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4.1 QA-QC Procedures
4.1 QA-QC Procedures
4.1 QA-QC Procedures
1.0 Purpose;
1.1 To establish a documented procedure to control non-conforming products and to detail how HTL shall
prevent the unintended usage and delivery of the product or material that does not conform to specified
requirements.
2.0 Scope;
2.1 This procedure is the requirement for the effective control by HTL of their out of specification products.
It covers all products of all stages
• When acceptance criteria for Quality control plan are exceeded
• Loss of control of operational parameters
• The products affected to the product safety, quality and legal requirements
3.0 Reference;
3.1 ISO9001:2015 Quality Management System – Requirements, Clause No 8.7
3.2 ISO14001:2015 Environmental Management System – Requirements, Clause No 10.2, 10.3
3.3 OHSAS 18001:2007 Occupational Health & Safety Management System
3.4 TL 9000:2016 Quality Management System Requirement Handbook (R6) - Requirements, clause .8.7
4.0 Responsibility;
4.1 Process owner, All Department Heads
5.0 Procedure:
5.1 Incoming material non conformances:
• All incoming materials for process are inspected for against Specifications.
• In case, if any deviations are observed the products are not processed further and kept aside with
identification and separate red mark rejection area.
• On verifying the nature of deviation, Quality Assurance Manager ensures to communicate the same
to the suppliers/customer in case of customer supplied materials.
• The deviated materials on agreement of deviation in material by supplier /customer, material will be
sending back to the supplier party and replacement is arranged once the supplier/customer agrees.
• If the material accepted under concession or deviation, CA report shall be filed and the entire usage
of the same material monitored closely.
CA – Corrective Action
5.2 In –process non conformances:
• If any deviation observed during in-process inspection, & it should be recorded in the CA report
and reprocessing the same.
• The products which can be re-worked are shifted to re-work yard and identified with tags.
• Where possible, re- work of products shall be done as per instructions in CA report.
• The details shall be recorded, in the Production report if re-works are done,
• All re-worked products are 100% re-inspected as per specifications and inspection reports are
maintained.
• Products which can’t be re-worked will be discarded & the details will be recorded in the CA
report.
• Corrective actions shall be updated in the risk register
• Rejected product it should be kept in Separate Red rejection Area
5.3 Final inspection
• Production incharge shall finished goods handover to QA, after inspected as per FG declaration by
QA incharge .
• All the finished goods are inspected as per order requirement by QA incharge handover to Dispatch
department and if any deviations observed during final inspection, it should be recorded in the CA
report and will be reprocessed after QA confirmation.
• Where reprocess is not possible, the same is discarded. All accepted products are shifted to packing
area. NC’s observed at this stage are recorded in CA reports.
• Where required, Head/COO decides to obtain concession on deviation from customer to dispatch
non-conformance under deviation.
• Deviation products are not authorized for delivery to customer under concession.
• The material dispatched under deviation will be properly identified on each lot.
• Production Head ensures to carry out analysis of non-conformance products once in a month by
using QC tools & prioritize the deviations for taking corrective actions.
• Corrective actions are taken as per the Production Head.
• Corrective actions shall be updated in the risk register.
Revision Record
Revision Description of the changes Prepared Date
1.0 Purpose;
1.1 To establish a system for measurement to evaluate compliance to monitor progress in achieving IMS objectives and
operational requirements.
2.0 Scope;
2.1 Applicable to all the products and the IMS at HTL.
3.0 Reference;
3.1 ISO9001:2015 Quality Management System – Requirements, clause –9.1
3.2 ISO14001:2015 Environmental Management System – Requirements, clause – 9.1
3.3 OHSAS 18001:2007 Occupational Health & Safety Management System Requirements, clause – 4.5.1
3.4 TL 9000:2016 Quality Management System Requirement Handbook (R6) - Requirements, clause-9.1
4.0 Definitions;
4.1 Inspection- conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing
or gauging.
4.3 Verification – confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled.
4.4 Audit – systematic, independent and documented process for obtaining audit evidence and evaluating it objectively
to determine the extent to which audit criteria are fulfilled.
5.0 Responsibility;
5.1 MR, Internal Auditors and Auditee, QA Head, QA Engineer
5.2 Production Head, Production Engineer
5.3 Area Incharge
6.0 Records;
6.1 Record must be maintained in prescribed format register with document control cell.
7.0 Procedure;
7.1 Raw Material Inspection
Incoming good receipt shall be checked / tested by IGI incharge as per quality test plan and RMS, record
should be maintained in RM test format.
After completion inspection of RM, Material reject or passed as per test result and marked Red tag for reject
RM and Green tag for passed RM , Yellow tag for under testing RM ,Rejected material shall to be send NCR
area
Rejected material send back to supplier and purchase head shall take corrective action from supplier
IGI inspection based on sampling basis plan QA-XRM-WI-SPRM-033
Supplier Performance Rating by Purchase/ QA department as per procedure QA-XRM-WI-XSPR-035
Above 95 and QI rating above 50% - Excellent
80- 95 and QI rating above 50% - Very Good
60 – 80 and QI rating above 50% - Good
50 -60 and QI rating above 50% - Average
Below 50 – Poor
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-XMMP-024
Issue 02, Rev: 01
Procedure for Monitoring and Date: 02.01.2017
Measurement Page 2 of 3
If Product is OK put it Green tag on product and if product is HOLD then put White tag on product and send to
define NCR area
Keep all record in In process test format electronic copy or hard copy
Based on the quality achievement first time right (FTR) is analyzed for measuring the process performance.
Overall equipment efficiency (OEE) is monitored for measuring the effectiveness of the process and the
efficiency of the machineries.
On time delivery (OTD) is monitored to ensure customer expected scheduled delivery or met.
If any deviation observed during in-process inspection, & it should be recorded in the CA report and
reprocessing the same.
Maintenance is responsible for calibration of inspection instruments; measuring and test equipments’ used for
monitoring and measurements of IMS attributes and shall maintain the records of the same.
The instruments used for Monitoring IMS parameters shall be calibrated by maintenance (in house or external).
External assistance can be taken for such calibration, and those labs shall be recognition of national standard or
NABL accreditation.
A master list of instruments & equipments required to be calibrated maintained by maintenance team on a
periodical basis.
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-XMMP-024
Issue 02, Rev: 01
Procedure for Monitoring and Date: 02.01.2017
Measurement Page 3 of 3
Safety walk shall be conducted once in a month by IMS team to indentify effectiveness as well as deficiency of
the EHS implementation.
REVISION RECORD
Revision Description of the changes Prepared Date
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-CACI-027
Issue 02, Rev: 01
Procedure for Nonconformity Date: 02.01.2017
Corrective Action and continual
Page 1 of 5
improvement
1.0 Purpose;
1.1 To define a procedure for Nonconformity and corrective action, continual improvement.
2.0 Scope;
2.1 Applicable to non conforming products discovered at all stages of production or after delivery or start use of the
product material at HTL.
3.0 Reference;
3.1 ISO9001:2015 Quality Management System – Requirements, clause – 10.2
3.2 ISO14001:2015 Environmental Management System – Requirements, clause – 10.2
3.3 OHSAS 18001:2007 Occupational Health & Safety Management System Requirements –Clause -4.5.3.2
3.4 TL 9000:2016 Quality Management System Requirement Handbook (R6) - Requirements, clause-10.2
4.0 Definitions;
4.1 Nonconformity: Non-fulfilment of a requirement
4.2 Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.
4.3 Correction: A correction is any action that is taken to eliminate nonconformity. However, corrections do not address
root causes. When applied to products, corrections can include reworking products, reprocessing them, regarding
them, assigning them to a different use, or simply destroying them.
4.4 Continual improvement: recurring activity to enhance performance, continual improvement process is in detail
developed Deming cycle PDCA (Plan – Do – Check – Act).
5.0 Responsibility;
4.1 All Department Heads
6.0 Records;
5.1 Records to be maintain prescribed formats mention in CA Report -QA-OFC-FR-XXCA-013 and Internal Audit
Report IMS-XMR-FR-XIAR-004
7.0 Procedure;
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-CACI-027
Issue 02, Rev: 01
Procedure for Nonconformity Date: 02.01.2017
Corrective Action and continual
Page 2 of 5
improvement
7.1.7 After re inspection QA inspector will update the remark in FG Declaration format QA Inspector
PR-XFG-FR-XFGD-001
7.1.8 In case any downgrading approval is required from customer obtain necessary Production Head
approval in written from customer
7.1.9 For any NC occurrence, departmental head / process owner shall verify the risk IMS coordinator
register for the particular NC is addressed or not. If addressed IMS team shall
investigate the particular instance and impart effective mitigation plan, if not IMS
team shall update the risk register
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-CACI-027
Issue 02, Rev: 01
Procedure for Nonconformity Date: 02.01.2017
Corrective Action and continual
Page 3 of 5
improvement
7.3.8 For any NC occurrence, departmental head / process owner shall verify the risk IMS Coordinator
register for the particular NC is addressed or not. If addressed IMS team shall
investigate the particular instance and impart effective mitigation plan, if not IMS
team shall update the risk register
7.4.2 Obtain necessary delivery date extension from customer for further supply of Sales
material
7.4.3 Respective departments will take corrective action after cause analysis both for ex- HOD
works and Logistics failures. Cause analysis and corrective will be recorded in the
format no QA-OFC-FR-XXCA-013
7.4.4 Calculation of OTD as per Format PR-XFG-FR-XOTD-002, OTD performance HOD
and corrective & preventive actions will be reviewed in Management Committee
meetings.
7.4.5 For any NC occurrence, departmental head / process owner shall verify the risk IMS
register for the particular NC is addressed or not. If addressed IMS team shall Coordinator
investigate the particular instance and impart effective mitigation plan, if not IMS
team shall update the risk register
7.5.1 A situation of noncompliance with safety, environmental or other regulations EHS Officer
7.5.2 Any external complaints, complaints from employees, near miss EHS Officer
7.5.3 A recurring problem with a process or work operation with the potential for safety HOD
or environmental impact.
7.5.4 Noncompliance or non-conformance observed during an internal, corporate or EHS Officer
third-party audit
7.5.5 Accidents or incidents with the potential for safety or environmental impact. HOD
7.5.6 Significant aspect or hazards control. HOD
7.5.7 For any NC occurrence, departmental head / process owner shall verify the risk EHS Officer
register for the particular NC is addressed or not. If addressed EHS Officer shall
investigate the particular instance and impart effective mitigation plan, if not EHS
Officer shall update the risk register
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-CACI-027
Issue 02, Rev: 01
Procedure for Nonconformity Date: 02.01.2017
Corrective Action and continual
Page 4 of 5
improvement
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No :
SOP Document IMS-XMR-PR-CACI-027
Issue 02, Rev: 01
Procedure for Nonconformity Date: 02.01.2017
Corrective Action and continual
Page 5 of 5
improvement
action completed: the effectiveness and efficiency of the improvement project owner/HOD
should be evaluated and consideration should be given for using its solution
elsewhere in the organization
REVISION RECORD
Revision Description of the changes Prepared Date
Prepared by: IMS Coordinator Format No. IMS-XMR-FR-XSFP-003 Approved by: Management Representative
Name: Hemlata Thakur Revision No. 0.0 Name: Mr.Anil Lagad
The information contained in this document is proprietary to HTL and shall not be disclosed in whole or in part in any form or for any reason except as
expressly stated in writing by HTL.
Doc No:
Flow Chart QA-PFC-FR-IGIF-001
Issue 01, Rev: 00
Incoming good inspection Flow Chart Date: 12.03.2016
Page 1 of 1
1.0 Purpose;
1.0 A flowchart visually displays the sequence of activities in a process Incoming good inspection.
2.0 Scope;
2.1 Cover all activity of Incoming good inspection.
Checking of Vendor
Test Report parameter
and MSDS for new
RM
QA Department Reject RM
Inspection
Accept
Raw Material
Material Return Stock
to Vendor
1.0Purpose –
Purpose of this flowchart is streamline the finished product flow with handling responsibility at
each stage from production till dispatch
2.0Flow Chart –
Flow Chart Document Responsibility
Rework / Retest
N ok QC Quality
ok
Quality
Top / Bottom with Outgoing register
End cap and pulling
Eye attachment