SBS - The Best Value in QMS software

Test Design Exclusion

J

Jimmy Olson

#1
Test Design

Howdy everyone. I have yet another question related to design.

We are looking at all aspectsd before claiming an exclusion for design and development. Our customers are responsible for designing the products and we manufacture them. The question I have is related to product testing. Usually the test procedures are provided by the customers, but sometimes they're not and we have to develop the test procedure. If the procedure is based on the specifications and requirements the customer provides, can we still claim exclusion?

I hope this question makes sense. Let me know if you need more information. :)
 
Last edited by a moderator:
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Your position should remain that you do not design a product per se.

You cooperate with the customer in test planning but the 'design' of the test is not applicable in the same way design of the product is. If that were NOT true, almost everything could be technically classified as a design. 'Your' test design is tangental to the product design and you do it in consenance with your customer.

However, it sounds as you may be speaking design of validation tests in which case I would classify you as a part of their design process. It might be that they should be addressing the issue in their system as well.

I'm currently putting together what is actually design testing to set a specification limit for a customer part for a client. My client does not do design work. Technically the customer has asked for help. We won't change the scope of the registration to include design just because my client helps a customer by designing a test which will set a specification limit and one that will be used during production once the specification is set.

Yup - you should be able to stay on the Design Excluded list in my opinion.
 
J

Jimmy Olson

#3
We do a couple different tests, but one test is a functional test (which would be a validation test I guess). We develop the test to determine the steps we need to do to make the product do what it's supposed to. Basically do step 1,2, and 3 and the light should come on.

The customer is the one that specifies that the light should come on as a function of the product and then says to test the product to make sure it works. Even though we develop the steps of the test, the required results are specified by the customer. I think we can still claim excluded, but I know this is kind of a gray area.
 
J

Jimmy Olson

#4
One other aspect that I forgot to mention is that we design a lot of our own test fixtures. This applies to tests that are provided by the customer as well as tests we develop.

Management really wants to exclude desgin and development and I want to make sure that we can instead of having something come back and bite us in the :ca: :p
 
Thread starter Similar threads Forum Replies Date
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
J Is Design Validation required for fixtures or test systems used to manufacture a product? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K Minitab Lack-of-Fit Test in DOE (Design of Experiments) Using Minitab Software 4
C Performance Test Results - for TESTS or for REQUIREMENTS specifiied in Design Record? APQP and PPAP 3
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Checklist for RA and QA Review of DVT (design verification test) for Software Other US Medical Device Regulations 2
A Dial Test Indicator Design & Operation when Approach Angle is Different General Measurement Device and Calibration Topics 5
T Is a Design and Development Plan required for Test Items? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F Medical Device Cleaning Lifecycle test - Developing a Design Verification Spec Other Medical Device and Orthopedic Related Topics 2
D Beta > 1 for new design? Durability test for a new system and no previous test data Reliability Analysis - Predictions, Testing and Standards 1
T Need to design a test to measure inspection effectiveness Design and Development of Products and Processes 9
P DOE (Design of Experiments) or Hypothesis test? Applicability and use of each? Six Sigma 6
N Test plan of Design Validation Plan and Report (DVP & R) Design and Development of Products and Processes 7
C Calibration process study help needed - Have I have selected a correct test design? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
L MSA application to Continuous Conformance and Design Engineering Test Laboratories Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P Burst Test Acceptability Criteria ISO 13485:2016 - Medical Device Quality Management Systems 2
A 60601-1 clause 8.11.3.6 Test Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Secondary Circuits, Voltage Test and Clearance/Creepage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Fogging test as per DIN 75201(50ug/g ) VDA Standards - Germany's Automotive Standards 3
R HV Test of HF Surgical Unit IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E 60950-1 resistance to abnormal heat test Various Other Specifications, Standards, and related Requirements 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9

Similar threads

Top Bottom