Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions
Think about your quality system. When you initially automate a quality process, you begin by determining the ideal process flow, data you wish to capture, check points to be recorded, and how information should flow between members of your team.
But what about the intersection of where a quality process ends and another business process begins? Some of these intersections may be critical checkpoints between quality and compliance processes and the rest of your business. Notifying Quality about customer complaints, updating Production with nonconformance dispositions, or providing access to documents that need to be referenced from quality records are just a few of the examples of where quality systems interacts with the rest of the business in real-time.
Updating the right system at just the right time (and using a core set of master data between systems) builds quality into every process within your business. Plus, the data integrity between integrated systems provides a common language, or single source of truth, that your entire organization can use to communicate and improve.
In today’s post, we’ll explore 5 ways to bring quality into the loop and enable the quality system to “talk” to other business processes within your enterprise.
The Building Blocks – Master File Data
This data comprises the building blocks of your quality system and other business systems as well. Data defining sites, departments, positions, products, parts, failure modes, risks, and dispositions are pieces of information that could or should be shared across systems.
Your quality system should be able to automatically populate, update, and/or synchronize master file data. Examples of this type of integration include:
- Synchronizing items and parts and their attributes between systems.
- Creating new supplier records when a new supplier is created in the Enterprise Resource Planning (ERP) system.
- Importing users.
Keep Processes Running Smoothly – Synchronize Events
Sometimes an event happens within an external system such as Enterprise Resource Planning (ERP), Statistical Process Control (SPC), Laboratory Information Management System (LIMS), or another key business system that should trigger action in the quality system. Some examples of this include receiving or shipping nonconformances or out-of-specification results. It is important to have the flexibility to generate a record in your quality system when one of these events occurs and to be able to return results when the event is complete or dispositioned. An enterprise-grade quality management solution should be able to handle this two-way communication to keep your Processes Running Smoothly.
Quality system data may also need to be leveraged with third-party systems that reside outside of your four walls (or your cloud). Complaint data for electronic medical device reporting (eMDR), for example, needs to be extracted, sent through the FDA’s gateway, and updated when acknowledgements are received.
Keeping Tabs on Users – Active Directory Integration
As employees join, leave, or change their status within the company, their user information needs to be updated. For larger companies, this can lead to spending a significant amount of time updating information in each affected business system. Many organizations use a solution like Active Directory to manage users at the network/organization level.
Integrating with Active Directory enables you to automatically populate and update user data from your Active Directory system and synchronize it with your quality system. User changes to the Active Directory, including additions, deletions, and modifications, are automatically updated in the quality system as additions, de-activations, or updates. Additionally, an Active Directory Utility (ADU) should keep data safe by disabling quality system logon privileges for users who have been deleted from the Active Directory.
Staying Aware of Complaints
Customer data, especially customer complaints, may be stored in a number of systems throughout your business. Also, it’s possible that complaints can originate from a number of sources outside of the Quality and Regulatory groups including the company website, Customer Relationship Management (CRM) system, or other field and legacy systems. When it comes to complaints, consider extending your QMS by:
- Enabling a quality portal to receive complaints from field personnel or members of your extended value chain, such as doctors. A secure portal can then interact with your quality system to create and route incoming cases properly.
- Creating cases within the quality system when a case is created in the CRM (Salesforce, etc.).
- Closing the case in the CRM when the case is closed in the quality system.
- Extracting QMS data for complaint-related electronic submissions to the FDA.
Linking to Updated Documents
In previous posts, we’ve discussed the path to an enterprise-grade quality management system. Often times, the path begins by automating a single process, such as document management. There are numerous document management systems on the market today. However, many of these systems are focused on document organization rather than quality and compliance. But it is still possible to integrate your QMS with these external systems. If you already have a document management system but are expanding your quality system to additional processes, consider a quality management solution that can:
- Integrate with your existing document management system to generate a list of documents that a user or team needs to be trained on.
- Link corrective and preventive action (CAPA) records, complaints, audits, or other quality records to the most current version of a document that is stored in a third-party system to provide work instruction or other relevant documents.
- Update document records and links within the quality system when a document is revised within a third-party document management system.
- Allow document viewing through hyperlinks.
Integrating quality processes with other business systems is key to advancing your quality maturity, and ultimately increasing the value of quality to your organization. Automating these integration points above will help you reduce error, keep processes running smoothly, and build a consistent language for reporting beyond the quality team.
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