{"id":48802,"date":"2025-05-09T14:01:55","date_gmt":"2025-05-09T08:31:55","guid":{"rendered":"https:\/\/plyinsight.com\/?p=48802"},"modified":"2025-05-31T10:41:53","modified_gmt":"2025-05-31T05:11:53","slug":"revised-guidelines-for-dealing-with-non-conformity-of-products-unsatisfactory-performance","status":"publish","type":"post","link":"https:\/\/plyinsight.com\/hi\/revised-guidelines-for-dealing-with-non-conformity-of-products-unsatisfactory-performance\/","title":{"rendered":"Revised Guidelines for dealing with non-conformity of product(s) &#038; Unsatisfactory performance"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><div class=\"vc_row wpb_row\"><div class=\"wpb_column column_container col-sm-12\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p><span style=\"color: #000000;\"><strong>\u092a\u0943\u0937\u094d\u0920\u092d\u0942\u092e\u093f<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Increased surveillance<\/strong> frequency and samples testing<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">Need for more comprehensive overall review of performance<\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Scheme of Inspection and Testing <strong>(SIT)<\/strong> made recommendatory.<\/span><\/li>\n<li><span style=\"color: #000000;\">Manufacturers allowed to define their<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">Own levels of control<\/span><\/li>\n<li><span style=\"color: #000000;\">Batch\/Lot\/Control Unit<\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">REQUIREMENT FOR <strong>IN-HOUSE TEST FACILITIES<\/strong> RELAXED<\/span><\/li>\n<li><span style=\"color: #000000;\">Initiation of practice classifying certain requirements as non-critical in nature<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\"><strong> REVISED GUIDELINES FOR DEALING WITH NON-CONFORMITY<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>Outlines procedures for managing non-conformity <\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Include <\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Review of Performance (RoPs)<\/span><\/li>\n<li><span style=\"color: #000000;\">Submission and verification of corrective actions<\/span><\/li>\n<li><span style=\"color: #000000;\">Risk assessment for Product recall<\/span><\/li>\n<li><span style=\"color: #000000;\">Imposition of suspension (SuS)<\/span><\/li>\n<li><span style=\"color: #000000;\">Revocation of suspension (RoS)<\/span><\/li>\n<li><span style=\"color: #000000;\">Deviations in Marking and labelling requirements<\/span><\/li>\n<li><span style=\"color: #000000;\">Intentional and\/or repeated production of non-conforming product<\/span><\/li>\n<li><span style=\"color: #000000;\">Enhanced surveillance mechanism<\/span><\/li>\n<li><span style=\"color: #000000;\">Cancellation<\/span><\/li>\n<li><span style=\"color: #000000;\">Re-certification of cancelled licences<\/span><\/li>\n<\/ul>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong> SALIENT MODIFICATIONS\/ NEW PROVISIONS<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\">Issues faced in <strong>dealing with<\/strong> instances of <strong>sample failures, evaluation of outcomes and actions to be taken<\/strong> were <span style=\"text-decoration: underline;\">reviewed and addressed<\/span> in the revised guidelines:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Comprehensive Review of Performance<\/strong> (RoP)<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Outcomes of all Test Reports<\/strong> received over a period of <strong>2 years<\/strong> to be considered<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Cycle of counting<\/strong> first or consecutive sample failure for action broken.<\/span><\/li>\n<li><span style=\"color: #000000;\">Critical or Non-Critical failures to have different repercussions.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Intentional \/ repeated use of Standard<\/strong> Mark on non-conforming products<\/span><\/li>\n<li><span style=\"color: #000000;\">Handing deviations in <strong>Marking and Labelling<\/strong> requirements introduced<\/span><\/li>\n<li><span style=\"color: #000000;\">Visits after seeking corrective action to be <strong>treated as surveillance visit<\/strong>.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Onus of informing corrective action<\/strong> is on manufacturer.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Enhanced surveillance<\/strong> of <strong><u>Non-compliant manufacturers<\/u> (criteria &amp; duration)<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Re-application of cancelled licences addressed<\/span><\/li>\n<\/ul>\n<ol start=\"3\">\n<li><span style=\"color: #000000;\"><strong> Examination of Test Reports<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Grade, type, class variety if <u>not marked<\/u> (where required as per ISS\/SIT) <\/strong><\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #0000ff;\"><strong>Sample to be <u>tested as per most stringent grade<\/u> covered in standard<\/strong><\/span><\/li>\n<li><span style=\"color: #0000ff;\"><strong>Evaluate TR as per the most stringent grade in standard <\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>\u00a0(Unless variety apparently distinguishable and is technically appropriate)<\/strong><\/span><\/p>\n<ol start=\"4\">\n<li><span style=\"color: #000000;\"><strong> Dealing with Non-conformity<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>Non-conformity<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">ANY FAILURE IN Third Party Laboratory<strong> (TPL) <\/strong>or Factory Testing <strong>(FT)<\/strong><\/span><\/p>\n<ol>\n<li><strong><span style=\"color: #0000ff;\">First \/ NON-CONSECUTIVE Non-Conformity<\/span><\/strong><\/li>\n<li><strong><span style=\"color: #0000ff;\">Consecutive Non-Conformity<\/span><\/strong><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong>CRITICAL AND NON-CRITICAL PARAMETERS<\/strong> <u>WHERE SPECIFIED<\/u> ARE TO BE TAKEN INTO ACCOUNT<\/span><\/li>\n<\/ul>\n<ol>\n<li><strong><span style=\"color: #0000ff;\">Critical or Non-Critical FAILURES to have different repercussions.<\/span><\/strong><\/li>\n<li><strong><span style=\"color: #0000ff;\">ALL PARAMETERS SHALL BE CONSIDERED CRITICAL UNLESS SPECIFIED<\/span><\/strong><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong>SITUATIONS<\/strong> ARE DEFIND EXPLICITLY WHICH LEAD TO<\/span><\/li>\n<\/ul>\n<ol>\n<li><strong><span style=\"color: #0000ff;\">SEEKING CORRECTIVE ACTIONS<\/span><\/strong><\/li>\n<li><strong><span style=\"color: #0000ff;\">SUSPENSION<\/span><\/strong><\/li>\n<li><strong><span style=\"color: #0000ff;\">CANCELLATION<\/span><\/strong><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>5. Comprehensive Review of Performance (RoP)<\/strong><\/span><\/p>\n<p><strong><span style=\"color: #0000ff;\">Non-conformity is TPL or Factory Testing (FT): RoP TO BE CONDUCTED<\/span><\/strong><\/p>\n<p><strong><span style=\"color: #0000ff;\">Key Actions in RoP:<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Determine if <strong>FIRST\/ NON-CONSECUTIVE\/CONSECUTIVE<\/strong> non-conformity.<\/span><\/li>\n<li><span style=\"color: #000000;\">Perform <strong>RISK ASSESSMENT<\/strong> analysis<\/span><\/li>\n<li><span style=\"color: #000000;\">Record as <strong>CRITICAL UNLESS<\/strong> specified as <strong>NON-CRITICAL<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">List All <strong>RELEVANT TEST REPORTS<\/strong> \u0914\u0930 <strong>SAMPLES<\/strong> drawn in <strong>PAST 2 YEARS<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Calculate <strong>PERCENTAGE<\/strong> of samples non-conforming in <strong><u>CRITICAL<\/u><\/strong> requirements<\/span><\/li>\n<li><span style=\"color: #000000;\">Record &amp; Assess <strong>LICENSEE&#8217;S PERFORMANCE<\/strong> over last 2 year<\/span><\/li>\n<li><span style=\"color: #000000;\">Review deviations in <strong>LABELING AND MARKING<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Other Actions like corrective actions, recall and recommendations<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">COMPLETE DECISION ON ROP IN <strong>5 WORKING<\/strong> DAYS FROM RECORDING OF NON-CONFORMITY. RoP facilitates <strong>Data Driven Decision <\/strong>Making<strong>.<\/strong><\/span><strong style=\"color: #000000;\">\u00a0<\/strong><\/p>\n<ol start=\"6\">\n<li><span style=\"color: #000000;\"><strong> Non-Compliance to Labelling and Marking Requirements<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">Deviation Handling PROCEDURE:<\/span> <\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Shall <strong>not be<\/strong> <strong>treated<\/strong> as sample non-conformity .<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>RoP shall be put up<\/strong> depending upon seriousness of deviation<\/span><\/li>\n<li><span style=\"color: #000000;\">Deviations addressed with a <strong>structured approach<\/strong>.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">CATEGORIES\u00a0 of Deviations: CLASSIFED AS UNDER<\/span> <\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(a) Minor Deviations: for example.:<\/strong> batch no.\/C.U.\/lot no.\/ D.O.M. (non-food products) etc<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(b) Intermediate Deviations: for example:<\/strong>\u00a0 grade, type, variety etc.<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(c) Major Deviations: for example:<\/strong> expiry date (food products), Shelf life, BIS licence number, SAFETY LABELLING etc.<\/span><\/p>\n<ol start=\"7\">\n<li><span style=\"color: #000000;\"><strong> Non-Compliance to Labelling and Marking Requirements<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>Action Process<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(a) Minor Deviations:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>1st and 2nd instance:<\/strong> Seek corrective actions<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>3rd instance:<\/strong> Issue notice for suspension.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>(b) Intermediate Deviations:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>1st instance:<\/strong> Seek corrective actions.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>2nd instance:<\/strong> Issue notice for suspension.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>(c) Major Deviations: <\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>1st instance:<\/strong> Issue notice for suspension.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Repeated instances:<\/strong> Initiate proceedings for license cancellation.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>(d) FOR 4TH INSTANCE OF DEVIATON IN ANY LABELLING AND MARKING REQS (IRRESPECTIVE OF MINOR, INTERMEDIATE, MAJOR) THE CASE MAY BE PUT UP FOR CONSIDERING CANCELLATION <\/strong><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><strong>\u00a0Determining 2nd or 3rd\u00a0 or 4th Instances OF deviations:<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>2 YEARS DURATION<\/strong> STARTING FROM THE DATE OF REPORTING OF CURRENT DEVIATION SHALL BE USED.<\/span><\/p>\n<ol start=\"8\">\n<li><span style=\"color: #000000;\"><strong> SITUATIONS LEADING TO Corrective Actions for Product Non-Conformity<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>Corrective actions are initiated in cases involving:<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(A) FIRST \/ NON-CONSECUTIVE NON-CONFORMITY<\/strong> IN ANY REQUIREMENT OR<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(B)<\/strong> <strong>CONSECUTIVE (2nd ) NON-CONFORMITY <\/strong>WITH ONE OF THEM IN NON-CRITICAL REQUIREMENT,<\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\"><strong>C) CONSECUTIVE (2ND) NON-CONFORMITY <\/strong>WITH BOTH OF THEM IN NON-CRITICAL REQUIREMENT<\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>Submission of Evidence of conformity:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Manufacturer to provide <strong><u>corrective actions<\/u><\/strong>, supporting <strong><u>evidence<\/u><\/strong>, including <strong><u>root-cause<\/u><\/strong> analysis,<\/span><\/li>\n<li><span style=\"color: #000000;\">In-house or recognized\/empanelled\/ NABL accredited LAB test reports (TR) OF SAME VARIETY accepted as evidence.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">Verification Procedure:<\/span> <\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Head BO <strong>TO ARRANGE EARLY SURVELLIANCE<\/strong> VISIT FOR <strong>CA VERIFICATION<\/strong><\/span><\/li>\n<\/ul>\n<ol start=\"9\">\n<li><span style=\"color: #000000;\"><strong> INSPECTION THROUGH Surveillance Visit for Verification of Corrective Actions<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>1. Testing and Sampling Procedure during the visit:<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>All possible tests in a day ON FOLLOWING SAMPLES:<\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\">a) Variety(ies) that was found non-conforming<\/span><\/li>\n<li><span style=\"color: #000000;\">b) Additional sample(s) from stock (if available) with production done before the date of corrective actions shall also be tested.<\/span><\/li>\n<li><span style=\"color: #000000;\">c) Variety(ies) found non-conforming shall also be drawn for <strong>TPL testing<\/strong>.<\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\">In case during above surveillance inspection <strong>sampling for FT or TPL<\/strong> could not be done BO to plan <strong><u>another surveillance inspection<\/u><\/strong> within a month<\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"color: #0000ff;\"><strong> Verification Report:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Highlights implementation of corrective actions<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Unsatisfactory implementation LEAD TO <u>SUSPENSION THROUGH NOTICE<\/u>. <\/strong><\/span><\/li>\n<\/ul>\n<ol start=\"10\">\n<li><span style=\"color: #000000;\"><strong> Non-Receipt of Corrective Actions<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>1. Onus of Corrective Actions:<\/strong> <\/span><\/p>\n<p><span style=\"color: #000000;\">Responsibility for corrective actions <strong>lies with the manufacturer<\/strong>.<\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\"> Presumption of Corrective Actions:<\/span> <\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\">If corrective actions are <strong><u>not received within 30 DAYS<\/u><\/strong> (as applicable), it&#8217;s presumed that the manufacturer has taken corrective actions.<\/span><\/p>\n<ol start=\"3\">\n<li><span style=\"color: #0000ff;\"><strong> Incomplete or Irrelevant Corrective Actions: <\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>Deficiencies in the reply<\/strong> are communicated to the manufacturer.<\/span><\/p>\n<ol start=\"4\">\n<li><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\"> Early Surveillance Planning:<\/span> <\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\">In case of non-receipt or inadequate corrective actions, an early surveillance visit <strong>shall be arranged by Head BO preferably by CO or otherwise by TA <\/strong><\/span><\/p>\n<ol start=\"11\">\n<li><span style=\"color: #000000;\"><strong> SITUATIONS LEADING TO Notice and imposition of suspension<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #0000ff;\"><strong>1. Suspension may be imposed with prior notice of 10 days<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">(i) 1st non-conformity of <strong><u>food products<\/u><\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">(ii) Consecutive (2nd) <strong><u>Critical<\/u><\/strong> non-conformity of samples.<\/span><\/p>\n<p><span style=\"color: #000000;\">(iii) Consecutive (3rd) non-conformity of samples <strong><u>(Critical or Non-Critical).<\/u><\/strong><\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"color: #0000ff;\"><strong> Suspension due to repeated use of Standard Mark on non-conforming goods<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\"><strong><u>iv) MORE than 1\/3rd<\/u><\/strong> of surveillance samples tested failing in <strong><u>Critical Requirements<\/u><\/strong> during the <strong>last 2 years. (Atleast 3 samples drawn and tested)<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>(v)<u>More than 3\/4th<\/u><\/strong> of surveillance samples tested failing in any\u00a0 <strong><u>Non-critical or Critical Requirements<\/u> (IF SPECIFIED)<\/strong> <strong>during the last 2 years.\u00a0 (Atleast 4 samples drawn and tested)<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">(vi) In case there is evidence that the non-conforming goods with standard mark are being produced <strong><u>intentionally and repeatedly.<\/u><\/strong><\/span><\/p>\n<ol start=\"12\">\n<li><span style=\"color: #000000;\"><strong> Inspection (SPECIAL) for VERIFICATION OF CA AFTER SUSPENSION NOTICE OR Revocation of Suspension (RoS)<\/strong><\/span><\/li>\n<\/ol>\n<p><a href=\"https:\/\/www.vimbaply.com\/contact.html\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-41783\" src=\"https:\/\/plyinsight.com\/wp-content\/uploads\/2024\/01\/Vimba-Ply-GIF.gif\" alt=\"Vimba Ply GIF\" width=\"1431\" height=\"161\" \/><\/a><\/p>\n<p><span style=\"color: #0000ff;\"><strong>Manufacturer with In-House Test Facility<\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\"><strong> Factory Testing Procedure:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Samples tested in the factory for <strong><u>all possible tests<\/u><\/strong>, including requirements with <strong><u>non-conformity<\/u><\/strong>, if testing can be completed within <strong><u>TWO DAYS.<\/u><\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\"><strong><u>Compliance to SIT<\/u><\/strong> since last surveillance shall be checked and reported.<\/span><\/li>\n<\/ul>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong> Sample Selection:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Variety <strong>found non-conforming last<\/strong> and produced after corrective actions.<\/span><\/li>\n<\/ul>\n<ol start=\"3\">\n<li><span style=\"color: #000000;\"><strong> Options for Manufacturers:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">with in-house facilities may request <strong><u>visit for a higher no. of days<\/u><\/strong><\/span><\/li>\n<\/ul>\n<ol start=\"4\">\n<li><span style=\"color: #000000;\"><strong> Basis for CONTINUATION OF NORMAL OPERATION or RoS:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong><u>Based on outcome of Factory Testing <\/u><\/strong><\/span><\/li>\n<\/ul>\n<ol start=\"5\">\n<li><span style=\"color: #000000;\"><strong> Alternative Option:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">For longer testing times (&gt;2 days) sample may be drawn for <strong><u>TPL testing<\/u><\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Continuation of Normal Operation or RoS<\/strong> may proceed <strong><u>based on possible tests<\/u><\/strong> \u0914\u0930 <strong><u>undertaking <\/u><\/strong>by Mfr.<\/span><\/li>\n<\/ul>\n<ol start=\"13\">\n<li><span style=\"color: #000000;\"><strong> Inspection for VERIFICATION OF CA AFTER SUSPENSION NOTICE OR Revocation of Suspension (RoS)<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">Manufacturer without In-House Test Facility<\/span> <\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\"><strong> Third Party Laboratory (TPL) Testing Procedure:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Samples drawn for <strong><u>TPL testing<\/u><\/strong> and tested for <strong><u>all requirements<\/u><\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Requirements with testing time over 30 days tested if non-conforming<\/span><\/li>\n<\/ul>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong> Sample Selection:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Samples include variety found <strong><u>non-conforming<\/u><\/strong><u> <strong>last<\/strong><\/u> and produced after corrective actions<\/span><\/li>\n<\/ul>\n<ol start=\"3\">\n<li><span style=\"color: #000000;\"><strong> Basis for THE CONTINUATION OF NORMAL OPERATION OR RoS:<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Based <strong><u>on conforming test reports of samples<\/u><\/strong> drawn for TPL testing during the visit (including long duration tests, if applicable)<\/span><\/li>\n<\/ul>\n<ol start=\"14\">\n<li><span style=\"color: #000000;\"><strong> Handling Non-Conforming Samples FOR VERIFICATION OF CORRECTIVE ACTIONS AFTER SUS NOTICE OR Revocation of Suspension (RoS)<\/strong><\/span><\/li>\n<\/ol>\n<p><strong style=\"color: #0000ff;\">1. Non-Conformity in <u>Critical<\/u> Requirement:<\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">If sample drawn <strong>FOR TPL <\/strong>\u092f\u093e<strong> FT<\/strong> shows non-conformity in <strong><u>CRITICAL<\/u><\/strong> requirement in testing <strong><u>SUSPENSION<\/u><\/strong> <strong>is imposed immediately.<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Proceedings for <strong><u>CANCELLATION<\/u><\/strong> initiated<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>Note#1: After taking a review of the overall performance of licence over a period of 2 years and based on the merits <u>DDGR may give another opportunity<\/u> for improvement. <\/strong><\/span><\/p>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\"> Non-Conformity in <u>Non-Critical<\/u> Requirement:<\/span> <\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">If sample(s) show non-conformity in <strong><u>NON-CRITICAL<\/u><\/strong> requirement in <strong>testing (TPL) OR<\/strong> <strong>(FT),<\/strong> <strong>license put under SUSPENSION again or Suspension may continue. <\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Licensee advised to take <strong><u>FURTHER CORRECTIVE ACTIONS<\/u><\/strong> and re-offer improved lots for RoS consideration.<\/span><\/li>\n<\/ul>\n<ol start=\"15\">\n<li><span style=\"color: #000000;\"><strong> Provisions for Cancellation of Licence DUE TO NON-CONFORMITY OF SAMPLES<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>1. Cancellation Process:<\/strong> Regulation 11 of BIS (CA) Regulations, 2018.<\/span><\/p>\n<p><strong><span style=\"color: #0000ff;\">a) Cancellation due to Suspension in vogue for more than a year<\/span><\/strong><\/p>\n<p><strong><span style=\"color: #0000ff;\">b) Cancellation due to repeated use of Standard Mark on non-conforming goods:<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Proceedings for cancellation of licence shall be initiated <strong><u>with suspension<\/u><\/strong> of licence in following cases:<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">(i) <strong>More than half of surveillance sample<\/strong> test reports (with at least 4 samples) are non-conforming in <strong><u>critical requirements<\/u><\/strong> in independent testing over the last 2 years.<\/span><\/p>\n<p><span style=\"color: #000000;\">ii) Consecutive failure of 3 surveillance samples in <strong><u>critical requirements<\/u><\/strong><\/span><\/p>\n<p><span style=\"color: #0000ff;\"><strong>C) Cancellation DUE TO EVIDENCE OF INTENTIONAL AND REPEATED USE of Standard Mark on non-conforming goods<\/strong><\/span><\/p>\n<ol start=\"16\">\n<li><span style=\"color: #000000;\"><strong> Enhanced surveillance on non-compliant manufacturers<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">1. Non-complaint Manufacturers Prioritized:<\/span> <\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Manufacturers with operative licence and non-conforming surveillance samples prioritized for enhanced surveillance.<\/span><\/li>\n<\/ul>\n<ol start=\"2\">\n<li><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\"> Criteria for Enhanced Surveillance:<\/span> <\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>(a) IN CASE OF FIRST\/ NON-CONSECUTIVE NON-CONFORMITY <\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">After verification of CA, the manufacturer shall be kept under enhanced surveillance as below:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Factory surveillance once every 3 months<\/span><\/li>\n<li><span style=\"color: #000000;\">Market surveillance twice every three months<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">This shall continue <strong>till 3 surveillance sample<\/strong> shall show conformity.<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>(b) Cases where SUS notice IS ISSUED \/SUS IS DONE and normal operation\/ RoS allowed <\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">The manufacturer shall be kept under enhanced surveillance as below:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Factory surveillance once every 3 months<\/span><\/li>\n<li><span style=\"color: #000000;\">Market surveillance twice every three months<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">This shall continue till <strong>4 surveillance sample<\/strong> shall show conformity.<\/span><\/p>\n<ol start=\"17\">\n<li><span style=\"color: #0000ff;\"><strong> Fresh Application of Cancelled Licences<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>Eligibility for Re-Application:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Manufacturers whose licence was cancelled due to product non-conformity reasons are <strong><u>ineligible to re-apply under simplified procedure.<\/u><\/strong><\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>Revised Guidelines for dealing with unsatisfactory performance (other than product samples non-conformity)<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Central Marks Deptt-1<\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\"><strong> Outcomes of BIS Surveillance Inspections<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>Outcomes of BIS Surveillance Inspections <\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">(I) Performance Adjudged <span style=\"color: #0000ff;\"><strong><u>Satisfactory<\/u><\/strong><\/span><\/span><\/p>\n<p><span style=\"color: #000000;\">(ii) Performance Adjudged <span style=\"color: #0000ff;\"><strong><u>Unsatisfactory<\/u><\/strong><\/span><\/span><\/p>\n<p><span style=\"color: #000000;\">(iii) Visit Proved to be <span style=\"color: #0000ff;\"><strong><u>Infructuous<\/u><\/strong> <\/span>(None of the <strong>objectives<\/strong> OF SURVEILLANCE COULD BE ACHIEVED)<\/span><\/p>\n<p><span style=\"color: #000000;\">(iv) Visit Proved to be <span style=\"color: #0000ff;\"><strong><u>Partially Infructuous<\/u><\/strong><\/span><u> <strong>eg<\/strong>.,<\/u> No sampling for FT or TPL<\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\"><strong> Infructuous surveillance visits<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">CASES where factory<strong> surveillance is infructuous OR PARTIALLY INFRACTOUS <\/strong><\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">Sample could not be drawn for testing<\/span><\/li>\n<li><span style=\"color: #000000;\">Plan another factory surveillance within a month<\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Manufacturers with regular production but <strong><u>not providing consignee details<\/u><\/strong> and market surveillance is ineffective<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">Seek corrective actions and review<\/span><\/li>\n<li><span style=\"color: #000000;\">For repeat instance &#8211; issue notice for <strong>suspension<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong> Dealing with unsatisfactory performance (other than product samples non-conformity)<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">Comprehensive Review of Performance (RoP)<\/span> <\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\">Performance of last 2 years<\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong><span style=\"color: #0000ff;\">Suspension NOT to be done for following reasons:<\/span> <\/strong><\/span><\/p>\n<ol>\n<li><span style=\"color: #000000;\">Absence of <strong><u>quality control<\/u> personnel<\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">Non-adherence to declared Quality Assurance Plan <strong><u>(QAP)\/ SIT<\/u><\/strong> (where accepted)<\/span><\/li>\n<li><span style=\"color: #000000;\">Non-availability of <strong><u>test facilities<\/u><\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"color: #000000;\"><strong>Only advice<\/strong> for taking corrective actions &amp; plan early surveillance<\/span><\/p>\n<ol start=\"3\">\n<li><span style=\"color: #000000;\"><strong> Corrective actions and verification)<\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\">Visit after seeking corrective actions from the manufacturer<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">To be treated as a <strong><u>surveillance visit<\/u><\/strong><\/span><\/li>\n<li><span style=\"color: #000000;\">As far as possible, visit <strong><u>by BIS officer <\/u><\/strong><\/span><\/li>\n<\/ol>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Onus is on<\/strong> the manufacturer to take corrective actions<\/span><\/li>\n<\/ul>\n<ol>\n<li><span style=\"color: #000000;\">If <strong>no reply<\/strong> received in 30 days or partial reply received<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Presume that corrective actions<\/strong> have been taken<\/span><\/li>\n<\/ol>\n<hr \/>\n<p style=\"text-align: center;\"><span style=\"color: #ff0000;\"><strong>\u00a0<\/strong><strong>\ud83d\udc47 Please Note\u00a0<\/strong><strong>\ud83d\udc47<\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><span style=\"color: #ff0000;\"><strong>Thank you for reading our article!<\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><span style=\"color: #ff0000;\"><strong>If you don&#8217;t received industries updates, News &amp; 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Manufacturers allowed to define their Own levels of control Batch\/Lot\/Control Unit REQUIREMENT FOR IN-HOUSE TEST FACILITIES RELAXED Initiation of practice classifying certain requirements as non-critical in nature REVISED GUIDELINES FOR DEALING WITH [...]","protected":false},"author":1,"featured_media":48809,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9405],"tags":[9479,1680,9478,9477,8832,9476,6142,9475,9474],"class_list":["post-48802","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-may-articles-2025","tag-critical-unless","tag-guidelines","tag-new-provisions","tag-non-conformity","tag-performance","tag-scheme-of-inspection-and-testing","tag-sit","tag-surveillance","tag-unsatisfactory"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Revised Guidelines for dealing with non-conformity of product(s) &amp; Unsatisfactory performance - PLY INSIGHT<\/title>\n<meta name=\"description\" content=\"COMPLETE DECISION ON ROP IN 5 WORKING DAYS FROM RECORDING OF NON-CONFORMITY. 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