Retired equipment that was never validated

PeterLe

Involved In Discussions
#1
Our engineering group just recently retired a piece of equipment that was currently on our Master Validation Plan gap list. This piece of equipment was making product that never had the software validated. In addition, it was identified that the equipment also needed cleaning validation, which was never conducted. We do not plan on using this equipment again.

My question is from a compliance side, is there something we should do? For example a memo to file stating that the equipment made good product and it has no risk for both cleaning and software?

Also, this piece of equipment did have equipment qualification performed but neither cleaning or software validation was involved in that.

Any advice would be greatly appreciated! Thanks!
 
Elsmar Forum Sponsor

dubrizo

Involved In Discussions
#2
Hi Peter,

I would base this retrospective decision on risk.
-1st stop: Does your QMS give direction on this topic?
-Can you prove to your customer or an auditor that the product which touched that machine is built to Spec/Print and is in no way OOT?
-Are there other cases where validations have been missed or not completed per schedule. This includes software as well as hardware.
-What is your gut saying is the right thing to do in this situation? AKA, the smell test.

My $.02
 

PeterLe

Involved In Discussions
#3
Hi Dubrizo, I really appreciate your reply. I'll answer your questions below.

1) Our QMS does not give direction on this topic. The only direction is when retiring equipment, it must be calibrated before retirement. This has been completed.

2) The purpose of this equipment was to fill a chamber with solution and also seal the chamber. We do conduct pull testing on the seal on random samples. In addition, we do Bio-Burden testing on samples once a month. The data shows since conducting Bio-Burden testing, the equipment has never failed. We can provide that data if asked.

3) We have a massive gaps in our validation program (which we are addressing via a CAPA). So yes, we have plenty of instances of validation not complete. Luckily we do have a lot of downstream checks that check output. But we have many examples like the one I described above where we are just missing validations of software, cleaning, equipment, etc.

4) I'm being challenged by our engineering group because I responded that if an auditor were to look at the retired equipment and ask to see a software validation or a cleaning validation, we can't provide that. We can provide the equipment qualification was done on this equipment however. My gut is telling me a memo stating that this product was producing acceptable product is the right thing to do. But I have nothing to point to compliance wise to say that writing a memo stating this equipment produced good product through its lifetime. Seems like our engineering group is avoiding work they deem not value added (and I do understand where they are coming from).

To me, in an ideal world, we would at least have a memo stating this equipment produced good product by passing all seal tests and bio-burden testing. Hence the software was operating as designed and it produced clean product. But I'm not sure I can enforce this on our engineering group.

Now that I'm writing this out and based on above, I do believe the risk is actually low. However, there isn't documentation all in one place to retrieve, just in case an auditor were to ask. We can definitely pull the data but it would take some time.

Again, thank you for your helpful reply.
 
Thread starter Similar threads Forum Replies Date
Marc From the "I'm glad I'm retired" Department (Oct 2019) Career and Occupation Discussions 7
F UMDNS and GMDN Codes - When a Preferred Term has been Retired Other Medical Device Regulations World-Wide 1
D Gage Tracking Systems - Infinity's QS GTS System and Retired Gages General Measurement Device and Calibration Topics 4
M Training Records for Retired (Obsoleted) Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO/TS16949 Quality Systems Assessment Checklist is being retired as of 1 June 2004 IATF 16949 - Automotive Quality Systems Standard 1
H DIN 12880:2007-05 Clause 7.2 Test Equipment Description CE Marking (Conformité Européene) / CB Scheme 0
B Painted surface of a protective Class I equipment. CE Marking (Conformité Européene) / CB Scheme 1
K What are the differences between the certificates required for home and medical medical equipment? US Food and Drug Administration (FDA) 1
B ISO 13485 Qualification of R&D Equipment Qualification and Validation (including 21 CFR Part 11) 1
R EU 2017-745 - Dental Equipment CE Marking (Conformité Européene) / CB Scheme 4
T Need advice on what inspection equipment to buy. General Measurement Device and Calibration Topics 2
Q What is considered "Multimedia equipment" (60601-1-2 section 7.1.3) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
armani Monitoring and measuring equipment for occupational health and safety purposes Occupational Health & Safety Management Standards 10
P Type of MSA study according to measurement equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Rene Minassian Control of (TMME) Testing and Measurement Equipment Oil and Gas Industry Standards and Regulations 2
M Cameras and Visual Inspection Equipment General Measurement Device and Calibration Topics 3
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Equipment IQ and OQ ISO 13485:2016 - Medical Device Quality Management Systems 9
D PPE (Personal Protective Equipment) in the UK CE Marking (Conformité Européene) / CB Scheme 1
D Recommendations for equipment used to validate cold storage units General Measurement Device and Calibration Topics 3
T PFMEA vs MFMEA or DFMEA on equipment/machinery FMEA and Control Plans 19
E Brass in medical equipment Other Medical Device and Orthopedic Related Topics 5
G QSB+ : capability of measurement equipment IATF 16949 - Automotive Quality Systems Standard 15
M Gage R&R automated test equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G Developing our custom test methods and test equipment US Medical Device Regulations 5
E Compressed air quality in ME equipment (used in OR) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M ISO 17025:2017 Clause 6.4 - Measuring Equipment Validity ISO 17025 related Discussions 2
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 0
Y Creating Equipment qualification protocol Qualification and Validation (including 21 CFR Part 11) 2
R Suggest modern equipment/instrument for plastic bottle inspection? Quality Tools, Improvement and Analysis 1
S Certification of equipment after move General Measurement Device and Calibration Topics 14
B Building my own measurement equipment General Measurement Device and Calibration Topics 3
J Process Capability - Determining the process capability of certain equipment Lean in Manufacturing and Service Industries 6
W Classes and Applied Part IEC60601 Electromedical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A PPAP Alternate Equipment IATF 16949 - Automotive Quality Systems Standard 10
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
E Comparison of Respiratory Protective Equipment Standards (China Standard Compare with EU standard of EN149 Occupational Health & Safety Management Standards 2
M Calibration of equipment IATF 16949 - Automotive Quality Systems Standard 4
P 7.5.10 Customer property - applies to leased/rented equipment? ISO 13485:2016 - Medical Device Quality Management Systems 10
S Class I Equipment with mobile power inverter IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
U Calculate acceptance of equipment reading after calibration General Measurement Device and Calibration Topics 2
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Equipment Bracketing Approach US Food and Drug Administration (FDA) 0
H Still having trouble as to what equipment falls under 8.5.1.1 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
J Register of the monitoring and measuring equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2

Similar threads

Top Bottom