Laboratory Equipment Quality System - Calibration, Maintenance and Inspection

[AnaMariaVR2]

Could anybody share your experience about what kind of calibration, maintenance and inspection is required for laboratory equipment for a small biotech company.

under ISO 9001:2008 clause 7.6 "Control of monitoring and measuring equipment".

What quality systems should I develop, evaluate, apply and/or monitor in order to have a robust quality system that controls equipment in our facility?

Does anybody have any ideas or experience on this area? I'm doing this from scratch. I started with the equipment database, wrote a general equipment SOP and now writing specific equipment/instrumentation SOPs. Now, what else?

What approach would Elsmar Cove recommend?

Should I develop this system based on the 6 activities that ISO must document? As it follows:

4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of NC products
8.5.2 Corrective Action
8.5.3 Preventive Action​

Thanks in advance to all!

Ana

 

[Ajit Basrur]

Re: Equipment Quality System

Hi Ana,

Firstly, I have moved your question to the FDA section since it focuses on a Biotech organization and you could get more focused answers

All the laboratory equipment / instruments are Qualified as per IQ, OQ and PQ before they are put into use. On a regular basis, these are calibrated and maintained as per supplier recommendations, and could vary from one instrument to another based on the usage and complexity.

With regards to the 6 procedures of ISO 9001, my 2 cents are -

4.2.3 Control of Documents - yes, these are in the form of Work Instruction on the usage of the instrument / equipment.

4.2.4 Control of Records - whenever, there is a revision, these WIs would be superceded.

8.2.2 Internal Audits - yes

8.3 Control of NC products - as part of Laboratory Investigations.

8.5.2 Corrective Action - built in Lab Investigation

8.5.3 Preventive Action - built in Lab Investigation

Take a look at the attachment from ISO for detailed info on Clause 7.6
.

 

[Umang Vidyarthi]

Re: Equipment Quality System

Could anybody share your experience about what kind of calibration, maintenance and inspection is required for laboratory equipment for a small biotech company.

under ISO 9001:2008 clause 7.6 "Control of monitoring and measuring equipment".

What quality systems should I develop, evaluate, apply and/or monitor in order to have a robust quality system that controls equipment in our facility?

Does anybody have any ideas or experience on this area? I'm doing this from scratch. I started with the equipment database, wrote a general equipment SOP and now writing specific equipment/instrumentation SOPs. Now, what else?

What approach would Elsmar Cove recommend?

Should I develop this system based on the 6 activities that ISO must document? As it follows:

4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of NC products
8.5.2 Corrective Action
8.5.3 Preventive Action​

Thanks in advance to all!

Ana

Ajit has provided sound advise. There is another thread concurrently going on similar lines The best way to quickly review the quality situation, and another here. You may benefit from the suggestions provided therein.

Umang

 

[AnaMariaVR2]

Re: Equipment Quality System

Thank you Ajit & Umang for your prompt response!

...& thanks for suggesting & moving the thread to the FDA section. I was unsure where to posted since yes FDA regulations apply but we are also pursuing ISO certification. I appreciate both of your help & insight.

Ana

 

[Umang Vidyarthi]

Re: Equipment Quality System

Thank you Ajit & Umang for your prompt response!

...& thanks for suggesting & moving the thread to the FDA section. I was unsure where to posted since yes FDA regulations apply but we are also pursuing ISO certification. I appreciate both of your help & insight.

Ana

You are Welcome AnaMaria

Umang

 

[yodon]

Re: Equipment Quality System

A little late to the party, but...

One thing that's apparently often overlooked in procedures is what to do if you find something that is out of calibration. You will need to assess the impact and take actions accordingly. This means that anything that was measured using the equipment since the last known calibration date is suspect.

So think beyond the procedures to keep things in calibration when you're developing the procedures.

 

[AnaMariaVR2]

Re: Equipment Quality System

Thank you Yodon...don't worry, you are not too late for the party...the party is on & goes on at ELSMAR!

You are right, if there is no calibration schedule, inspections or routine preventive maintenance going on, how can I ensure that the data generated by those instruments is real?! And the impact to studies that used that uncalibrated equipment?

Maintenance, calibration, inspection and even simple cleaning activities are so crucial to prove that equipment is fit for use.

I'll follow your suggestion and I'll add a procedure to follow when equipment is out of calibration. Good point



If you have more suggestions for me, I have a patient ear or better saying, a grateful eye to read it in this forum.

Does anybody has an equipment malfunctioning or out of calibration SOP?

 

[AnaMariaVR2]

Equipment Quality System MAP

Here is my train of thought with regards to this topic.
Does this makes sense? Am I missing something?

Please comment on my equipment mindmap when you can.

Thank you,
Ana

 

[Ajit Basrur]

Re: Equipment Quality System

This is cool - thanks Ana

 

[BradM]

I guess since the others covered the big stuff, I'll hit some of the general basic stuff.

First, give some thought to what you are purchasing. Buy just what you need in terms of accuracy and use. Try to stay as consistent as possible.

Develop some unique, high quality identification tags and start from the beginning correctly identifying the instruments.

Develop some kind of master record for each instrument. It should have the make, model, serial, procedure, required tolerance, test points, etc. on it. This will always be a good reference to specify why you purchased the item, who is going to use it, and what it is to be used for.

Also, develop a good calibration sticker, a warning/do not use sticker, and possibly, a limited calibration sticker.

I might say also add a For Reference Only sticker. But honestly, if you're small, if you don't calibrate it, you can probably get rid of it.

I might spend the money calibrating instruments in a smaller interval, to assure you minimize the out of tolerance conditions. Once stability is established, you can open it up.

Nothing really earth shattering that I've said. Just start from the beginning with good documentation and labeling of your equipment/instrumentation.