Good morning.
After question about the qualification of chromatographic column, today I have another question and need your opinion.
The question regards the SOP for calibration scales (balances). The SOP describes the check of balances every 6 months executed by external contractor under the supervision of the operator of plant.
Moreover in plant, the ordinary check for calibration is commissioned to another contractor but under the final supervision of our operator.
Which kind of schedule must we use for the check?
Which kind of control must it be reported in the schedule? (Have you an example to see?)
Must the external contractor be qualified?
Is it important to have a quality agreement?
How do I qualify the external contractor?
I hope to have described the situation without any confusion borns to you
I don’t understand your schedule questions. Sounds like your SOPs spell it out pretty well.
So let me address your other questions.
Should the contractor be qualified? Without intending to sound snide, why would you think otherwise? All standards and regulations require that personnel are competent to perform their tasks. This applies to contractors you bring in to perform a task. If the individuals were not qualified, could you trust the results? Generally speaking, the qualification should also be documented.
Is it important to have a quality agreement? This is probably more debatable for a service provider and your decision should be risk-based. I could see a quality agreement stating something to the effect that personnel will be qualified (trained on procedures to carry out the calibration – and records of training available on request), gauges used will be calibrated and traceable to standards (material available on request), and so on. You could probably even define accuracy tolerance in such a document, if not already specified in the purchase order.
How do you qualify the contractor? One good measure for calibration labs is ISO 17025. Most reputable labs are registered to this standard. I would start there and then add additional requirements as needed. Ensure that the scope of their registration includes balances!
Quality agrrement is a need to get the services of your desire (Some times it becomes legal document).
Qualification of contractor…you can do by yourself or you can hire a third party to do on your behalf.
One thing in my opininon you can revisit the schdule & dual application of calibrations…I guess it may be simplified, But question is not exploring the end application of these balances. So I will suggest that you should assess that whether is existing schdule with dual criteria is required /