Monitoring Specific Reasons and Categories of Yield Loss of Online Rejects

v9991

Trusted Information Resource
#1
most of our SOPs identify the categories of online rejects; (used for training purposes)
the question is, should these categories/reasons for yield loss be captured in BMR, which can be later used for tracking & trending the process performance.?
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
I presume when you say BMR, its "Batch Manufacturing Record", right ?

For the tracking and trending of online rejects and documenting in Batch Manufacturing Records, there isnt any hard and fast rule and either way is fine.

But my preference would be that QA Dept should monitor it offline each batch and use it as an agenda item in Monthly Meetings and a tool for yield improvement.
 
Thread starter Similar threads Forum Replies Date
D Customer Specific Requirements - Does anyone use a web crawler for monitoring these? Customer and Company Specific Requirements 5
J Need a contract monitoring Tool General Information Resources 0
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
K Monitoring the identified side-effects and contraindications ISO 14971 - Medical Device Risk Management 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
E Insulation diagram for ECG monitoring and diagnosis system. IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S HIPAA-compliant monitoring software (advice needed) Hospitals, Clinics & other Health Care Providers 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
CPhelan Best metrics for monitoring low volume (<1000) parts per vendors Supply Chain Security Management Systems 1
qualprod Monitoring of lead time - Good KPI identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
A How to set up Continuous CpK monitoring of an injection mold process Reliability Analysis - Predictions, Testing and Standards 7
P IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Textiles needed for home monitoring device - any suggestions? Other Medical Device Related Standards 1
G Problem Resolution Report Monitoring - Customer complaint or PRR as general motors use Customer Complaints 12
E ISO 13485 7.6 Control of monitoring and measuring equipment - Assess the Validity ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
Q AS9120B - ESD monitoring devices part of 7.1.5 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
P IATF 16949 - Monitoring Suppliers for Premium Freight IATF 16949 - Automotive Quality Systems Standard 12
qualprod ISO 9001 Clause 9.1 - Monitoring measurement analysis and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 13485 8.2.5. Monitoring and measurement of quality management system processes ISO 13485:2016 - Medical Device Quality Management Systems 1
A Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
chris1price Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment Other Medical Device Related Standards 3
dhuot1990 Issues with REES Environmental Monitoring System Manufacturing and Related Processes 1
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
I FDA requirement for 0.5 and 5 micron particle monitoring US Food and Drug Administration (FDA) 0
qualprod Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc New Posts and New Threads - Monitoring (aka "Watching") Elsmar Xenforo Forum Software Instructions and Help 1
L Monitoring transmitted data from a bluetooth medical product IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
T How to plan the monitoring of suppliers ISO 13485:2016 - Medical Device Quality Management Systems 1
M CQI-9 monitoring of temperature in die Various Other Specifications, Standards, and related Requirements 2
qualprod ISO 9001:2015 Cl. 4.1 and 4.2 - Evidences for Monitoring ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G IATF 9.1.1.1 Monitoring and Measurement of Manufacturing Processes IATF 16949 - Automotive Quality Systems Standard 5
qualprod ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Supplier monitoring - The meaning of "8.4.2.4 " Customer disruptions IATF 16949 - Automotive Quality Systems Standard 1
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
E IATF 16949 Cl. 9.1.2 - Monitoring Process Performance IATF 16949 - Automotive Quality Systems Standard 1
C Method of Monitoring our Internally Produced Non-Conforming Products Quality Tools, Improvement and Analysis 7
B IATF 16949 Section Clause 8.3.4.1 - Monitoring - Design and Development Input(s) IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom