User requirements for a Calibration Management System

Hi there,
we are in the process of creating a URS for a calibration management system, we understand our need but would welcome others experience in purchasing & deploying an off the shelf calibration Management System - experiences both good & bad, as well as what system you deployed & how it is working out for you.

We do not calibrate in house - all instruments are sent outside - we just need to plan & track for calibration.

Some thoughts:

• Identify all instruments on the register as they are bought & move to instrument quarantine pending calibration.
• Identify those instruments that require calibration/verification & frequency.
• Schedule calibration to (a) ensure it is carried out during off peaks wherever possible (b)ensure that the instrument users have adequate instruments left in house to carry out work as normal. Long weekends, Public holidays, holiday season.
• Set up advance notifications for both in-house & Vendor, these notification when printed off will act as a tracking log to show where the instrument is currently located – In-house or at Vendors place.
• Raise P.O. based on quotation (currently this is done on a monthly basis – consider doing on an annual basis to reduce duplication of administration)
• Vendor collects instruments for calibration.
• Receive back instruments, reports & certs.
• Review certs & approve or RTV together with instrument.
• Establish instrument quarantine for instruments where calibration has expired or is pending first calibration.
• Centralise certificates.

 What is the need for CMS validation?
 What is in place in terms of data back up & recovery?

Thanks all,
Ger.

You have put in an Excellent way. This is what most of companies do when they out source the calibration services.
One needs to identify the team of members to carry out execute such procedures.
Your deviation management must be perfect.
You need to verify the status of claibrations at the site where your equipments are being calibrated.

Regards

Hi Ger

For this aspect of the question, all this can be done online to avoid any confusion by setting up standard templates using the solution from Kneat.com
http://www.kneat.com
. In fact this is the perfect solution to this aspect of the workflow.

Feel free to contact me if you need some help with this.

Best Regards

[quote=DURGA PRASAD]
One needs to identify the team of members to carry out execute such procedures.[/quote]

Thanks for your input Durga, I agree 100%, responsibility must be explicit.

Can you expand on this a little? Are you talking about deviations in the sense that the instrument is returned from the Vendor & the report or cert is found to be flawed under review?

I was hoping to avoid going to the Vendor site alltogether except for annual audits, why can I not verify the status of the instruments, reports & certs after they are returned to me?

[quote=gokeeffe]Hi Ger

For this aspect of the question, all this can be done online to avoid any confusion by setting up standard templates using the solution from Kneat.com
http://www.kneat.com
. In fact this is the perfect solution to this aspect of the workflow.

Feel free to contact me if you need some help with this.

Best Regards[/quote]

Thanks, let me take a look at that & see if it fits my needs.

Deviation Management : Why you hve sent an Instrument for calibration? That was as a standrad calibartaion procedure or is it showing erraneous results or is it observed by QA-Compliance team or did this particular system is responsible for manufacturing deviation?
When such instruments come back what ever the reason might be, they should be a review team to review, look back into system and properly place such system back.

There should be a tracking team for such instruments where deviation cannot repeatedly occur.

You need toi develop a template why these has gone, what was verified, certificate of calibration etc etc.
After calibration some one from that external agency needs to wtach the system for its accuracy atleast during 2 cycles of processing.

As you mentioned such certificates must be reviewed and any flaws existing must be rectified by competent person in the organization

2.Vendor review and Quality agreements with vedors are very much essential. Quality agreements must contain who is attending to perform such calibration programmes and what is their training and certificate of training are much needed. If you look ICH Q9/Q10 agreements training is much needed and its mandatory. In this case since your company do not have this competency to perform --FDA looks in to such agency how copetrent they are and your review report.

Regards

In your list, I didn’t see “what to do if something is found out of calibration.”

If an instrument is found to be out of calibration, efforts need to be taken to determine impact. This could result in quarantining undistributed product and/or recalling distributed product. Whatever the outcome, the analysis effort needs to be documented showing whatever conclusions are made.

If, for example, equipment comes back from calibration and the vendor determines that the equipment was received out of calibration, any product assessed with that equipment since the previous known good calibration date (quite possibly the last calibration date) is suspect.

Note the implications here are that you have to know what product was assessed with what equipment.

[quote=yodon]In your list, I didn’t see “what to do if something is found out of calibration.”

[/quote]

Fair enough, it’s not in the list, we have catered for such instances in our SOP however, thanks.
You’re second point is interesting & I need to look into whether or not our current calibration Vendor reports to us when an instrument is received in an "out of calibration " state or if this is even checked.

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