Release 12.1
Part Number E13679-04
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The Quality Audits Solution enables you to plan, track, and measure the effectiveness of the Quality Management System (QMS). Quality Audit Solution gives a framework that helps you to standardize and streamline the process of conducting quality audits across the organization. It provides an electronic method to conduct audits and allows you to tailor the audit solution according to the business needs. It helps to identify quality systems problems across the organization as well as compare organizations in terms of compliance standards.
The audits solution provides seeded parent-child collection plan templates that help to collect data and conduct quality audits. You can also store audit questions in the Audits Questions Bank and re-use them in different audits based on the scope of each audit.
Audit Solution Templates comprise of seeded collection plans that can be copied, modified and implemented to conduct audits.
The objectives of the Quality Audits Solution are to perform the following business functions:
To establish the level of compliance to published standards
To document any corrective actions needed
To assist in the review processes and identify any weaknesses, risks and areas of future improvement
To track previously identified non-conformances and monitor the implementation the required corrections
In order to achieve the objectives, the audits solution templates contain the following:
Seeded collection elements and associated lookup values for some of the seeded elements
Seeded Template collection plans and corresponding values and actions
Parent-child collection plan structure with seeded collection elements and collection element in-list values
Copy collection process and logging of corrective action
Seeded workflow for sending pre-configured workflow notifications
The following table gives the key features provided with the audits solution:
| Key Feature | Supported Activities |
|---|---|
| Audit Initiation and Lifecycle Tracking | Initiate and create a audit number to track its lifecycle Record the scope and objectives of the audit Attach policies and standards for auditors to review Define audit area and assign lead auditor for that area Create or copy questions for the audit Notify personnel of the upcoming audit Enable auditors to record findings of the audit Review and record if procedures are adequate and compliant Log Corrective Action Requests if needed Review if corrective actions have been implemented and end audit lifecycle by closing the audit |
| Copy audit questions from a Question Bank | Choose and copy the relevant audit questions from the Question Bank for the audit that has been initiated |
| Attachments support for additional documents, references, evidence or standards | Ability to add attachments like additional unstructured information such as evidence, multimedia files, etc., to collection results and collection plans |
| Security and Privileges | User access to the system can be restricted so that User Groups and “Grant Privileges will be used to grant or restrict the ability to enter, update, delete or view Quality Results as well as change plan setup |
| Audit Trail through “History” collection plans | The implementer of the system can choose the data elements that need audit trail by using the history collection plans |
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