Not only Oracle Quality offers a means to manage your Quality records and can be fully compliant with your Quality standards but it can be used to improve your Quality processes:
Minimize your workload and paper work and streamline your Quality processes
Standardize your Quality Management Processes across all of your organizations
Manage Quality KPIs in a consolidated way.
Traceability and Quality Standard Compliance: the basics you require!
What would be a basic (and still powerful) setup for Oracle Quality?
First establish your inspection points: receipts, work order operations and final inspection, repair, maintenance, ad-hoc inspections… Secondly, devise and create the inspection plans and attach them to every component, sub-assembly or product. When possible, group them by item family. Finally, grant access rights to allow the Inspectors using the Inspection Plans.
Quality Inspectors immediately can record inspection results, accept or reject lots. Their work is simplified by using sampling and specifications:
Oracle Quality automatically proposes the right sample quantity during inspection. This is based on standard AQL levels. The lot is accepted or rejected accordingly.
Specifications can be assigned to every inspection point to automatically accept or reject a measurement.
Oracle Quality is fully integrated with Purchasing, Discrete and Process Manufacturing (and other modules) it is easy to implement and highly customizable. Quality records are stored in the system and managed in a secured and auditable way.
Minimize your workload and paper work
The Quality team workload is often critical. It’s with worth reducing it. Oracle Quality offers several means to achieve this purpose.
Non Conformance Management:
Oracle Quality allows to create a workflow to manage non-conformances from rejected lots to MRB decisions and disposition tracking. You can either use the pre-seeded workflow provided by Oracle or customize your own workflow.
In both cases one unique integrated system is used by your Quality team to manage inspection and non-conformances.
This approach can be extended to CAPA’s and Audits.
Skip lot inspections
After establishing strong quality processes with your suppliers, you can build and apply skip lot rules to skip inspections when allowed. You get a full traceability of skipped lots. Your quality team saves time and concentrates on the critical products.
Zero paper using the Electronic Signature
Oracle Quality allows you to track and sign off Quality records in a secured and auditable way. The Electronic Record and Electronic Signature tool is 21 CFR part 11 compliant. Any Quality record can be stored, secured and retrieved for audits.
ERES is a very strong and stable tool. Once the rules are established and setup there is no way to escape to them.
Despite of a slight increase of time at sign-off this drastically reduces the amount of paper in your facilities, secures your quality records and facilitates any kind of audits.
Streamline your processes
Highly customizable Oracle Quality sticks to your Quality processes and helps improving them. A few examples in the Quality area:
Track your customer complaints
by creating an ad-hoc plan fulfilled by your customer services
Manage complex Inspection instructions
by referring to or replicating your Quality documentation in Oracle Quality
Manage Calibration and Maintenance
Either by building specific collection plans
Or by using Enterprise Asset Management and Quality together.
Build Standard Quality Processes
To support your company processes, create your typical inspection plans and typical non-conformance workflow:
. By using child plans build your Non Conformance Workflow: nonconformance event, MRB decision and disposition, corrective action tracking.
. Use statuses to open and close non conformances and actions.
. Add email alerts and customized reports. As an example, a customized report can be launched from a plan to print out a claim letter to your supplier.
Make this a standard by saving your plans as templates in your master org. Train your Quality Managers to create a new plan from these templates. Be sure your Quality Managers can easily get an IT support to solve new questions or potential issues.
Based on this approach, all of your organizations have the same Quality plan structure. Only the list of inspection points is adjusted to the organization parts. Non-conformance Management, Complaints management is the same across all of your organizations with the same statuses, disposition codes…
Manage Quality KPI’s in a consolidated way
Based on standard processes and inspection plans you can now build your monthly KPI’s. As all of your plans have the same statuses and same codes it’s easy to get statistics by product line, supplier and facility.
You can use the Quality reports to generate your KPI’s or work with your BI team to generate them. Using your BI tool makes the calculation automatic and global allowing reports by facility and for your company.
Building this level of solution requires a business and IS team working together in a project oriented approach. Except for Month-end customized reports it’s fully standard. However, it needs to be considered as technical setup: SQL scripts are part of it.
In a few months a project team made from Quality Managers and Oracle Consultants can move your solution from a set of inspection plans to compliant and global quality procedures based on high standards.