- \n
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.\u00a0<\/span><\/li>\n\n\n\n
- Whether the drug\u2019s proposed labeling is appropriate and what it should contain <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug\u2019s quality are adequate to preserve the drug\u2019s identity, strength, quality, and purity<\/span>\u00a0<\/span><\/li>\n<\/ul>\n\n\n\n
C<\/span>omplet<\/span>ing <\/span>risk assessments<\/span> of<\/span> your instruments<\/span> using the <\/span>above-mentioned<\/span> documents<\/span> will<\/span> determine<\/span> the proper <\/span>criticality, <\/span>calibration frequency<\/span>,<\/span> test points, and<\/span> tolerance<\/span>s<\/span> based on scientific data<\/span>,<\/span> not a rule of thumb or guesswork<\/span>. It also helps <\/span>ensure<\/span> resources <\/span>are<\/span> concentrated<\/span> in the most critical areas of your facility<\/span> to maximize <\/span>utilization<\/span> and <\/span>reduc<\/span>e<\/span> cost.<\/span><\/span> <\/span><\/p>\n\n\n\n
The first step is assembling a team to perform the risk assessments, which should include: <\/span> <\/span><\/p>\n\n\n\n
- \n
- Process\/System Engineer – identify parameters & limits, critical steps in the process, and process tolerances. They will also be responsible for approving the calibration specifications and frequencies and approving the risk assessments.<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration\/Metrology Specialists – initiate & manage the risk assessment process, develop the calibration specifications and frequencies, select and approve the appropriate instruments to meet the process requirements, set up the calibration strategy, and approve the risk assessments.\u00a0<\/span><\/li>\n\n\n\n
- Quality Assurance – ensure the process parameters and limits meet the regulatory submission, review the calibration specifications and frequencies for compliance with site procedures and the final approval of the risk assessments.<\/span>\u00a0<\/span><\/li>\n<\/ul>\n\n\n\n
After assembling the team,<\/span> download a <\/span>report<\/span> from your <\/span>Computer<\/span> Maintenance <\/span>M<\/span>anagement System<\/span> (<\/span>CMMS<\/span>) <\/span>that <\/span>includes<\/span> the instruments <\/span>for the process or system<\/span> you will assess<\/span>. <\/span>It will be helpful if the report includes <\/span>information <\/span>pertaining to<\/span> the measurement location in the process\/system<\/span>, the <\/span>manufacturer and model number of the <\/span>installed <\/span>instrument,<\/span> and the <\/span>current calibration specifications<\/span>.<\/span> The risk assessment <\/span>proces<\/span>s<\/span> will include answering several questions<\/span> to <\/span>determine<\/span> the <\/span>correct calibration<\/span> process<\/span>, limits<\/span>,<\/span> and frequency<\/span>. <\/span>Below is<\/span> an overview of the risk assessment process.<\/span><\/span> <\/span><\/p>\n\n\n\n
![\"\"](\"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/02\/Blog-Diagram_REV.jpg\")
<\/figure>\n\n\n\n<\/p>\n\n\n\n
An SOP should be written that details how the risk assessment should be completed and what information is required. Below is a list of the information required to complete a risk assessment, as well as an example assessment process.<\/span> <\/span><\/p>\n\n\n\n
- \n
- Instrument ID<\/span><\/li>\n\n\n\n
- Instrument description <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Instrument manufacturer, model & serial number <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Instrument range & accuracy<\/span>\u00a0<\/span><\/li>\n\n\n\n
- What system\/process is the instrument installed <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Process range, operating range & tolerance<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Instrument Criticality<\/span><\/li>\n\n\n\n
- Calibration range, test points & tolerance <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration frequency <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Signatures of the risk assessment team members <\/span>\u00a0<\/span><\/li>\n<\/ul>\n\n\n\n
Most of the above information comes from the installed instruments and the process documentation. The calibration specifications are determined by answering questions like the ones below.<\/span> <\/span><\/p>\n\n\n\n
- \n
- Instrument Criticality (may have been previously determined by an impact assessment):<\/span>\u00a0<\/span>\n
- \n
- Is the instrument used for cleaning and\/or sterilization of equipment?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Would a failure impact the product quality or patient safety?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Would a failure impact the process effectiveness or other business aspect?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Would a failure create a safety or environmental impact?<\/span>\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n
If the answer to any of the above questions is \u201cyes,\u201d then the instrument is classified as critical. If the answer to all the questions was \u201cno,\u201d then the instrument is classified as non-critical.<\/span> <\/span><\/p>\n\n\n\n
- \n
- Calibration range: should be slightly wider than the process range, or alarm range if applicable, to ensure accuracy within the operating range. If an operating range has not been defined or is unknown, calibrating the full range of the instrument is recommended.<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration test points should be at the low and high ends of the calibration range and contain at least one point within the operating range.<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration tolerance should be greater than the manufacturer’s accuracy and less than the process tolerance.\u00a0<\/span><\/li>\n\n\n\n
- Calibration frequency may be based on risk factors like these:<\/span>\u00a0<\/span><\/li>\n\n\n\n
- \n
- \n
- If a failure occurs, what\u2019s the impact on product release?\u00a0<\/span><\/li>\n\n\n\n
- If a failure occurs, how much product re-work is your company willing to accept?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- If a failure occurs, what\u2019s the environmental impact your company is willing to accept?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Do you have historical data on-site for the same manufacturer and model instrument?<\/span>\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n\n\n\n
- \u00a0<\/li>\n<\/ul>\n\n\n\n
Through an exercise such as this, your instruments will have increased accuracy and precision throughout the operating range, and completing out-of-tolerance investigations becomes easier now that you have a documented rationale for how the instrument impacts the process. Additionally, most companies determine that some, if not most, of their critical instruments do not need to be calibrated every 6 months. Some companies also opt to extend the calibration frequency of non-critical instruments to 18 to 24 months. Another method used to extend calibration frequency is by using historical data. In this case an initial calibration frequency is set, and after the third calibration is completed a review of the data is performed. If the instrument passes all three calibrations without adjustment, the frequency may then be extended by 50 or 100%. Below is an example of extending the calibration frequency. <\/span> <\/span><\/p>\n\n\n\n
![\"\"](\"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/02\/Blog-Picture2.png\")
<\/figure>\n\n\n\n<\/p>\n\n\n\n
Extending calibration frequencies is where the cost savings will be most noticeable, as less calibration events throughout the year means resources can perform other activities. The important thing to remember is to update any existing procedures that may dictate calibration frequencies. <\/span> <\/span><\/p>\n\n\n\n
If your organization would benefit by implementing a risk-based approach to calibration, CAI would like to help. CAI has cross-functional experience in validation, quality, human performance, project management, and maintenance & calibration. Let us become your trusted partner in GMP asset management.<\/span> <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of full-scale range and use a tolerance of 1.5 or 2 times the manufacturers\u2019 tolerance. Many companies standardize frequencies to calibrate all critical instruments every six months and non-critical instruments once […]<\/p>\n","protected":false},"author":41,"featured_media":300910,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[155,151],"tags":[290,362,434,435,436,437,438,439,440],"resource-featured-status":[],"resource-type":[819],"class_list":["post-299283","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-asset-management-and-reliability","category-asset-management-and-reliability-asset-performance-management-risk-based-approach-maintenance","tag-quality-risk-mgt","tag-risk","tag-asset-management","tag-reliability","tag-maintenance","tag-calibration","tag-pharma","tag-engineer","tag-drug","resource-type-blog"],"acf":[],"featured_image_src":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/02\/Joe-Leuser-Blog.jpg","featured_image_src_square":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/02\/Joe-Leuser-Blog.jpg","author_info":{"display_name":"Christina Stanevich","author_link":"https:\/\/caiready.com\/life-sciences\/blog\/author\/christina-stanevich\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/299283","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/comments?post=299283"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/299283\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media\/300910"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=299283"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=299283"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=299283"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=299283"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=299283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
- If a failure occurs, how much product re-work is your company willing to accept?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration test points should be at the low and high ends of the calibration range and contain at least one point within the operating range.<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Would a failure impact the product quality or patient safety?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Is the instrument used for cleaning and\/or sterilization of equipment?<\/span>\u00a0<\/span><\/li>\n\n\n\n
- Instrument description <\/span>\u00a0<\/span><\/li>\n\n\n\n
- Calibration\/Metrology Specialists – initiate & manage the risk assessment process, develop the calibration specifications and frequencies, select and approve the appropriate instruments to meet the process requirements, set up the calibration strategy, and approve the risk assessments.\u00a0<\/span><\/li>\n\n\n\n
- Whether the drug\u2019s proposed labeling is appropriate and what it should contain <\/span>\u00a0<\/span><\/li>\n\n\n\n