List Error Proofing in the Process FMEA or the Control Plan

C

cavrdave

#1
We are using a shadow boards for kitting many parts at each of the many work stations. The customer wants me to list this as "Error Proofing" but she list this issue under her pfmea complaints for the same ppap and not the control plan portion of the ppap. I'm leaning toward that she made a mistake and that ERROR PROOFING goes into the CONTROL PLAN portions of the PPAP. Since it is about Control. Thanks for all your input. Much appreciated.
 
Elsmar Forum Sponsor
G

gbcqc

#2
Re: ERROR PROOFING: list it in the pfmea or control plan

I agree with you that it would go in the control plan, but I would also use it to see how it would affect my RPN in the PFMEA and could mention it as a reason for lowering the occurance score. Just my opinion.
 

Jim Wynne

Leader
Admin
#3
We are using a shadow boards for kitting many parts at each of the many work stations. The customer wants me to list this as "Error Proofing" but she list this issue under her pfmea complaints for the same ppap and not the control plan portion of the ppap. I'm leaning toward that she made a mistake and that ERROR PROOFING goes into the CONTROL PLAN portions of the PPAP. Since it is about Control. Thanks for all your input. Much appreciated.
There are "Current Process Control" columns on the PFMEA form (one for prevention controls and one for detection controls). You are describing a current process control. It should be on both the PFMEA and the control plan.
 
Thread starter Similar threads Forum Replies Date
G Root cause for outsourced pest control service not in approved supplier list ISO 13485:2016 - Medical Device Quality Management Systems 4
Pmarszal Technical File - Critical Supplier List Questions CE Marking (Conformité Européene) / CB Scheme 2
Quality Specialist AS9100D Approved Supplier List requirements and how to apply Supplier Quality Assurance and other Supplier Issues 11
R Customer Listed on Approved Supplier List (ASL) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
G Codes for forms, check list and labels. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
G Control of Approved Supplier List (ASL) When Employees Make Purchases Supplier Quality Assurance and other Supplier Issues 6
A How to control distribution list? Document Control Systems, Procedures, Forms and Templates 2
A GAGE R&R Binomial with master list (for method validation) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
M List of FAA Part 145 Repair Stations in MS Excel format? Federal Aviation Administration (FAA) Standards and Requirements 0
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Management review check-list Management Review Meetings and related Processes 3
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
R Qualification list of businesses approved to Off-Shore Aerospace work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 10
D List A IVD - Change to material supplier EU Medical Device Regulations 3
M Sites to List on Multi-Site Certifications Registrars and Notified Bodies 1
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Forms Master List versus Record Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
K List of Deregulated Devices in Mexico Other Medical Device Regulations World-Wide 2
G Harmonized List - MDD 93/42/EEC Other ISO and International Standards and European Regulations 2
M EU – REACH Authorisation Decisions List REACH and RoHS Conversations 0
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 1
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
M Informational EU – Candidate List of substances of very high concern for Authorisation Medical Device and FDA Regulations and Standards News 0
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
P List of ISO certificate registrars around the world - ISO certification databases ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Informational US FDA – Priority List of Patient Preference-Sensitive Areas Medical Device and FDA Regulations and Standards News 0
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 10
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
R List of countries that require only CE Mark certificate for product registration Various Other Specifications, Standards, and related Requirements 4
T Medical device Clinical trial exemption list China Medical Device Regulations 2

Similar threads

Top Bottom