Audits

The AODocs for Life Sciences Grow package lets you manage CAPAs, Quality Events and Audits. Use the Grow package to enrich and expand your quality management system with automated workflows and processes. Learn more about the AODocs for Life Sciences packages.

Audit documents in AODocs for Life Sciences contain pre-defined properties that you can track throughout the Audit life cycle. You can easily access all your and related Audit Findings (Quality Events) during compliance audits.

This article explains how to create Audits. You can also find information about the Audit workflow and Audit properties.

How do Audits integrate with other AODocs for Life Sciences processes?
Create an Audit
          New Audit
          Scheduled
          In progress
          Post-Audit analysis
          Audit review
          Audit closed
The Audit workflow
Audit properties

How do Audits integrate with other AODocs for Life Sciences processes?

Audits usually have related Audit Findings (a type of Quality Event), which themselves can have related CAPAs. Your related Audit Findings and CAPAs can have related Documents.


Create an Audit

Below is a description of how to create an Audit. Each section corresponds to a different state in the workflow, corresponding to the lifecycle of an Audit. Learn more: The Audit Workflow.

Some properties are optional throughout the workflow. Others become mandatory or are recommended at various workflow states. You can fill in optional properties at any point. When you create your Audit, you may want to fill in all the properties that will become mandatory throughout the workflow. You can consult the full list of Audit properties.

In this description of how to create an Audit, we assume you haven’t filled in properties in advance; we indicate when optional properties become mandatory as the document progresses through the Audit workflow.

New Audit

1. As a member of the Collaborators group, on your library homepage, press New and select Audit. An unsaved Audit document opens.

Learn more from AODocs: Create documents from a template.

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2. In the unsaved Audit document, fill in the mandatory property Audit Title.

Learn more from AODocs: Edit custom properties.

3. If required, fill in the Scheduled Date property.

Note: You can leave the Scheduled Date property empty in your new Audit. In this case, the Audit will remain in the New Audit workflow state. When you fill in Scheduled Date property and save, the Audit transitions to the Scheduled workflow state.

4. Save your Audit.

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When you save your Audit:

  • the Audit # property is filled in automatically with a reference number used to populate the title of your Audit, along with the Audit Title property
  • the Document Owner property is filled in automatically with the email address of the person who created the Audit – learn more: Audit properties
  • it transitions to the Scheduled workflow state if you have defined a Scheduled Date

Scheduled

If you filled in the Scheduled Date property and saved your Audit, it is in the Scheduled workflow state. There are two mandatory properties in this state:

  • Lead Auditor
  • Audit Team

Note: You are also recommended to define one or more reviewers.

Contributors see an orange warning sign indicating that there is at least one mandatory property that isn’t filled in. Workflow participants see a message indicating that the workflow action is disabled until the mandatory properties are filled in.

Learn more from AODocs: Mandatory properties haven’t been filled in.

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1. Press the Edit button.

2. Fill in the Lead Auditor property with one person.

3. Fill in the Audit Team property with one or more people or Google groups.

4. Optionally, fill in the Reviewers property with one or more people or Google groups.

5. Save your Audit. The Workflow button becomes available.

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6. Select Scheduled and then Start Audit.

7. If required, leave a comment in the Perform workflow action pop-up, then press Submit.

When you start your Audit:

  • the Audit start date property is filled in automatically with the current date – learn more: Audit properties
  • your Audit transitions to the In progress workflow state

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In progress

Your Audit is now in the In progress workflow state.

During the In progress state, you can initiate:

  • Audit Findings by creating related items in your Audit
  • CAPAs through the workflow in your related Audit Findings
  • related Documents by creating related items in your Audit Findings or CAPAs

Learn more: Quality Events.

Scroll down to Related items to create related items. Learn more from AODocs: Create new related items.

Important:
– When you create related items, make sure you create Audit Findings. Don’t create related Customer Complaints or Incidents in an Audit.
– You can create Audit Findings only when your Audit is in the In progress state. When you’re in any other state, it isn’t possible to create Audit Findings.

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Update the list of related Documents

At any time, you can refresh the list of related Documents. Open the custom action menu and select Update list of related Documents. The following properties are updated:

  • Completion progress: ratio of Audit Findings completed
  • Summary of findings: details of related Audit Findings and CAPAs
  • Related Documents: details of related Documents in the Audit Findings or CAPAs
    Learn more: Audit properties.

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Transition the Audit document

When you have collected all your findings, your audit is complete. However, some of your findings may not yet be resolved. During the In progress workflow state, the All findings resolved switch remains inactive, indicating that one or more of your Audit Findings is still open.

1. When the Audit is complete, select In progress and then Audit completed.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.

  • If one or more of your findings is still open, the All findings resolved switch remains inactive and your Audit transitions to the Post-Audit analysis state.
  • If all your findings are resolved, the All findings resolved switch changes to active and your Audit transitions to the Audit review state.

When you complete your audit, the Audit Completed property is filled in automatically with the current date. Learn more: Audit properties.

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Post-Audit analysis

Your Audit is in the Post-Audit analysis workflow state if you completed the Audit with one or more Audit Findings still open. The All findings resolved switch is inactive.

During the post-audit analysis, investigate and resolve any unresolved findings. You can’t add any new findings during this workflow state. However, if required, document owners can reopen the Audit and transition it back to the In progress state: press Post-Audit analysis and select Reopen audit.

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When all your findings are resolved, the All findings resolved switch automatically changes to active and your Audit transitions to the Audit review workflow state.

Note: Your library administrator can manually change the state of the All findings resolved switch. For example, some findings may still be open, but you may decide not to resolve these findings.

Audit review

Your Audit is in the Audit review workflow state if the All findings resolved switch is active.

During the audit review, inform the relevant people about the Audit Findings and discuss what was resolved and what wasn’t resolved. You can’t add any new findings during this workflow state. However, if required, reviewers can reopen the Audit and transition it back to the In progress state: press Post-Audit analysis and select Reopen audit.

When you are ready to close your Audit:

1. As a reviewer, select Audit review and then Audit closed.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.
Your Audit transitions to the Audit closed workflow state.

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Audit closed

Your Audit is now in the Audit closed workflow state. Learn more: The Audit Workflow. The workflow for your Audit is complete.


The Audit workflow

The workflow below shows the states involved in creating an Audit.

Learn more about the properties that need to be filled in at each state.

Audit_workflow.png


Audit properties

Below is a list of the properties available throughout the process of creating an Audit.

Section Property Description Mandatory at which state in the CAPA workflow?
Top level of list of properties Audit #

Incremental reference number that is automatically generated and filled in. It’s used to populate the title of your Audit (along with the value of Audit Title) when you save it.

Note: If you change its value, it is overwritten with the automatically generated value.

N/A
  Audit Title

Fill in the title manually.

Populates the title of your Audit when you save it (along with the value of Audit #).

New Audit
  Audit Type

Manually select one of:

  • External - Scheduled
  • External - Unscheduled
  • Internal - Scheduled
  • Internal - Unscheduled
Always optional
  Department

Select from the list of departments specific to your organization.

Always optional
  Location

Select from the list of locations specific to your organization.

Always optional
Personnel Document Owner

Owner of the process.
You can define one or more people.

Filled in automatically with the email of the person who created the Audit.

If you enter a different name during the Audit creation phase (New Audit), it is replaced with your name when you save your Audit. However, you can choose a different name or add other names once the Audit has been created.

Mandatory throughout the process (you can’t save an Audit without the Document Owner property filled in)
  Lead Auditor

Fill in manually.

You can define only one person.

Scheduled
  Audit Team

Fill in manually.

You can define one or more people or Google Groups

Scheduled
  Reviewers

Fill in manually.

Reviewers sign off the Audit review, thereby transitioning the Audit to Closed.

You can define one or more people or Google Groups.

Always optional, but must be defined before the Audit review.
Dates Scheduled Date

Fill in manually. When filled in, the Audit transitions to Scheduled.

Always optional, but the Audit remains in the New Audit state until Scheduled Date is filled in.
  Audit Start Date

Filled in automatically with the date the Audit transitions to In progress.

N/A
  Audit Completed

Filled in automatically with the date the Audit transitions to Post-Audit analysis or Audit review.

If the audit is reopened (in the Post-Audit analysis or Audit review state) and transitioned back to In Progress, the Audit Completed property becomes blank.

N/A
  Audit Closed

Filled in automatically with the date the Audit transitions to Audit closed.

N/A

 

Scope and details All findings resolved

When you transition the Audit from In progress, this switch:

  • changes to active if all related Audit Findings are closed; your Audit transitions to Audit review
  • remains inactive if one or more Audit Findings are open; your Audit transitions to Post-Audit analysis

If the audit is reopened (in the Post-Audit analysis or Audit review state) and transitioned back to In Progress, the All findings resolved switch becomes inactive again.

Note: Library administrators can manually activate or deactivate this switch.

N/A
  Summary of findings

Filled in automatically with the following information:

  • total number of related Audit Findings
  • total number of CAPAs initiated from related Audit findings
  • list of Audit Findings with their status (Open or Closed) and title

Tip: Use the custom action menu to update the list. Learn more: Update the list of related Documents.

N/A
  Related Documents

Filled in automatically with the titles of any Documents related to:

  • Audit Findings created from your Audit
  • CAPAs created from your Audit Findings

You can click the titles to open the related Documents.

Tip: Use the custom action menu to update the list. Learn more: Update the list of related Documents.

N/A
  Audit Scope Manually enter details of the audit scope. Always optional
  Audit Report This feature isn’t currently implemented. N/A

 

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