M.

TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

Name: AMIT PAUL

Group Name: INDIVIDUAL
ID: 2019ht74101
Email: 2019ht74101@wilp.bits-pilani.ac.in
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

1) How have you complied with the requirements of Clause No 4 (Internal issues, External
issues, Needs and expectations of Interested parties , Scope , QMS system and Processes)
and Clause 6?
Answer:
Clause 4 Context of the Organization
Clause 4.1 Understanding the organizational context

Nature of exposure to
Contextual Factors Impact on organization
organization
Purpose & Strategic Direction
External Factors
QMS Objectives
Risk or Opportunity QMS Products & Services
Internal Factors QMS Scope
QMS Resources

Company Background
Philips Healthcare – Healthcare Innovation Center (referred to as HIC India) is a division of Philips India Ltd., which develops and manufactures
medical imaging products and accessories for diagnostics and interventional procedures. Philips India Ltd, a subsidiary of Royal Philips
Netherland is leading healthcare, lighting and consumer lifestyle Products Company.

Philips is operating in India for many decades and expanding healthcare in India by establishing development and manufacturing capabilities to
provide quality healthcare products to its customers. HIC India is having Manufacturing locations in India. HIC India is committed to Patient
safety by providing safe and high quality product and services
The following types of documents and tools are used to provide contextual information:

1. Policy statement(s) regarding purpose and strategic direction;

2. Individual strategy documents underpinning policies that provide a road map to achieve goals;
3. Management Review meetings where context is routinely discussed and monitored;
4. Risk assessments of external and internal issues;
5. PESTLE (Political, Economic, Social, Technological, Legal, Environmental) analysis for external issues;
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
6. SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis tools for internal issues;
7. Documented information describing organizational context, included as part of a quality manual.

External Issues – PESTLE Analysis

(P)olitical factors (E)conomic factors (S)ocio-cultural (T)echnological factors (E)nvironmental factors (L)egal factors
factors

Examining the political These factors are The consumer is These factors have a huge This is also of ahuge impact as This factor takes into
factors, such as determinants of an mapped out by impact since Philips is a Philips deals with Radiation consideration all legal
government decisions. economy’s performance means of socio- Medical Devices emitting devices which directly aspects. This point is
cultural factors. This affect a Patient and a User. We
Legislation and that directly impact Industry/Healthcare. Assess closely related to political
makes it possible to determine we have
regulations. organization and have any big technological factors but focuses more
determine, among environmental aspects consisting
resonating long term other things, how far developments and determine of: on the actual laws and not
Following questions are effects. the power lies with how they can impact our  What are the values of on the political directions of
assessed to understand the consumer. The organisation. These our a country or region. This
the political factors following questions are socio-cultural factors questions are asked: stakeholders/investors? can include regular
 Are there used to find out the can be examined by  Are there new  Are there assessment:
changes in important factors: asking the following technologies that environmental  Are their new
fiscal  How stable is the questions: we could be using? problems at environmental
conditions of current  Are people  Do any of our international or permitting
changing national level?
the company? economy? Is it in competitors have requirements for
 Are there an period of
buying
access to new  What is the attitude of our sector?
habits? our staff?
changes in growth or  How do technologies that  Are there any
legislation recession? religious will result in a changes in the
that directly  How is beliefs and competitive Country specific
affect us? globalization lifestyle advantage? Regulation?
 Could any affecting the choices  Are there other  Are there
change in economic affect the technological changes in
trade environment? population? developments that employees’ law?
agreements  Do consumers  Are there could affect our
any new
with other and businesses industry?
social
countries, have easy access
trends?
customs or to credit? If not,
taxation how will this
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
affect our affect our
organization? organization?

External Issues & Internal Issues– SWOT Analysis

Strengths: Weaknesses:
Years of Experience • Time to market
Strong family ownership • Employees don’t trust leadership
Business knowledge • Lack of customer diversification • Narrow market
Employee engagement • Marketing
Financial strength Leverage technology • Burn out
Internal
“A” level talent • Turnover
State of the art production equipment Patents Competitive benefits • Anticipated retirements
Close tolerance • Employees not reliable
Strong Customer Relationships • Supervision focus on production while stated goal is customer quality
Friendly family-like atmosphere Company values are modeled at • Lack of knowledge on new equipment
every level • Low productivity (sales $ per employee)
Opportunities: Threats:
Available capacity Competition Change of industry regulations
New markets Strength of dollar
Automation Environment
New raw material development Access to capital Expiring patents
External Proactive supply chain management
Free Trade
New business development
High demand for product
Apprenticeship programs
Prevention based quality
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

Clause 4.2 Understanding interested parties’ needs

RIP (Relevant Interested What QMS requires from a What a RIP requires from
Responsibilities
Parties) RIP QMS

Customer; distributors, Product and service Receive Quality check procedures set-up
specifications quality Flying Quality Squad Team set-up
for design, manufacture, products and services that meet their Customer requirements and applicable regulatory
delivery, support, specifications. Consistency of quality. requirements are determined and met
documentation; etc. Complaints and other customer input / feedback
are continually monitored and measured to
identify opportunities for improvement
End-user Details of their needs and Get good product Design control documentation is followed as
expectations performance/ease of use/ safety/ per ISO 13485 and FDA 21CFR820
for intended use reliability/
maintainability/disposability,
etc.
Owner/shareholder Financial investment; Profitability/return on Large Market capture and Business Analysis
decisions and support investment/growth in market value of is conducted in Management Review
organization.
Management Leadership; direction; Management Review Meeting Conducted
resources; involvement; Increased growth, sales & Monthly
motivation; etc. profitability/efficiency & effectiveness
of
operations.
Employees Produce products and Good work environment/job Employee Survey and Satisfaction Programe
services; follow QMS security/health/safety/ training/ Set-up
policies and procedures; promotion, recognition and
etc. reward
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

Clause 4.3 Determining the scope of QMS

HIC India has determined and established the processes to maintain the effectiveness of Quality Management System in accordance with the
applicable regulations and standards as defined in scope of this quality manual.

The QMS is based on the business processes. The main business processes and their interactions for HIC India are depicted in the Block below.
The process owners for each business process are defined in respective procedures. Risk based approach is applied to control of the main
business processes. Management reviews the suitability, adequacy and effectiveness of these processes periodically by establishing proper
monitoring and measurement & ensures adequate resources are provided
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
Clause 4.4 QMS and its processes
QMS documents established for HIC India is based on the definitions depicted in the Pyramid below.

Quality Manual is the first tier: It contains or references the highest-level policies and procedures for the HIC India QMS. This document
outlines our policies regarding all applicable standard and regulation requirements.

The second tier represents all Procedures: A procedure describes and defines in more detail specific process steps.

The third tier represents Work instructions and Templates: A work instruction describes a specific qualitative or quantitative instruction how to
manufacture a product. Work instructions are always related to a specific product or product family. A template is used to document required
quality system data. After data are filled in, the template becomes a quality record.
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

The Fourth tier represents Quality records Quality records provide documented evidence of conformity to quality system requirements and of
effective operation of the quality management system.

Clause 6 Planning
Clause 6.1 Actions to Address Risks and Opportunities

Building upon the need to include the influence of the wider elements of the organization, planning fully embraces the risk and opportunity
management concept. Risk and Opportunities is a key activity to achieve quality goals on a continual basis, including an evaluation of the risk
management process and a priority/scaling of when, how, where and to what level it should be applied. Risk is captured during initial stages and
throughout the lifecycle through Market Surveillance.

HIC India takes action to eliminate the cause of non-conformities in order to prevent recurrence and appropriate corrective actions taken without
undue delay for non-conformities observed.

Documented procedure established for

 reviewing non-conformities (including customer complaints),

 determining the cause of non-conformities,
 evaluating the need for action to ensure that non-conformities do not recur,
 Planning, documenting and implementing action needed and effectiveness.
 Verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and
performance of the medical device.
 records of the results of action taken and
 reviewing effectiveness corrective action taken
 determining potential non conformities and their causes
 evaluating the need for action to prevent occurrence of nonconformities
 Planning , documenting and implementing action needed
 Verifying that the preventive action does not adversely affect the ability to meet applicable regulatory requirements or the safety and
performance of the medical device
 records of the results of action taken
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
Clause 6.2: Quality Objectives and Planning to Achieve Them
The Quality objectives are set by the Management Team and reviewed periodically. The review is to ensure that objectives are measurable and
consistent with the Quality policy. These objectives are made measurable and communicated relevant functions and levels throughout the
organization.

Clause 6.3: Planning of Changes

QMS changes planning is done based on different process in organization and process are defined to meet Quality objectives.
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

2)What tools and techniques have you used it?

The following tools are used for particular sections of Clauses 4 and 6:

A) Clause 4.1: PESTLE Analysis for External Issues – (exact details are confidential)

External Issues – PESTLE Analysis

(P)olitical factors (E)conomic factors (S)ocio-cultural (T)echnological factors (E)nvironmental factors (L)egal factors
factors

Examining the political These factors are The consumer is These factors have a huge This is also of ahuge impact as This factor takes into
factors, such as determinants of an mapped out by impact since Philips is a Philips deals with Radiation consideration all legal
government decisions. economy’s performance means of socio- Medical Devices emitting devices which directly aspects. This point is
cultural factors. This affect a Patient and a User. We
Legislation and that directly impact Industry/Healthcare. Assess closely related to political
makes it possible to determine we have
regulations. organization and have any big technological factors but focuses more
determine, among environmental aspects consisting
resonating long term other things, how far developments and determine of: on the actual laws and not
Following questions are effects. the power lies with how they can impact our  What are the values of on the political directions of
assessed to understand the consumer. The organisation. These our a country or region. This
the political factors following questions are socio-cultural factors questions are asked: stakeholders/investors? can include regular
 Are there used to find out the can be examined by  Are there new  Are there assessment:
changes in important factors: asking the following technologies that environmental  Are their new
fiscal  How stable is the questions: we could be using? problems at environmental
conditions of current  Are people  Do any of our international or permitting
changing national level?
the company? economy? Is it in competitors have requirements for
 Are there an period of
buying
access to new  What is the attitude of our sector?
habits? our staff?
changes in growth or  How do technologies that  Are there any
legislation recession? religious will result in a changes in the
that directly  How is beliefs and competitive Country specific
affect us? globalization lifestyle advantage? Regulation?
 Could any affecting the choices  Are there other  Are there
change in economic affect the technological changes in
trade environment? population? developments that employees’ law?
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
agreements  Do consumers  Are there could affect our
with other and businesses any new industry?
countries, have easy access social
customs or to credit? If not, trends?
taxation how will this
affect our affect our
organization? organization?

B) Clause 4.1: SWOT Analysis for External and Internal Issues

Strengths: Weaknesses:
Years of Experience • Time to market
Strong family ownership • Employees don’t trust leadership
Business knowledge • Lack of customer diversification • Narrow market
Employee engagement • Marketing
Financial strength Leverage technology • Burn out
Internal
“A” level talent • Turnover
State of the art production equipment Patents Competitive benefits • Anticipated retirements
Close tolerance • Employees not reliable
Strong Customer Relationships • Supervision focus on production while stated goal is customer quality
Friendly family-like atmosphere Company values are modeled at • Lack of knowledge on new equipment
every level • Low productivity (sales $ per employee)
Opportunities: Threats:
Available capacity Competition Change of industry regulations
New markets Strength of dollar
Automation Environment
New raw material development Access to capital Expiring patents
External
Proactive supply chain management
Free Trade
New business development
High demand for product
Apprenticeship programs
 M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
Prevention based quality

C) Clause 4.2: Modified RACI matrix

RIP (Relevant What QMS requires from a What a RIP requires from
Responsibilities
Interested Parties) RIP QMS

Customer; Product and service specifications Receive Quality check procedures set-up
distributors, for design, manufacture, delivery, quality Flying Quality Squad Team set-up
support, documentation; etc. products and services that meet their
specifications. Consistency of quality.
End-user Details of their needs and Get good product Design control documentation is followed as
expectations performance/ease of use/ safety/ per ISO 13485 and FDA 21CFR820
for intended use reliability/
maintainability/disposability,
etc.
Owner/shareholder Financial investment; decisions Profitability/return on Large Market capture and Business Analysis is
and support investment/growth in market value of conducted in Management Review
organization.
Management Leadership; direction; resources; Management Review Meeting Conducted
involvement; motivation; etc. Increased growth, sales & Monthly
profitability/efficiency & effectiveness
of
operations.
Employees Produce products and services; Good work environment/job Employee Survey and Satisfaction Programe
follow QMS policies and security/health/safety/ training/ Set-up
procedures; etc. promotion, recognition and
reward
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

D) FlowChart
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

3) What are the documents (only names) that you can use to prove it?

Clause Number Details of Clause QMS Documents

4.1 Understanding the Context of Organization Quality Manual

Quality Manual
4.2 Understanding interested parties’ needs
Determining the scope of QMS Quality Manual
4.3
Quality Manual
4.4 QMS and its processes

6.1 Actions to Address Risks and Opportunities Risk Management Procedure

6.2 Quality Objectives and Planning to Achieve Them Quality Manual, Management Review,
Quality Manual Control Board

6.3 Planning of Changes Change Management Procedure, Medical

Device File
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH

4) Please give examples of 4 SIPOC processes from four different functions in your
organization.

A) Complaint Handling Process

Suppliers Inputs Process Outputs Customers

High Level Receives a
Provide Input to the Resources Required Deliverables from the
Description of Deliverable from the
Process by the Process Process
Activities Process
Complaint Investigator Complaint Record ready Assign Complaint for Complaint Record Complaint Investigator (as
for review review assigned to a REVIEWER REV)
according to assignment
schedule

B) Post Market Surveillance Process

Suppliers Inputs Process Outputs Customers

High Level Receives a
Provide Input to the Resources Required Deliverables from the
Description of Deliverable from the
Process by the Process Process
Activities Process
Post Market Post Market Surveillance Set-up of a Product Post Market Surveillance Project manager
Reports Monitoring team to gather Plan
Surveillance Lead
and analyze PMS data.

Create the Post Market

Surveillance Plan, which
includes a PMCF plan.
Inputs from the following
processes shall be used:
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
- Conclusions and
actions from
product risk
management based
on the Product Risk
Management
Procedure
- Conclusions and
actions from design
verification based
on the Verification
procedure
- Conclusions and
actions from Design
Validation based on
the Design
Validation
Procedure
- Conclusions and
actions from Clinical
Evaluation based on
the Product Clinical
Evaluation
Procedure
- Conclusions and
actions Usability
based on the
Usability
Engineering
Procedure.
- Determine with the
Product Validation
responsible (i.e.
M.TECH SEMESTER: 2 - QMS ASSIGNMENT 2 – 2019:2021 BATCH
Factory Best or
Philips Pune) what
conclusions and
actions from
Process Validation
are inputs for PMS.

C) CAPA (Corrective Action & Preventive Action) Process

Suppliers Inputs Process Outputs Customers

High Level Receives a
Provide Input to the Resources Required Deliverables from the
Description of Deliverable from the
Process by the Process Process
Activities Process
CAPA initiator CAPA Request Initiation Initiate and Evaluate Approved CAPA CAPA Review Board
and Evaluation Form CAPA Request Request/Reject CAPA Chair
Request

D) Engineering Change Management Process

Suppliers Inputs Process Outputs Customers

High Level Receives a
Provide Input to the Resources Required Deliverables from the
Description of Deliverable from the
Process by the Process Process
Activities Process
Product, Quality & Engineering Change Assign Engineering Acceptance of ECR by Project Manager
Maintenance Manager Request Change Request for Change Review Board
Change Review Board and promotes to
Descision Engineering Change
Order