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IQ, PQ, OQ

IQ, PQ, OQ

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I just assigned to make an IQ/PQ/OQ validation report to pre... - Apr 09, 2019 by Thomas

Here's a good summary: https://www.fda.gov/downloads/Drugs/D... - Apr 10, 2019 by davef

Are you currently ISO 13485 certified, or are you just tryin... - Apr 12, 2019 by Steve Thomas

We are ISO 13485 Certified. The previous PE who handles such... - Apr 12, 2019 by Thomas

Do you have some IQ/OQ/PQ records for other validations that... - Apr 12, 2019 by Steve Thomas

That's the most difficult part I am trying to figure it out.... - Apr 12, 2019 by Thomas

To qualify the equipment for production use, you need to onl... - Apr 15, 2019 by Sr. Tech

Sorry that list is supposed to be bulleted. Site is acting w... - Apr 15, 2019 by Sr. Tech

"To qualify the equipment for production use, you need to on... - Apr 15, 2019 by Steve Thomas

You demonstrate it and record it by the report. The report c... - Apr 15, 2019 by Sr. Tech

The reason I asked is that in every AS9100 or ISO13485 envir... - Apr 15, 2019 by Steve Thomas

Thomas

#82324

IQ, PQ, OQ report question. | 9 April, 2019

I just assigned to make an IQ/PQ/OQ validation report to prepare for a couple of new yet very simple medical assemblies we are to build for. I have no idea how to make this report. All I know is I have to come with the validation report for all the pieces of equipment to be used for those assemblies. Only one SMT PnP would be needed; also one of the assemblies would need to hand solder one PTH part too. My question is What would be the minimum things I need to be prepared for the IQ/PQ/OQ report? I don't believe my company has been properly keeping all the machinery setup/install records. So please advice what would be the best approach to start my assignment.

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davef

#82338

IQ, PQ, OQ report question. | 10 April, 2019

Here's a good summary: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466496.pdf

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Steve Thomas

#82350

IQ, PQ, OQ report question. | 12 April, 2019

Are you currently ISO 13485 certified, or are you just trying to meet compliance standards for a certified customer?

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Thomas

#82351

IQ, PQ, OQ report question. | 12 April, 2019

We are ISO 13485 Certified. The previous PE who handles such technician things is no longer working with us. I am not sure where to start at, and what exactly needs to be done. Current, my main question is there some sort of a list what would be the minimum things must be done to meet the compliance standard?

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Steve Thomas

#82352

IQ, PQ, OQ report question. | 12 April, 2019

Do you have some IQ/OQ/PQ records for other validations that you can use as templates?

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Thomas

#82353

IQ, PQ, OQ report question. | 12 April, 2019

That's the most difficult part I am trying to figure it out. I am unable to locate an IQ/OQ/PQ record that I could use as a template. That's why I am looking for if there is a sample one out there, which I can use it as the reference.

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Sr. Tech

#82363

IQ, PQ, OQ report question. | 15 April, 2019

To qualify the equipment for production use, you need to only do IQ, OQ.

There are two parts to this.

1.) The protocol. What you are going to test.

2.) The report. Did the testing meet the spec and supporting test sample data.

Example of typical things found in the protocol:

Where equipment will physically be installed What will be inspected when it is received Power, lighting, air, gas, requirements in place Is training criteria in place Maintenance schedules Operator SOP Software back-up requirements Hazardous waste review Waste stream mapping Sample sizes

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Sr. Tech

#82364

IQ, PQ, OQ report question. | 15 April, 2019

Sorry that list is supposed to be bulleted. Site is acting weird

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Steve Thomas

#82365

IQ, PQ, OQ report question. | 15 April, 2019

"To qualify the equipment for production use, you need to only do IQ, OQ."

Even in a scenario where you're installing a piece of duplicate equipment, how do you demonstrate (and record) that the new machine provides acceptable product?

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Sr. Tech

#82366

IQ, PQ, OQ report question. | 15 April, 2019

You demonstrate it and record it by the report. The report contains the check off items that you defined in the protocol along with supporting data from the testing you did. This usually involves part numbers,data points, and photos.

The report should state "meets IQ and OQ requirements"

PQ is used when you cannot statistically measure something within reason. Such as verifying solder joint integrity from a new soldering iron. Or how well a new stencil washer cleans stencils for example.

Hope that makes sense and answers the question.

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Steve Thomas

#82368

IQ, PQ, OQ report question. | 15 April, 2019

The reason I asked is that in every AS9100 or ISO13485 environment where I've been employed our equipment qualifications have included a PQ in order to provide evidence that the machine can (and did) produce product that meets or exceeds the pass/fail criteria previously defined.

You just have to be prepared to perform 100% visual inspection on some assigned sample size.

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