Pre-Launch Control Plan Contents - What should I include?

V

VALERIE548

#1
Pre-Launch Control Plans

Can anybody help me?
I have no idea what I am s'posed to include in a pre-launch control plan...we don't do prototype control plans. What all goes into the pre-launch???

I'm distressed!!!
 
Elsmar Forum Sponsor
A
#3
Actually, it is really that bad at all.

During my training classes and, more importantly, based upon feedback from the customer, I have learned the following:

1) The CUSTOMER wants to see a difference between the pre-launch and production control plans ---> specifically, more frequent inspections at the standard points of inspection, and, as applicable, more areas inspected. (Depending upon your business, there may be different processes and the like...)

2) The understanding is, once the "bugs" have been worked out of the process, the production control plan MAY show scaled back inspections (less frequency or smaller samples), or the elimination of non-value added processes, inspections, etc.

That is a basic starting point. The philosophy being that, during the "pre-launch" phase, you are doing more checking, more scrutiny, and perhaps trying different things. At the "production" phase, you have the core process pretty much honed to where the above mentioned items MAY be reduced, changed, and/or new implementation for production.

ALM
 
L

Lassitude

#4
To add to ALM's reply, I often see where the initial (prototype) control plan is the same as the production control plan so there is no set rule. I have watched several registrations where thia was the case and it was not argued after the reason was explained to the auditor.

As ALM says - it's not a big deal when you understand it.
 
A
#5
Lassitude -> so true. In my business we don't have prototype situations. Our pre-launch and production plans are "operationally" the same (that is... the process for making product is typically the same from pre-launch to production), but the frequency and sample size of inspections are higher for the pre-launch. We may also check out some areas in the pre-launch that may not require a second-glance during production.

Keep in mind, though, it does all depend on what you are making/what your business is.

ALM
 
Thread starter Similar threads Forum Replies Date
J Are the Pre-Launch Control Plan and Pre-Launch PFMEA obligatory? FMEA and Control Plans 3
Q How Many Control Plans Needed? Prototype, Pre-launch and Production? FMEA and Control Plans 3
B GM GP-12 Pre-Launch - They asking for a I chart Statistical Analysis Tools, Techniques and SPC 2
J The difference between Safe Launch and Pre-Launch? FMEA and Control Plans 4
J Which will be the differences between PFMEA and Pre-Launch PFMEA? FMEA and Control Plans 4
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
H Queries: RFD & Pre-RFD Program Medical Device and FDA Regulations and Standards News 0
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
R Gauge R&R on pre-set torque wrench Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Pre-Production Capability Assesment Reliability Analysis - Predictions, Testing and Standards 5
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 0
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
J Pre-clinical Studies for RUO Product Other Medical Device Regulations World-Wide 1
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
D Redacted pre-submission bundle that you would be willing to share US Food and Drug Administration (FDA) 3
I Bench Testing & Pre-verification vs. Formal verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
A Users won't return devices from pre-CE performance evaluation study EU Medical Device Regulations 3
GoSpeedRacer Pre-Work and Study for ISO 13485:2016 Lead Auditor Class ISO 13485:2016 - Medical Device Quality Management Systems 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Writing a Pre-Submission to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 44
P EASA STC (Supplemental Type Certificate) on a Pre-mod FAA STC Configuration EASA and JAA Aviation Standards and Requirements 1
H Pre compliance test for Glucometer Other Medical Device and Orthopedic Related Topics 1
V Pre-dispensed API material received in predetermined quantities & given to production Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Is pre-conditioning supplier component before incoming inspection tests allowed? Quality Manager and Management Related Issues 16
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q FDA Consensus Standard for PMA (Pre-Market Approval) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
V 510(K) Cyber Security Documentation for Pre-market Submission (Templates) Other US Medical Device Regulations 6
A Infusion Pump - Pre-Clearance Inspections Learnings US Food and Drug Administration (FDA) 4
Crimpshrine13 ISO/TS 16949 Pre-Audit Requirement IATF 16949 - Automotive Quality Systems Standard 18
Marc USA to insist on pre-flight mobe power probe Travel - Hotels, Motels, Planes and Trains 3
G 510(k) Pre-market approval Application Requirements - Effectiveness of the product Other US Medical Device Regulations 1
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
D Pre-Design Verification - Using Continuous / Variables Data Statistical Analysis Tools, Techniques and SPC 2
A Pre-clinical Animal Studies for long term implantable medical devices EU Medical Device Regulations 5
V Should template/formats be pre configured to claim 21 CFR part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 5
M Ownership of Pre-Clinical cGMP Stability Testing Other Medical Device and Orthopedic Related Topics 2

Similar threads

Top Bottom