Deviation in Design verification

Chef100

Involved In Discussions
#1
Hi all
I am in the Medical Device business and we are internally having a discussion regarding deviations in Design Verification tests.
You can do Design Verification on prototype items but by that you also say that you have a risk of a deviation which is related to the manufacturing process. How do you guys handled this?
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Your production controls should eliminate the likelihood of introducing deviations. That should be the whole idea behind design transfer: ensure that you can build what was designed and include the controls (in process and final acceptance) along the way to confirm you AREN'T deviating.

Note that while verification can be done on prototypes, validation needs to be done using "representative" product (13485) / "initial production units, lots, or batches, or their equivalent" (820).
 

Chef100

Involved In Discussions
#3
Your production controls should eliminate the likelihood of introducing deviations. That should be the whole idea behind design transfer: ensure that you can build what was designed and include the controls (in process and final acceptance) along the way to confirm you AREN'T deviating.

Note that while verification can be done on prototypes, validation needs to be done using "representative" product (13485) / "initial production units, lots, or batches, or their equivalent" (820).
I of cause agree, but the nature of prototypes is that you haven't validated your production process etc at the time the prototypes are produced. Why do final design transfer and validation if the Design verification reveals problems that should be adressed by design changes.
 

yodon

Leader
Super Moderator
#4
Maybe I'm misunderstanding. When you say "risk of a deviation which is related to the manufacturing process" are you talking about the manufacturing of the prototype or the manufacturing of final product?

The point I was trying to make is that once you work all the kinks out (prototyping, verifying, etc.) your production process controls are intended to reduce the risk of deviations in manufacturing.
 

Chef100

Involved In Discussions
#5
Maybe I'm misunderstanding. When you say "risk of a deviation which is related to the manufacturing process" are you talking about the manufacturing of the prototype or the manufacturing of final product?

The point I was trying to make is that once you work all the kinks out (prototyping, verifying, etc.) your production process controls are intended to reduce the risk of deviations in manufacturing.
I mean a risk of a deviation when you produce your prototypes for the DV.
 

yodon

Leader
Super Moderator
#6
At least in my experience, prototypes intended for DV are made with a considerable amount of care and go through a fair amount of check-out and so deviations are pretty unlikely. I guess you could elevate your check-out process, considering where your risks for deviation are.
 
#7
What kind of deviation are you talking about? Does the product still meet its design specifications? If you are building a prototype device and your manufacturing process is still being defined, you just need to ensure that you obtain approval for using the device for the verification test.

You can change a manufacturing process without affecting the design. It is difficult to know the situation from your description though. Sometimes the product is so fully dependent on the manufacturing process that you would not want to do DV prior to having controlled production.

If you do a design verification test, and it fails, indicating that you need to redesign your product or process, you correct the design or process and then repeat the design verification test(s). The records of the design review and any actions need to be captured in your design history file.
 
Thread starter Similar threads Forum Replies Date
W Can I use the o/p for a Design of Experiments as Standard Deviation of the flow? Design and Development of Products and Processes 4
CaliperJim Uncertainty and Accuracy Requirement Deviation Provision General Measurement Device and Calibration Topics 2
B Wrong standard deviation calculation in AIAG SPC manual? Capability, Accuracy and Stability - Processes, Machines, etc. 13
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S NC and Deviation approach - please help Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 12
L Product and process Deviation procedure Manufacturing and Related Processes 1
E Annual PPAP+ deviation request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P ECO Disposition - Deviation Needed for Use As Is? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Class Fixed ME Equipment (US Deviation) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
M Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
E IEC 60335-1 power input deviation - Table 1 Values Other ISO and International Standards and European Regulations 0
P Large data sets of continuous individual data - Estimated or actual deviation Capability, Accuracy and Stability - Processes, Machines, etc. 2
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S When should a note-to-file be used in a QMS vs Deviation Report ISO 13485:2016 - Medical Device Quality Management Systems 1
Coury Ferguson MiniTab 17 Question-Standard Deviation Default Capability, Accuracy and Stability - Processes, Machines, etc. 5
S When a deviation is opened but what does it mean to close a deviation? Misc. Quality Assurance and Business Systems Related Topics 1
K Please Help! what is ARL for the range and standard deviation Statistical Analysis Tools, Techniques and SPC 0
S Standard Deviation Selection on Control Charts - Minitab "pooled deviation" Statistical Analysis Tools, Techniques and SPC 3
T IATF 16949 - Customer Authorization for Concession or Deviation Permit IATF 16949 - Automotive Quality Systems Standard 22
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
V Looking for advice on Pooled Standard Deviation between Minitab and MS Excel Statistical Analysis Tools, Techniques and SPC 1
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 9
A How to calculate Mean and standard deviation without sample size in Minitab Using Minitab Software 5
knightarmourus Initial Samples with dimensional deviation in Serial Production Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Standard Deviation vs. Standard Deviation of the Mean (Standard Error) Measurement Uncertainty (MU) 7
B Historical Standard Deviation or Select Parts for MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
alonFAI AGILE PLM - Deviation - What is the "Assigned Owner" Field Quality Assurance and Compliance Software Tools and Solutions 3
F How to Calculate the unbiased Standard Deviation in Excel using Minitab Formula Capability, Accuracy and Stability - Processes, Machines, etc. 6
Chennaiite Can an Auditor question Top Management decision to approve deviation? IATF 16949 - Automotive Quality Systems Standard 30
C 95% CI vs Mean +/- sample standard deviation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G MS Excel for LSL, USL in Histogram and Standard Deviation Six Sigma 26
T Deviation/Waiver Requiring a Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
J EN ISO 14971:2012 Annex ZA Deviation #4 Clarification ISO 14971 - Medical Device Risk Management 3
J Annex ZA of ISO 14971:2012 - Deviation 7 - Incorrect Interpretation ISO 14971 - Medical Device Risk Management 10
K Marking Aerospace parts after concession/deviation & use as is dispositioning AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 30
E RSD (Relative Standard Deviation) Calculation for two series of numbers Statistical Analysis Tools, Techniques and SPC 4
somashekar Can Process Deviation be handled under control of Nonconforming Product? ISO 13485:2016 - Medical Device Quality Management Systems 2
S Definition Deviation and Nonconformity - What is difference? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Combining both Deviation and Non-Conformance Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Standard Deviation Estimation Formula - Student Question Statistical Analysis Tools, Techniques and SPC 4
M Using Minitab to Compute & Compare the Mean and Standard Deviation Amount Using Minitab Software 7
V PPAP to Customer with Deviation Request APQP and PPAP 4
B Corrective Action for Deviation (delay) in the Delivery Schedule Quality Manager and Management Related Issues 10
T Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Documenting Exceptions and use of Deviation Request Form APQP and PPAP 2
Q What is the relationship between Standard Deviation and 6 Sigma? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom