SmartCAPATM Setup

Organization Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Organizations	Yes	Yes
Departments	Yes	Yes
Standard Operations	Yes	No
Operations	Yes	No
Clients	Yes	No
Work Centers	Yes	No
Production Lines	Yes	No
Machines	Yes	No
Plant Areas	Yes	No

User Management Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Rights Groups	Yes	Yes
Roles	Yes	Yes
Users	Yes	Yes
Single Sign On	Yes	No

Product Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Product Lines	Yes	Yes
Parts	Yes	Yes
Unit of Measurement	No	No

Failure Mode Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Failure Modes	Yes	Yes
Failure Mode Category	Yes	Yes
Severity	Yes	Yes
Cause	Yes	No
Cause Category	Yes	No
Failure Mode Update	Yes	No

Exception Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Exception Type	Yes	Yes
Numbering Schemes	Yes	Yes
Priority	Yes	Yes
Activity Types	Yes	No
Activity Signatures	Yes	No
Reference Types	Yes	No
Exception Resolution	No	Yes
Exception Policies	Yes	No
Exception Auto Rules	Yes	No
ESA Integration	No	No

Issue Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Issue Type	No	Yes
Numbering Scheme	Yes	Yes
Issue Status	No	Yes
Issue Phase	No	No
Priority	Yes	No
Issue Policy	No	No

Task Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Task Types	No	No
(General) Task	No	No
Containment	No	No
Correction \| Product Correction	No	No
Disposition	No	No
Disposition Type	No	No
Investigation	No	No
Response	No	No
Action Plan Types	No	No
Implementation	No	No
System Tasks	No	No
Capture Signature on Task Item Closure	No	No
Update Completed Date with Sign-off	No	No
Checklist	Yes	No
Task Escalation	No	No
Groups	Yes	No
Task Model	No	No
Get External Date for Task Sign-off	No	No
Do Not Assign Issue Owner as Task Owner	No	No

Review Setup

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Groups	Yes	No
Checklist	Yes	No
Review Escalation	Yes	No
Rules	Yes	No
Review Types	No	No
Review Models	No	No
Always Restart Issue Review	No	No
AutoStart Issue Review	No	No
Show all Issue Reviews in User Mode	No	No

Introduction

As an administrator it is important to become familiar with the various setup and policy tables available off the shelf with SmartCAPATM.

Please see the SmartCAPATM End User Guide for more information on SmartCAPATM end user functions and how to maintain end user records once the system is configured for use.

Prior to configuring the SmartCAPATM system it is very important to meet with the key stakeholders of the SmartCAPATM application. You should discuss exactly what business requirements must be met in the system, who is responsible for these requirements, and the standards for the completed requirements.

This common practice is not only needed to configure the SmartCAPATM system successfully; but also helps Pilgrim customer’s to revisit their business processes and work to ensure that these processes are effective and efficient (continually improved to ensure processes use the least amount of resources).

Process Mapping Pointers

Some important things to consider when implementing SmartCAPATM:

It helps a great deal to start with one simple model and build your configurations from this one scenario, then you can pull in the rest of your scenarios after testing the scenario to see if these configurations will work. Trying to do everything at one time causes proven delays in your implementation so keep it simple!

How many other SmartSolve© systems will, or have already been implemented within your organization?

If any other systems have already been implemented, obtain a copy of the Software Requirements Specification (configuration documentation) and refer to this documentation as well as collaborate with other SmartSolve© administrators on how these other SmartSolve© systems were configured.
It is important when process mapping to try not to figure out “what” is going to go “where” in the SmartCAPATM system yet; but to make sure the business requirements are clearly illustrated.
Map out a process flow for reporting an exception (i.e., product nonconformance) and discuss the following:
- Define the type of event (exception) you wish to start with and how event will be recorded (by end user reporter, or imported from other third

party application using the SmartSolve Synchronization Agent - SSA.

- Identify all entry fields required for reporting the exception (i.e., products, failure modes, business entities involved, etc,).
- Map out the process for managing the exception (who will own the exception and oversee it throughout its life cycle).
- Determine when you may need to create an Issue from the exception record (if applicable).
- Illustrate the different steps performed by various user roles to record and resolve the exception and issue (step sequence from simple resolution to most complex model for resolving, for example Product Disposition, Initial Investigation, CAPA).
- Determine how exceptions and issues will be looked up (Advanced Searches) and how information will be analyzed through reports (queries), etc.

CAPA Process Workflow Diagram

SmartCAPATM Integration

Exception Data Sources

Anyone can submit an exception. Exceptions can come from customers, end users, or distribution partners, etc. The importance of the exception record in SmartCAPATM is having the ability to track, record, classify and trend all the exceptions that are submitted.

The illustration below shows some of the different ways in which exceptions could be reported in SmartCAPATM:

Data Source Scenarios

The scenarios below explain a little more in-depth how the complaint reporting examples above could be carried out using SmartCAPATM:

Scenario	Description
Field Service Scenario	People in the field (i.e., auditor) could have the data entry form on their lap tops so that they could enter the information into their template while in the field. Once back in the office, they connect to the network (within the office or via VPN connection), access the solution over the server, then synchronize and upload the information into the SmartCAPATM exception record.
Manufacturing Shop Floor Scenario	Product and/or process failures may be recorded from the manufacturing floor during product testing, inspections, audits, etc. In such cases, a plant supervisor, inspector, or operator may typically enter the information locally in to their ERP system (i.e., MES). The ERP system would then synchronize with SmartCAPATM and push the information into the SmartCAPATM record.
Customer/Partner Scenario	Customers/clients may also submit their events directly through your company website. The information which is entered through the web site can then be pushed into SmartCAPATM to be managed and resolved through the SmartCAPATM record.

NOTE: These approaches would require interfacing with systems such as ERP systems or web sites. However, the event can also be entered manually by the user. The next step in the process is recording an exception (event) in SmartCAPA with all required information and validated data.

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Scenario

Description