Audit Setup

Please select the object link below for more information on how to configure the object.

Object

Shared with other SmartSolve© Applications

Required for SmartAuditTM

Audit Types

No

Yes

Numbering Scheme

Yes

Yes

Audit Status

No

Yes

Audit Phase

No

Yes

Audit Result Types

No

Yes

Audit Note Types

No

Yes

Severity

Yes

Yes

Priority

Yes

Yes

Standard Note Text

No

No

Audit Response Types

No

Yes

Audit Member Types

No

Yes

Audit Review Types

No

Yes

Audit Review Model

No

Yes

AutoCalculate Audit End Date

No

No

Audit Word Report

No

No

 

Audit Types

Audit Types are used to categorize audits and audit programs. The option is given for the audit type to control whether work group security is applied to audits. By enabling the audit type's Apply Security check box, the Work Group Access Only check box is automatically enabled in audits based on this type and only internal team members have access to view the audit.

The audit type also determines the numbering scheme to apply to audits. Each audit type can have its own numbering scheme or the same numbering scheme can be used for all audits.

 
User Rights

The following rights must be assigned to a user to manage or view audit types:

Rights

Description

ATY_MANAGE

Allows administrator to add new audit types, modify existing audit types, or delete audit types.

 

ATY_VIEW

Allows user to access audit type to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Types will be inherited by all local organizations. 

·         Local Audit Types will only be viewed and used within that local organization.

 

How to Create an Audit Type

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Type.

2.     Right click and select Add.

3.     Enter information in the following fields:

Fields

Description

Name

Enter a name for the audit type.

 

Description

Enter a description of the audit type.

 

Apply Security

Click the check box to enable security, if applicable.

 

NOTE: if Apply Security is checked, then only members listed in the Internal Team folder of the Audit record can view the audit from the system.  The Apply Security option enables the Work Group Access only option in the audit record.  

 

Numbering Scheme

Select a numbering scheme from the drop down list.

 

Add Another

Click this box to add another audit type.

 

 

4.     Click the Save button.

 

Managing Audit Type Data

The following options are available within Audit Type objects and can be managed accordingly by an administrator:

 

How to Edit Audit Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Type.

The Audit Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Type to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Type.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Types

Audit Types can only be deleted from SmartSolve© if the audit type has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Type.

The object list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the audit type to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

Numbering Scheme

Please see Numbering Scheme under System Wide Setup.

 

Audit Status

Audit Status indicates the point in the workflow of the audit. The following statuses come as defaults with the system and can be changed if you wish to apply your own terminology, or if needed local organizations can create their own statuses and apply them to their audit workflows:

The following statuses are applied to the audit workflow listed below in the order that they would appear:

Status

Description

INWORKS

When an audit is first created, the INWORKS status is displayed. The audit status remains INWORKS while the audit sections and notes are worked on by the audit team. The INWORKS status remains displayed in the audit until the Finding Review is completed.

 

FINDINGS APPROVED

Once the finding review is completed, the status of the audit changes to FINDINGS APPROVED. This status remains until audit results are assigned (if no findings require action), or until Response Review (Action Plan Approval) is completed for findings requiring further action.

 

ACTION PLANS APPROVED

Once the response review (Action Plan Approval) is completed, the status of the audit changes to ACTION PLANS APPROVED. This status remains until audit results are assigned.

 

PRERELEASED

The PRERELEASED status is only displayed in the audit if audit results have been assigned and an Implementation Review scheduled; otherwise, the PRERELEASED status is skipped in the audit (see CLOSED Status below).

 

CLOSED

The CLOSED status is displayed in the audit record when results are assigned with no implementation review scheduled; or, after it has been determined that no further implementation review will need to be performed and the audit can be closed.

 

 

User Rights

The following rights must be assigned to a user to manage or view Audit Statuses:

Rights

Description

AST_MANAGE

Allows administrator to add new audit statuses, modify existing statuses, or delete statuses.

 

AST_VIEW

Allows user to access audit status to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Statuses will be inherited by all local organizations. 

·         Local Audit Statuses will only be viewed and used within that local organization.

 

How to Create Audit Status

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Status.

2.     Right click and select Add.

3.     Enter the Audit Status

4.     Select the Primary Status

Primary Status

Description

ABORTED

Audit has been aborted.

 

INWORKS

Audit is in process.

 

PRERELEASED

Audit is complete and Implementation Review is Scheduled.

 

RELEASED

Audit is completed.

 

      5.   Click the Save button.

      Use the Add Another check box to add additional statuses as needed.
 
Managing Audit Statuses

The following options are available within Audit Status objects and can be managed accordingly by an administrator:

 

How to Edit Audit Statuses

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Status.

The Audit Statuses list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Status to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Status.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Statuses

Audit statuses can only be deleted from SmartSolve© if the audit status has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Status.

The Audit Statuses list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Status to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Phase

Phases indicate all possible audit phases. When each step in the audit is completed, the audit record is updated to the phase specified by the step to indicate the current stage or milestone in the audit's life cycle. Audit phases are setup up in the audit review model.

The following default phases are applied to the audit workflow listed below in the order that they would appear:

Phase

Description

DISCOVERY

When an audit is first created, the INWORKS status is displayed and the phase specifies DISCOVERY. The audit phase remains DISCOVERY while the audit sections and notes are worked on by the audit team. The DISCOVERY phase remains displayed in the audit until the finding review is routed.

 

FINDINGS APPROVAL

Once the finding review is routed by the audit owner, the phase of the audit changes to FINDINGS APPROVAL. This phase remains until finding approval is completed.

 

 

Suggestion: some customers rename this Phase UNDER FINDINGS APPROVAL.

 

RESPONSE

Once the finding review is completed, the phase of the audit changes to RESPONSE. This phase remains until investigation of action plans in exceptions are completed by the exception owner (if applicable).

 

 

Suggestion: some customers rename this Phase UNDER INVESTIGATION.

 

ACTION PLAN APPROVAL

Once the response review (Action Plan Approval) is routed by the audit owner, the phase of the audit changes to ACTION PLAN APPROVAL. This phase remains until action plan approval is completed.

 

 

Suggestion: some customers rename this Phase UNDER ACTION PLAN APPROVAL.

 

IMPLEMENTATION

Once the response review is completed, the phase of the audit changes to IMPLEMENTATION. This phase remains until action plans have been marked as complete.

 

 

Suggestion: some customers rename this Phase UNDER IMPLEMENTATION.

 

COMPLETE

Once all action plans have been marked complete, the phase of the audit changes to COMPLETE. This phase remains until the audit owner assigns results to the audit to close it.

 

 

Suggestion: some customers rename this Phase ACTION PLANS COMPLETED.

 

CLOSED

The CLOSED phase is displayed in the audit record when audit results are assigned by the audit owner.

 

 

User Rights

The following rights must be assigned to a user to manage or view audit phases:

Rights

Description

PHS_MANAGE

Allows administrator to add new audit phases, modify existing phases, or delete phases.

 

APH_VIEW

Allows user to access Audit Phase to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 
Global vs. Local

·         Global Audit Phases will be inherited by all local organizations. 

·         Local Audit Phases will only be viewed and used within that local organization.

 

How to Create an Audit Phase

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Phase.

2.     Right click and select Add.

3.     Enter the Audit Phase.

4.   Click the Save button.

Click the Add Another check box to add additional phases as needed
 
Managing Audit Phases

The following options are available within Audit Phase objects and can be managed accordingly by an administrator:

 

How to Edit an Audit Phase

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Phase.

The Phases list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Phase to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Phase.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete an Audit Phase

Audit Phases can only be deleted from SmartSolve© if the phase has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Phase.

The Phases list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Phase to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Result Types

Each Audit Result Type is its own set of valid audit results. Valid audit results must be equated to either Pass or Fail. For example, the audit result type has multiple results (or result sets) that can be associated with each result type. An audit result type can be named "S/U" and define two audit responses: Satisfactory and Unsatisfactory. The result type Satisfactory can be equated to the system result type Pass, and the result type Unsatisfactory can be equated to the result type Fail.

 

User Rights

The following rights must be assigned to a user to manage or view Audit Result Types:

Rights

Description

RTY_MANAGE

Allows administrator to add new Audit Result Types, modify existing Audit Result Types, or delete Audit Result Types.

 

RTY_VIEW

Allows user to access audit result type to view and select.

 

Please see Rights Group to assign rights groups to users

 

Global vs. Local

·         Global Audit Result Types will be inherited by all local organizations. 

·         Local Audit Result Types will only be viewed and used within that local organization.

 

How to Create Audit Result Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Result Type.

2.     Right click and select Add.

3.     Enter the Audit Result Name and Description.

4.   Click the Save button.

5.     Select the Result folder.

6.     Right click and select Add.

7.     Enter Result Name and Primary Result Type.

8.   Click the Save button.

Click the Add Another check box to add additional results as needed.

 

Managing Audit Result Type Data

The following options are available within Audit Result Type objects and can be managed accordingly by an administrator:

 

How to Edit Audit Result Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Result Type.

The Result Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Result Type to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Result Type.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Result Types

Audit Result Types can only be deleted from SmartSolve© if the result type has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Result Type.

The Result Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Result Type to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Note Types

Audit Notes are comments recorded by auditor’s while performing an audit. The auditor must select the Audit Note Type to apply to their note as they enter it in the system. The Audit Note Type contains the policy which tells the auditor the level of importance of the note they entered and whether or not further action needs to be taken by the auditee on this note (i.e., Finding which will later become an exception in the system).

Each audit record, audit section, and section question can have notes attached. Each note has two options that determine whether the note requires further action to be taken on the question for which the note is recorded:

·         Include in Summary - this option indicates that the note is transferred to the audit summary.

·         Requires Action Plan - this option indicates that an action plan against the question for which the note is recorded must be created to continue with the audit process.

The Note Types provided at installation contain the following predefined settings:

Base Note Types

Description

COMMENT

Notes of this type do not require further action to be taken on the audit section, question or sub question. This note simply represents additional remarks for the audited item.

 

FINDING

Notes of this type must be approved by the audit team. This process is referred to as Findings Approval. The findings approval cannot be started until:

·         A result is assigned to all sections at the root level.

·         All questions that require a note have a note attached to them.

Findings cannot be automatically deleted if they are rejected during the approval process. The option is given to save or delete the finding upon rejection. During the approval process, a response approver enables the Action Plan Required check box when signing off their response which requires an action plan to be created.

 

RECOMMENDATION

Notes of this type are recorded in the audit summary but do not require further action.

 

 

User Rights

The following rights must be assigned to a user to manage or view Audit Note Types:

Rights

Description

NTY_MANAGE

Allows administrator to add new Audit Note Types, modify existing Audit Note Types, or delete Audit Note Types.

 

NTY_VIEW

Allows user to access Audit Note Types to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Note Types will be inherited by all local organizations. 

·         Local Audit Note Types will only be viewed and used within that local organization.

 

How to Create Audit Note Types

      1.     From the SmartSolve© tabs select Admin > Policy. Under Audit select Audit Note Type.

      2.     Right click and select Add.

      The Note Type window displays.

      3.     Enter information in the following fields:

Field

Description

Base Type

Select a base type from the drop down list.

 

Name

Enter the name of the audit note.

 

Description

Enter the audit note description.

 

Requires Action Plan

Check this box if this note requires that an exception be created in the audit. (Include in Summary will automatically be checked if you select this option).

 

Include in Summary

Check this box to include in the summary.

 

Severity

Select a severity from the drop down box.

 

Priority

Select a priority from the drop down box.

 

Add Another

Check this box to add another note type.

 

4.   Click the Save button.

 

Managing Audit Note Type Data

The following options are available within Audit Note Type objects and can be managed accordingly by an administrator:

 

How to Edit Audit Note Types

1.     From the SmartSolve© tabs select Admin > Policy. Under Audit select Audit Note Type.

The Note Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Note Type to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your audits note type.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Note Types

Audit Note Types can only be deleted from SmartSolve© if the Note Type has not currently been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Policy. Under Audit select Audit Note Type.

The Note Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Note Type to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

Severity

Please see Severity under System Wide Setup.

 

Priority

Please see Priority under System Wide Setup.

 

Standard Note Text

The Standard Note Text list is used in conjunction with audit note types and is configured to help minimize the workload for a lead auditor when adding audit record notes or findings. This list also helps to standardize notes entered in audit to help in searching for audit exceptions.

 

NOTE: Standard note text can only be used when entering audit notes directly into the audit record sections or notes folder from the tree. (This function cannot be performed within the offline or online editing form.)

 

 

User Rights

The following rights must be assigned to a user to manage or view Standard Note Text:

Rights

Description

SNT_MANAGE

Allows administrator to add new Standard Note Text, modify existing Standard Note Text, or delete Standard Note Text.

 

SNT_VIEW

Allows user to access Standard Note Text to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Standard Note Text will be inherited by all Local organizations. 

·         Local Standard Note Text will only be viewed and used within that local organization.

 

How to Create Standard Note Text

1.     From the SmartSolve© tabs select Admin > Setup. Under System Wide select Standard Note Text.

2.     Right click and select Add.

The Standard text list window displays.

3.     Enter information in the following fields:

Field

Description

Audit Note Type

Select the audit note type to which the Standard Note Text will apply.

 

Code

Enter the code for the Standard Note Text.

 

Standard Note Text

Enter the Standard Note Text.

 

Add Another

Check this box to add additional Standard Note Text.

 

4.     Click the Save button.

 

 

Managing Standard Note Text Data

The following options are available within Standard Note Text objects and can be managed accordingly by an administrator:

 

How to Edit Standard Note Text

1.     From the SmartSolve© tabs select Admin > Setup. Under System Wide select Standard Note Text.

The Standard text list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Standard Note Text to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Standard Note Text.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Standard Note Text

Standard Note Text can only be deleted from SmartSolve© if the note text has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under System Wide select Standard Note Text.

The Standard text list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Standard Note Text to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Response Types

Audit Response Types are used by the following criteria and audit areas:

Each Audit Response Type is its own set of valid responses for audit sections and questions/sub questions. For example, an audit response type can be named YES/NO and define two audit responses, YES and NO. Use this audit response type when the audit material can be answered by either a YES or NO answer.

The Audit Response Type can also determine which response requires a note to be created and is the default response:

Each response is equated to one of four system responses:

Response

Description

Skipped

Item does not require an answer.

 

Pass

Item has met or exceeded expectations. When configuring response Yes could equal Pass.

 

Fail

Item has not met expectations. When configuring response No could equal Fail.

 

In Review

Item is still under investigation.

 

 

User Rights

The following rights must be assigned to a user to manage or view Audit Response Types:

Rights

Description

ART_MANAGE

Allows administrator to add new Audit Response Types, modify existing Audit Response Types, or delete Audit Response Types.

 

ART_VIEW

Allows user to access Audit Response Type to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Response Types will be inherited by all local organizations. 

·         Local Audit Response Types will only be viewed and used within that local organization.

 

How to Create Audit Response Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Response Type.

2.     Right click and select Add.

3.     Enter information in the following fields:

Field

Description

Name

Enter the name of the response type.

 

Description

Enter a description for the response type.

 

Add Another

Check this box to add another response type.

 

4.   Click the Save button.

5.   Select the Response tab then right click and select Add.

6.     Enter information in the following fields:

Field

Description

Name

Enter a name for the response.

 

Primary Response Type

Select a primary response type from the drop down list.

 

Note Required

If the response requires a note, check this box.

 

Default Response

Check this box if this response will be the default response within the audit.

 

Add Another

Check this box to add another response.

 

7.   Click the Save button.

 

Managing Audit Response Type Data

The following options are available within Audit Response Type objects and can be managed accordingly by an administrator:

 

How to Edit Audit Response Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Response Type.

The Audit Response Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Response Type to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Response Type.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Response Types

Audit Response Types can only be deleted from SmartSolve© if the response type has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Audit Response Type.

The Audit Response Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Response Type to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Member Types

Team Member Types are used in defining work team responsibilities. There are two default member types: Lead and Member. The audit owner is assigned the lead member type while additional team members can be assigned as member.

The Lead Member Type is a default value in the SmartAuditTM system and cannot be deleted.

 

User Rights

The following rights must be assigned to a user to manage or view Audit Member Type:

Rights

Description

AMT_ MANAGE

Allows the administrator to add new audit types, modify existing audit types, or delete audit types.

 

AMT_VIEW

Allows user to access Audit Member Type to View and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Team Types will be inherited by all local organizations. 

·         Local Audit Team Types will only be viewed and used within that local organization.

 

How to Create Audit Member Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Team Type.

The Member Types window displays.

2.     Right click and select Add.

3.     Enter information in the following fields:

Field

Description

Name

Enter the name of the team member.

 

Primary Type

Grayed out, no action needed.

 

Add Another

Check this box to add another response type.

 

4.   Click the Save button.

 

Managing Audit Member Type Data

The following options are available within Audit Member Type objects and can be managed accordingly by an administrator:

 

How to Edit Audit Member Types

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Team Type.

The Member Types list displays.

2.     Click the  icon to switch to Local view (if applicable).

3.     Select the check box of the Audit Member Type to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your Audit Member Type.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Audit Member Types

Audit Member Types can only be deleted from SmartSolve© if the Member Type has not been attached to any SmartSolve© records.

1.     From the SmartSolve© tabs select Admin > Setup. Under Audit select Team Type.

The Member Types list displays.

2.     Click the  icon to switch to local view (if applicable).

3.     Select the check box of the Audit Member Type to delete, then select Action > Delete from the main menu (or right click).

4.     Click the Save button.

The object has now been removed from the system.

 

 

Audit Review Types

Audit Review Types determine the reviews which need to be performed within the audit record throughout its life cycle. Audit Review Types are later attached to the Audit Review Model which enforces the Audit Workflow.

The SmartAuditTM system comes with three default Review Types that can be used within the audit record:

Review Type

Description

FINDINGS REVIEW

The Findings Review is similar to the exit meeting of the audit. It is used when a group of signatures needs to be captured after all findings have been documented by the auditor during the audit. This review is performed to seal an agreement between the auditor and auditee that these findings have in fact been verified by both parties. 

This review type is optional in the system and if needed, can be removed from the audit workflow by the system administrator.

Finding Review as it is displayed in audit record tree:

Please see Audit Review Model to remove this Review Type from your audit workflow.

RESPONSE REVIEW

The Response Review (commonly referred to as Action Plan Approval) is a review that only needs to take place in the audit record if findings occur during the audit that may require the auditee to identify action plans.  Results cannot be assigned to an audit record by the auditor until after response review has been completed if findings require further action.

If no findings are documented that require further action, this approval can be skipped within the audit record and results can be assigned to the audit record by the auditor.

Response Review as it is displayed in the audit record tree:

IMPLEMENTATION REVIEW

The Implementation Review is a review that only needs to take place in the audit record if findings occur during the audit that may require the auditee to identify and complete action plans. This review can be scheduled by the auditor when assigning results to the audit record if the auditor wishes to keep the audit record open in order to come back at a later date to verify that all action plans that have since been approved have been completed as needed.

The Implementation Review can be scheduled as a periodic review with a user defined Interval. For example, if the auditor wishes the system to send notification in a month to come back and review the progress of the action plans currently under implementation.

If no findings are documented that require further action, or the auditor does not wish to schedule an implementation review if action plans do exist, then this approval can be skipped within the audit record

Implementation Review as it is displayed in the audit record tree:

Please see Audit Review Model to remove or add this Review Type to and from your audit workflow.

 

User Rights

The following rights must be assigned to a user to manage or view Audit Review Types:

Rights

Description

RTA_MANAGE

Allows administrator to modify existing Audit Review Types.

 

RTA_VIEW

Allows user to access Audit Review Type to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Audit Review Types will be inherited by all local organizations. 

·         Local Audit Review Types will only be viewed and used within that local organization.

 

Managing Review Type Data

The following options are available within Audit Review Type objects and can be managed accordingly by an administrator:

 

How to Edit a Review Type

1.     Log into the global organization.

2.     From the SmartSolve© tabs select Admin > Policy. Under Audit select Review Type.

3.     Select the review type, right click and select Edit.

4.     Enter information in the following fields:

Field

Description

Name

The name of the review type is already entered.

 

Review Purpose

Enter a review purpose. This is required by the FDA.

 

Review Group

Does not apply for SmartAuditTM.

 

Checklist

Does not apply for SmartAuditTM.

 

Applicable Status

Select an applicable status from the drop down list.

 

To Status

Select a to status from the drop down list.

 

Phase on Start

Select a phase on start from the drop down list.

 

Phase on Close

Select a phase on close from the drop down list. This is the phase the audit will change to after the review has been closed.

 

5.     Click the Save button.

 

 

Audit Review Model

As previously mentioned Audit Review Types determine the reviews which need to be performed within the audit record throughout its lifecycle. Audit Review Types are later attached to the Audit Review Model which enforces the audit workflow.

Only one review can be performed in the audit record at a time and these reviews are activated by the audit status which is attached to each review type. The Review Model contains schedules that define which review types should be transferred into the audit record when it is created.

NOTE: Each organization can only use one review model which will enforce the reviews to be used for both scheduled and ad hoc audits created in the system.

 

Review Matrix

This matrix illustrates the setup tables involved with audit review.

 

User Rights

The following rights must be assigned to a user to manage or view Audit Review Models:

Rights

Description

RMA_MANAGE

Allows administrator to add new Audit Models, modify existing Audit Models, or delete Audit Models.

 

RMA_VIEW

Allows user to access Audit Model to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         The Global Review Model will be inherited by the global organization and all local organizations which don’t have their own local review model.

·         The Local Review Model will override the global review model

 

Review Model Configuration Matrix

It is important to use this matrix when configuring the Review Model which will fit your specific organizational needs.

 

Review

Options

Review

Type

Phase

Applicable Status

To

Status

Phase on Start

Phase on Close

Finding Review + Response Review

Standard off the shelf configuration

FINDING REVIEW

DISCOVERY

INWORKS

FINDINGS APPROVED

FINDINGS APPROVAL

RESPONSE

RESPONSE REVIEW

RESPONSE

FINDINGS APPROVED

ACTION PLAN APPROVED

ACTION PLAN APPROVAL

IMPLEMENTATION

Response Review only

 

You must modify Phase and Applicable Status

RESPONSE REVIEW

DISCOVERY

INWORKS

ACTION PLAN APPROVED

ACTION PLAN APPROVAL

IMPLEMENTATION

Finding Review + Response Review + Implementation Review

FINDING REVIEW

DISCOVERY

INWORKS

FINDINGS APPROVED

FINDINGS APPROVAL

RESPONSE

You must attach Implementation Review if you wish it to be required

RESPONSE REVIEW

RESPONSE

FINDINGS APPROVED

ACTION PLAN APPROVED

ACTION PLAN APPROVAL

IMPLEMENTATION

 

IMPLEMENTATION REVIEW

 

IMPLEMENTATION

PRERELEASED

CLOSED

COMPLETE

CLOSED

 

How to Edit the Audit Review Model

1.     Log into the appropriate organization to set the model.

2.     From the SmartSolve© tabs select Admin > Policy. Under Audit select Review Model.

3.     Select the Schedule link.

4.     Delete any reviews which will not apply to the model.

5.     Tag and edit to change any reviews based on which reviews will be used in the model using the above matrix.

 

 

AutoCalculate Audit End Date

Please see Application Options to configure Audit End Date.

 

Audit Word Report

The Audit Word Report is an add-on purchase to using the SmartAuditTM solution.  The purpose of this report is to generate final audit summary report to be distributed to all parties involved with the audit.  Once an Audit is complete (or at anytime during the Audit process) a Detail Report can be run from the Audit record show key information in the audit such as:

 

How to Setup the Audit Word Report

Please make sure you have purchased this add on prior to configuring the report.