Tech, ExplainedEnterprise SaaS and software
Product

Quality management system (QMS)

Proving to auditors you followed the rules.

BEFORE ITAFTER ITQuality managementsystem (QMS)IdeagenSmart Food SafeJ. J. Keller & AssociatesPARTFood traceability+COVERSNon-conformanceCAPAAudit scheduleDocument controlCoordinate measuringmachine (CMM)↗ INDUSTRIAL AUTOMATIONsends failedmeasurementsLeak testing↗ INDUSTRIAL AUTOMATIONsends failedleak testsupdatesmachinechecklistsManufacturing executionsystem (MES)↗ INDUSTRIAL AUTOMATIONsends auditfindingsGRC platform↗ GOVERNANCE, RISKAND COMPLIANCEBEFORE ITAFTER ITQuality managementsystem (QMS)IdeagenSmart Food SafeJ. J. Keller & AssociatesPARTFood traceability+COVERSNon-conformanceCAPAAudit scheduleDocumentcontrolCoordinatemeasuringmachine (CMM)↗ INDUSTRIALAUTOMATIONsends failedmeasurementsLeak testing↗ INDUSTRIALAUTOMATIONsends failedleak testsupdatesmachinechecklistsManufacturingexecutionsystem (MES)↗ INDUSTRIALAUTOMATIONsends auditfindingsGRC platform↗ GOVERNANCE, RISKAND COMPLIANCEBEFORE ITCoordinate measuring machine (CMM)↗ INDUSTRIAL AUTOMATION↓ sends failed measurementsLeak testing↗ INDUSTRIAL AUTOMATION↓ sends failed leak testsQuality management system (QMS)IdeagenSmart Food SafeJ. J. Keller & AssociatesFood traceability+Non-conformanceCAPAAudit scheduleDocument controlAFTER IT↓ updates machine checklistsManufacturing execution system (MES)↗ INDUSTRIAL AUTOMATION↓ sends audit findingsGRC platform↗ GOVERNANCE, RISK AND COMPLIANCE
The quality management system receives failed measurements and failed leak tests, runs each problem through investigation and corrective action, and sends updated checklists to the MES and audit findings to the GRC platform.
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A quality management system (QMS) is software that records how a company controls the quality and safety of its work, so that it can show auditors and customers that it followed its own rules and the rules of its industry. It holds the company's procedures, its audit findings, its defects and the corrections that followed. Strictly, QMS is the name of the system of rules itself, and the software keeps its records.

Regulated industries must prove good work, not only do it. An aircraft parts maker, a hospital, a food factory and a car parts supplier are all audited regularly. The auditor may come from a customer, a certification body or a regulator. Many companies follow ISO 9001, the international standard for quality management. Aerospace suppliers follow a stricter version called AS9100. The auditor asks three questions. What is your procedure? Did you follow it? What did you do when something went wrong?

The core of the software is a loop. A problem is recorded as a non-conformance, a finding that something did not meet its requirement. Someone investigates the root cause, the real reason it happened. A corrective and preventive action (CAPA) is planned, and assigned to a person with a deadline. Later, someone checks that the action worked. Every step is signed and dated.

Take, for example, a precision machining company in Belagavi that makes aluminium brackets for aircraft seats. An inspector checks a batch of 500 brackets on a coordinate measuring machine (CMM). 14 brackets have a hole drilled 0.05 mm out of position. The inspector records a non-conformance in the QMS, and the 14 brackets are set aside. The investigation finds that a drill bit was used beyond its working life. The CAPA says: change the drill bit every 2,000 holes, and add this to the machine's checklist in the manufacturing execution system (MES). A month later, the quality engineer checks the next three batches and closes the CAPA. When the customer's auditor visits, she can see the whole record in a few minutes.

The software also schedules internal audits, keeps the latest version of each procedure and records which staff have been trained on it. Safety incidents at the plant, such as an injury, are often recorded in EHS software, which covers environment, health and safety. Drug makers use a stricter version, the QMS for pharma. Airlines and repair shops record aircraft maintenance in aviation MRO software. A food maker adds food traceability. The company's wider list of risks and controls is kept in its GRC platform.

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