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Ron Rompen
22nd August 2017 03:34 PM
Customer Complaint Definition - Food Distributor
There seems (IMHO) to be a disconnect in the definition of 'customer'. Everyone is focusing on the end user as the customer - the way that it should be considered is that the customer is the NEXT... (101 views, 4 replies)
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22nd August 2017 03:32 PM
Corporate Services as Externally Provided Service
Unless the rules changed when the 5th edition was published, they have to be included as a remote supporting function for each of the certified manufacturing sites. (42 views, 1 replies)
New Post
22nd August 2017 11:54 AM
Qualification of a Temperature Controlled Unit have to be empty?
The very first place to start would be your written requirement for storage and a little time thinking about its application. Does the room require uniform temperature or is it acceptable to have... (75 views, 3 replies)
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Jen Kirley
22nd August 2017 11:43 AM
SWOT Outputs - Risks, Opportunities and Improvements
SpinDr99 has cracked the code! :applause: (180 views, 4 replies)
New Post
22nd August 2017 11:04 AM
Waste - Definition
A byproduct that is generated and which has to be disposed with or without any treatment. Apart from this there is wasted power, wasted time, wasted money, wasted resources, wasted manhours, wasted... (79 views, 3 replies)
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22nd August 2017 11:04 AM
IATF 16949 Cl. 8.6.6 - Acceptance Criteria - Zero Defects Attribute Data Sampling
I would say the intent of this requirement is for sampling of incoming, in-process, or final inspection of product. There are other requirements for PPAP and layouts. Of course anything you submit... (100 views, 2 replies)
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22nd August 2017 10:47 AM
IATF 16949 Cl. - Verification after Unplanned Shutdown
Why couldn't you use the set-up for planned shutdowns for the unplanned too? Is there a need to create a different process? (73 views, 1 replies)
New Post
22nd August 2017 10:42 AM
Demand Flow Technology vs. Lean Manufacturing - Same method with just another name?
Team DFT, I have deleted your last two posts. We are certainly appreciative of you contributing to the forums. However, self-promoting posts (posts primarily intended to promote/ sell a... (11,584 views, 9 replies)
New Post
22nd August 2017 10:30 AM
Documenting Self-Training and Effectiveness - ISO 13485:2016
I'm presuming the training form you mention is simply something that has the person's name and position, along with the training material/subject and date. If this presumption of mine is true, then... (90 views, 2 replies)
New Post
22nd August 2017 10:27 AM
Are Capability Requirement(s) Valid for All Characteristics?
Is there a standard that you're working to? Do you have customer requirements for this? (94 views, 1 replies)
New Post
22nd August 2017 08:44 AM
Software Validation Clause 4.1.6 of ISO 13485:2016
That is a really well written approach. thanks for the great advice! We have a lot of this information but formalizing it as an approach to meet the validation requirements is the link we were... (3,705 views, 9 replies)
New Post
22nd August 2017 08:34 AM
Medical Device Labeling - Order No. 6 Effective Oct 01, 2014
Yo QAengineer13, I would liked to and I can post links now,WHOOP! Here the labeling announcement: ???????????????????? ???????????????????? ?? Here the order no. 6:... (1,916 views, 7 replies)
New Post
22nd August 2017 07:24 AM
Label Expiration Date - Single Use Combination Medical Device
Yes, it is possible to buy additional capsules. (90 views, 2 replies)
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Bev D
22nd August 2017 06:35 AM
MSA on a process using different fixtures
Well it depends. Does the size at one phase effect the ability of subsequent phases to be completed or measure properly? Frankly given the importance of the blade to the system I would err on... (61 views, 1 replies)
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22nd August 2017 05:32 AM
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
Hi there, It is an injector pen containing a biologic drug. (70 views, 4 replies)
New Post
22nd August 2017 05:15 AM
ISO 9001:2015 - Required Processes and required Documented Processes
:applause: Thankyou so much :) should've known my mac would pick it straight away .. (266 views, 5 replies)
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22nd August 2017 05:13 AM
Adverse Event Reported during Non-Approved Indication Use
I definitely get your point and further arguing here if it's an abnormal use or not would lead us to far from the original topic :) Thank you for your time! (91 views, 4 replies)
New Post
22nd August 2017 12:46 AM
Short Term vs. Long Term SPC Study - Where is Cp and Cpk Defined
Thanks a lot Bev D for excellent tips and showing the path. This will really help. Thank you both for sharing. :applause: Thanks word is small as compared to the help, but don't how to thank you for... (219 views, 8 replies)

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