What does DMR mean in manufacturing?
DEVICE MASTER RECORD
A DEVICE MASTER RECORD (DMR) CONTAINS ALL OF THE INFORMATION AND SPECIFICATIONS NEEDED TO PRODUCE A MEDICAL DEVICE FROM START TO FINISH, INCLUDING INSTRUCTIONS FOR ALL MANUFACTURING PROCESSES, DRAWINGS, DOCUMENTED SPECIFICATIONS AND LABELING AND PACKAGING REQUIREMENTS.
What is non conforming material report?
A Non-Conforming Material Report or NCMR is the standard way to report a material that does not meet the predetermined specifications identified during an inspection. This inspection can occur during receiving, manufacturing, in-process, or final inspection.
What does discrepant material mean?
A discrepant material report, or DMR, is used to report nonconforming material. It indicates that a manufacturer should perform a corrective action preventive action (CAPA) to resolve the situation. The report is useful for launching deviations and submitting supplier corrective action requests (SCARs).
What is NCR in quality control?
NCR REPORTS. The quality issues observed in construction practices are addressed in a report called the non-conformance report or the non-conformity report (NCR). An NCR explains the deviation of a specific construction work or task from the required standards and specifications.
What is NCR in audit?
Non-conformance reporting (NCR) provides a wide range of benefits to quality management. Nonconformities are an integral component in the auditing of the processes within your organization. Internal audit reports can identify non-conformance issues and provide procedures for documenting and correcting them.
What is discrepant mean?
being at variance : disagreeing
Definition of discrepant : being at variance : disagreeing widely discrepant conclusions.
How do you use discrepant?
These findings are discrepant with data from several other studies. The plot cleverly brings initially discrepant stories into accord. Had he studied the read-out carefully, he would have noticed the discrepant address and birth date.
What is DHF remediation?
DHF remediation is a process of making all the Design Control/DHF elements to be compliant with the regulation 21 CFR Part 820, and the global international standard ISO 13485:2003/ISO 13485:2016. Design Verification is one of the prime/important element in the DHF.
What is DMR in ISO?
A Device Master Record (DMR) is a document that contains the details necessary in order to build and test a device. DMR is mentioned in 21 CFR Part 820.40.
What is NC in quality?
Non conformance (NC) is an ISO 9000 audit designation indicating the quality management system or a portion of it does not meet the requirements established by ISO 9000.
What is CAPA and scar?
Business Challenge Key Features Business Benefits. SupplierSoft provides a comprehensive non-conformance and CAPA/SCAR Management solution that enables companies to streamline their corrective action processes and drive continuous improvements.