The Cal.ibration and Asset Management is one of the key requirements for ISO9001, ISO13485 and other ISO standards. Effective Calibration Management is one of the mandatory requirement s for compliance with 21 CFR 820.
PART 820 — QUALITY SYSTEM REGULATION
Subpart G–Production and Process Controls
| Sec. 820.72 Inspection, measuring, and test equipment. |
| (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented. (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. (2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment. |
If you are running a calibration, preventative maintenance, and asset management operation with paper based or Excel spreadsheets, it may be taking lot of your valuable time scheduling, tracking and recording data for calibration and preventative maintenance activities. There are many automated solutions available that can make your life much simple and easy. Following key requirements should be considered when looking for automated solutions.
(1) The computer software should be easy to use and automate manual transactions and calculations involved in the calibration/PM and asset management processes.
(2) The computer software shall comply the FDA validation and Part 11 requirements
The Following presentation provides the details about the requirements and solutions
(1) Equipment design and selection shall be appropriate for the process requirements. (Defined through the process validation), Equipment shall be properly installed (confirmed through IQ), Functionality of Equipment shall match the process requirements (confirmed through OQ and PQ), The equipment shall be properly maintained (PMs, Repairs)
(2) Establish and maintain schedules for PM/Inspections. The inspections, including the date and individual(s) conducting the inspections, shall be documented
(3) Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented
(4) The equipment shall be calibrated in regular intervals
(5) Establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained.
(6) Calibration procedures shall include specific directions and limits for accuracy and precision
(7) When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.
(8) Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards
Calibration Records
The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented
(1) Equipment: Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.
(2)Maintenance schedule: Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.
(3) Inspection: Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.
(4) Adjustment: Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.
You can contact us to set up a demo to see the Qualcy Calibration Management Software. Also you can get a word copy of this document.
