CHEMLINE INDIA

LTD
QUALITY ASSURENCE
QUALITY CONTROL
▶ QA is the part of Quality Management
▶ This is the part of Quality focused on providing confidence that quality
Management system focused on requirement will be fulfilled .
fulfilling of quality
requirement.
▶ QA is the set of activities that ensuring
quality in the process by which products are
▶ QC is the set of activities for developed.
ensuring quality in products .
The activities focus on
identifying defects in the actual
products produced.
LAB TEAM INTRODUCTION
NAME POST KRA REPORTIN NAME POST KRA REPORTIN
G G
Mr. Anil Manager Development of New System , SOP Mr. Sanjay Jha
Pandey (QA) Making , Reducing the variation in Mr. Sachin Chemist Incoming Mr. Rakesh
process & defect free item producing , material
space in which have improvement
Mr. Anil
inspection /work
opportunities , elimination of waste
(Non value added activity) , RCA on
on task as given
Customer customer complaints , by HOD
Working on internal failure and /Providing test
external failure/utilization of non report
moving material . ISO Audit Incoming
Mr. Sunil Chemist Mr. Rakesh
documentation . Review the overall
material Mr. Anil
system related with safety .
inspection /work
Mr. Manager Managing QC activity (Incoming Mr. Sanjay Jha on task as given
Rakesh (QC) material inspection monitoring , sort by HOD
Srivastava out the QC related issue, task as given
/Providing test
by Management and etc. Co-ordination
with purchase , HO & with R&D. report
Customer complaint handling .
Customer handling coming to factory
for visit .
Ankush Kumar : .(Chemist) : Looking the incoming material inspection /
Mr. Babli Sr. Incoming material RM/PM/SF /Finish Mr. Rakesh work on task as given by HOD /Providing test reports test report
Executive goods inspection , working on deviation Mr. Anil
& RCA , Assist to seniors for System
implementation and another task as
given by HOD /Providing test report.
 Quality Control vs Quality
Assurance

QUALITY CONTROL FOCUS ON QUALITY ASSURENCE FOCUS ON

▶ QC aims to identify (and correct) defects ▶ QA aims to prevent defects with a focus
in the products in the finish product , on the process used to make the product .
Quality Control , therefore , is a reactive It is a proactive quality process.
process.
Quality Control vs Quality Assurance Goal differences

▶ The goal of Quality control is to identify ▶ The goal of QA is to improvement

defects after a products is developed development and test process so that
and before it is released defects do not arise when the products
is being developed.
 Finding and elimination sources of quality problems through tools and equipment so that customers requirement are c

Established a good quality management system and the assessment of its adequacy , periodic audits of the operation of
 RESPONSIBILITY

 Prevention of quality problem through planned and

systematic activities including documentation.
 Everyone on the team involved in developing the products is
responsible for quality assurance.

 The activities or technique used to achieve and maintain the

product quality and service.
 Quality control is usually the responsibility of specific team that
test the product for defects
ANIL PANDEY

JOB DISCRIPTION
KEY RESULT AREA
▶ Managing the issue of incoming product like RM,PM, SF
and finish product. ▶ Evaluation the Quality Variation /Under deviation & Rejection
of Raw/Packing , Semi finish & Finish Product material .
▶ Reducing the variation controlled in incoming products ▶ Handling and investigation of market complaints
and for online process issue .
▶ SOPs & Specification Control
▶ Communication between another departments. ▶ Manpower management
▶ Working on Nonmoving. ▶ 5S implementation

▶ Implementation of ISO 9001:2015 system in lab. ▶ Verification and management of all laboratory records
▶ Review the job profile implementation of every officer
▶ New system making for QC/QA effectively working. as distributed .
▶ Execution of quality trend on incoming product . ▶ Coordination with the outside agencies like vendors, auditors,
regulatory departments, same as coordination with internal
▶ SAP related activities and additional changes in SAP internal department like stores, maintenance, purchase,
production etc.
. Monitoring of result recording process.
▶ Changes in current packing & Systems, accordingly changes in
▶ Sort out the issue between QC/QA departments internal another chain .
& externals. ▶ Tracking gap between procedure vs Actual activities done by All
QC officer
▶ CAPA implementation on internal and external complaints.
▶ Playing key role by cordinating /contributing in Development of
▶ Market complaint handling . new packing to be started & ensure product meet quality &
efficiency standard set by senior management with regular
observations & testing of trial samples.
RAKESH SRIVASTAVA

JOB DISCRIPTION
KEY RESULT AREA
▶ Do application testing as per customer requirement.
▶ Product application testing
▶ Utilization of market return material.
▶ Weather impact on products
▶ Sort out the process issue associated with product.
▶ Self life product observation
▶ Role as communicator between R&D & QC specially for
water base adhesive and for Hot melt adhesive. ▶ Safety training .

▶ Execution of system and documents of QC officer ▶ Additional testing in RM/PM/SF.

those are looking of RM and SF inspection activity.
▶ Supporting to seniors .
▶ Sales rejection checking ▶ Party rejection handling
▶ Preparation of market demo sample.
▶ Customer complaint handling .
▶ Work on projects as given by seniors .
▶ Execution of system and documents of QC officer those
▶ Monitoring of QC Officer working . are looking of RM and SF inspection activity.
BABLI KUMAR
JOB DISCRIPTION KEY RESULT AREA
▶ Entry of In process material receiving from Hot melt
Adhesive , Labeling plant , UV and PU Plant and Cold
Glue Plant .
▶ Send the Quality report at end of the month .
▶ Daily inspection of incoming RM and PM . NCB Batches details and taken action on
▶ Listing of COA , maintain the under deviation batches these batches must be required in this report
records & NCB Batches . .
▶ 5S implementation in his area & sample forwarding to
required place. ▶ Data feeding of Semi-finish Material at
the end of month & send to HOD.
▶ Lab Cleaning & storage of controlled sample .
▶ Random checking of log Sheet /process in plant . ▶ New points need for improvement sharing
Crosscheck the process through SOP as available in with HOD .
Plant.
▶ Reviewing the inspection format on daily
▶ Review the storage of RM/PM /In-house
material (Molding) inspection.
basis like as internal calibration , testing ,
SOP implementation , Safety trainings
▶ Chemicals arranging for solution making & providing and etc.
the test report for RM and Finish goods
SACHIN KUMAR
JOB DISCRIPTION KEY RESULT AREA
▶ Entry of In process material receiving from Hot melt
Adhesive , Labeling plant , UV and PU Plant and Cold
Glue Plant .
▶ Daily inspection of incoming RM and PM .
▶ Send the Quality report at end of the month .
NCB Batches details and taken action on
▶ Listing of COA , maintain the under deviation batches
records & NCB Batches . these batches must be required in this report
.
▶ 5S implementation in his area & sample forwarding to
required place.
▶ Detail of RM received in whole month
▶ Lab Cleaning & storage of controlled sample . along with testing result to be submit to
▶ Random checking of log Sheet /process in plant . HOD in excel format
Crosscheck the process through SOP as available in
Plant. ▶ Data feeding of Semi-finish Material, at the
▶ Review the storage of RM/PM /In-house material end of month & send to HOD.
(Molding) inspection.
▶ New points need for improvement sharing
▶ Chemicals arranging for solution making & providing
the test report for RM and Finish goods with HOD .
▶ Solution making /Normality Checking for
titration activity.
SUNIL KUMAR
JOB DISCRIPTION KEY RESULT AREA
▶ Entry of In process material receiving from Hot melt
Adhesive , Labeling plant , UV and PU Plant and Cold
Glue Plant .
▶ Daily inspection of incoming RM and PM .
▶ Send the Quality report at end of the month .
NCB Batches details and taken action on
▶ Listing of COA , maintain the under deviation batches
records & NCB Batches . these batches must be required in this report
.
▶ 5S implementation in his area & sample forwarding to
required place.
▶ Detail of RM received in whole month
▶ Lab Cleaning & storage of controlled sample . along with testing result to be submit to
▶ Random checking of log Sheet /process in plant . HOD in excel format
Crosscheck the process through SOP as available in
Plant. ▶ Data feeding of Semi-finish Material, at the
▶ Review the storage of RM/PM /In-house material end of month & send to HOD.
(Molding) inspection.
▶ New points need for improvement sharing
▶ Chemicals arranging for solution making & providing
the test report for RM and Finish goods with HOD .
▶ Solution making /Normality Checking for
titration activity.
ANKUSH KUMAR
JOB DISCRIPTION KEY RESULT AREA
▶ Entry of In process material receiving from Hot melt
Adhesive , Labeling plant , UV and PU Plant and Cold
Glue Plant .
▶ Daily inspection of incoming RM and PM .
▶ Send the Quality report at end of the month .
NCB Batches details and taken action on
▶ Listing of COA , maintain the under deviation batches
records & NCB Batches . these batches must be required in this report
.
▶ 5S implementation in his area & sample forwarding to
required place.
▶ Detail of RM received in whole month
▶ Lab Cleaning & storage of controlled sample . along with testing result to be submit to
▶ Random checking of log Sheet /process in plant . HOD in excel format
Crosscheck the process through SOP as available in
Plant. ▶ Data feeding of Semi-finish Material, at the
▶ Review the storage of RM/PM /In-house material end of month & send to HOD.
(Molding) inspection.
▶ New points need for improvement sharing
▶ Chemicals arranging for solution making & providing
the test report for RM and Finish goods with HOD .
▶ Solution making /Normality Checking for
titration activity.
 PROCESS FLOW CHART FOR INSPECTION OF RM, PM AND FOR FINISH
PRODUCT

Checking of RM/PM against specif

Sampling
Information /RM Format received from store

Filling value in RM format /Final Remark &

Record data in inspection format
OK or Reject
Quality Assurance
▶ The purpose of quality assurance is to create confidence that the quality plan and controls are
working properly. Time must be allocated to review the original quality plan and compare
that plan to how quality is being ensured during the implementation of the project.
▶ Process Analysis
▶ The flowcharts of quality processes are compared to the processes followed during actual
operations. If the plan was not followed, the process is analyzed and corrective action taken.
The corrective action could be to educate the people involved on how to follow the quality plan,
or it could be to revise the plan.
▶ The experiments that sample products and processes and collect data are examined to see if
they are following statistically valid sampling techniques and that the measurement methods
have small enough tolerances to detect variation within control limits.
▶ The purpose of quality assurance is to build confidence in the client that quality standards
and procedures are being followed. This is done by an internal review of the plan, testing,
and revisions policies or by an audit of the same items performed by an external group or
agency.
APQP PROCESS PICTORIAL DIAGRAM
APQP : Advanced Product Quality Planning
▶ Quality planning and more
▶ Total integration of quality tools with management function
▶ Multi disciplinary team approach to quality planning
▶ Tools to enable supplier to not only meet but exceed customer requirement
▶ To promote early identification of required changes
▶ To avoid late changes
▶ To provide a quality product on time at the lowest cost
▶ Facilitate communication with everyone involved
▶ Developing easily understandable formats by supplier and customers
FUNDAMETAL OF PRODUCT QUALITY PLANNING
▶ Organize the team : to make multi disciplinary team from manufacturing, Engineering , Quality
, Materials , Sales , Service , Sub contractors and customers.
▶ Define the scope : Team leader , role and responsibilities , customer (internal & external) ,
customer requirement , Additional members , feasibility assessment , Cost , timings , constraints
, customer assistance & documentation.
▶ Team to Team : Established line of communication with customer team and other in house team.
▶ Training : Identification and organizing for providing trainings .
▶ Customer & Supplier involvement : identification of issues needs interaction with
customer/sub contractor and resolution.
 MONTHLY QUALITY REPORTING FORMAT
CHEMLINE INDIA
LTD
SONIPAT HARYANA

Annex.1 Summery:
ref:
1 No. of Total RM/PM /SF /Finish materials received Annex.1
2 No. of Total RM/PM /SF Finish materials approved Annex.1
3 No. of RM/PM /SF Finish materials accepted under deviation Annex.2
4 No. of RM/PM /SF Finish material Rejected Annex.3
7 No of CAPA Analysis details sort out by Finish Annex.4
Annex.2 No of RM/PM /SF /Finish Accepted Under Deviation
S.no. MATERIAL NAME WORKCENTRE ORDER NO/BATCH NO LOT QNTY(kg) DOR DOA REMARK Sign.

2
3
4

Annex.3 No of RM/PM /SF /Finish Material Rejected

S.no. MATERIAL NAME WORKCENTRE ORDER NO/BATCH NO LOT QNTY DOR DOA REMARK Sign.

Annex.4 CAPA/6WIH/WHY-2 ANALYSIS REGARDING THE PROBLEM OF UNDER DEVIATION ACCPTED FINISH MATERIAL
S.no. MATERIAL NAME WORKCENTRE ORDER NO/BATCH NO LOT NO DOR DOA REMARK Sign.

Remarks:-
DOR- Date of Rejection
DOA-Date of Approval
DOP-Date of Production
DWM (DAILY WORK MANAGEMENT)
▶ This system provide the ability to manage department function where in process followed are defined
, standardized , controlled & improved by the process owners.
▶ Step -01
▶ Established ownership
▶ Defined function
▶ Primary
▶ Secondary
▶ Tertiary
▶ Established responsibility and accountability.
▶ Responsibility defined what to do?
▶ Authority defined degree of power to make decision.
▶ Established accountability
 DWM (DAILY WORK MANAGEMENT)
▶ Step-02 : “Process & measurement”

▶ Defined process (how can run)

▶ Business flow chart
▶ Procedure
▶ SOP , Work instruction and etc.
▶ Measurement of accountability KNOW THE CAUSES DO NOT KNOW THE CAUSES
▶ Key checkpoint for process control Route cause analysis Understand the fact through
data collection
▶ Step-03 : “Gap Analysis” Generate solution / Data analysis
▶ Gap analysis
Generate the solution/Select best Perform route cause analysis
solution
▶ Identify the gap
Standardized the process Standardized the process
Monitor the success Monitor the success
Horizontal deployment Horizontal deployment
Step : 04 : Time management in DWM
i. Do the focus on activities
ii. Do the focus on priorities
iii. Do the focus on making schedule
iv. Think positively
v. Be mature
vi. Think you can manage solution .
COST OF QUALITY
▶ Cost of quality is a method for calculating the costs companies incur ensuring that products meet
quality standards, as well as the costs of producing goods that fail to meet quality standards. The
goal of calculating cost of quality is to create an understanding of how quality impacts the bottom
line.
▶ Cost of Quality is a methodology used to define and measure where and what amount of an
organization’s resources are being used for prevention activities and maintaining product quality as
opposed to the costs resulting from internal and external failures. The Cost of Quality can be
represented by the sum of two factors. The Cost of Good Quality and the Cost of Poor Quality equals
the Cost of Quality, as represented in the basic equation below:
▶ CoQ = CoGQ + CoPQ
▶ The Cost of Quality equation looks simple but in reality it is more complex. The Cost of Quality
includes all costs associated with the quality of a product from preventive costs intended to reduce or
eliminate failures, cost of process controls to maintain quality levels and the costs related to failures
both internal and external.
How to Measure Cost of Quality (COQ)
Cost of Quality (COQ)
▶ The methods for calculating Cost of Quality vary from company to company. In many cases, organizations
like the one described in the previous example, determine the Cost of Quality by calculating total
warranty dollars as a percentage of sales. Unfortunately this method is only looking externally at the
Cost of Quality and not looking internally. In order to gain a better understanding, a more comprehensive
look at all quality costs is required.
▶ The Cost of Quality can be divided into four categories. They include Prevention, Appraisal, Internal
Failure and External Failure. Within each of the four categories there are numerous possible sources of
cost related to good or poor quality. Some examples of typical sources of Cost of Quality are listed
below.

▶ The Cost of Good Quality (CoGQ)

▶ Prevention Costs – costs incurred from activities intended to keep failures to a minimum. These
can include, but are not limited to, the following:
▶ Establishing Product Specifications
▶ Quality Planning
▶ New Product Development and Testing
▶ Development of a Quality Management System (QMS)
▶ Proper Employee Training
Cost of Quality (COQ)
▶ Appraisal Costs – costs incurred to maintain acceptable product quality levels. Appraisal costs can
include, but are not limited to, the following:
▶ Incoming Material Inspections
▶ Process Controls
▶ Check Fixtures
▶ Quality Audits
▶ Supplier Assessments

▶ The Cost of Poor Quality (CoPQ)

▶ Internal Failures – costs associated with defects found before the product or service reaches the customer.
Internal Failures may include, but are not limited to, the following examples:
▶ Excessive Scrap
▶ Product Re-work
▶ Waste due to poorly designed processes
▶ Machine breakdown due to improper maintenance
▶ Costs associated with failure analysis
Cost of Quality (COQ)
▶ External Failures – costs associated with defects found after the customer receives the product or service. External Failures may
include, but are not limited to, the following examples:
▶ Service and Repair Costs
▶ Warranty Claims
▶ Customer Complaints
▶ Product or Material Returns
▶ Incorrect Sales Orders
▶ Incomplete BOMs
▶ Shipping Damage due to Inadequate Packaging

▶ These four categories can now be applied to the original Cost of Quality equation. Our original equation stated that the Cost of Quality
is the sum of Cost of Good Quality and Cost of Poor Quality. This is still true however the basic equation can be expanded by applying
the categories within both the Cost of Good Quality and the Cost of Poor Quality.
▶ The Cost of Good Quality is the sum of Prevention Cost and Appraisal Cost (Co GQ = PC + AC)
▶ The Cost of Poor Quality is the sum of Internal and External Failure Costs (Co PQ = IFC + EFC)
▶ By combining the equations, Cost of Quality can be more accurately defined, as shown in the equation below:
▶ COQ = (PC + AC) + (IFC + EFC)
▶ One important factor to note is that the Cost of Quality equation is nonlinear. Investing in the Cost of Good Quality does not necessarily
mean that the overall Cost of Quality will increase. In fact, when the resources are invested in the right areas, the Cost of Quality
should decrease. When failures are prevented / detected prior to leaving the facility and reaching the customer, Cost of Poor Quality
will be reduced.
Cost of Quality (COQ)