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Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Requirement

S

saisai

#1
hi, All,

Does barcode scanner need IOPQ or just a simple verification for the following case?

1. barcode scanner save the barcode into the server for future traceability, need IOPQ or simple verification?

2. if the barcode scanner is integrated into final inspection station on the line, the barcode will be saved together with the QC data, so barcode scanner need IOPQ or just verification?

thanks
 
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somashekar

Staff member
Super Moderator
#2
Re: Barcode scanner IOPQ?

hi, All,

Does barcode scanner need IOPQ or just a simple verification for the following case?

1. barcode scanner save the barcode into the server for future traceability, need IOPQ or simple verification?

2. if the barcode scanner is integrated into final inspection station on the line, the barcode will be saved together with the QC data, so barcode scanner need IOPQ or just verification?

thanks
A verification test would suffice.
You would be better of, if your printed barcode that is scanned is from a good print source and to the right size and standard on a white background, for correct and repetitive accurate scan...
 

yodon

Staff member
Super Moderator
#3
Re: Barcode scanner IOPQ?

While I don't disagree with Somashekar, I would want to know more about the intended use and the risk if the read fails.

What is the 'throughput' for the scans? If the reader is embedded in a manufacturing system and scans 100 a minute, there could be a risk of getting out of sync. If it's just a manual scan and the operator can confirm a good read each time, probably low risk.

I would suggest a (documented) risk assessment to drive your decision. The verification Somashekar recommends may well be appropriate; but without the risk assessment, you really haven't justified your approach.
 
G

gzmrxm

#5
Re: Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Require

Hello guys, I apologize for the intrusion. I am actually working on a OQ validation for bar code scanners and have certain doubts. These scanners will definitely present a potential risk for our customer since they are used for the packaging process in a medical device; so my question is: What parameters should I challenge here? Would a software validation be enough?

Your advice would be greatly appreciated

Jorge
 

Sam Lazzara

Trusted Information Resource
#6
Re: Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Require

Is it a barcode scanner (reader) or a barcode verifier?
Also, whatever it is, please provide the manufacturer and model number so I can offer better advice. The absolute minimum control should be to enter it into your equipment calibration/maintenance system with periodic checks for ability to accurately read the barcode style(s) you use. You will need a "standard" for this like the "test cards" provided by GS1, for example.
http://productcatalog.gs1us.org/Store/tabid/86/List/1/CategoryID/4/Level/a/Default.aspx

For verifiers, there is typically a reflectance calibration performed using a black/white calibration standard provided by the verifier manufacturer. Also, to determine conformance with the ISO/ANSI barcode verifier standards you need to use a "test card" typically sold by the barcode issuing agencies (such as GS1 for example).

From Wikipedia:
Barcode verification examines scanability and the quality of the barcode in comparison to industry standards and specifications. Barcode verifiers are primarily used by businesses that print and use barcodes. Any trading partner in the supply chain can test barcode quality. It is important to verify a barcode to ensure that any reader in the supply chain can successfully interpret a barcode with a low error rate. Retailers levy large penalties for non-compliant barcodes. These chargebacks can reduce a manufacturer's revenue by 2% to 10%.[24]

A barcode verifier works the way a reader does, but instead of simply decoding a barcode, a verifier performs a series of tests. For linear barcodes these tests are:

Edge Determination
Minimum Reflectance
Symbol Contrast
Minimum Edge Contrast
Modulation
Defects
Decode
Decodability

2D matrix symbols look at the parameters:

Symbol Contrast
Modulation
Decode
Unused Error Correction
Fixed (finder) Pattern Damage
Grid Non-uniformity
Axial Non-uniformity[25]

http://en.wikipedia.org/wiki/Barcode
 
G

gzmrxm

#7
Re: Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Require

Mr. Lazzara,

Your advice was very complete and It opened my eyes on this matter, I had no thought to check the calibration system.Thanks a lot!

Just to asnwer to your initial questions:

Our barcodes scanners are readers. The brand is BANNER models: IVUPRBR04 and IVUPRBR08.

So I am writing this OQ protocol and there's a section where I have to fill the parameters that have to be challenged, so ...do you think I should answer: "The parameters are going to be the calibration requirements of the barcode scanner"


Thank you very much
 
I

IVD_RA

#8
Re: Barcode scanner IOPQ?

Hi Somasker,

Do you aware of regulatory requirements pertaining to barocde scanner? I am aware of laser requirements. On the FDA site, they listed for class II laser product( our barcode scanner is class II laser product), manufaturer needs to follow under 21 CFR 1000 to 1005. can anyone help?
 
I

IVD_RA

#9
Re: Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Require

HI Lazzara,

can you help me to identify regualatory requirements associated with barcode reader? the model no is KDC350. we are getting this product from supplier and having our own company name on barcode scanner as distributor. any help is appreciated.
 

Sam Lazzara

Trusted Information Resource
#10
Re: Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Require

The best source for bar code reader regulatory requirements should be the manufacturer.
It is not a medical device I don't believe so I am a little out of my main area of expertise.
If you look at the manufacturer's spec sheet (attached to this post) it mentions regulatory compliance for laser safety and EMC.
 

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