3 replies to this topic

[BAkermanjr]

I am brand new to this, we've had plenty of cGMP audits, and are now in the process of getting our program written, and implemented for an audit sometime in Q1 of 2024.

 

I am tasked with implementing, and being as we are a "small" family owned business, I will be the one tasked with monitoring and keeping records of all processes and procedures, at least until we re 100% confident in the process.

 

So, the company writing our program has started sending me paperwork to start monitoring our freezers, coolers and ovens, of which I am well versed in doing all of the above.  The question comes in for training.

 

What is the proper way to "train myself" in monitoring these temperatures?  I can write whatever I want, but how, or what is the proper procedure for me to train myself?  Is it basically just me verifying that I followed the manufacturers direction on the proper use of the instruments that I will be using to take and verify temps?  What about calibrations?  I have equipment from Thermoworks that is calibrated from the factory, with certification, for I believe 5 years, pending no major issues.  I have all of that documented and stored away in temp log books.

 

Thanks, I'm sure I will have 100000 questions as this process moves forward, and this forum has already been a wealth of knowledge.

Edited by BAkermanjr, 02 October 2023 - 12:41 PM.

[kingstudruler1]

Are you the SQF practitioner?   

 

 

Is "the company writing our program" also creating the training portion?   It might be a question for them.  The purpose of training for the items you listed (freezers, coolers, ovens)  is to make sure that the individual knows why its important,  when to take temps, how to take temps, what to do if the temp is not in specification, and how to document these.   The training should cover these.  While you know how to do these currently the training should be created for those that don't.   Some people create a powerpoint that covers training.  In all GFSI standards,  there needs to be a way to prove that training is effective.   This could be by a test or by observation.    I would suggest you look at the SQF section on training.   (2.9.2).   

 

 

Calibrations - no the factory certificate is not enough.   All measuring devices need to at least be checked to ensure they are functioning properly throughout there life.   see 11.2.3.   Since you brought up thermometers, they should be checked to a reference thermometer, in ice, etc at some frequency.  

 

For someone new to SQF, I cant stress enough to read the standard.   Over and over and over.   then compare what you are doing to the standard.   over and over and over.   Make improvements as needed.   

[jfrey123]

In to hear opinions.  I always struggled when I was a QA Manager to show training documents on myself to auditors.

 

"Who trained you in this sampling SOP?"

 

"I was the one who created the SOP, and I train the employees on how to perform it."

 

"Yes, but who trains you on taking samples?"

 

"I reviewed industry standards on sterile sampling procedures and instructions from the manufacturers of the scoops and bags."

 

"Yes, but who trained you on your company's sampling procedures?"

 

"I wrote them.  Does that mean I trained myself?"

 

So on...So forth...  This went on until we implemented that I would train the production manager on SOPs and then a month later he would train me on the same SOPs.  Made the auditors happy to see I had a completed training matrix, but it made absolutely no sense in my mind.

[Tony-C]

I am brand new to this, we've had plenty of cGMP audits, and are now in the process of getting our program written, and implemented for an audit sometime in Q1 of 2024.

 

I am tasked with implementing, and being as we are a "small" family owned business, I will be the one tasked with monitoring and keeping records of all processes and procedures, at least until we re 100% confident in the process.

 

So, the company writing our program has started sending me paperwork to start monitoring our freezers, coolers and ovens, of which I am well versed in doing all of the above.  The question comes in for training.

 

What is the proper way to "train myself" in monitoring these temperatures?  I can write whatever I want, but how, or what is the proper procedure for me to train myself?  Is it basically just me verifying that I followed the manufacturers direction on the proper use of the instruments that I will be using to take and verify temps?  What about calibrations?  I have equipment from Thermoworks that is calibrated from the factory, with certification, for I believe 5 years, pending no major issues.  I have all of that documented and stored away in temp log books.

 

Thanks, I'm sure I will have 100000 questions as this process moves forward, and this forum has already been a wealth of knowledge.

 

Hi BAkermanjr,

 

 

Welcome to the IFSQN forums.

 

You need to identify and control measuring equipment used to monitor critical control points, product safety and legality. There should be a register of equipment and its location. Such equipment should be tagged with a calibration due date. A NPL calibrated thermometer should be used to conduct regular verification checks.

 

I would expect an annual calibration of an oven if cooking is a CCP.

 

In short you need your own procedures that include manufacturer’s guidance. You posted in a BRCGS Forum but quoted SQF. Here are the SQF Requirements which should be incorporated into your procedures:

11.2.3 Calibration

11.2.3.1 The methods and responsibility for calibration and re-calibration of measuring, testing, and inspection equipment used for monitoring activities outlined in prerequisite programs, food safety plans, and other process controls, or to demonstrate compliance with customer specifications, shall be documented and implemented. Software used for such activities shall be validated as appropriate.

11.2.3.2 Equipment shall be calibrated against national or international reference standards and methods or to an accuracy appropriate to its use. In cases where standards are not available, the site shall provide evidence to support the calibration reference method applied.

11.2.3.3 Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers’ recommended schedule.

11.2.3.4 Procedures shall be documented and implemented to address the resolution of potentially affected products when measuring, testing, or inspection equipment is found to be out of calibration.

11.2.3.5 Calibrated measuring, testing, and inspection equipment shall be protected from damage and unauthorized adjustment or use.

11.2.3.6 A directory of measuring, testing, and inspection equipment that require calibration and records of the calibration tests shall be maintained.

 

Regarding training, if you are the SQF Practitioner then an “Implementing SQF Systems” training course is available online and through the SQFI network of licensed training centers. SQF practitioners, who are responsible for designing, implementing, and maintaining the requirements of the SQF Food Safety Code: Food Manufacturing, are encouraged to participate in a training course. The “Implementing SQF Systems” training course is not mandatory for SQF practitioners but is strongly recommended.

Details of the training courses are available at sqfi.com.

 

SQF Practitioners with knowledge and experience that can demonstrate competence do not need to complete the training.

 

Also note: SQF practitioners are required to successfully complete HACCP training that is a minimum two-day duration and assessed.

 

Kind regards,

 

Tony