I. First, ensure the completeness: The record must fully include the 6 types of content (missing any one makes it incomplete)
\nBasic information is complete
\nEquipment name, position number, location of the clean area, grade (A\/B\/C\/D)
\nDate, start\/end time
\nOperator, reviewer
\nMaintenance items are complete
\nFan operating status (abnormal noise, vibration, temperature)
\nDampers cleaning, installation, sealing
\nInitial\/middle\/high efficiency filter pressure difference
\nFilter appearance, leakage, sealing condition
\nExhaust ceiling frame, ceiling sealing
\nData record is complete
\nPressure difference: initial, current, final resistance judgment
\nInstrumentation number, calibration validity period
\nData comparison before and after maintenance
\nAbnormal situations are complete
\nAre there any abnormalities?
\nAbnormal description
\nInitial cause judgment
\nTreatment measures
\nVerification and closed-loop completeness
\nRe-measurement data after treatment
\nHas it returned to normal?
\nHas deviation\/change been opened?
\nSignature and review completeness
\nOperator’s signature
\nReviewer’s signature
\nAuditor’s signature
\nII. Ensure the completeness of 5 execution methods (directly follow the on-site procedures)
\n1. Use standardized, check-mark style templates, no freehand writing allowed
\nAll items should be fixed as check marks + fill-in, do not just write “normal”.
\nThe template should indicate: This item is mandatory, cannot be blank.
\nOne page covers all content to avoid scattered and lost pages.
\n2. Execute “Do one, record one, complete immediately”
\nDo one, record one, do not allow to complete later.
\nProhibited: Only do not record, only record not doing, recalling and writing later.
\n3. Force “Record even if there is no abnormality”
\nNo problem \u2192 Write: “No abnormality”, cannot leave blank.
\nShutdown, stop production, not running \u2192 Write: “Equipment shutdown, not maintained”, and sign.
\nNever allow blank columns, blank dates.
\n4. Abnormalities must “Write completely from beginning to end”
\nAs long as an abnormality occurs, 4 things must be recorded:
\nWhat was discovered
\nWhat was done for handling
\nData after handling
\nIs the conclusion qualified
\nOne item missing means incomplete content and does not comply with GMP.
\n5. The reviewer only checks one thing: Are there any missing items
\nWas the pressure difference written?
\nWas the time filled in?
\nWas the abnormality closed-looped?
\nDid all signatures complete?
\nWere there any blank items left unfilled?
\nThe reviewer’s signature = confirmation of complete content.
\nIII. The most important sentence for auditing (can be directly written into the SOP)
\nThe daily maintenance record of the exhaust ceiling should be complete in terms of items, data, abnormal closed-loop, and complete signatures, without missing items, blank spaces, or gaps, ensuring full traceability throughout the process and compliance with GMP requirements.<\/p>","protected":false},"excerpt":{"rendered":"
I. First, ensure the completeness: The record must fully include the 6 types of content (missing any one makes it incomplete) Basic information is complete Equipment name, position number, location of the clean area, grade (A\/B\/C\/D) Date, start\/end time Operator, reviewer Maintenance items are complete Fan operating status (abnormal noise, vibration, temperature) Dampers cleaning, installation, […]<\/p>","protected":false},"author":3,"featured_media":5032,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/comments?post=5308"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5308\/revisions"}],"predecessor-version":[{"id":5309,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5308\/revisions\/5309"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media\/5032"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media?parent=5308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/categories?post=5308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/tags?post=5308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}