Revised Guidelines for dealing with non-conformity of product(s) & Unsatisfactory performance

Background

• Increased surveillance frequency and samples testing

1. Need for more comprehensive overall review of performance

• Scheme of Inspection and Testing (SIT) made recommendatory.
• Manufacturers allowed to define their

1. Own levels of control
2. Batch/Lot/Control Unit

• REQUIREMENT FOR IN-HOUSE TEST FACILITIES RELAXED
• Initiation of practice classifying certain requirements as non-critical in nature

1. REVISED GUIDELINES FOR DEALING WITH NON-CONFORMITY

Outlines procedures for managing non-conformity

Include

• Review of Performance (RoPs)
• Submission and verification of corrective actions
• Risk assessment for Product recall
• Imposition of suspension (SuS)
• Revocation of suspension (RoS)
• Deviations in Marking and labelling requirements
• Intentional and/or repeated production of non-conforming product
• Enhanced surveillance mechanism
• Cancellation
• Re-certification of cancelled licences

2. SALIENT MODIFICATIONS/ NEW PROVISIONS

Issues faced in dealing with instances of sample failures, evaluation of outcomes and actions to be taken were reviewed and addressed in the revised guidelines:

• Comprehensive Review of Performance (RoP)
• Outcomes of all Test Reports received over a period of 2 years to be considered
• Cycle of counting first or consecutive sample failure for action broken.
• Critical or Non-Critical failures to have different repercussions.
• Intentional / repeated use of Standard Mark on non-conforming products
• Handing deviations in Marking and Labelling requirements introduced
• Visits after seeking corrective action to be treated as surveillance visit.
• Onus of informing corrective action is on manufacturer.
• Enhanced surveillance of Non-compliant manufacturers (criteria & duration)
• Re-application of cancelled licences addressed

3. Examination of Test Reports

• Grade, type, class variety if not marked (where required as per ISS/SIT)

1. Sample to be tested as per most stringent grade covered in standard
2. Evaluate TR as per the most stringent grade in standard

 (Unless variety apparently distinguishable and is technically appropriate)

4. Dealing with Non-conformity

Non-conformity

ANY FAILURE IN Third Party Laboratory (TPL) or Factory Testing (FT)

1. First / NON-CONSECUTIVE Non-Conformity
2. Consecutive Non-Conformity

• CRITICAL AND NON-CRITICAL PARAMETERS WHERE SPECIFIED ARE TO BE TAKEN INTO ACCOUNT

1. Critical or Non-Critical FAILURES to have different repercussions.
2. ALL PARAMETERS SHALL BE CONSIDERED CRITICAL UNLESS SPECIFIED

• SITUATIONS ARE DEFIND EXPLICITLY WHICH LEAD TO

1. SEEKING CORRECTIVE ACTIONS
2. SUSPENSION
3. CANCELLATION

5. Comprehensive Review of Performance (RoP)

Non-conformity is TPL or Factory Testing (FT): RoP TO BE CONDUCTED

Key Actions in RoP:

• Determine if FIRST/ NON-CONSECUTIVE/CONSECUTIVE non-conformity.
• Perform RISK ASSESSMENT analysis
• Record as CRITICAL UNLESS specified as NON-CRITICAL
• List All RELEVANT TEST REPORTS and SAMPLES drawn in PAST 2 YEARS
• Calculate PERCENTAGE of samples non-conforming in CRITICAL requirements
• Record & Assess LICENSEE’S PERFORMANCE over last 2 year
• Review deviations in LABELING AND MARKING
• Other Actions like corrective actions, recall and recommendations

COMPLETE DECISION ON ROP IN 5 WORKING DAYS FROM RECORDING OF NON-CONFORMITY. RoP facilitates Data Driven Decision Making. 

6. Non-Compliance to Labelling and Marking Requirements

Deviation Handling PROCEDURE:

• Shall not be treated as sample non-conformity .
• RoP shall be put up depending upon seriousness of deviation
• Deviations addressed with a structured approach.

CATEGORIES  of Deviations: CLASSIFED AS UNDER

(a) Minor Deviations: for example.: batch no./C.U./lot no./ D.O.M. (non-food products) etc

(b) Intermediate Deviations: for example:  grade, type, variety etc.

(c) Major Deviations: for example: expiry date (food products), Shelf life, BIS licence number, SAFETY LABELLING etc.

7. Non-Compliance to Labelling and Marking Requirements

Action Process

(a) Minor Deviations:

• 1st and 2nd instance: Seek corrective actions
• 3rd instance: Issue notice for suspension.

(b) Intermediate Deviations:

• 1st instance: Seek corrective actions.
• 2nd instance: Issue notice for suspension.

(c) Major Deviations:

• 1st instance: Issue notice for suspension.
• Repeated instances: Initiate proceedings for license cancellation.

(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

 Determining 2nd or 3rd  or 4th Instances OF deviations:

2 YEARS DURATION STARTING FROM THE DATE OF REPORTING OF CURRENT DEVIATION SHALL BE USED.

8. SITUATIONS LEADING TO Corrective Actions for Product Non-Conformity

Corrective actions are initiated in cases involving:

(A) FIRST / NON-CONSECUTIVE NON-CONFORMITY IN ANY REQUIREMENT OR

(B) CONSECUTIVE (2nd ) NON-CONFORMITY WITH ONE OF THEM IN NON-CRITICAL REQUIREMENT,

1. C) CONSECUTIVE (2ND) NON-CONFORMITY WITH BOTH OF THEM IN NON-CRITICAL REQUIREMENT

Submission of Evidence of conformity:

• Manufacturer to provide corrective actions, supporting evidence, including root-cause analysis,
• In-house or recognized/empanelled/ NABL accredited LAB test reports (TR) OF SAME VARIETY accepted as evidence.

Verification Procedure:

• Head BO TO ARRANGE EARLY SURVELLIANCE VISIT FOR CA VERIFICATION

9. INSPECTION THROUGH Surveillance Visit for Verification of Corrective Actions

1. Testing and Sampling Procedure during the visit:

All possible tests in a day ON FOLLOWING SAMPLES:

1. a) Variety(ies) that was found non-conforming
2. b) Additional sample(s) from stock (if available) with production done before the date of corrective actions shall also be tested.
3. c) Variety(ies) found non-conforming shall also be drawn for TPL testing.

In case during above surveillance inspection sampling for FT or TPL could not be done BO to plan another surveillance inspection within a month

2. Verification Report:

• Highlights implementation of corrective actions
• Unsatisfactory implementation LEAD TO SUSPENSION THROUGH NOTICE.

10. Non-Receipt of Corrective Actions

1. Onus of Corrective Actions:

Responsibility for corrective actions lies with the manufacturer.

2. Presumption of Corrective Actions:

If corrective actions are not received within 30 DAYS (as applicable), it’s presumed that the manufacturer has taken corrective actions.

3. Incomplete or Irrelevant Corrective Actions:

Deficiencies in the reply are communicated to the manufacturer.

4. Early Surveillance Planning:

In case of non-receipt or inadequate corrective actions, an early surveillance visit shall be arranged by Head BO preferably by CO or otherwise by TA

11. SITUATIONS LEADING TO Notice and imposition of suspension

1. Suspension may be imposed with prior notice of 10 days

(i) 1st non-conformity of food products

(ii) Consecutive (2nd) Critical non-conformity of samples.

(iii) Consecutive (3rd) non-conformity of samples (Critical or Non-Critical).

2. Suspension due to repeated use of Standard Mark on non-conforming goods
3. iv) MORE than 1/3rd of surveillance samples tested failing in Critical Requirements during the last 2 years. (Atleast 3 samples drawn and tested)

(v)More than 3/4th of surveillance samples tested failing in any  Non-critical or Critical Requirements (IF SPECIFIED) during the last 2 years.  (Atleast 4 samples drawn and tested)

(vi) In case there is evidence that the non-conforming goods with standard mark are being produced intentionally and repeatedly.

12. Inspection (SPECIAL) for VERIFICATION OF CA AFTER SUSPENSION NOTICE OR Revocation of Suspension (RoS)

Manufacturer with In-House Test Facility

1. Factory Testing Procedure:

• Samples tested in the factory for all possible tests, including requirements with non-conformity, if testing can be completed within TWO DAYS.
• Compliance to SIT since last surveillance shall be checked and reported.

2. Sample Selection:

• Variety found non-conforming last and produced after corrective actions.

3. Options for Manufacturers:

• with in-house facilities may request visit for a higher no. of days

4. Basis for CONTINUATION OF NORMAL OPERATION or RoS:

• Based on outcome of Factory Testing

5. Alternative Option:

• For longer testing times (>2 days) sample may be drawn for TPL testing
• Continuation of Normal Operation or RoS may proceed based on possible tests and undertaking by Mfr.

13. Inspection for VERIFICATION OF CA AFTER SUSPENSION NOTICE OR Revocation of Suspension (RoS)

Manufacturer without In-House Test Facility

1. Third Party Laboratory (TPL) Testing Procedure:

• Samples drawn for TPL testing and tested for all requirements
• Requirements with testing time over 30 days tested if non-conforming

2. Sample Selection:

• Samples include variety found non-conforming last and produced after corrective actions

3. Basis for THE CONTINUATION OF NORMAL OPERATION OR RoS:

• Based on conforming test reports of samples drawn for TPL testing during the visit (including long duration tests, if applicable)

14. Handling Non-Conforming Samples FOR VERIFICATION OF CORRECTIVE ACTIONS AFTER SUS NOTICE OR Revocation of Suspension (RoS)

1. Non-Conformity in Critical Requirement:

• If sample drawn FOR TPL or FT shows non-conformity in CRITICAL requirement in testing SUSPENSION is imposed immediately.
• Proceedings for CANCELLATION initiated

Note#1: After taking a review of the overall performance of licence over a period of 2 years and based on the merits DDGR may give another opportunity for improvement.

2. Non-Conformity in Non-Critical Requirement:

• If sample(s) show non-conformity in NON-CRITICAL requirement in testing (TPL) OR (FT), license put under SUSPENSION again or Suspension may continue.
• Licensee advised to take FURTHER CORRECTIVE ACTIONS and re-offer improved lots for RoS consideration.

15. Provisions for Cancellation of Licence DUE TO NON-CONFORMITY OF SAMPLES

1. Cancellation Process: Regulation 11 of BIS (CA) Regulations, 2018.

a) Cancellation due to Suspension in vogue for more than a year

b) Cancellation due to repeated use of Standard Mark on non-conforming goods:

• Proceedings for cancellation of licence shall be initiated with suspension of licence in following cases:

(i) More than half of surveillance sample test reports (with at least 4 samples) are non-conforming in critical requirements in independent testing over the last 2 years.

ii) Consecutive failure of 3 surveillance samples in critical requirements

C) Cancellation DUE TO EVIDENCE OF INTENTIONAL AND REPEATED USE of Standard Mark on non-conforming goods

16. Enhanced surveillance on non-compliant manufacturers

1. Non-complaint Manufacturers Prioritized:

• Manufacturers with operative licence and non-conforming surveillance samples prioritized for enhanced surveillance.

2. Criteria for Enhanced Surveillance:

(a) IN CASE OF FIRST/ NON-CONSECUTIVE NON-CONFORMITY

After verification of CA, the manufacturer shall be kept under enhanced surveillance as below:

• Factory surveillance once every 3 months
• Market surveillance twice every three months

This shall continue till 3 surveillance sample shall show conformity.

(b) Cases where SUS notice IS ISSUED /SUS IS DONE and normal operation/ RoS allowed

The manufacturer shall be kept under enhanced surveillance as below:

• Factory surveillance once every 3 months
• Market surveillance twice every three months

This shall continue till 4 surveillance sample shall show conformity.

17. Fresh Application of Cancelled Licences

Eligibility for Re-Application:

• Manufacturers whose licence was cancelled due to product non-conformity reasons are ineligible to re-apply under simplified procedure.

Revised Guidelines for dealing with unsatisfactory performance (other than product samples non-conformity)

Central Marks Deptt-1

1. Outcomes of BIS Surveillance Inspections

Outcomes of BIS Surveillance Inspections

(I) Performance Adjudged Satisfactory

(ii) Performance Adjudged Unsatisfactory

(iii) Visit Proved to be Infructuous (None of the objectives OF SURVEILLANCE COULD BE ACHIEVED)

(iv) Visit Proved to be Partially Infructuous eg., No sampling for FT or TPL

1. Infructuous surveillance visits

• CASES where factory surveillance is infructuous OR PARTIALLY INFRACTOUS

1. Sample could not be drawn for testing
2. Plan another factory surveillance within a month

• Manufacturers with regular production but not providing consignee details and market surveillance is ineffective

1. Seek corrective actions and review
2. For repeat instance – issue notice for suspension

Dealing with unsatisfactory performance (other than product samples non-conformity)

Comprehensive Review of Performance (RoP)

1. Performance of last 2 years

Suspension NOT to be done for following reasons:

1. Absence of quality control personnel
2. Non-adherence to declared Quality Assurance Plan (QAP)/ SIT (where accepted)
3. Non-availability of test facilities

Only advice for taking corrective actions & plan early surveillance

3. Corrective actions and verification)

• Visit after seeking corrective actions from the manufacturer

1. To be treated as a surveillance visit
2. As far as possible, visit by BIS officer

• Onus is on the manufacturer to take corrective actions

1. If no reply received in 30 days or partial reply received
2. Presume that corrective actions have been taken

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