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

It is not designed to cover everything 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. The ability to customize the tool will be important Allows quicker deployment than a bespoke system, yet has the functionality to be what you want it to be

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. PROQUIS’ ability to define Audits by Type : Risk Assessment / Safety / Training to manage all audits beyond the standard types of audit: System, Product, Process is all possible.

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).

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 R.A.P maybe of interest depending on network security issues – IT security will dictate the usage of the RAP as its effectively allowing third parties in. (NDA has a very strict policy about access to their network / systems from the outside).

Audit Management - 1 Audit & Assessment system home page 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 * To Do Items can be viewed for “As a Person” , “As All” or “My Organisation” – this allows you to just see the activity that is going on within the area of the business that you belong to, based on the settings of the organisation tree and its members. Another useful filter.

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 By Hierarchy is a good pointer Create “real” audits from planner screen ready for auditors’ final preparations Live update of Plan Graph and status reports on Audits home page

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 Good to mention customisation of terminology and workflow of screens This screen builds the core audit report summary

Audit Management - 4 Define the Subjects to be covered by the audit Return to menu Audit Management - 4 Define the Subjects to be covered by the audit Each subject can then have associated list of Auditees Subjects can also be copied in from a previous audit, including questions Useful tool for repetitive style audits so you don’t have to reformat from the start 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

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 Questions can be downloaded from controlled questionnaires held in Document Control You can even tag the questionnaire to an “Audit Type” so when that type is selected it automatically deploys the document Q’s You can mark all areas for NCR / Evidence Document Complete your audit and then return to the questions and create your NCR’s etc. from the displayed markers in this view 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

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 Raise a DCR – enter notes / upload a sample / auto email to doc owners and an auto document review created with To Do’s Capacity to upload evidence documents in many formats

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

Nomad Audit Management - 8 Return to menu Nomad Audit 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….

Nomad Audit Management - 9 Return to menu Nomad Audit Management - 9 PROQUIS Nomad gives 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

Audit Management - 10 Sample Audit reports All reports are tailorable 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

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

Details of other Applications available on request 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

PROQUIS enterprise Back to Main Menu - click here. 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… 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 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 Visit our Web Site : WWW.PROQUIS.COM

Got to end and contact details 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