QMS MODULE_V8_14APR2016
Degree of compliance Overview (per section)
Total
Section Green Yellow Orange Red N/A Questions
1. General Management Elements
2. Senior Management Commitment
And Continual Improvement
3. Management System
4. Product Control
5. Product Conformity Assessment
6. Process Control
7. Personnel
OVERALL
Audit Findings Summary
Critical Non-conformance Section
Clause Clause Requirement Levels of Non- Audit Findings
No. Conformance
3 MANAGEMENT SYSTEM
3.8.3 The company can identify, trace, and Critical
locate 100% of finished product ( RED )
lots/batches from raw material (based
on random sampling).
3.8.4 The company can identify, trace, and Critical
locate 100% of raw materials used in ( RED )
customer products (based on random
sampling).
Please submit a corrective action plan within 14 days after the audit for the nonconformance’s mentioned in the above
and underneath sections.
The above reflects our findings for the particular factory in concern on the date of our service only. This report does not certify, confirm or imply: a) compliance with any Page 1 of 8
government, industry or association regulations or standards, unless stated otherwise; or, b) the quality of any specific products manufactured by the factory/sellers/suppliers; or,
c) the shipment of any specific products. This report does not discharge or release the factory/sellers/suppliers from their commercial, legal or contractual obligations with buyers
in respect of products manufactured by the factory/sellers/suppliers. Our services, including reports and certificates, are subject to the General Conditions of Service of Bureau
Veritas which have been sent to your company. They can be resent upon written request. This report cannot be partially copied. Any reader other that the party for which this
report has been specifically issued is hereby informed that the General Conditions of Service of Bureau Veritas contain liability limitation provisions.
Bureau Veritas Consumer Products Services (India) Pvt. Ltd. Address: F-5, Sector 8, Noida, Uttar Pradesh, India, Phone: +911204768154, Email:
nishant.anand@bureauveritas.com.
Audit Findings Summary
Clause Clause Requirement Levels of Non- Audit Findings
No. Conformance
1 General Management Elements
1.7.2b The company shall have a record Major
showing implementation of the ( ORANGE )
production item control procedure (e.g.
needles or blades)
1.7.5 The company shall establish and Major
implement corrective action and
( ORANGE )
reporting procedures for lost/broken
items that could contaminate production
(e.g. broken needles or broken blades).
These will include the retrieval of
lost/broken parts, isolation / quarantine
and re-inspection of affected production
lots.
1.2.1 The process flow from intake to dispatch Minor
shall be designed to prevent product ( YELLOW )
contamination and damage.
1.3.1 Premises are sufficiently illuminated in Minor
order to permit effective cleaning, ( YELLOW )
production, monitoring, and inspection.
1.3.3 Where appropriate, humidity and Minor
ambient temperatures are controlled to
( YELLOW )
ensure product integrity.
2 SENIOR MANAGEMENT COMMITMENT
AND CONTINUAL IMPROVEMENT
2.2 Metrics are in place to measure on-time Major
delivery. A process is in place to ( ORANGE )
communicate to the customer, in
advance, when the possibility of missing
a delivery exists.
2.3 ''Quality Improvement Process is in- Major
place. Daily quality review meetings ( ORANGE )
with action plans developed and
implemented. Representatives of
Production, Equipment AND Machinery
Maintenance, and Operator Training
departments regularly attend the
meetings.
''
3 MANAGEMENT SYSTEM
The above reflects our findings for the particular factory in concern on the date of our service only. This report does not certify, confirm or imply: a) compliance with any Page 2 of 8
government, industry or association regulations or standards, unless stated otherwise; or, b) the quality of any specific products manufactured by the factory/sellers/suppliers; or,
c) the shipment of any specific products. This report does not discharge or release the factory/sellers/suppliers from their commercial, legal or contractual obligations with buyers
in respect of products manufactured by the factory/sellers/suppliers. Our services, including reports and certificates, are subject to the General Conditions of Service of Bureau
Veritas which have been sent to your company. They can be resent upon written request. This report cannot be partially copied. Any reader other that the party for which this
report has been specifically issued is hereby informed that the General Conditions of Service of Bureau Veritas contain liability limitation provisions.
Bureau Veritas Consumer Products Services (India) Pvt. Ltd. Address: F-5, Sector 8, Noida, Uttar Pradesh, India, Phone: +911204768154, Email:
nishant.anand@bureauveritas.com.
3.3.3 The company shall have a system in Major
place, to ensure that the company is
( ORANGE )
kept informed of all relevant legislation,
product safety issues, legislative,
scientific and technical developments,
as well as any applicable
Industry/Customer Codes of Practice.
3.4.1 The company shall ensure that Major
processes are in place to determine ( ORANGE )
their customer's needs and
expectations. Performance indicators
relating to customer satisfaction have
been established.
3.11.2 All documents in use are the correct Major
version. ( ORANGE )
3.8.2 Raw materials (including packaging), Minor
work in progress and finished products ( YELLOW )
shall be identified to ensure traceability.
3.8.5 The system shall be regularly tested to Minor
ensure traceability can be determined ( YELLOW )
from raw material source to finished
product and vice-versa.
3.10.1 The company shall have, and operate in Minor
accordance with written detailed ( YELLOW )
procedures, instructions, and reference
documents to cover all manufacturing
processes.
3.11.1 The company shall establish and/or Minor
maintain proper documentation for ( YELLOW )
control of formulas, specifications, BOM,
procedures and work instructions
4 PRODUCT CONTROL
4.3.3 Materials and products are used Major
following a FIFO policy or based on its ( ORANGE )
shelf life.
4.4.2 Records indicate that finished products Major
are released by authorised personnel. ( ORANGE )
4.5.2 Corrective actions shall be implemented Major
to avoid recurrence of non-conformance ( ORANGE )
and documentation kept of the action
taken.
4.1.3 Glass control records related to Minor
maintenance, breakage and corrective ( YELLOW )
actions shall be completed and
maintained on file.
4.2.1 The company shall establish procedures Minor
for the control of any chemicals used in ( YELLOW )
the facility.
4.2.2 All Material Safety Data Sheets (MSDS) Minor
or equivalent documents are on file and ( YELLOW )
up to date.
4.2.4 All chemicals are segregated during Minor
The above reflects our findings for the particular factory in concern on the date of our service only. This report does not certify, confirm or imply: a) compliance with any Page 3 of 8
government, industry or association regulations or standards, unless stated otherwise; or, b) the quality of any specific products manufactured by the factory/sellers/suppliers; or,
c) the shipment of any specific products. This report does not discharge or release the factory/sellers/suppliers from their commercial, legal or contractual obligations with buyers
in respect of products manufactured by the factory/sellers/suppliers. Our services, including reports and certificates, are subject to the General Conditions of Service of Bureau
Veritas which have been sent to your company. They can be resent upon written request. This report cannot be partially copied. Any reader other that the party for which this
report has been specifically issued is hereby informed that the General Conditions of Service of Bureau Veritas contain liability limitation provisions.
Bureau Veritas Consumer Products Services (India) Pvt. Ltd. Address: F-5, Sector 8, Noida, Uttar Pradesh, India, Phone: +911204768154, Email:
nishant.anand@bureauveritas.com.
storage and separated from raw ( YELLOW )
materials and finished products by a
physical barrier.
4.3.1 Procedures shall be in place at storage Minor
and production areas to prevent cross ( YELLOW )
contamination and misuse of raw
materials,
packaging and finished products.
4.3.2 Record shall be available showing the Minor
prevention of cross contamination and
( YELLOW )
misuse of raw materials, packaging and
finished products.
4.4.1 Finished products, including critical raw Minor
materials, shall be subjected to a ( YELLOW )
positive release system.
4.5.1 The company shall establish procedures Minor
for the identification, segregation, ( YELLOW )
investigation and disposition of non-
conforming raw materials (including
packaging), work-in-
progressand finished products.
Disposition of finished products shall be
per any applicable customer
requirements.
4.5.3 Records of non-conforming products are Minor
routinely verified against product lots
( YELLOW )
held in a controlled area awaiting
disposition.
5 PRODUCT CONFORMITY ASSESSMENT
5.3.1 Pre-final and final inspection (including Major
apperance, function, workmanship, ( ORANGE )
quantity) shall be conducted as per
factory procedure and customer
requirements (If any).
5.2.1 Data sheets, working instructions, and Minor
templates, etc shall be installed working ( YELLOW )
areas and utilized by the operators.
5.2.3 The inspectors shall use a formal, Minor
documented inspection schedule and ( YELLOW )
sampling plan with documented records,
which cover all critical/major elements of
the manufacturing process.
5.2.4 The inspection criteria (e.g. defect Minor
classification, specifications) shall be
( YELLOW )
available and comply with customer
requirements (if any).
6 PROCESS CONTROL
6.1.1 An inspection plan including defect Major
classification, sample size, and
( ORANGE )
accept/reject criteria for incoming
materials and components shall be
defined.
The above reflects our findings for the particular factory in concern on the date of our service only. This report does not certify, confirm or imply: a) compliance with any Page 4 of 8
government, industry or association regulations or standards, unless stated otherwise; or, b) the quality of any specific products manufactured by the factory/sellers/suppliers; or,
c) the shipment of any specific products. This report does not discharge or release the factory/sellers/suppliers from their commercial, legal or contractual obligations with buyers
in respect of products manufactured by the factory/sellers/suppliers. Our services, including reports and certificates, are subject to the General Conditions of Service of Bureau
Veritas which have been sent to your company. They can be resent upon written request. This report cannot be partially copied. Any reader other that the party for which this
report has been specifically issued is hereby informed that the General Conditions of Service of Bureau Veritas contain liability limitation provisions.
Bureau Veritas Consumer Products Services (India) Pvt. Ltd. Address: F-5, Sector 8, Noida, Uttar Pradesh, India, Phone: +911204768154, Email:
nishant.anand@bureauveritas.com.
6.2.1 Measuring and monitoring equipment Major
used to verify conformance to
( ORANGE )
specifications are routinely calibrated to
recognized national standards.
6.2.3 Records indicate that measuring and Major
monitoring equipment found to be ( ORANGE )
outside tolerance is immediately re-
calibrated or replaced.
The above reflects our findings for the particular factory in concern on the date of our service only. This report does not certify, confirm or imply: a) compliance with any Page 5 of 8
government, industry or association regulations or standards, unless stated otherwise; or, b) the quality of any specific products manufactured by the factory/sellers/suppliers; or,
c) the shipment of any specific products. This report does not discharge or release the factory/sellers/suppliers from their commercial, legal or contractual obligations with buyers
in respect of products manufactured by the factory/sellers/suppliers. Our services, including reports and certificates, are subject to the General Conditions of Service of Bureau
Veritas which have been sent to your company. They can be resent upon written request. This report cannot be partially copied. Any reader other that the party for which this
report has been specifically issued is hereby informed that the General Conditions of Service of Bureau Veritas contain liability limitation provisions.
Bureau Veritas Consumer Products Services (India) Pvt. Ltd. Address: F-5, Sector 8, Noida, Uttar Pradesh, India, Phone: +911204768154, Email:
nishant.anand@bureauveritas.com.
6.2.2 Records of equipment calibration Minor .
and re-calibration are ( YELLOW )
maintained.
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