RCA (Request for Corrective Action) on an Information Transaction Process

#1
Dear coves

During one of the CAPA investigations, I have taken over a task to identify RCA statements. My plan is to analyze the defect data, create the process map and work flow of the activities supporting the process, come up with a list of hypothesis and then test them to prove the root causes.

I will like to get coves opinion on this method and have a discussion on how to create a process map.

The idea is to only process map the steps where the defect can occur and replicate it. can some one please advise if this is going on the right track ?
 
Elsmar Forum Sponsor

Stijloor

Leader
Super Moderator
#2
Dear coves

During one of the CAPA investigations, I have taken over a task to identify RCA statements. My plan is to analyze the defect data, create the process map and work flow of the activities supporting the process, come up with a list of hypothesis and then test them to prove the root causes.

I will like to get coves opinion on this method and have a discussion on how to create a process map.

The idea is to only process map the steps where the defect can occur and replicate it. can some one please advise if this is going on the right track ?
Can someone help with this?

Thank you!!

Stijloor.
 
S

ssz102

#3
firstly,i think that you should collect some records from previous defect and customer complaints and other relate to quality;
then, you analysis it in according with acquire infor to find the mainly defect to improvement or call QCC activities
 
Thread starter Similar threads Forum Replies Date
C RCA - Internal Audit Request for Corrective Action ambiguity Internal Auditing 4
J RCA (Request for Corrective Action) Instructions or Guidelines Nonconformance and Corrective Action 8
Vader22 5 Why RCA for failure to test Contingency Plan IATF 16949 - Automotive Quality Systems Standard 9
normhowe Why is RCA essential? Problem Solving, Root Cause Fault and Failure Analysis 19
drgnrider Corrective Action for not meeting target-RCA obvious ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S RCA examples for Finance Problem Solving, Root Cause Fault and Failure Analysis 3
GStough Is "Did Not Follow Procedures" Sufficient for RCA? Problem Solving, Root Cause Fault and Failure Analysis 30
A Who should be the CAR owner & Who is involved with RCA, CAPA plan & CAPA evaluation? Nonconformance and Corrective Action 3
Ajit Basrur RCA Training by 8D approach - Ideas appreciated :) Problem Solving, Root Cause Fault and Failure Analysis 18
A Root Cause Analysis - Whether one can do RCA for Positive Findings Problem Solving, Root Cause Fault and Failure Analysis 19
V Integrating the FMEA process with problem investigation/RCA process and PFMEA FMEA and Control Plans 11
Q Can any one help me on RCA (Root Cause Analysis) Problem Solving, Root Cause Fault and Failure Analysis 9
C Training for RCA - Root Cause Failure Analysis Problem Solving, Root Cause Fault and Failure Analysis 9
J How I Was Pushed Into RCA Coffee Break and Water Cooler Discussions 4
S Standardization of Problem Solving - 6 Sigma, Red-X, 8D, VA/VE, PDCA, RCA, C&E Quality Tools, Improvement and Analysis 15
A What specific Quality "Must have's" would you like included in a Request For Quotation? Customer and Company Specific Requirements 3
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
H Ever given an Operations Manager an internal Corrective Action Request? Nonconformance and Corrective Action 5
G Notified body quotation request ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
somashekar Stage 1 Finding. Request views and comments ISO 13485:2016 - Medical Device Quality Management Systems 3
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
M Resume Review Request - Quality Assurance Career and Occupation Discussions 11
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 4
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
Q Request Calibration Info Calibration and Metrology Software and Hardware 16
J Drawing Example Request: Inspection Section Plane of Aluminum Casting Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
M Pre-Sub preparation (for de Novo request) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Supplier not responding to PPAP request APQP and PPAP 5
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
E Annual PPAP+ deviation request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Medical Device and FDA Regulations and Standards News 2
T NAFTA request for form with no part numbers showing Supply Chain Security Management Systems 0
R IATF Exemption Request Letter IATF 16949 - Automotive Quality Systems Standard 0
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
C Supplier blowing off CAR request Registrars and Notified Bodies 14
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
D IMDS for machining - Can my customer request a IMDS number for a part? APQP and PPAP 2
E CAR (Corrective Action Request) Due Dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom