I am new to the SQF standard, just a few months in it. I am task with the responsibility of continuing were my predecessor left off. I am having some challenges with the procedures created as I think there are a bit too bulky in the responsibility section and the procedure section does not identify who should do what. I am coming form a FSSC facility. Can you have a look at the format below (and) and let me know if I do need to amend or the procedure is fine as is:
Sample: Calibration Procedure
The purpose of the Procedure is to establish guidelines for ensuring that measuring, testing and inspection instruments and equipment, have the accuracy and precision appropriate to their intended use.
The Procedure applies to all measuring, testing and inspection instruments and equipment. These include the pH meter, the thermometers and the scales.
3.1 Internal Reference
1. The Manufacturer’s/Supplier’s Manuals for the Instruments and Equipment which are Calibrated
3.2 External References
1. SQF Food Safety Code for Manufacturing Edition 8.1 _clause 11.2.11
2. BRC Global Standard for Food Safety Issue 8_clause 6.4
For the purpose of this Procedure, traceability refers to the property of the result of a measurement or the value of a standard, whereby it can be related to stated references (usually national or international standards), through an unbroken chain of comparisons, all having stated uncertainties.
5.1 The Director of Operations
The Director of Operations is responsible for:
- Ensuring that budgetary support is always provided for the continual improvement of the Equipment Prerequisite Programme.
5.2 The Quality Assurance Manager
The Quality Assurance Manager is responsible for:
- Providing any necessary guidance to facilitate the continual improvement of the Equipment Calibration Programme
- As required, reviewing critical and major corrective action plans relevant to equipment calibration, to assess the appropriateness of the corrective measures proposed.
5.3 The Meat Plant Manager
The Meat Plant Manager is responsible for liaising with the Quality Assurance Supervisor to ensure that:
- All relevant instruments and equipment are calibrated on schedule
- Critical and major corrective actions relevant to instruments and equipment calibration, are effectively closed out within the specified time frames.
5.4 The Quality Assurance Supervisor
The Quality Assurance Supervisor is responsible for ensuring that:
- All relevant instruments and equipment are calibrated on schedule
- Personnel responsible for calibrating instruments and equipment receive relevant training
- Corrective actions relevant to instruments and equipment calibration, are effectively closed out within the specified time frames
5.5 The Food Safety and Quality Assurance Officer
The Food Safety and Quality Assurance Officer is responsible for:
- Liaising with the Quality Assurance Supervisor to ensure that personnel responsible for calibrating instruments and equipment receive relevant training
- Ensuring that records of the calibration of instruments and equipment are maintained.
6.1 Calibration Schedule
- An Instruments and Equipment Calibration Schedule (MP_EQU_S_2.1, Revision 00) must be maintained for the instruments and equipment which require calibration. The Instruments and Equipment Calibration Schedule must include:
- Each measuring, testing and inspection instrument and equipment which require calibration
- The location of the instruments/equipment
- The unique identification number of each instrument/equipment
- The frequency for calibrating each instrument/equipment
- The personnel or accredited agency/laboratory that is responsible for calibrating each instrument/equipment
- The methods/procedures to be employed for the calibration of each instrument/equipment.
- Calibration Reference Standards and Calibration Instructions
- Instruments and equipment requiring calibration must be calibrated against a reference standard, showing traceability of calibration to a recognized national or international standard.
- Instruments and equipment may also be calibrated using the manufacturer’s instructions. These instructions must be maintained on file.
- In cases where reference standards are not available, evidence must be provided to support the calibration reference method used.
6.3 Calibration Frequency
1. All measuring, testing and inspection instruments and equipment which require calibration, must be calibrated based on the frequency stated in the Instruments and Equipment Calibration Schedule (MP_EQU_S_2.1, Revision No. 00).
- The frequency of calibration must be based on:
- The type of instrument or equipment
- The manufacturer’s recommendation
- Regulatory requirements
- The frequency and condition of use of the instrument/equipment
- The stability of the instrument/equipment
- The required accuracy and precision of the instrument/equipment.
- Aside from a Calibration Certificate or a Certificate of Accuracy, newly purchased measuring, testing and inspection instruments and equipment, must be provided with written calibration instructions.
- Calibration Activities
- Personnel who perform calibration activities must be appropriately trained, and they must understand the relevant instructions and procedures.
- The calibration instructions and or procedures used, must describe the frequency of calibration, the calibration method and the acceptable range of variation.
- Reference standards (e.g. reference thermometers) must have a current Calibration Certificate before they are used. The Certificate must be issued by an accredited agency or laboratory.
- If an instrument or equipment is to be transported to an accredited agency/laboratory for calibration, it must be handled, packaged (if required) and transported in a manner to protect it from damage.
- During the performance of calibration activities, instruments and equipment must be handled with care, to protect them from damage.
- Personnel who use calibrated instruments and equipment must be suitable trained.
6.5 Identification of Calibrated Instruments and Equipment
- The calibration status, where possible, must be clearly displayed on each piece of instrument/equipment or it’s storage box. Where this is not possible, the user of the instrument/equipment must refer to the relevant Calibration Record.
- The next calibration due date, shall be recorded on each calibration status tag.
6.6 Protection of Calibrated Instruments and Equipment
- Safeguards must be in place to prevent unauthorized adjustments of calibrated instruments and equipment. Among other things, these safeguards shall include:
- Prohibiting the movement of the instrument/equipment, if this may invalidate the calibration
- Ensuring that calibrated instruments and equipment are only used by appropriately trained personnel.
- Calibrated instruments and equipment must be handled and stored in a manner to protect their calibration status.
6.7 Out of Service Instruments and Equipment
1. Measuring, inspection and testing instruments and equipment must not be used if:
- They are outside their designated calibration period
- They have failed in operation
- Are suspected or known to be outside designated limits
- Show evidence of physical damage which may affect their accuracy.
- These instruments and equipment must be conspicuously identified, immediately removed from use, and stored in a designated area until repaired or re-calibrated.
- Large equipment that cannot be physically moved, must be tagged with the appropriate identification until repaired or
- If the instrument or equipment cannot be repaired or re-calibrated, it must be removed from service.
- Records of Calibration
- Records of calibration activities must be maintained. The records must include the:
- Identification and location of the instrument or equipment
- Date of calibration
- Person or accredited agency/laboratory which carried out the calibration
- Calibration results
- Next due date of calibration, as applicable
- Corrective Actions taken (if any).
This Procedure shall be followed each time relevant instruments and equipment are to be calibrated.
1. The Quality Assurance Supervisor shall verify conformance to this Procedure by reviewing the Calibration Records on a
- The Food Safety and Quality Assurance Officer shall verify conformance to this Procedure by:
- Reviewing the Instruments and Equipment Calibration Schedule at least one every 4 months.
- Conducting an annual audit of the Equipment Calibration Programme.
9.0 Corrective Actions
a. If instruments and equipment calibrated internally are not calibrated on schedule, the Quality Assurance Supervisor shall have the team member who is responsible for carrying out the calibration:
- Calibrate the instruments/equipment in accordance with the relevant requirements of this Procedure.
- Receive re-training in the requirements of this Procedure, and general requirements for calibration of instruments and equipment.
b. If instruments and equipment calibrated by an accredited agency/laboratory are not calibrated on schedule, the Quality Assurance Supervisor shall:
- Make the necessary arrangements with the accredited agency/laboratory to calibrate the instruments/equipment
- Have the accredited agency/laboratory calibrate the instruments/equipment
- Initiate the calibration of instruments/equipment by the accredited agency/laboratory, at least two months before the expiration dates of the calibration.
c. If food safety has been compromised due to instruments/equipment which are out of calibration, the Quality Assurance Supervisor shall:
1. Quarantine the implicated raw materials or products
2. Treat the raw materials or products as non-conforming materials/products (refer to the Non-Conforming Raw Materials and Products Procedure (MP_NPE_SOP_1.1, Revision No. 00).
10.0 Associated Documents and Records
- The Non-conforming Raw Materials and Products Procedure (MP_NPE_SOP_1.1, Revision 00)
- The Instruments and Equipment Calibration Schedule (MP_EQU_S_2.1, Revision 00)
- The Thermometer Calibration Form (MP_EQU_FM_3.1, Revision 00)
- The Bench Top pH Meter Calibration Record (MP_EQU_FM_3.2, Revision 00)
- The Portable pH Meter Calibration Record (MP_EQU_FM_3.3, Revision 00)
- The Scale Weight Test Sheet (MP_EQU_FM_3.4, Revision 2.0)
Edited by Simon, 07 September 2021 - 06:01 PM.
split from topic 41978.