The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Click the graphic above.
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  #1  
Old 16th May 2007, 02:44 PM
Rick St Rick St is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Dec 2001
Location: MN
 
Posts: 7
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 52
Karma: 10
Rick St has less than 100 Karma points so far.
Please Help! Validation protocol for a crimped contact on a stranded wire

Does anyone have an example of a validation protocol for a crimped contact (one that is crimped to a stranded wire??

Last edited by ScottK; 16th May 2007 at 03:07 PM. Reason: Clarifying title of thread

Sponsored Links
  #2  
Old 16th May 2007, 03:08 PM
ScottK's Avatar
ScottK ScottK is offline
Not out of the crisis

 
Registration Date: Apr 2006
Location: Butler, NJ
 
Posts: 2,513
Thanks Given to Others: 175
Thanked 672 Times in 488 Posts
Karma Power: 295
Karma: 5384
ScottK is appreciated, and has over 1700 Karma points.
ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.ScottK is appreciated, and has over 1700 Karma points.
Re: Validation protocol for a crimped contact

Quote:
In Reply to Parent Post by Rick St View Post

Does anyone have an example of a validation protocol for a crimped contact (one that is crimped to a stranded wire??
Rick St - I clarified the title to make it easier for searches and to jump out at people with significant validation experience.

__________________

Time for a new sig line.
My LinkedIn Profile
Sponsored Links

  #3  
Old 16th May 2007, 03:25 PM
Benjamin28 Benjamin28 is offline
Inactive Registered Visitor

 
Registration Date: Dec 2006
Location: CT
 
Posts: 379
Thanks Given to Others: 89
Thanked 161 Times in 109 Posts
Karma Power: 69
Karma: 982
Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.Benjamin28 is appreciated, and has over 900 Karma points.
Re: Validation protocol for a crimped contact

Don't know if this would be applicable to what you're looking for....

http://engineers.ihs.com/news/2006/a...imped-wire.htm
  #4  
Old 16th May 2007, 04:24 PM
Rick St Rick St is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Dec 2001
Location: MN
 
Posts: 7
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 52
Karma: 10
Rick St has less than 100 Karma points so far.
Re: Validation protocol for a crimped contact

These generally just recommend standard QA process controls (crimp height/tensile test/visual crimp attributes). What I need is an "OQ" and "PQ" protocol that defines sample size, methodology, etc. for the validation.

My thought at this point is to make it an attribute test with crimp height and tensile requirements. Essentially, we would have to run and OQ of a certain sample size at the upper and lower crimp height specs and use a minimum tensile strength as the pass/fail definition. I realize that both crimp height and tensile are variables data, but I would prefer not to have to deal with the assumtion of normal distribution for both of these. Making it an attribute type test allows me to define sample size based upon confidence limits and the number of defects allowed (we would use 0).
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Preparation for Product Validation Protocol ctct61t ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 6 10th August 2011 05:04 AM
Tablet De-Duster Cleaning Validation Protocol Help erniel Manufacturing and Related Processes 4 27th August 2010 10:14 AM
Electronic Signature Validation Protocol example or template jostell13 Qualification and Validation (including 21 CFR Part 11) 2 9th July 2009 09:50 AM
Pharmaceutical & Validation Protocol Listings? suziwann Qualification and Validation (including 21 CFR Part 11) 16 6th May 2007 05:59 PM
Validation Protocol for a paperless system? steend Records and Data - Quality, Legal and Other Evidence 6 13th May 2005 12:40 PM



The time now is 12:59 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272