Check resource requirements & coverage of processes, documents, products & suppliers • Create “real” audits from planner screen ready for auditors’ final preparations • Live update of Plan Graph and status reports on Audits home page

8. Return to menu Audit Management - 3 • Audit main screen allows planning of audits and completion of results • Shows main auditor, but audit team can be listed too • Notes and results are expanding notes fields • Scoring is optional • Various analysis codes available here • Audits can be checked out for remote editing using PROQUIS Nomad

9. Return to menu Audit Management - 4 • Define the Subjects to be covered by the audit • Each subject can then have associated list of Auditees • Each subject can have an associated set of questions or items to be reviewed • Associate with a set of references to internal & external requirements or regulations

10. Return to menu Audit Management - 5 • Questions are drawn from definitions of questionnaires in document control • Questions can have Yes/No, multi-choice or comment answers • When completing the audit, non-compliances can be raised against each question • You can also cross-reference evidence documents uploaded to PROQUIS • PROQUIS maintains a matrix of requirements covered by your audit programme

11. Return to menu Audit Management - 6 • When problems are found, you can create non-compliances (NCRs or issues) • These detail the problem, expected actions, required completion date, responsibilities and so on • These can be emailed to the person to take action • PROQUIS warns if NCRs are not completed on time • Automatic notification of NCRs, plus user-defined reminders and escalation

12. Return to menu Audit Management - 7 • Further actions can also be defined, along with other related details and correspondence • PROQUIS warns if actions are not completed on time • Reasons & causes can be assigned against the NCR for analysis

13. Return to menu NomadAudit Management - 8 • For off-line auditing, PROQUIS allows you to assign subjects to auditors. • The Auditors can then download their subjects to the PROQUIS Nomad system • Nomad allows the user to record audit results while disconnected from the main PROQUIS enterprise system • The Lead Auditor assigns the subjects to the auditors for them to download….

14. Return to menu NomadAudit Management - 9 • PROQUIS Nomadgives the off-line auditor full control of his audit subjects • The auditor downloads assigned subjects from main enterprise system. • The auditor can edit all details on his/her assigned subjects • Lead Auditor can edit any details. • Once complete, the audit details can be uploaded to enterprise, & PROQUIS will synchronize the data

15. Return to menu Audit Management - 10 • Sample Audit reports • All reports are tailorable • Write your own reports using Crystal Reports & add them to the reports list

16. Audit Management - 11 Compare results over time or against others/standard.

17. Audit Management • Clear Plans • Plan Graph & coverage review analysis • Audit & Assessment Findings on-line • Manages NCR completion • Off-line auditing with Nomad module • Synchronizes data from Nomad • Analysis of Results Return to menu Details of other Applications available on request

18. Back to Main Menu - click here. PROQUIS enterprise • Examples of other application modules available on request • Ask about our Flowcharting/Process analysis software - allCLEAR • ASP options available for PROQUIS enterprise For more information, contact… USA / Canada / S.America Proquis, Inc. 1015, West Wise Road, Suite 200/201 Schaumburg, IL 60193 Tel: 847 278 3230 Fax: 847 278 3237 Email: quality@proquis.com UK / Europe /World-wide Proquis Ltd. 1050 Cornforth Drive Sittingbourne Research Centre Sittingbourne, Kent ME9 8PX Tel: 01795 479001 Fax: 01795 479009 Email: sales@proquis.com Visit our Web Site :WWW.PROQUIS.COM

19. More Details For more details on this and other modules, please contact us or visit our websites: http://www.proquis.com http://www.allCLEARonline.com Return to menu Got to end and contact details