Qualification of pest control service in a "virtual manufacturer"

P

PBuckley

#1
#1
We are a specification developer that designs a product used to take measurements of certain health statistics, (blood pressure, pulse, weight, etc.), with placement primarily in retail locations. Other than Design Control, Risk Management, & some R&D for future development, we have outsourced most other key manufacturing processes, including manufacturing, service, packaging and shipping, purchasing, complaint handling, etc., so we consider ourselves more of a virtual manufacturer. During a recent ISO 13485 surveillance audit, we received a minor non-conformance for not having our calibration lab and Pest Control service on our approved supplier's list. I can understand the Calibration Lab since we do use inspection and measurement equipment to determine product specifications and need to have a reliable lab with traceable standards, but am slightly puzzled on the observation for Pest control :confused:

If our finished product is not manufactured, assembled, or stored at our facility, and we don't maintain component inventory used for the product's manufacture, why would we have to qualify a Pest Control service? I would appreciate anyone's thoughts on this matter :thanks:
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#2
#2
I?ve moved the thread to the ISO 13485 forum - usually better to put related questions here.

As for your question, pest control is not a specific requirement of ISO 13485 (it would be under the general environmental control or contamination control requirement), so I would argue that, unless there?s is a risk related to pest control (from your analysis), you would not need to qualify it.

ON the other hand, there?s at least one medical device regulatory requirement (ANVISA GMP) which formally require pest control...maybe the auditor was familiar with this and ended up requiring too much on ISO 13485...
 
somashekar

somashekar

Staff member
Admin
#3
#3
why would we have to qualify a Pest Control service?
Click to expand...
but am slightly puzzled on the observation for Pest control
Click to expand...
When you do not have pest control service supplier on your approved supplier list, you may have no good control over pest, which in turn will harm you and prevent you from doing good specification development, thereby effecting your design outputs / final product ~~~ :lmao::popcorn::sarcasm:
Hii, Can you please put here the NC statement as issued to you by the CB auditor.
Approved supplier list is your QMS requirement and not from the ISO13485. What you put into this depends on your purchasing procedures that you have defined. The controls you exercise depends upon the effects of the purchased products on subsequent realizations or final product.
So the guy who supplies you your evening burgers daily need not be on this list, so is your pest control service provider if you have one.
 
P

PBuckley

#4
#4
somashekar said:
Hii, Can you please put here the NC statement as issued to you by the CB auditor.
Click to expand...
The minor non-conformance stated: Two suppliers; Terminix (pest control) and Trident Calibration Laboratories (calibration) are being used, but
are not on the Approved Vendor List (AVL).

Requirements were based on the ISO 13485:2003(E) Purchasing Process clause 7.4.1. In hindsight, I think that the concern was that we were unable to show we had evaluated the supplier and classified them by risk, rather than their selection of their service "being dependent upon the effect of the purchased product on subsequent product realization or the final product."

Our easiest course of action will probably be to classify them as a low risk supplier, put a note to file that they meet our requirements for keeping bugs off the premises, put them on our ASL and call it a day.

Thanks to both you and Marcelo for your feedback. Now it's off to qualify that burger supplier . . . :lol:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G RO/DI water system qualification Qualification and Validation (including 21 CFR Part 11) 3
A Qualification of clinical assessment scales EU Medical Device Regulations 1
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
R Qualification list of businesses approved to Off-Shore Aerospace work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
Z Qualification of AzureDevOps in Gxp Qualification and Validation (including 21 CFR Part 11) 12
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
Rameshwar25 IATF ADP - How to proceed for new auditor qualification IATF 16949 - Automotive Quality Systems Standard 17
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Qualification of weights used for curing epoxy Manufacturing and Related Processes 3
M Qualification of Freezer with IQ and PQ but no OQ Qualification and Validation (including 21 CFR Part 11) 2
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
O AS9100 AQMS AEA Qualification Audits 4 Full QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3

Similar threads

Top Bottom