There are two types of audits. Ad hoc audits are one time audits created and performed outside of an audit program. All other audits are created within an audit program.
Audit teams perform the audit following criteria established during the creation of the audit. Upon completion, the results of the audit define the action to be taken. If there are findings that require further action, action plans are created and assigned. If no findings occur which require action to be taken the audit results can be assigned and the audit record closed.
The following rights must be assigned to a user to manage or view audits:
Rights |
Description |
AUD_CREATE |
Allows user to create an audit record.
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AUD_DELETE |
Allows user to delete an audit record.
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AUD_MANAGE |
Allows user to manage audits that the user owns and allows users to perform Audit Reviews.
|
AUD_SUPERVISOR |
Allows user to manage audit record that any user owns.
|
AUD_VIEW |
Allows user to view audit records.
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APG_VIEW |
Allows user to view audit Programs.
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AEX_VIEW |
Allows user to view audit exceptions.
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QAP_SUBMIT |
Allows user to view audit exception response form and submit action plan response for approval (bypassing Exception Response Sign-off). Please see Auditee Response Form.
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QAP_EDIT |
Allows user to view audit exception response form and save action plan response to later come back and edit if needed. Please see Auditee Response Form.
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AEX_MANAGE |
Allows user to manage audit exceptions that the user owns.
|
AEX_SUPERVISOR |
Allows user to manage audit exceptions that any user owns.
|
CRI_VIEW |
Allows user to access audit criteria to view and select.
|
ATE_VIEW |
Allows user to access auditees to view and select.
|
ATY_VIEW |
Allows user to access audit types to view and select.
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RTY_VIEW |
Allows user to access audit result types to view and select.
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ACT_VIEW |
Allows user to access actor to view and select.
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ROL_VIEW |
Allows user to access role to view and select.
|
ART_VIEW |
Allows user to access audit response type to view and select.
|
NTY_VIEW |
Allows user to access Audit Note Type to View and select.
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SNT_VIEW |
Allows user to access Standard Note Text to View and select.
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XPR_VIEW |
Allows user to access priority to view and select.
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XSV_VIEW |
Allows user to access severity to view and select.
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RTA_VIEW |
Allows user to access audit review type to view and select.
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SCH_VIEW |
Allows users to view the schedule in an audit program record.
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Please see the Admin Guide to assign Rights Groups to users.
· Audits created from the global organization can be performed and assigned results from either the global organization or any local organization by users with appropriate rights.
· Audits created from the local organization can be performed and assigned results only from that local organization by users with appropriate rights.
The following audit creation options are available:
Audit Scenario |
Options |
Ad Hoc Audit |
Option 1 From the Smart Solutions tab on the Portal Page, select SmartAudit > Create Ad-hoc Audit. Option 2 From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit. Right click and select Add. |
Scheduled Audit |
Option 1 From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, under Scheduled Items, select Audit Needs To Be Created. Click the check box of the Audit to create, then select Action > Create Audit from the main menu (or right click). Option 2 From the Audit Program, select the Schedules folder > select the check box of the Audit to create, then select Action > Create Audit from the main menu (or right click).
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The Audit creation window displays after selecting any of the options above.
1. Enter information in the following fields:
Field |
Description |
Title |
Enter the audit title (if applicable).
|
Comment |
Enter the audit comment.
|
Begin Date |
Enter the date the audit begins.
|
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NOTE: this field can later be modified if needed.
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End Date |
Enter the end date for the audit.
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NOTE: this field can later be modified if needed.
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Duration |
Enter a numeric amount for the length of time the audit is to last and select an interval from the drop down list to the right (if applicable).
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Required Response Time |
Enter a numeric amount for the length of time allowed for an assignee to respond in the Required Response Time field and select an interval from the drop down list to the right (if applicable).
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Follow-up To Audit No. |
Zoom to select the audit to which this audit is a follow-up (if applicable).
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Contact Role |
Zoom to select the role of the contact from the auditee contact role field (if applicable).
|
Contact |
Zoom to select the auditee primary contact (if applicable).
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NOTE: this actor will display as the exception owner for any findings requiring action in this audit.
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Criteria No. |
Zoom to select a Criteria (if applicable).
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Audit Type |
Select an audit type from the drop down list (if applicable).
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Result Type |
Select a result type for the audit from the drop down list.
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Add Another |
Click the check box to add another audit.
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2. Click the Save button.
The Audit window appears.
The Audit Detail is always the first information displayed when entering the audit record. The following information is available:
Information |
Description |
Header
|
The Header of the audit record is always displayed at the top of the screen and contains the following information: Audit Number – Unique number assigned to the audit record (this cannot be changed). Status – The current status of the audit (INWORKS, COMPLETE, etc.). Audit Type –Type of audit this audit record is grouped by. Phase – User defined field that displays the current activities for the audit while in the current workflow status (i.e., DISCOVERY, ACTION PLAN APPROVAL). Title – Title of the audit (can be modified if needed). Result – Result will display once audit has been completed. Begin Date and End Date – these dates can be modified if needed while the audit record is still open.
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Ownership |
Each audit record contains an owner who will be responsible for overseeing the activities within the Audit Record (i.e., performing or managing the audit and auditors, managing approval, managing changes, etc.). Audit ownership can be changed at anytime.
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Work Group Access Only |
Security can be set to lock the audit. Other users cannot access this audit record even if they have rights to view other audits. Security is setup by audit type and when enabled only users who are assigned to this audit record, such as the owner, internal audit team members, and auditee contact, can access the audit. See your system administrator to setup Audit Security.
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Contact Role |
This is the auditee contact who will own any audit exceptions if findings occur in the audit that require further action. Typically this is the line manager responsible for the area being audited. At anytime this contact can be in the audit record by the audit owner.
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Program No. & Criteria No. links |
The user viewing the audit record can enter the program or criteria at anytime by clicking on the link from the audit record to view more information.
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Auditee Information |
Information on the business unit and process/product being audited or who is doing the auditing.
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Content |
Audits can be checked out of SmartAuditTM using the online auditor or offline auditor worksheet. The editor window displays the sections, subsections, questions, auditor response, and auditor notes (findings, etc.) in a more user friendly format than viewing this information from the audit tree.
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The following options are available within the audit record and can be managed accordingly by a user with appropriate rights:
· Audits can be edited and deleted.
· Audit ownership can be changed at anytime, if needed.
1. From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit.
The Audit list displays.
2. Select the Audit No. to enter the audit record.
3. Select Action > Edit from the main menu.
4. Edit any information for the audit.
5. Click the Save button.
All changes should now be reflected in the audit.
Audits can only be deleted from SmartSolve© if absolutely necessary. Most customers do not allow users to delete an audit record.
1. From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit.
The Audit list displays.
2. Select the Audit No. to enter the audit record.
3. Select Action > Delete from the main menu.
4. Select Ok from the Confirm Delete Operation prompt.
The Audit has now been removed from the system.
1. From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit.
The Audit list displays.
2. Select the Audit No. to enter the audit record.
3. Select Action > Change Owner from the main menu.
4. Zoom from the Audit Owner field and select the new Owner.
Only users with the role assigned can be applied as the owner.
See How to Change Audit Owner Roles.
5. Click the Save button.
The Audit Owner has now been changed.
Only users with audit supervisor rights can change audit owner roles.
1. From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit.
The Audit list displays.
2. Select the Audit No. to enter the audit record.
3. Select Action > Change Role from the main menu.
4. Zoom from the Owner Role field and select the new role.
5. Click the Save button.
The Audit Owner Role has now been changed.
Sections and subsections are the primary content in a scheduled audit record. Subsections are dependent on sections and must be responded to before the associated section can be signed off. Sections and subsections can contain the information necessary to perform an audit. Audit sections, subsections, and questions can be copied from other audits and/or audit criteria which is maintained in the system.
NOTE: Audit sections come from criteria records and are not required for ad hoc audits |
Criteria can be copied into a new audit record if new sections and or questions need to be attached to the audit record ad hoc.
1. From the Audit record, select the Sections folder
2. Select Action > Add from the main menu.
3. Enter information in the Section window fields:
Field |
Description |
Number |
Enter the section number.
|
Title |
Enter the title of the section or subsection.
|
Objective |
Enter the objective of the section or subsection.
|
Response Type |
Select a Response Type for the Section or Subsection from the drop down list. Please see Response Type Setup to configure Audit Question Response Types.
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4. Click the Save button.
The new section displays.
Questions and sub questions make up sections and subsections in a criterion or audit record. Like subsections, sub questions cannot stand alone; sub questions must be associated with a question
1. From the Audit record, select the Section or Subsection Number.
2. Select the Question tab.
3. Select Action > Add from the main menu.
4. Enter information in the Question window fields.
Field |
Description |
Number |
Enter the question number.
|
Question |
Enter the question.
|
Response Type |
Select a response type for the question from the drop down list. Please see Response Type Setup to configure Audit Question Response Types.
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5. Click the Save button.
Response sign-off occurs once all sections and questions are completed. Before performing finding review, all sections listed under the audit record must display a Yes value under the Response column.
NOTE: If Yes is not displayed under all sections, an error will occur in the system if the audit owner tries to start the finding review. |
1. From the Audit record, select the Section folder.
2. Select the check box of the Sections to Sign-off (if applicable).
NOTE: You can select multiple Sections to Sign-off. |
3. Select Action > Response Sign-off from the main menu.
4. Enter appropriate Response.
5. Click the check box Include in Follow-up for any section you need to attach to a follow-up audit (if applicable).
6. Click the Save button.
The Responded field now displays Yes.
You can reference documents and other quality records to the audit record. In addition, the audit owner can setup the relationship between linked references. The following relations can be applied when referencing audit records to documents, or other SmartSolve© records:
Related – references which may have a brother-to-sister relationship.
Master/Sub – references which may have a parent-to-child relationship.
Deviation/Deviation Affected – used in SmartDocTM only.
Fulfilled Criteria/Fulfillment Criteria – used in SmartTrainTM only
SmartSolve© Reference Matrix
The following references can be attached to the References folder of criteria and can be seen when zooming under the Document No. field when adding the reference:
Reference Type |
Description |
Document Tab
|
SmartDocTM Document records. SmartAuditTM Criteria records. SmartTrainTM Course records.
|
Record Tab |
SmartAuditTM Audit and Program records. SmartDocTM Change Order records. SmartCAPATM Issue records.
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1. From the Audit tree, select the References folder
2. Select Action > Add from the main menu.
3. Zoom and select a Document No (this will be your reference document or record).
4. Select the Document or Records to reference.
5. Select the Relation option.
6. Enable the Fixed Rev check box if this relationship only applies to this revision of the Reference.
Even if a new revision is created, this reference only stays at this revision.
7. Click the Save button.
Audit teams perform audits. The following audit team folders are contained in an audit record:
Internal Team - Internal team members are those actors responsible for performing an audit and approve findings and action plans, if specified in the team approval model in the audit program.
External Team - External team members are experts that can be contacted for questions regarding the audit in which they are associated. These persons do not take part in the audit process.
The following primary member types are predefined:
· Lead Auditor
· Member
Each team member is assigned a level in the audit team approval model that determines the order in which each team member approves findings and/or action plans. A scheduled audit must have an audit team that includes at least one member. By default, this is the lead auditor.
The lead auditor may be responsible for:
· Scheduling audits.
· Creating the audit.
· Creating and maintaining the audit team.
· Coordinating the audit process once the scheduled audit date arrives.
· Assigning roles to team members as needed.
NOTE: The audit team cannot be modified once an audit has been closed. |
1. From the Audit, select the Internal Team folder.
The lead auditor (audit program owner) and other team members may be displayed in the Member Type list.
2. Select Action > Add from the main menu.
3. Select a Member Type (only one lead auditor can be assigned to the audit).
4. Zoom from the Auditor field and select an auditor.
5. Add other team members as needed.
6. Click the Save button.
The new members have now been added to the Internal Audit Team.
1. From the Audit, select the External Team folder.
The external team members may be displayed.
2. Select Action > Add from the main menu.
3. Enter external team member information as needed.
4. Add other team members as needed.
5. Click the Save button.
The new members have now been added to the external audit team.
Any number of uncontrolled attachments can be added to the audit record. The attachments will be saved to the database; therefore, you do not need to keep them on your hard drive. Some examples of attachments that Pilgrim customers may attach to audit records include, but are not limited to:
· Customer or regulatory audit reports provided after third party has audited your facility.
· Supplier documentation provided by suppliers you have audited.
1. From the Audit tree, select the Attachments folder.
2. Select Action > Add from the main menu.
3. Enter the Description of the attachment.
4. Select the Browse button and locate and select the file to attach to the Program.
5. Click the Save button.
The file is now attached to the Audit.
A note is a free-form comment recorded by an auditor while performing an audit. Note types indicate to the auditor and/or auditee the level of importance of the note and whether or not it will result in an audit exception. Each section, subsection or question in an audit may have a note list attached to it. Notes are recorded at the following two levels:
· Audit level - these notes are recorded against the overall audit.
· Sections and Questions level - these notes are recorded against a specific section or question.
Note types can be added any of the following ways in the audit record:
Option |
User Steps |
Add section specific note directly from audit record |
Select the Sections folder > select the Number link > select the Notes tab.
|
Add question specific note directly from audit record |
Select the Sections folder > select the Number link > select the Question folder > select the Note tab.
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Add a general note |
From the Audit tree, select the Notes folder.
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Add notes to Online Audit Form |
Please see How to Check Out Audit Online.
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Add notes to Offline Audit Form |
Please see How to Check Out Audit Offline.
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The Note folder appears
1. Select Action > Create Note from the main menu.
2. Select a note type from the Note Type drop down list.
NOTE: Each note window contains the same fields only the Requires Action Plan and Include In Summary checkboxes will vary based on the selected note type. |
3. Enter a short description or title for the note in the Short Description field.
4. Enter a description of the finding in the Description field.
OR
Zoom to check the standard text check box and click the Transfer button. Please see Standard Note Text
NOTE: The exception's Description field may provide rich text formatting if the rich text editor is enabled. If so, apply formatting in the same manner that formatting is applied in a word processing program, such as Microsoft Word. Please see Full Text Search. |
5. Check/Uncheck check boxes by note type, as follows:
Base Note Type |
User Steps |
Finding |
For a finding note type, the Requires Action Plan check box is checked by default. This field is modifiable. Keep the check box checked if the note requires an action plan (an exception will later be created for each note requiring an action). OR Un check the Requires Action Plan check box if an action plan is not required.
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Comment |
For a comment note type, the check boxes are not checked by default since neither option is required for a comment. If applicable: Check the Requires Action Plan check box to require an action plan. (an exception will later be created for each note requiring an action). Check the Include In Summary check box to display the comment in the Finding Summary folder.
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Recommendation |
For a Recommendation note type, the Include In Summary check box is checked. This check box is modifiable. The recommendation does not need to be included in the Finding Summary.
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6. Select a Severity and Priority.
7. Select the name of the note creator from the Entered By drop down list.
NOTE: The Entered By field is populated with the members of the audit's internal team. |
8. Click the Save button.
The note has been added to the audit record.
Evidence personnel are the individuals being audited and can be attached to each unique audit note.
1. From the audit tree, select the Notes folder
2. Select the Evidence Person link.
3. Select Action > Add from the main menu.
4. Enter the first and last name of the person in the Name field.
5. Enter a phone number where the person can be contacted in the Contact No. field.
6. Select the Save button.
The person has now been added to the Evidence Person list.
Attachments are any visual evidence that can be attached to each unique audit note for reference.
1. From the audit tree, select the Notes folder
2. Select the Evidence Person link.
3. Select Action > Add from the main menu.
4. Enter the Description of the attachment.
5. Select the Browse button and locate and select the file to attach to the Program.
6. Click the Save button.
The file is now attached to the audit.
Findings are established through observations and evidence (notes) recorded while performing an audit. A finding is the note type selected during an audit when an observation is recorded. Finding(s) that require action plans result in audit exception(s).
Each finding has an indicator 
to
the left of the Note Type field that tells the approver that this finding
is not approved. Findings can be sorted and re-arranged in the Finding
Summary folder. The Insert and Mark To Move functions provide approvers
the capability to present audit findings to the response approvers in
an organized manner.
NOTE: Audit exceptions can be created manually from the Finding Summary folder only when the FINDING_REVIEW review model schedule is not attached to the audit review model. |
NOTE: Findings cannot be edited in the Finding Summary once the approval status is ROUTED. |
1. From the audit record, select the Finding Summary folder.
2. Select the check box of the finding to edit.
3. Select Action > Edit from the main menu.
4. Enter changes.
5. Click the Save button.
The changes have been applied to the finding.
NOTE: Findings cannot be deleted in the Finding Summary once the approval status is ROUTED. |
1. From the audit record, select the Finding Summary folder.
2. Select the check box of the finding to delete.
3. Select Action > Delete from the main menu.
4. Click the Ok button to confirm the delete operation.
The finding has been deleted.
Findings can be reorganized in the Findings Summary folder in an effort to present the findings information to the auditee in the best way. The Mark To Move function must be used in conjunction with the Insert function to complete this process.
The Approval Status for the findings summary must be PENDING or STOPPED to perform this function.
NOTE: Only one item at a time can be marked to move and then inserted. |
1. From the audit record, select the Finding Summary folder.
2. Select the checkbox of the Finding to move, then select Action > Mark to Move from the main menu.
The finding has now been marked to move. Please see How to Insert an Audit Finding.
Findings can be reorganized in the Findings Summary tab in an effort to present the findings information to the auditee in the best way. The Insert function must be used in conjunction with the Mark To Move function to complete this process.
The Approval Status for the findings summary must be PENDING or STOPPED to perform this function.
NOTE: Only one item at a time can be marked to move and then inserted. |
1. Please perform steps for How to Mark Findings to Move.
2. From the audit record, select the Finding Summary folder.
3. Select the check box of the Finding where the new Finding will be inserted, then select Action > Insert from the main menu.
The finding has now been inserted into the line specified.
Finding Review is optional in the system. Please see Audit Review Types for more information on Finding Review.
1. From the audit record, select the Approval Routing folder under the Finding Summary.
2. Select Action > Add to add approvers or check off the user and select Action > Edit to edit approvers as needed.
Please see How to Add Approvers to an Audit Program or How to Setup Groups.
3. Click the Start button to notify Approvers.
The Finding Review has now been routed.
NOTE: Approval Status will specify HOLD, until the system renders a PDF report for the Audit Findings. This only takes a few seconds. Click F5 to refresh your browser and the HOLD Status changes to ROUTED. If it doesn’t, SmartCommTM will need to be restarted. Please see SmartCommTM. |
Please see How to Perform Finding Review.
1. From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, select Items Need Approval – Audit Finding
2. From the Audit Finding Approval List, select the check box for the audit to review.
3. Select Action > Sign-off from the main menu.
4. From the Audit Finding Sign-off screen, select APPROVED or REJECTED from the Status drop down field.
NOTE: If the Approver selects the INREVIEW status the review will remain on this user’s Things To Do List until APPROVE or REJECT is selected. INREVIEW is used to stop the Review Escalation Policy (if applicable) and it is used to let the audit owner know that the approver is still reviewing the content before a final decision is made. |
5. Enter Note From Approver.
6. Enter Password.
7. Click the Save button.
The Audit Finding Review has now been completed.
Exceptions are deviations from the auditor's criteria and may include any defects found during the course of the audit. Audit exceptions are auto-generated from findings that require an action plan and display in the audit record's Exceptions folder. Audit exceptions can only be created from an audit record. When an audit exception is created, the audit exception owner information is gathered from the Contact Role and Contact fields in the audit record.
NOTE: Audit exceptions can be created manually from the Finding Summary folder only when the FINDING_REVIEW review model schedule is not attached to the audit review model. |
1. From the Audit tree, select the Finding Summary folder.
2. Check off all Findings which require action plans.
3. Select Action > Create Exception from the main menu.
4. Click the Ok button to confirm exception creation.
The Exception Detail is always the first information displayed when entering the audit exception record. The following information is available:
Information |
Description |
Header
|
The header of the exception record is always displayed at the top of the screen and contains the following information: Exception Number – Unique number assigned to the audit exception record (this cannot be changed). Status – The current status of the audit exception (INWORKS, CLOSED, etc.). Category – All audit exceptions are categorized automatically by the system as AUDIT. Please see SmartCAPATM and SmartComplaintsTM for other exception type categories. Occurrence Date – This is the date that the audit exception was created in the system. Audit Response Time works with the Audit Exception Occurrence Date to ensure timely audit finding investigations. Severity & Priority – Severity and priority transfers to the audit exception from the Audit Note Type. Title – This is the title of the Audit Note as entered from the audit record by the auditor.
|
Ownership |
Each audit exception record contains an owner who will be responsible for overseeing the activities within the audit exception record (i.e., performing or managing the Action Plan Investigations, etc.). Auditee Primary Contacts are automatically assigned as audit exception owners; however, audit ownership can be changed at anytime.
|
Auditee Information |
Information on the organization unit and process/product being audited is also attached to each audit exception automatically.
|
Resolution |
The Resolution section of the audit exception contains Resolution Code and Description identifying verification of closure of the exception record once all action plans have been completed.
|
Exceptions are also managed by status. The following Audit Exception Statuses are used in the system:
Status |
Description |
OPEN |
The OPEN status places the newly created audit exception under the exception owner’s Things To Do List: Items Need Attention – Audit Exception.
|
INWORK |
When exceptions are owned or if rejected during response (Action Plan) review, or implementation review the INWORK status displays. Rejected audit exceptions display under the Things To Do List: Items Need Attention – Audit Exception.
|
RESPONDED |
When action plans have been proposed and the audit exception has been routed for response (Action Plan) review, or implementation review the RESPONDED status displays. This status is triggered when the exception owner performs Response Sign-off.
|
RESPONSE APPROVED |
When Response (Action Plan) Review, or Implementation Review is completed and all action plans have been approved, the RESPONSE APPROVED status is displayed.
|
ATTACHED |
If an issue is created from the audit exception, or the exception is attached to an existing issue, the ATTACHED status displays. Please see the SmartCAPATM End User Guide for more information on issues.
|
CLOSED |
Once all Action Plans are marked as complete, the audit exception owner can close the exception by assigning a resolution. Once closed, the audit exception status displays as CLOSED. If the Audit Exception has been attached to an issue, then the issue record will later close the exception. Please see the SmartCAPATM End User Guide for more information on issues.
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The following options are available within audit exception records and can be managed accordingly by a user with appropriate rights:
· Audit exceptions cannot be edited or deleted from the system.
· Audit exception ownership can be changed at anytime if needed.
· Attachments can be added to exceptions.
· Activities can be attached to exceptions.
· Action Plans can be attached to exceptions.
· Exceptions can be attached to SmartCAPATM issues.
1. From the Smart Solutions tab on the Portal Page, select SmartAudit > Find > Audit.
The Audit list displays.
2. Select the Audit No. to enter the Audit record.
3. Select the Exceptions folder from the Audit tree.
4. Select the Exception No. to enter the Audit record.
5. Select Action > Change Owner from the main menu.
6. Zoom from the Audit Exception Owner field and select the new Owner.
Only users with the role assigned can be applied as the owner.
7. Click the Save button.
The Audit Exception Owner has now been changed.
When an exception is owned, it is moved from the Items Need Attention – Exception list down to Items Under My Ownership – Exception. This functionality is typically only used if multiple users may be responsible for owning exceptions and is an optional feature.
1. From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, select Items Need Attention > Exception.
The Exception list displays.
2. Select the Exception No. to enter the Exception record.
3. Select Action > Own from the main menu.
4. Select the Ok button to confirm ownership
The Audit Exception Status now displays INWORK and the exception can now be accessed under Items Under My Ownership – Exception on the Things To Do List.
When an exception is disowned, it is moved from the Items Under My Ownership – Exception Things to Do List back up to Items Need Attention – Exception. This functionality is typically only used if multiple users may be responsible for owning exceptions to take care of updates.
1. From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, select Items Under My Ownership > Exception.
The Exception list displays.
2. Select the Exception No. to enter the Exception record.
3. Select Action > Disown from the main menu.
4. Enter a Comment and Password.
5. Click the Save button.
The Audit Exception Status now displays OPEN and the Exception can now be accessed under Items Need Attention – Exception on the Things To Do List.
1. From the Audit Exception, select the Attachment tab.
2. Select Action > Add from the main menu.
3. Enter the Description of the attachment.
4. Select the Browse button and locate and select the file to attach to the Program.
5. Click the Save button.
The file is now attached to the Audit Exception.
The pushpin icon 
appears
in the exception record's detail window to signal that a file is attached
to the record.
An attachment's content cannot be edited from the record to which it is attached. Content must be edited from the file's location in the external directory, deleted from the attachment folder and re-attached to the record.
NOTE: The procedure to view an attachment is dependent on the browser. |
Not all information may be available at the time the exception is created. When more information is gathered or additional actions performed in evaluating or processing the exception, SmartAudit provides the ability to track activities such as customer/supplier communication, meetings, etc.
1. From the Audit Exception, select the Activity tab
2. Select Action > Add from the main menu.
3. Select the Activity Type from the drop down menu.
Please see How to Create Exception Activity Types
4. Enter the date the Activity was carried out in the Performed Date field (if in the past).
5. Enter the name of the person who performed the activity in the Performed By field (if other than you).
6. Enter Comment of Activity.
7. Click the Save button.
The activity is added to the audit exception.
Also, some system generated activities are tracked in the exception record for future reference such as:
Activity Type |
Description |
Change Owner |
Anytime ownership is changed in the exception, the activity is tracked.
|
Own |
Anytime an exception is owned by a user, the activity is tracked.
|
Disown |
Anytime an exception is disowned by a user, the activity is tracked.
|
Response |
Anytime an exception owner performs response sign-off to trigger Action Plan Approval, the activity is tracked.
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Response Approved |
Anytime action plans are approved, the activity is tracked.
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Response Rejected |
Anytime Action Plans are rejected, the activity is tracked.
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Attach To Issue |
Anytime a new issue is created from the exception, or the exception is attached to an issue, the activity is tracked. Please see the SmartCAPATM End User Guide for more information on issues.
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Close |
Anytime an exception is closed by a user, the activity is tracked.
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Reopen |
Anytime an exception is reopened by a user, the activity is tracked.
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At least one action plan must be added to the exception in order to later close it. Once in the exception screen, the exception owner can enter Action Plans and mark an Action Plan complete, if they have been completed prior to the current date.
1. From the Audit Exception, select the Action Plan tab.
2. Select Action > Add from the main menu.
3. Select Corrective or Preventive Action Plan from the drop down menu.
Please see How to Create Action Plan Types.
4. Enter Required Time and Target Completion Date (if applicable).
5. Enter the Action Plan Description (what you are going to do).
6. Click the Save button.
The Action Plan has now been added to the audit exception.
Please see How to Mark Action Plans Complete if the actions you just added are completed.
If the exception owners assigned are line managers or users who must log into the system to enter exception response they can do so using the Auditee Response form.
NOTE: The Form below must first be installed by your System Administrator. Please see the Auditee Response Form. |
1. From the Things To Do List select Items Need Sign-off > Audit Exception.
2. From the Audit Exception Sign-off list select the Exception No. to enter the Response Sign-off sheet.
3. Expand the Action Plans Section for the Exception for which you wish to propose Action Plans.
4. Select Corrective or Preventive action plan from the Type field drop down menu.
Please see How to Create Action Plan Types.
5. Enter Required Time and Target Completion Date (if applicable).
6. Enter the Action Plan Description (what you are going to do).
7. Click the Save button if you wish to save information and return later to enter more response; or, click on the Submit button to submit your action plans for approval.
Please see How to Mark Action Plans Complete if the actions you just added are completed.
NOTE: This function only needs to be performed if the Submit button was not clicked on above. |
Once the exception owner defines all of the appropriate Action Plans, they must sign off on the exception in order to push the exception to the next phase of Action Plan Approval within the audit record.
1. From the Audit Exception, select the Detail tab
2. Select Action > Response Sign-off from the main menu.
3. Enter Resolution Description.
4. Enter Password.
5. Click the Save button.
The Audit Exception Status now displays as RESPONDED.
Please see How to Perform Action Plan Approval or Implementation Review.
Once the action plans have been approved, all action plans listed in the exception must be marked complete before the audit exception can be closed in the system.
1. From the Audit Exception, select the Action Plan tab.
2. Select the Action Plan(s) to mark as complete.
3. Select Action > Mark As Complete from the main menu.
4. Enter Target Completion Date (you can back date).
5. Enter Password.
6. Click the Save button.
The Action Plan Status now displays as COMPLETED.
Please see How to Close Audit Exceptions.
Action plans can be aborted in the system; however, once aborted, an implementation review must be attached to the audit record in order for the action plan abort process to be approved. It is only once the aborted action plans are approved that the exception record can be closed.
1. From the Audit Exception, select the Action Plan tab.
2. Select the Action Plan(s) to mark as complete.
3. Select Action > Abort from the main menu.
4. Click the Save button.
The Action Plan Status now displays as ABORTED.
Please see How to Route Implementation Approval.
Once the exception owner completes all action plans, they can close the exception to push the audit to the next phase.
1. From the Audit Exception, select the Detail tab.
2. Select Action > Close from the main menu.
3. Enter Resolution.
Please see How to Create Exception Resolutions
4. Enter Password.
5. Click the Save button.
The Audit Exception Status now displays as CLOSED.
Please see How to Reopen Audit Exceptions.
Audit exceptions can only be reopened by users with audit exception supervisor rights.
1. From the Audit Exception, select the Detail tab.
2. Select Action > Reopen from the main menu.
3. Select the Ok button to confirm the reopen process.
4. Enter a Comment.
5. Enter Password.
6. Click the Save button.
The Audit Exception Status now displays as OPEN.
Audit Exception Integration with SmartCAPATM
The diagram below indicates how audit exceptions can be integrated with issues. Completed action plans return to the Audit Exception > Action Plan folder at multiple stages in the audit lifecycle. Action plans are dependent on when the issue is closed, deleted or aborted. As the audit process can be at any stage when the issue is closed, action plans can be transferred to the audit at any time.
Please see SmartCAPA Setup for more information on setting up Issues.
Action plans are entered into the audit record via the audit exception. The Action Plan folder is a read only folder which summarizes all action plans that have been attached to each audit exception that exists within the audit.
Please see How to Add Action Plans to Audit Exceptions.
All action plans entered in the audit exception require approval. Approval for action plan(s) actually takes place from within the audit record through the response review.
Once audit exception response is signed off, the response review may auto start; however, if for any reason the review needs to be stopped to add additional approvers, you can follow the steps below.
1. From the audit record, select the Approval Routing folder under Action Plans.
2. Select Action > Add or check of the user and select Action > Edit as needed.
Please see How to Add Approvers to an Audit Program or How to Setup Groups
3. Click the Start button to notify approvers.
The Response Review has now been routed.
NOTE: Approval status will specify HOLD, until the system renders a PDF report for the audit findings. This only takes a few seconds. Click F5 to refresh your browser and the HOLD status changes to ROUTED. If it doesn’t, SmartCommTM will need to be restarted. Please see SmartCommTM. |
Please see How to Perform Action Plan Response Review.
1. From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, select Items Need Approval > Audit Action Plan.
2. From the Audit Action Approval List, select the check box for the Audit you wish to review.
3. Select Action > Sign-off from the main menu.
4. From the Audit Action Plan Sign-off screen, select APPROVED or REJECTED from the Status dropdown field.
NOTE: If the approver selects the INREVIEW status the review will remain on this user’s Things To Do List until APPROVE or REJECT is selected. INREVIEW is used to stop the Review Escalation Policy (if applicable) and it is used to let the audit owner know that the approver is still reviewing the content before a final decision is made. |
Please see How to Reject Action Plans.
5. Enter Note From Approver.
6. Enter Password.
7. Click the Save button.
The Audit Response Review for this user has now been completed.
Action Plans can be rejected during the approval process. The following rules apply when rejecting Action Plans:
If you want to reject all exceptions and action plans attached then simply select the REJECTED status in the Approval Sign-off screen.
If you want to reject individual exceptions or individual action plans, select the REJECTED status, then check off the Select Exceptions/Action Plans for rejection check box. Scroll down to see all exceptions and action plans:
Check off the exception to reject all action plans within the exception.
Check off the individual action plans if rejecting one action plan within the exception, etc.
All other exceptions and/or action plans not checked will be marked as approved.
Rejecting one exception or action plan will not hold up all other approved exceptions from being completed (as long as approval for Action Plan is not in a ROUTED state).
Anytime an action plan or entire exception has been rejected it will go back to a Status of INWORK. The Rejection Notes can be viewed within the Activity folder of the rejected exception.
The exception owner must once again edit, or add new action plans and perform response sign-off to reroute the exception for Action Plan Approval.
See How to Add Action Plans to Audit Exceptions.
The Action Plans History folder is accessed from the Build No. link in the Audit Exception Action Plan folder. When an action plan is rejected, the audit exception's status changes back to INWORKS and a history record is recorded in the Action Plans History folder. The Rejected Date field displays the current date and the Reject Comment field displays any comments.
Activity notes are recorded as activities in the Audit Activities folder. Activity notes can also be recorded from the sign-off window during sign-off of an audit finding, audit response or audit implementation record.
In audit records, activity history displays in this folder. This information is organized by document build no. and includes the access activity (e.g., check in, remark), associated note, who entered the note and the date. Audit Online and Offline Check Out and Check In Notes are transferred into the Activity Note folder.
Activity notes that are manually added into an audit record, are labeled as remarks. The Access Activity field displays remark for the manually entered notes. These are the only notes that can be edited or deleted from this folder.
1. From the Audit record, select the Activity Notes folder.
2. Select Action > Add from the main menu.
3. Enter the Note.
4. Click the Save button.
An audit result can be assigned to an audit record when:
· an audit record is created and there are no findings
· an audit record is in ACTION PLAN APPROVED status.
1. From the Audit record, click Action > Assign Result.
2. Enter information in the following fields:
Field |
Description |
Result |
Select a result for the audit from the drop down list. Please see How to Create Audit Results.
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FollowUp Flag |
If a follow up audit is required based on the audit result selected, check the Follow Up Flag check box.
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NOTE: An ad hoc audit cannot be scheduled for a follow up audit.
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FollowUp Date |
Click the calendar icon next to select a date for the follow up audit.
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Review Required |
If an implementation review is required for an action plan associated with an audit exception, select the Review Required check box. The Audit window expands to include review related fields. Please see Implementation Approval.
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Interval |
Enter a numeric amount to determine how long the implementation of an action plan will take to finish. Then select a unit from the drop down list.
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Advanced Notice |
Enter a numeric amount to determine how far in advance the reviewers must be notified. Then select a unit from the drop down list.
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NOTE: The Earliest Target Date and the Latest Target Date are given to indicate the window of time allowed for the action plan to be implemented.
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Target Date |
Click the calendar icon to select a target date for the action plan implementation to be completed.
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Comment |
Enter a comment if applicable.
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Confirm Password |
Enter your Password.
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3. Click the Save button.
The Audit Status will display as CLOSED if no Implementation Review was scheduled.
The Audit Status will display as PRERELEASED if an Implementation Review was scheduled.
The Implementation Review is a review that only needs to take place in the audit record if findings occur during the audit that 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 later to verify that all approved action have been completed.
The Implementation Review can be scheduled as a periodic review with a user defined interval. For example, if the auditor needs the system to send notification in a month to review the progress of the action plans currently under implementation.
If no findings are documented that require further action, or the auditor does not want to schedule an Implementation Review if action plans do exist, then this approval can be skipped in the Audit record.
Implementation Review is optional in the system. Please see Audit Review Types for more information on Implementation Review.
1. From the audit record, select the Approval Routing folder under the Implementation Approval.
2. Select Action > Add or check the approver and select Action > Edit as needed.
Please see How to Add Approvers to an Audit Program or How to Setup Groups.
3. Click the Start button to notify Approvers.
The Implementation Approval has now been routed.
NOTE: Approval status will specify HOLD, until the system renders a PDF report for the audit findings. This only takes a few seconds. Click F5 to refresh your browser and the HOLD status changes to ROUTED. If it doesn’t, SmartCommTM will need to be restarted. Please see SmartCommTM. |
Please see How to Perform Implementation Approval.
1. From the Things To Do List on the SmartSolve Legacy Portal dashboard on the Portal Page, select Items Need Approval > Audit Implementation.
2. From the Audit Implementation Approval List, select the check box for the audit you wish to review.
3. Select Action > Sign-off.
4. From the Audit Implementation sign-off screen, select APPROVED or REJECTED from the status drop down field.
NOTE: If the approver selects the INREVIEW status the review will remain on this user’s Things To Do List until APPROVE or REJECT is selected. INREVIEW is used to stop the Review Escalation Policy (if applicable) and it is used to let the audit owner know that the approver is still reviewing the content before a final decision is made. |
5. Enter Note From Approver.
6. Enter Password.
7. Click the Save button.
The Audit Implementation Approval for this user has now been completed.
Please see How to Reject Action Plans.
The audit owner must manually close the review once all approvals are completed.
1. From the Audit tree, select the Implementation Approval folder.
2. Select Action > Close from the main menu.
3. Enter the Review Note.
4. Select the option No Further Review Required only if this Review is to Close and not be performed again in the Audit record.
Enter Target Date, Interval, and Advance Notice only if you are scheduling another Review.
5. Enter Password.
6. Click the Save button.
If no further review is required, the approval is closed and the audit status displays CLOSED.
If another review (Implementation Approval) was scheduled, the audit status displays PRERELEASED.
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:
Company Header
Audit Title, Auditee and Dates
Audit Team
Audit Background
Executive Summary
Observations
Action Plans
Please contact your pilgrim representative for more information on the Audit Word Report.