Elements of a Management

System : TQM and Six Sigma

Prof. Dr. Muhammad Rashedul Islam

 Role of the Quality Unit

• Compliance with all relevant regulations and commitments

made in license applications or supplements
• Systems that assure control over the manufacturing and
timely disposition process, regardless of location
• Assure that products meet all safety claims, have the identity
and strength and meet all the quality and purity
characteristics stated
• Provide leadership in the Continuous Improvement Process
leading to risk reduction and improved customer satisfaction
 GMPs in the 21st Century – Objective : Provide high quality, cost-
effective oversight of industry manufacturing, processing and
distribution to reduce risk.

• Apply the most current scientific knowledge about risk

management and quality assurance to the FDA's requirements,
including Current Good Manufacturing Practice (CGMP)
inspection, compliance, and enforcement activities.
• Develop new inspection approaches to more effectively utilize
new and existing resources.
• Implement an efficient, risk-based system to promote the wide
availability of safe FDA-regulated imports by increasing the
standards and improving the practices of source countries
and at points of entry into U.S. commerce, improving detection
of noncompliant products, and developing standards and
procedures to maximize the cost-effectiveness of agency
oversight.

https://www.fda.gov/oc/mcclellan/
strategic_risk.html
 Quality Systems

Corrective &
Preventive
Actions
Process Production &
Transfer Process Controls

Management

Material Equipment &

Controls Facility Controls
Records,
Documents, &
Change Controls

http://www.fda.gov/ora/inspect_ref/igs/qsit/
qsitguide.htm
Global Standards Program
Global Standards Program Hierarchy
Core Stakeholders Approves program approach,
Quality responsibility, resources
Manual

Lead Team/Steering
Committee Global Defines “must have”
Standards

Working Groups SOP Work/Job Answers “how to”

Instructions

Working Groups Other Supporting Provides Records

Documentation
 Different types of documents
• Batch records
• Specifications
• Validation & Qualification
Records
• Calibration Records
• Standard procedure
• Room Temperature/ %RH
Records
• Stability Study Summary
Report
• Machine Logs
• Product and sample labels
• Analytical Methods
• Manufacturing
Procedures
 Document Vs Record

• A document can be a procedure, specification, drawing,

work instruction and the record is also a document with the
difference that it provides evidence of compliance with
established requirements and effectiveness of the operation
of QMS.

8
 Elements of a Management System
• Management Commitment
– Top management shall……………….
– Participation in Management Reviews
– Provide input for continuous improvement
– Accountable for resource management

• Resource Management
– Identification of resources including human, technical,
information and financial
– Identification of roles, accountability and responsibility (RACI)
– Competence, awareness & training
 Elements of a Management System

• Management Reviews
– Required inputs including reviews of audits, customer feedback,
performance measurements, improvements, changes
– Required outputs including actions recorded for improvements,
documented improvements and the effectiveness of those
improvements, additional follow-through of actions identified such
as resource needs or completion of changes identified

• Document & Records Control

– Documented procedure for creating, approving, maintaining, protecting
archiving and destroying documents & records
– Identifying documents of external origin
 Elements of a Management System

• Internal Audit
– Document an audit plan
– Identify internal auditors, hire or train
– Document outputs and act upon findings
– Timely reporting

• Continual Improvement
– Organization shall continually improve the effectiveness of the
management system through the use of the policy, objectives, audit
results, analysis of data, corrective and preventive actions and
management review
– Corrective/Preventive Actions recorded, planned and updated timely
– Good Root Cause methodology
– Review of effectiveness of actions taken
 Benefits of the Management System
• There are obvious internal benefits -
• Competitive Advantage
• Commitment to detail for the scope; ie: quality, security, services, etc
• Better employee engagement through training, communication and
accountability
• Formalized & repeatable processes
• Accountability at all levels
• Ongoing internal and external audits ensure weaknesses are
identified and improvements are completed
• Better governance and management of suppliers and outsourced
processes
• More efficient ability to change
• Reduction in duplicate effort
Schedule M

13
 Quality management

• ISO 9001 is for quality management.

• Quality refers to all those features of a product (or service)
which are required by the customer.
• Quality management means what the organization does to
• ensure that its products or services satisfy the customer's
quality requirements and
• comply with any regulations applicable to those products or
services.
• Quality management also means what the organization does to
enhance customer satisfaction,
• achieve continual improvement of its performance.
 Processes, not products

• Processes affect final products or services.

• ISO 9001 gives the requirements for what the

organization must do to manage processes affecting
quality of its products and services.

• ISO 14001 gives the requirements for what the

organization must do to manage processes affecting
the impact of its activities on the environment.
 Accreditation
• Accreditation is like certification of the certification
body.
• It means the formal approval by a specialized body -
an accreditation body - that a certification body is
competent to carry out ISO 9001:2008 or ISO
14001:2004 certification in specified business
sectors.
• Certificates issued by accredited certification bodies -
and known as accredited certificates - may be
perceived on the market as having increased
credibility.
• ISO does not carry out or approve accreditations.
4031 University Drive, 206, Fairfax, VA 22030
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Benefits of ISO 9001 and ISO 14001
• International, expert consensus on state-of-the-art
practices for quality and environmental management.

• Common language for dealing with customers and

suppliers worldwide in B2B.

• Increase efficiency and effectiveness.

• Model for continual improvement.

 Benefits of ISO 9001 and ISO 14001

• Model for satisfying customers and other stakeholders.

• Build quality into products and services from design
onwards.
• Address environmental concerns of customers and
public, and comply with government regulations.
• Integrate with global economy.
• Sustainable business.
• Unifying base for industry sectors.
• Qualify suppliers for global supply chains.
• Technical support for regulations.
Benefits of ISO 9001 and ISO 14001
• Transfer of good practice to developing
countries
• Tools for new economic players
• Regional integration
• Facilitate rise of services
 Figure 1 -Model of a Process based Quality Management System

Continual Improvement of the quality management system

R S
E A
C Management
Q C T
U Responsibilit
U y U I
S I S S
T R Measuremen T
Resource t, F
O E O
Management Analysis & A
M M M C
E E Improvement E T
R N R
Output I
S T Inpu Product S
Realization Product
O
S t N
Value-adding
activities
Information
21
flow
 Limitations

1. Owners and managers do not have an adequate

understanding of the ISO 9000 certification process or
of the quality standards themselves.

2. Some business owners only find that their incomplete

understanding of the process and its requirements
results in wasted time and effort.

3. Funding for establishing the quality system is

inadequate - Critics of ISO 9000 certification
mentioned that achieving certification can be a very
costly process, especially for smaller firms.
 Limitations

4. This ISO 9000 certification process relies heavily on

documentation of internal operating procedures in
many areas .

5. Business executives and owners familiar with the ISO

9000 registration process warn that it is a process that
takes many months to complete.
 Total Quality Management (TQM)
• Total Quality Management (TQ, QM or TQM) and Six
Sigma (6σ) are sweeping “culture change” efforts to
position a company for greater customer satisfaction,
profitability and competitiveness.

• TQ may be defined as managing the entire organization

so that it excels on all dimensions of products and
services that are important to the customer.

• We often think of features when we think of the quality

of a product or service; TQ is about conformance
quality, not features.
 Total Quality Is…

• Meeting Our Customer’s Requirements

• Doing Things Right the First Time; Freedom from

Failure (Defects)

• Consistency (Reduction in Variation)

• Continuous Improvement

• Quality in Everything We Do
TQ: Transforming an Organization