SBS - The Best Value in QMS software

Internal transfer of work from one line to another?

F

FloridaST

Involved In Discussions
#1
#1
Good morning everybody, I have a quick question regarding the best way to handle transferring a medical product (board assembly, not a finished device), from one SMT line to another SMT line. We are a contract manufacturer and we need to move a pcb assembly from SMT line 1 to line 2 in order to free up manufacturing resources. Both lines have had IQ OQ PQ performed and both lines are currently in use.

Would performing only a FAI be sufficient to validate that the line change is able to produce products that meet requirements?

Wanted other opinions before I make a decision. Thanks!
 
Elsmar Forum Sponsor
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
#2
Good day FloridaST, I am sorry for the delay in this response.

Unless your customer states otherwise, I would say yes, but with a note that the FAI should have multiple parts and also include a functional test if you do that.
 
John Predmore

John Predmore

Trusted Information Resource
#3
#3
IMO your customer is the one to answer that question. They have a stake in the consequences if something unpredicted happens. One extra measure they might ask, or you might offer, is enhanced traceability by serial number or other method, even segregation of PCBs that deviate from the normal process flow until the quality data for the entire lot can be examined, rather than a first article piece or a small sample .
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 24
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 7
T How to conduct combined internal audits (9001 and 13485) Internal Auditing 1
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 6
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 1
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Thee Bouyyy Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 9
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 15
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
V Internal Auditor Competency KPI IATF 16949 - Automotive Quality Systems Standard 15
J ISMS - Internal Audits Internal Auditing 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
S ISO 9001:2015 Internal Auditing Internal Auditing 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
salaheddine96 Internal audit planning Internal Auditing 2
D CB and customer audits considered as internal audits? General Auditing Discussions 9
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
R IATF 16949 - Outsourcing of internal audits Internal Auditing 11
M Major vs. Minor for Internal Audits? Internal Auditing 10
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
C Internal Audits in a tiny Dx Company Internal Auditing 33
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6

Similar threads

Top Bottom