CNC OTS Software Validation Separate from full IQ/OQ/PQ for 21CFR Part 820

rogersr12

Starting to get Involved
#1
Hello,

I've recently started at a medical device company in RA and the FDA came in around the same time. During the inspection, an inspector claimed that despite an adequate IQ/OQ/PQ for a new CNC machine (that did not specifically treat the internal software as a separate entity), our company should have validated the internal software separately.
The parts from the CNC machine are also 100% inspected, so between the formal qualification and 100% inspection, my first impression is that asking for a separate qualification for OTS software is overkill.
Is separate OTS software qualification typically required by the FDA? In my prior FDA inspections, I've never heard this claim.

Thanks in advance.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
I'm not so sure the reference Ajit cited is applicable here. The guidance is for COTS used _in_ medical devices. In the decision tree, the first question is "Does the device include OTS software?" and if the answer is no, you're done (with this guidance). (Ajit, if you have additional information that brings this guidance into scope for manufacturing / manufacturing support equipment software, please correct me.)

That said, I expect there is some merit behind the auditor's concern. Take a look at 820.70:

(i)Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.

I expect this is the basis of the finding.
 

sagai

Quite Involved in Discussions
#4
Agree it does not really.
The relevant one in case it is implicitly required by the investigation is:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

Recently I also have a consideration how IQ/OQ/PQ can be used for non product software validation, because it was told me that it could, but with your comment my initial impression looks to be proven, GAMP is a far only step by step guidance in our industry.

As long as someone persuades me differently :)
Sz.
 
J

JaxQC

#5
Could it be, from the auditors viewpoint, that the status of the CNC software was not explicitly addressed within the protocols? ie… I’ve addressed it by stating within the IQ that the CNC software (OEM machine control) is embedded and verified through the OQ software prove out (CNC part specific program written in-house) which is also revision controlled. The OQ then states exactly how the program will be verified (axis specific, dims, and checking methods).

All auditors are slightly different but they’ve all bought this ideology.
 

sagai

Quite Involved in Discussions
#6
I would greatly appreciate if someone could share also experience and advice with IQ/OQ/PQ based validation of non product sw in a FDA environment.
 

yodon

Staff member
Super Moderator
#7
I would greatly appreciate if someone could share also experience and advice with IQ/OQ/PQ based validation of non product sw in a FDA environment.
We've used the IQ/OQ/PQ model many times successfully for non-product software validation. I think it's a nice, clean way to organize the effort. Depending on the size and risk of the software, we may combine all aspects into a single document, but the basic model, for me, works quite well.
 
A

ahshah

#8
Understanding what is stated in Section 6.3 is key to effective and efficient follow-thru to what was questioned during the audit. Many documents have been written since this 2002 guideline by FDA, of which some are public domani and others are acquired via membership/subscription.
The key factors to consider in any VALIDATION approach:
* Least Burdensome Approach (meeting requirements while minimizing non-productive activity)
* Objective Evidence (to meet intended use requirement)
* Effective Risk Management (making processes better as a result of the validation process)
 

sagai

Quite Involved in Discussions
#9
One day, I would ask clarification/help on this topic, may others can benefit also.
Thank you,
Sz.
 
M

maxenix

#10
IMO,what the inspector claim is: the CNC machine's program (not from the CNC manufacture) , which used for made product, it controls the path of the CNC working, need to validated. Operator can rejust program to make different product, diffenrent product,different progam, so before lot production, you need to validate the program( also you can call it automated process software), so do not confuse it with the CNC machine's own software.
About validation methods, you can see the software validation guidance of FDA: section6 validation of automated process equipment and quality system software
 
Thread starter Similar threads Forum Replies Date
H FAI Requirement After Moving CNC Machine? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
validationspec How to Validate the Automated Processes (CNC Lathe and Milling)? ISO 13485:2016 - Medical Device Quality Management Systems 5
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
B IQ/OQ/PQ of CNC Milling Machine Qualification and Validation (including 21 CFR Part 11) 2
GreatNate Qualifying a CNC machine Manufacturing and Related Processes 3
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Machine Setup for a CNC Machine Capability Study Capability, Accuracy and Stability - Processes, Machines, etc. 1
R Process Validation on CNC Lathe and Milling machining process Design and Development of Products and Processes 1
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
S Need Continuous improvement Suggestions - Small (30 of us) all-CNC machine shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
A ISO 9001 Control of Production Equipment - CNC Machines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C O-Ring Groove Measurement Method in CNC Machined Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
D OQ, PQ Requirement for Aerospace? Recently purchased CNC AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S FMEA for CNC Manufacturing FMEA and Control Plans 9
J CNC Machine Tool Calibration - 6 dof Calibration Interferometers General Measurement Device and Calibration Topics 1
V Ultrasonic NDT on CNC Product made of Stainless Steel General Measurement Device and Calibration Topics 2
M AS9100 Control of CNC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Quality Assurance Plan template for CNC Milling Industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Control plan example format for CNC machining activities FMEA and Control Plans 3
H FMEA sample for complete CNC machining process FMEA and Control Plans 1
L Caliper Calibration Standards - One for CNC and one for Sheet Metal? General Measurement Device and Calibration Topics 9
C Equipment Qualification of a CNC Mill Center ISO 13485:2016 - Medical Device Quality Management Systems 5
P Internal Audit of CNC Programing Internal Auditing 3
S CNC Machining Process Validation for Prototypes ISO 13485:2016 - Medical Device Quality Management Systems 1
A Are CNC Program Backups Required by TS 16949? IATF 16949 - Automotive Quality Systems Standard 3
G Sampling Plan for Inspection of Metal Parts after CNC Machining Inspection, Prints (Drawings), Testing, Sampling and Related Topics 34
P Machine Shop Tool Crib Procedure - Tooling for CNC mills Quality Tools, Improvement and Analysis 1
bobdoering Capability of new CNC machines Capability, Accuracy and Stability - Processes, Machines, etc. 32
V CNC Probe Qualification and DME Interface General Measurement Device and Calibration Topics 4
B SPC Software Selection for use in a CNC Machine Shop - InfinityQS and Lighthouse Quality Assurance and Compliance Software Tools and Solutions 3
B CNC Machining Shop still heavily relies on First Piece and Final QC Inspection Manufacturing and Related Processes 5
A Engineering Production Skills Matrix for Assembly or CNC Machinists Management Review Meetings and related Processes 6
V CNC Process Validation Cpk Ppk & In-Process Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
S Receiver Gages vs. CNC CMM Checks Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
M Commercially available software solution for the control of our CNC programs. Records and Data - Quality, Legal and Other Evidence 3
E Error Proofing to prevent Length Short - CNC Turning Process Manufacturing and Related Processes 4
A Examples of a Scope Statement - CNC Machining, Sheet Metal Fabrication, Assembly ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Collecting SPC Data Electronically? CNC Lathes, CNC Mills and CNC Grinders Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Probe on CNC machine - Inspecting on cnc machine tools vs. CMM Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
R Verify Accuracy for Validation of CNC Starrett Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B SMED in a vertical CNC Lathe Workstation consisting of 3 similar machines Lean in Manufacturing and Service Industries 2
Q Operational Qualification of a CNC machine ISO 13485:2016 - Medical Device Quality Management Systems 4
P CNC machine validation for Contract Manufacturer of medical devices Qualification and Validation (including 21 CFR Part 11) 1
D In Process Inspection Frequency and Documentation - CNC lathe/mill work Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Machined Parts PFMEA - Example of a CNC produced part PFMEA wanted FMEA and Control Plans 1
N Lot Capability - Forging -> CNC Machining -> Heat treatment -> Packaging Statistical Analysis Tools, Techniques and SPC 3
M Calculating OEE Performance Measurement for a CNC Plasma Cutter Manufacturing and Related Processes 19
C CNC Machine Operational Qualification Recoverability Testing Other Medical Device and Orthopedic Related Topics 1
B Is a work instruction mandatory - CNC machine ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20

Similar threads

Top Bottom