QUALITY MANAGEMENT SYSTEM

ISOVAX TECHNOLOGIES
Office Address: 601, 6th Floor, Lodha Supremus, iThink Techno Campus, Kanjurmarg (E), Mumbai-400042.

Factory Address: Building no 164/169 – 1, 163/170 – 5. Indian Corporation, Dapoda Village, Mankoli Naka, Bhiwandi
421302 Maharashtra.

PREPARED BY: APPROVED BY: DATE OF REVISION NO.:

QUALITY ENGINEER QUALITY MANAGER ISSUE

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 TABLE OF CONTENTS
1. QUALITY MANAGEMENT SYSTEM.

2. QA /QC ORGANIZATION CHART.

3. QUALITY ASSURANCE PLAN.

3.1. PURPOSE OF QA PLAN
3.2. ROLES & RESPONSIBILITIES
3.3. PROCESS STANDARDIZATION
3.4. TRAINING & ORIENTATION
3.5. SUPPLIERS/CONTRACTORS QA
3.6. DOCUMENT CONTROLS

4. QUALITY CONTROL PLAN.

4.1. PURPOSE OF QC PLAN
4.2. ROLES & RESPONSIBILITIES
4.3. SCOPE OF QUALITY CONTROL
4.4. STANDARDS & SPECIFICATIONS
4.5. INSPECTION & TESTING PLAN
4.6. SAMPLING & BENCHMARKING
4.7. CHECKLISTS & DOCUMENTATIONS
4.8. NON-CONFORMANCE MANAGEMENT

5. QUALITY MONITORING & REPORTING. (QMR)

5.1. PURPOSE OF QMR PLAN
5.2. CONTINUOUS MONITORING
5.3. QUALITY REPORTING

6. RCA-5 WHY ANALYSIS, FISHBONE DIAGRAM.

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 1. QUALITY MANAGEMENT SYSTEM (QMS)

I. Purpose:
The purpose is to highlight the processes help for the QMS for continual
improvement & to determine the criteria & methods required to ensure the
effective operation & control of the identified process.

II. Scope:
The scope should include QMS must comply with relevant legal, regulatory and
industry specific standards that helps to achieve the organizational quality goals.

III. References:
List of applicable codes, standards, specification & regulations that will be adhered
during the project - IS, BS, EN, ASME, ISO.

IV. Responsibilities:
QA/QC Manager - Oversees the entire QA/QC process & ensure adherence to the
plan.
Project Manager – Ensure that QA/QC process integrated into the project daily
operations & Coordinates between the departments.
QA/QC Inspectors & Technician – Perform regular inspections, testing &
verification to ensure quality requirements are met.
Team Members – Each member responsibility for maintaining quality in their
specific task.
Contractors – Contractor should be responsible for to ensure that all work is
performed to the required standards, specifications and regulatory requirement and
also follow the QA/QC methods, processes & procedure to ensure that all project
deliverables meet the required standards. This involves periodic inspections at
different stages of the work & verifying that materials & workmanship meet define
quality standards. Co- ordination with site team & QA/QC team.

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V. Principles of QMS:
1. Customer Focus- Organizations depends on their customers therefore
should understand current & future customer needs, meet customer
requirements and strive to exceed customer expectations.
2. Process Approach- Results are achieved more effectively & efficiently when
activities are understood and managed as interrelated processes that function
as a coherent system. The process approach involves the systematic definition
and management of processes and their interactions.
3. Leadership- Leaders establish unity of purpose and direction for the
organization. They should create and maintain the internal environment in
which people can become fully involved in achieving the organization’s
objectives.
4. Engagement of People- People at all levels are the essence of an
organization and their full involvement enables their abilities to be used for
the organization’s benefit. Involving employees in decision- making & process
improvement, it helps for quality of the output.
5. Factual Approach- Effective decisions are based on the analysis of data
and information. This principle emphasizes the importance of using reliable
data to make informed decisions that can be justified and evaluated.
6. System Approach- Identifying, understanding and managing interrelated
processes as a system contributes to the organization’s effectiveness and
efficiency in achieving its objectives.
7. Relationship Management- Organizations manage their relationships with
interested parties, suppliers, partners, and other stakeholders. Strong
relationships can lead to increased efficiency, and improved performance, and
ensure that the supply chain operates smoothly.
8. Continual Improvement- This involves continuous improvement of
processes, products, and services, which is necessary for organizations to
maintain current levels of performance, adapt to changes in their internal and
external environments, and create new opportunities.

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VI. Objectives of QMS:
1. Customer Satisfaction: Increase the customer satisfaction score day to
day.
2. Process Efficiency: It involves enhancing procedures, reducing waste and
ensuring consistency to achieve the high-quality outcomes without rework
and within time.
3. Waste Reduction: Decrease the material wastage in this year and will do
proper waste management.
4. Defect Rate: Lower defects rate in products and services day to day.
5. Employee Training: Ensure 100% of employees receive quality
management training.

VII. Quality Procedures in QMS:

Quality procedures in QMS are documented processes that guide how a project will
carry out its quality objectives, ensuring consistency and control across operations.
Here key elements of Quality Procedures in QMS:
1. Document Control Procedure:
 Ensure all QMS documents are created, reviewed, approved,
distributed and updated systematically.
 Prevents unauthorized and outdated documents from being used.
2. Control of Records:
 Manages how records are created, stored, protected, retrieved and
disposed of.
 Helps maintain evidence of compliance and quality performance.
3. Internal Audit Procedure:
 Describes the methods for regularly assessing the QMS through audit.
 Identifies area for improvement, evaluate compliance with the QMS
and ensures corrective actions are taken when necessary.

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4. Non-Conformance Control Procedure:
 Outlines steps to identify, document and address non-conforming
products and processes.
 Ensures corrective actions are taken to prevent recurrence.
5. Corrective Action and Preventive Action (CAPA) Procedure:
 Define how corrective and preventive actions are identified,
implemented and monitored.
 Addresses the root causes of nonconformities and prevents similar issues in
the future.
6. Risk Management Procedure:
 Establishes a method for identifying, assessing and mitigating risks to
product quality or compliance.
7. Supplier and Purchasing Control Procedure:
 Ensure suppliers meet quality requirements through evaluation,
selection and periodic review.
8. Customer Feedback and Complaint Handling Procedure:
 Provides a strategic approach to collecting, reviewing and
addressing customer feedback and complaints.
 Improves customer satisfaction by resolving issues and using
feedback for continuous improvement.
9. Employee Training Procedure:
 Ensures employees receive the necessary training and
demonstrate competence for their roles.

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 2. ORGANIZATION CHART.
DIRECTOR

PLANT HEAD

PRODUCTION QUALITY
MANAGER MANAGER
PLANT HEAD PLANT HEAD

SHOP / SITE SHOP / SITE

INCHARGE INSPECTOR

SUB-CONTRACTOR EXTERNAL INSPECTION

AGENCY

3. QUALITY ASSURANCE PLAN.

3.1 Purpose:
The purpose of QA plan is to ensure that products or services meet the customer
requirements and comply with industry standards or regulations. It set the foundation
for achieving consistent quality by specifying quality control & preventive measures.
QA focuses on the proactive steps taken to ensure that processes are followed,
minimizing the defects.

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3.2 Roles & Responsibilities:
The QA plan should define the roles & responsibilities of all personnel involved in QA
activities.
 QA/QC Manager- Oversee the entire QA process, develop policies and
ensure adherence to the plan.
 QA/QC Inspectors- Perform check & audits to verify compliance with
standards and identify any areas for improvement.
 Project Manager- Ensure that QA procedures are integrated into day- to-day
operations.
 Engineering/Technical Staff- Follow the QA plan and ensuring that
process function correctly to meet quality standards.

3.3 Process Standardization:

 Implement & standardize the procedure, WMS & best practices for project
to ensure consistency in quality.
 SOPs is detailed, written instructions that outline the specific steps to be
followed to complete tasks in a consistent & uniform manner.
 SOPs ensure that processes are carried out the same way every time,
regardless of who perform the task.
 QA/QC manager prepare the all WMS of the work activity and
approve/verify it from Senior managers of the QA/QC.
 QA/QC manager ensure that all SOPs are available & accessible to all
employees.

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  QA/QC manager ensure that all standard documents related to
processes such as WMS are properly managed & up to date.
 QA/QC manager review & revise the documents whenever changes are made
to processes.
 QA/QC team ensures that work process comply with WMS procedure &
contracts specifications and drawing.

3.4 Trainings & Meetings:

The QA plan should include strategy for training and ensuring the competence of
personnel involved in quality-related activities. Training helps that all employees,
contractors and suppliers understand the quality standards and procedures they must
follow.

Training & Meeting Program Element:

1. New Employee Training- Comprehensive on-boarding to introduce to the
quality standards & procedures.
2. Kick-Off Meeting- Prior to starting the work activities conducted this
meeting for Contractors & Staff, explain the detailed work procedure & scope of
work.
3. QAT-Subject Expert Training- Regular refresher subject expert trainings to
keep employees, contractors and workers updated and aware to processes and
standards.
4. Quality Review Meeting- It is essential to maintain control over the
quality processes, ensure continuous improvement and address any quality
related issues promptly.
5. On-Site Training- It is the part of continuous improvement strategy, where
employees and workers regularly updated on processes or industry best practices.
6. MIS meeting- To ensure that quality standards are being met across processes
and systems & utilize MIS data for improvement in quality performance. Also
effectively supporting for decision-making and strategic objectives.

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 QA/QC manager & inspectors ensure that all team members, contractors are
trained on projects quality standards, expectation & processes.
 QA/QC manager conduct the Kick-Off Meeting Prior to starting the work
task with Contractors, Site engineers & PM.
 QA/QC manager ensures that the contracts document has mentioned
work procedure and scope of work.
 During the kick-Off meeting QA/QC manager communicates the work task quality
requirement, work procedure as per WMS, required quality documents, record
keeping requirements, standard of workmanship, awareness of critical quality
requirements, work task quality inspection checklists etc.
 QA/QC manager conduct the weekly QRM with contractors, contractor
personnel’s & staff for reviewing the quality of work, process deviation & any
non-conformance.
 QA/QC manager maintain the record of QRM in training tracker or Quality
control report.
 QA/QC manager & team prepare the schedule of trainings for staff and
contractors and conduct/arrange the trainings according to schedule. (i.e. On
Job training, Subject Expert Training, Lessons Learned training, Critical to
quality training.)
 QA/QC manager maintain the record of trainings in training tracker or Quality
control report.
 Each day QA/QC team member will meet the QA/QC manager and discuss the
daily progress report or quality regarding any issue.
 QA/QC manager conduct the weekly meeting with staff for taking the review
of QA of material & approved process.

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3.5 Suppliers/Contractors QA:
 Ensure that materials from suppliers & work performed by contractors meets
the project quality requirements.
 QA/QC team will be responsible for evaluating all materials & goods received as
per approved specifications and determine their compliance with the contract
specifications prior to delivery on site.
 QA/QC inspectors ensure the suppliers/contractors material when arrived
on site is as per approved specifications.
 QA/QC inspectors check & verify the material as per approved
specifications by MTC, TDS, Field test & TPT.
 QA/QC inspectors maintained the test records of supplier’s/
contractor’s material. (i.e. MTC, TDS, MIR, FTR, TPTR)
 After checking material from the QA/QC inspectors then allowed for use.
 QA/QC inspectors have authority to reject the material if material not as per
approved specification or found any defects and convey this message to QA/QC
manager.
 QA/QC inspectors maintain the record of material rejections.
 QA/QC inspectors keep the records maintained of the material testing & verified
from QA/QC manager.
 QA/QC inspectors may stop the work activity if found the material not as per
approved specification and raised the NCR against contractor & Production
engineer.
 QA/QC manager coordinate with suppliers/contractors with quality
regarding matters/defects.
 QA/QC manager ensure all materials received on site is inspected.
 QA/QC manager ensure all materials testing is performed as per ITP.
 QA/QC inspectors assist to QA/QC manager regarding any material quality issues.

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3.6 Document Control:
 QA/QC manager prepare all quality related documents and ensure all
document is review & formally signed off by designated authorities.
 QA/QC inspectors ensures that all documents related to quality
processes are properly managed & updated.
 QA/QC manager ensure that all hard copies of document are distributed
accurately and outdated versions are removed.
 QA/QC inspectors shall inspect all materials received on site and these
materials are acceptable as per contract specifications document are
comparable to PO. Receiving inspections shall be recorded & fill the MIR.
 QA/QC inspectors shall be aware of every stages of construction and prior to
start the new activity ensure that material have been approved and maintained
the documents.
 Supplier/Manufacturer may proceed the material inspection in advance with the
Witness Point of QA/QC inspector and then proceed for further.
 Supplier may not proceed the work without witness by QA/QC
inspector.
 After arriving the material QA/QC inspectors filled the FTR, MIR as per
specifications and maintained record of TDS & MTC.
 QA/QC inspectors send the material for TPI as per ITP for QA purpose.
 QA/QC inspector check the material tags, labels & other markings for
traceability of the material.
 Document control system should be audited regularly to ensure
compliance with internal policies and external standards.
 Internal Audit should verify that –
-Only latest version of document are in use.
-Documents are reviewed & approved.
-Changes & revisions are clearly documented.
 Audit findings should lead to corrective actions if any compliance is identified in
the document control system.
 Internal audits findings will be reported to the senior QA/QC management and
all improvement actions & follow-up will be done by QA/QC manager.

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  QA/QC manager will review all internal audit reports & interact with the auditors
for suitable corrective actions.
 Results of the internal audits are reviewed during the management Review.

 Roles & Responsibilities in Document Control:

 QA/QC manager- Responsible for overseeing document control within the
quality management system. Ensure all documents are reviewed, approved
and distributed according to QAQC protocols.
 Document Controller- Dedicated personnel tasked managing the
document control system, ensuring proper handling, storage and access
to all QAQC documents.
 Reviewers & Approvers- These individuals (often department heads or
quality leads) are responsible for reviewing and approving document before
release.
 End Users (Engineers, inspectors)- Personnel who use QA/QC documents
for daily operations must ensure they are always using the latest approved
version of the documents.

 Benefits of Document Control in QA/QC:

1- Improved Consistency.
2- Enhanced Compliance.
3- Error Reduction.
4- Efficient Auditing.
5- Traceability.

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 Document Controlled in QA Plan:
 Following are the documents that are controlled in QA plan-
1. Approved Design / Drawing
2. Qualification Documents (DQ, IQ, OQ)
3. Inspection Test Plan (ITP)
4. Approved QC Procedures
5. Material Inspection Reports /Material Technical Specifications
6. Stage Inspection Reports
7. Factory / Site Acceptance Reports
8. Data Reports / IRN
9. Non-Conformity Reports

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 4. QUALITY CONTROL PLAN.

4.1 Purpose:
The purpose of QC plan is to ensure that every stage of production or service delivery is
monitored and controlled to meet quality standards. It helps to identify defects, non-
conformities or deviations early in process, allowing for timely corrections & minimizing
the risk defects reaching customers or affecting project outcomes.

4.2 Roles & Responsibilities:

QC plan outlines the specific roles & responsibilities of personnel involved in quality
control including,
 QA/QC Manager- Responsible for oversee the quality control activities and
ensures compliance with QC plan.
 QA/QC Inspectors- Perform inspections, tests and verifications during
production or project executions.
 Project Manager- Ensure that quality control procedures are integrated into
day-to-day operations.
 QA/QC Team- Ensures that the QC plan aligns with the overall QA
processes.

4.3 Scope of Quality Control:

QC plan specifying the areas that will be controlled and monitored including,
1. Material
2. Equipment
3. Workmanship
4. Work Activity Processes
5. Services & deliverables.

It describes where QC needed across the project lifecycle from procurement to final
inspection & testing.

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4.4 Standards & Specifications:
The QC plan must reference the Standards, Codes & Specifications that the QC
process will follow, which may include:
 Internal Standards- Company specific guidelines or product
specifications.
 Industry Standards- ISO standard, IS, API, ASTM, etc.

4.5 Inspection & Testing Plan (ITP):

ITP is key component of QC plan. It outlines the inspection points, testing stages and
verification activities to ensure that quality is maintained at every stage of
production or service delivery. It typically includes:
 Inspection Points- The stages where inspection occur (e.g. raw
material inspection, in-process inspection, final inspection)
 Test methods- The types of test to be performed.
-Visual inspection: Checking for visible defects like scratches, deformities,
color or inconsistency.
-Dimensional Checks: Measuring the physical dimensions of the product to
ensure it meets design specifications.
-Functional tests: Testing the performance of the product to ensure it operates
as intended.
-Laboratory test: Physical & chemical material testing to verify the compliance
with specifications.
 Acceptance Criteria- The specific criteria that must be met for the
product, service or process to be considered acceptable.
 Responsible Personnel- Specifies who will perform the inspections & tests.
- The inspection & testing activities are conducted as indicated in the ITPs.
- QA/QC manager will ensure that proposed approved 3rd party laboratories will
comply with the contract specification requirements.
- The Quality team will ensure necessary co-ordination with the 3rd party testing
Laboratories. They will ensure adequate quantities of samples of material are secured
and delivered.
- All construction material received on site will be subjected to receiving checks on site
by QA/QC inspectors to ensure these are as approved and specified.
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  Field Inspection Quality Control:
 Prior to starting the work QA/QC team will check all materials, drawings,
procedures & other relevant matters regarding the work.
 All materials should be as per approved material specifications,
drawings & procedures to be of the latest revisions.
 All material & drawing which are approved are to be rejected and
removed from the work site.
 After completion of work engineer raised the RFI for checking.
 Task-Ready for Inspection: - Engineer raised the RFI for work is ready for
quality inspections and it verify that conditions conform to the project quality
requirement.
 WIP-Quality Inspections: - Engineer performs an initial work in process
inspection when the first portion of the work activity is completed.
 QAQC engineer verify the work checklists and maintained the all
inspections records.
 During inspection found any defects or deviation in work process then QAQC
engineer highlights it immediately.
4.6 Sampling & Benchmarking:
Use sampling techniques for testing materials & work quality to ensure that what is
being produced matches the predefined standards.
 Incoming material inspection- S ampling materials from suppliers to ensure
they meet specifications before use in work.
 In-Process Inspection- Sampling during the production or service delivery
process to detect any deviations before the final product is completed.
 Final Inspection- Sampling finished products to ensure that meet
customer requirements and regulatory standards before release.

*Benchmarking in Quality Control*

1. Internal Benchmarking- Comparing performance across the different projects
processes, products.
2. Process Benchmarking- Comparing & improving internal processes to align
with best in class practices. (E.g.- Sampling, inspection & testing methods)

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 Define what we want to achieve through benchmarking such as:
- Reducing Defects.
- Improving Product Quality.
- Enhancing Process Efficiency.
- Reducing Customer Complaints.
A Sampling & benchmarking plan are essential components of an effective
Quality Control plan.
 Sampling ensures that representative portion of products or services is inspected to
maintain quality.
 While Benchmarking helps the organization set quality goals by comparing its
performance against industry standards or competitors.
Both plans contribute to achieving higher levels of product quality, customer
satisfaction and operational efficiency.
4.7 Checklists & Documentations:
Use inspection checklists to ensure evaluation of work at each stage of activity.
Maintain detailed records of test results, non-conformance & corrective actions.
It is the essential tools to ensure consistency, traceability & compliance with
quality standards.
Effective use of checklists ensures that critical tasks are not missed, while
documentation provides a clear record of inspections, test & corrective actions for
future reference or audits.

 Purpose of Checklists: -
1. Ensure that each stage of process is completed according to
predefined requirements.
2. Maintain consistency and prevent human error.
3. Provide quick reference tool for inspectors & quality personnel.
4. Act as an evidence of compliance with QA/QC standards.

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 QA/QC manager prepare all activity work checklists according
to requirements.
 After preparing the all work checklists give it for review, verification
and approval purpose to PM & Senior QAQC management.
 QA/QC manager ensure that all checklists are sign-off from
senior management team.
 Site PM ensure that all approved checklists are integrated in daily work.

 Documentation in QA/QC Plan: -

Documentation provide detailed records of the entire quality process,
ensuring traceability, accountability and compliance.

 Purpose of Documentation: -
- To provide record of all quality related activities.
- To track progress & performance of quality control measures.
- To ensure traceability of products, processes and corrective actions.
- To support audits, customer review and regulatory inspections.

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4.8 Non-Conformance Management:
It is the systematic process for identifying, documenting, addressing and resolving
deviations from the established quality standards or requirements.
Non-conformances can occur in materials, processes, products or services and need
to be an effectively managed to ensure that quality is maintained, corrective actions
are taken and preventive measures are implemented to avoid recurrence.
 Purpose of Non-conformance:
- Identify & control defective or non-compliant products, material or
processes.
- Mitigate Risk of defects reaching customers or causing further issues in
production or service delivery.
- Implement Corrective Actions to eliminate the Root Cause Analysis of Non-
Conformances.
- Prevent Recurrence of non-conformances through preventive actions and
continuous improvement.

 Key Steps in Non-Conformance Management:

1. Identification of Non-conformance- the 1st step is identifying deviations from
quality standards. NCs may detected during:
 In-Process quality control checks.
 Final Inspection or test.
 Incoming material Inspection. (If applicable)

2. Site engineer raised the RFI of the work, QA/QC engineer observed any defects,
process deviation during inspection then QA/QC engineer give observations
accordingly.
3. QA/QC engineer directly raised the NCs to Production engineer & contractor,
depends on severity of issues, repeated observations and observations are not
closed within 2 days then this observation will be converted into NCs.
4. Then Production In-charge/PM should be responsible for compliance and
mentioning the corrective & preventing action in Non-Conformance report.

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5. Process flow of Observations or issues-
Duration Process Flow
> 2 Days Pro-Active Notification
> 7 Days Site Observation
> 14 Days Violation
> 28 Days Non-Conformance Report

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 5. QUALITY MONITORING & REPORTING.
5.1 Purpose:
Monitoring is the essential for tracking quality performance throughout the project.
It helps maintain accountability, support decision making and foster continuous
improvement. Regular and accurate reporting provides insights into performance,
identifies areas for improvement and supports compliance with standards.

5.2 Continuous Monitoring:

QA/QC teams continuously monitor quality performance through inspections, audits
and reviewing data from tests & checklists.
It helps to identify any variations from quality standards.

5.3 Quality Reporting:

QC reports document the results of inspections, testing & monitoring activities. These
reports include data on defects, process deviations, non- conformance’s and corrective
& preventive actions taken

Components of reporting:
1. Inspections Report- It is the results of quality inspections carried
out during various stages of production or service process.
2. Non-Conformance Report- NCR document instances where a
product, process or service does not conform to predefined standards
or specifications.
3. CAPA Report- Addressing non-conformance and ensuring
continuous improvement.
Corrective Actions taken to resolve non-conformance.
Preventive Action taken to avoid recurrence of similar issues.
4. Incident Report- It is formally record and accidents or non-
conformances that occur during a project production and services.
5. Audit Report- It may be internal or external audit. These
reports evaluate compliance with the QA/QC plan, regulatory
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standards.

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6.RCA – 5 WHY ANALYSIS & FISHBONE DIA.

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