QMS Records
A quality management system is built on two kinds of controlled content.
The first is the set of documents that describe how work should be done. These are the procedures, work instructions, and templates that define your processes.
The second is the evidence that the work was actually carried out as described. QMS Records is where that evidence lives.
Where a document is the prescription, a record is the proof. A procedure might state how a risk assessment is performed. The completed risk management plan that results from following it is a record. A template defines the structure of a CAPA log, and each completed log is a record.
Records are what demonstrate, after the fact, that your organization does what its documents say it does. They are also what an auditor asks to see.
Keeping records inside the QMS, rather than scattered across personal drives and mailboxes, solves several problems at once.
Every record has a defined home, so there is no ambiguity about where a completed document belongs or who is responsible for reviewing and approving it.
Because a record can be created directly from a template, it inherits that template's classification and routing automatically. The system already knows the record type, the category it falls under, and who needs to review and sign it. This removes one of the most common sources of confusion in everyday quality work, which is having a finished document but no clear idea of where to file it or whom to send it to.
Records also follow a controlled path from draft to official. Anyone can create a record and work on it privately before it is ready to be shared.
Once it is complete, it is published into QMS Records, where it becomes accessible to the wider organization. It is then released through a review, approval, and electronic signature process. This ensures that no record becomes official without the right people having reviewed and formally approved it.
Records are organized into categories and subcategories, and each record is assigned a type. Technical documentation is a specialized type of record. It is filed alongside general QMS records, so that evidence relating to a product sits within the same controlled structure as everything else.
