How to Design a Quality system that meets compliance requirements 2014

HOW TO DESIGN A QUALITY SYSTEM THATHOW TO DESIGN A QUALITY SYSTEM THAT
MEETS COMPLIANCE REQUIREMENTS.MEETS COMPLIANCE REQUIREMENTS.
QUALITY SYSTEM DESIGN FORQUALITY SYSTEM DESIGN FOR
MEDICAL DEVICES,BIOTECH ANDMEDICAL DEVICES,BIOTECH AND
PHARMA.PHARMA.

PHASE ONE
KNOW YOUR QUALITY CONCEPTS

PHASE I:CONCEPTPHASE I:CONCEPT
QUALITYQUALITY
CONCEPTSCONCEPTS
http://www.cgmpuniversity.com 4

CONCEPT ICONCEPT I
THE QUALITY MANAGEMENTTHE QUALITY MANAGEMENT
SYSTEMSYSTEM
What is a Quality Management system?
(QMS)

1. ISO 8402:1994 DEFINITION1. ISO 8402:1994 DEFINITION..
“The organizational structure,
processes, procedures, and resources,
needed to implement Quality
management.
--ISO8402:1994
Key words and phrase:
1. Structure 4.Resources
2. Processes
3. Procedures
6

2.THE QSR DEFINITION2.THE QSR DEFINITION
The QSR defines a Quality Management
system as:
“The organizational structure,
responsibilities, processes, procedures, and
resources for implementing Quality
management”
---21CFR820.39 (V)
7

A.ORGANIZATIONALA.ORGANIZATIONAL
STRUCTURESTRUCTURE
This refers to the Org chart:

ORGANIZATIONAL STRUCTUREORGANIZATIONAL STRUCTURE
Organizational Structure:
The Organizational chart that defines roles is
required for your Quality Management system.
Roles has to be defined
Responsibilities have to be assigned
9

B.PROCESSESB.PROCESSES
Process: A set of steps that add value to an
input to produce an output
10

PROCESSESPROCESSES
Y= F(X), F Adds value to inputs to produce an
output Y
 There are inputs in each process
 The output of one process is the input of the
next process
 The inputs of a process are the 6Ms
 The output is the defined specifications
11

C. PROCEDURESC. PROCEDURES
Procedures, or Steps taken to accomplish an
objective, or a task should be:
Defined
Documented
Maintained
Controlled
Purpose:Purpose: To control variation in your
product, process, and service
12

C.PROCEDURESC.PROCEDURES
Types of Quality Management Procedure:
There are three types of Quality Management
procedures:
Standard operating procedures
Work Instructions
Job Aids: Manuals(External and Internal) check
sheets, and Forms.
13

D .RESPONSIBILITIESD .RESPONSIBILITIES..
Defined accountability, or ownership
for:
Departments
Functions
Job descriptions
14

D.RESPONSIBILITIESD.RESPONSIBILITIES
Defined responsibilities
Task ownership:
Accomplished through the following:
Job descriptions
Defined functions
Defined roles
15

E.RESOURCESE.RESOURCES
Resources for Quality Management include:
Trained personnel: “Know why they are
doing, what they are doing and how to do
it.”
Facilities: Buildings etc
Infrastructure
Equipment
The five elements are meant to implement
Quality Management
16

CONCEPT II: QUALITYCONCEPT II: QUALITY
MANAGEMENTMANAGEMENT

THE TWO PARTS OF QUALITYTHE TWO PARTS OF QUALITY
A Quality Management system(QMS)
must have two sets of activities taking
place at any given time:
 Quality Assurance ActivitiesQuality Assurance Activities
Quality control ActivitiesQuality control Activities

QUALITY ASSURANCE(QA)QUALITY ASSURANCE(QA)
Quality Assurance is a set of activities
intended to establish
confidence that quality requirements
will be met. QA is the first function of a
Quality management system
.
Source: ISO 9001:2005
19

QUALITY CONTROL (QC)QUALITY CONTROL (QC)
Quality control is a set of activities intended to ensure that
quality requirements are actually being met. Quality control
is the second part of quality management.
20

THE TWO SIDES OF QUALITYTHE TWO SIDES OF QUALITY

1.QUALITY1.QUALITY
ASSURANCEASSURANCE
 Activities in your Quality Management system
that are performed to establish confidence that
Quality requirements in your product and service
will be met.
Examples:
 Supplier Quality Management: Qualification,
Supplier Audits, supplier Quality Agreement
 Design validation
 Process validation
 Change control
 Quality Planning and Training

2.QUALITY CONTROL2.QUALITY CONTROL
Activities performed in your Quality
Management system to verify that
Quality in your products and services
was met
Example:
Incoming inspection
In-process testing
Final Inspection
Internal Audits
In-process inspection

3.System
Human body as an example:
➢
Digestive subsystem
➢
Reproductive
➢
Central nervous system
➢
Immune system

4.Process
Digestive:
●
Chewing
●
Swallowing

SUMMARYSUMMARY
By now you should Know:
1.The five components of your Quality
Management system.
2.What a process is
3.What a procedure is
4.The three types of Quality Management
procedures

MODULE ACTIVITYMODULE ACTIVITY

QUALITY CONTROL Vs QUALITYQUALITY CONTROL Vs QUALITY
ASSURANCEASSURANCE
Where should companies spend most of
their resources? And why?
What is the problem with Quality
Assurance? How do we change that?
What is the problem with Quality control?
What are the current issues in the industry?
Which one is more important?

PHASE II: QUALITY SYSTEMPHASE II: QUALITY SYSTEM
REQUIREMENTSREQUIREMENTS

PHASE TWO
KNOW YOUR QUALITY STSYEM
REQUIREMENTS

QUALITY SYSTEMQUALITY SYSTEM
There are four sets of Quality system
requirements:
Regulatory requirements: the QSR.
ISO 13485 for medical device
ISO 9001 for business
EU Medical device directive

A. REGULATORYA. REGULATORY

THE QSR: 21CFR Part 820.00THE QSR: 21CFR Part 820.00
Regulatory Quality system requirements
are defined in the Quality System
Regulation, or QSR:
820.5 Quality system
Each manufacture shall design,
implement, and maintain a Quality system
appropriate for the specific device designed
and/or manufactured

THE QSR: Part 820.00THE QSR: Part 820.00
Key words:
Design
Implement
Maintain
Appropriate

820.20(a) Quality Policy
Management with executive power is
supposed to:
Establish Quality objectives
A Quality policy
Ensure implementation of the Quality
policy at ALL levels

820.20(b)Organization
Defined roles and responsibilities
Adequate resources
An appointed Head of the Quality unit
The head of the Quality unit reports
on the performance of the Quality
system to upper management

820.20(c)Management Review
A management review SOP is required
Quality management review meeting
must be documented
Established review records
Established review period
Established Management review
matrices

820.20(d)Quality Plan
An established Quality plan that covers:
Design
Manufacturing
Testing
Marketing

820.20(e)Quality system procedures
Established Quality system procedures:
Outline of Documentation used
Quality system Instructions
Quality system procedures

820.22 Quality Audit
An Audit program is required
An SOP for the Quality Audit process
Audit plan
Audit schedule
Linkage of the Audit process to CAPA
Maintained Audit records

TH21E QSR: Part 820.002TH21E QSR: Part 820.002
820.25 Personnel
Trained and experienced PERSONNEL
Defined requirements for each job
Maintained Training records
Defined Training programs
A Training SOP
Defined GMP training

B. EU MEDICALB. EU MEDICAL
DEVICE DIRECTIVEDEVICE DIRECTIVE

MDD DIRECTIVE ANNEX I REQUIREMENTMDD DIRECTIVE ANNEX I REQUIREMENT
1.0 FULL QUALITY ASSURANCE
SYSTEM
The manufacturer must ensure
application of the quality system
approved for the design, manufacture
and final inspection of the products

MDD ANNEX I REQUIREMENTMDD ANNEX I REQUIREMENT
3.0 QUALITY SYSTEM
A notified body must assess your Quality
system before approval to market
3.2. Application of the quality system must
ensure that the products conform to the
provisions of this Directive which apply to
them at every stage, from
design to final inspection. All the elements,
requirements and provisions
adopted by the manufacturer for his
quality system must be documented in:

A systematic and orderly manner in the
form of written 1.0 policies
2.0 procedures such as quality
programmes,
3.0 Quality plans
4.0 Quality manuals
5.0 and quality record

All the elements, requirements and
provisions
adopted by the manufacturer for his
quality system must be documented in a
systematic and orderly manner in the
form of :
1.0 written policies and
2.0 procedures such as quality
programmes, quality plans, quality
manuals http://www.cgmpuniversity.com 46

C. ISO13485C. ISO13485
REQUIREMENTS FORREQUIREMENTS FOR
MEDICAL DEVICEMEDICAL DEVICE

C. ISO 13485 STANDARDSC. ISO 13485 STANDARDS
0.2 Process approach to Quality management
The output from one process directly forms the
input to the next
4.0 Quality management system requirements
The organization shall establish, document,
implement and maintain a quality
management system and maintain its
effectiveness

ISO13485 REQUIREMENTSISO13485 REQUIREMENTS
4.2 Documentation requirements
The quality management system documentation
shall include
(a) Documented statements of a quality policy
and quality objectives
(b) A quality manual,
(c) Documented procedures
(d) documents needed by the organization to
ensure the effective planning, operation and
control of its
Processes.
(e) Records

D. ISO 9001D. ISO 9001

4.0 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality
management system and
continually improve its effectiveness in accordance with the requirements of this
International Standard.
The organization shall
a) determine the processes needed for the quality management system and their
application throughout the
organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and
control of these processes
are effective,
d) ensure the availability of resources and information necessary to support the
operation and monitoring of
these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual
improvement of these processes.

b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both
the operation and control of these processes
are effective,
d) ensure the availability of resources and information necessary
to support the operation and monitoring of
these processes,
e) monitor, measure where applicable, and analyse these
processes, and
f) implement actions necessary to achieve planned results and
continual improvement of these processes.

D. ISO 9001 STANDARDD. ISO 9001 STANDARD
0.2 Process approach to Quality
Management system
4.1 The organization shall establish,
document, implement and maintain a
quality management system and
continually improvement
4.2 Documentation requirements
(a) A quality policy and quality
objectives(Plan)
(b) A quality manual http://www.cgmpuniversity.com 53

4.2.3 Document control
A documented procedure shall be established to
define the controls needed
(a) To approve documents for adequacy prior to
issue,
(b) To review and update as necessary and re-
approve documents,
(c) To ensure that changes and the current
revision status of documents are identified,
(d) To ensure that relevant versions of
applicable documents are available at points of
use,

(f) To ensure that documents of external
origin determined by the organization to
be necessary for the planning
and operation of the quality
management system are identified and
their distribution controlled, and
(g) To prevent the unintended use of
obsolete documents, and to apply
suitable identification to them if they
are

4.2.4 Control of records
The organization shall establish a
documented procedure to define the
controls needed for:
1. The identification,
2.Storage,
3. Protection,
4. Retrieval,
5. Retention and disposition of records.
Records shall remain legible, readily
identifiable and retrievable.

5.3 Quality policy
5.4 Quality plan
5.5 Responsibility and ownership
5.6 Management review process
6.06.0 Resource management:Training
7.07.0 Product realization: Production
process controls and design
controls,equipment and facilities
controls
8.08.0 Measurement Analysis:CAPA andhttp://www.cgmpuniversity.com 57

THE QUALITY SYSTEM REQUIREMENTTHE QUALITY SYSTEM REQUIREMENT
MATRIX.MATRIX.
QSR ISO13485 ISO9001 EU
DIRECTIVE
REQUIREMENT DOCUMENT
820.5 Documented
Quality system
Quality
manual
820.20(a) Quality policy Quality policy
820.20(b) Organizational
chart
Org.chart
820.20(b) Responsibilities Job
descriptions

CRITICAL THINKING
1.Which is better requirement ?
2.Discuss compliance requirementsVs
Standards
3.Discuss compliance requirementsVS
guidance
4.Which should I follow?

PHASE THREE
PICK A QUALITY SYSTEM MODEL

PHASE III: QUALITYPHASE III: QUALITY
SYSTEM MODELSSYSTEM MODELS

QUALITY SYSTEM MODELS.QUALITY SYSTEM MODELS.

QUALITY SYSTEM MODELSQUALITY SYSTEM MODELS
There are four Quality system models
you can choose from:
The CDRH seven subsystem Quality
system
The QSIT seven subsystems with Four
satellite Quality subsystems
The ISO13485 model
ISO 9001 Contious improvement
model

1.THE CDRH Seven Quality subsystem1.THE CDRH Seven Quality subsystem
MODELMODEL
65

2.THE QSIT MODEL2.THE QSIT MODEL

3.ISO 13485 MODEL3.ISO 13485 MODEL
General : Process based Quality system
67
F(X1) F(X4)F(FX3)F(X2)
Each process has tasks performed. Each task has steps that produce
An output for the next process in line. Work instructions are written for
Task completion.

4.ISO9001 MODEL4.ISO9001 MODEL
ISO 9001 Continuous improvement
model:

QUALITY SYSTEMQUALITY SYSTEM
The Quality system is made of
subsystems
Quality subsystems are made of
processes
Processes comprise tasks that are
accomplished through defined steps .
Key words:
Subsystems
Process
Tasks
Steps
69

Structural layout in a Quality system:Structural layout in a Quality system:
SUBSYSTEM
PROCESS
TASK
STEP
RECORD.
END.

MODULE SUMMARYMODULE SUMMARY
Subsystem
Process: The 6Ms
Tasks
Steps
Quality system models

MODULE ACTIVITY
1.Review some of the processes at work
2.Name some of the tasks in those
processes
3.Discuss ownership is required for the
process
4.Discuss whether Instructions are required

PHASE FOUR
DESIGN YOUR QUALITY SYSTEM

PHASE IV:DESIGNPHASE IV:DESIGN..

THE QUALITY SYSTEM DOCUMENTTHE QUALITY SYSTEM DOCUMENT
STRUCTURESTRUCTURE
MODULE ONEMODULE ONE
DEFINE YOUR QUALITY SYSTEM DOCUMENT
STRUCTURE.

DOCUMENT HIERARCHY
Quality system documents are arranged in a
hierarchy that portrays information flow in the
company:
1.Mission and vision of the founders and their
philosophy on Quality management
2.How our Quality system is organized
3.Precess management: work flow
4.Task performance:Work done
5.Records for task performance: Proof for
performed tasks
6.Job Aids:Aids for performing tasks

DOCUMENT HIERARCHYDOCUMENT HIERARCHY
78
Quality Policy
Quality Manual
Standard operating
Procedures(SOPs)
Work Instructions
Records
Templates and job
Aids
Tier 1
Tier 2
Tier 3
Tier 4
Tier 5

Document PropertiesDocument Properties
Each document in the Quality system
is meant to achieve a purpose
Each document is unique
There are five document Tiers in the
Quality system
Each tier should have its own
numbering scheme

DOCUMENT NUMBERING SCHEME
PREFIX DOCUMENT NUMBER PROCESS NOTES
QM XXXX Quality Manual QM 0001 Rev A N/A
QPXXXX Quality policy QP 0001 Rev A ALL
POL XXX Policy POL 1282 Rev
A
Management
review
POL XXX Policy POL 1212 Rev
P
Supplier
Quality
Management
SOP XXXX Standard
Operating
procedure
SOP 0234 Rev
C
Supplier
Qualification
SOP XXXX Standard
operating
procedure
SOP 3409 Rev
A
Product and
process
change control
WI XXXX Work
Instruction
WI 0476 Rev A How to perform
root cause
Analysis
WI XXX Work
Instructions
WI 0786 Rev A CAPA Initiation
RC XXX Record RC 0007 Rev A Incoming
Inspection

MODULE ACTIVITY
1.Summarize Quality system hierarchy
2.Define properties of each layer
3.Think of a numbering scheme for your
QMS

QUALITY POLICYQUALITY POLICY
MODULE TWOMODULE TWO
WRITE YOUR QUALITY POLICY

The Quality policy :
The most treasured document of any Quality
system
Defines the vision of the organization
Defines the mission of the organization
Defines the Quality objectives of the
organization
84

1.State the purpose of your
organization’s existence.
2.State the value of your existence to
the end-user of your product, or
service.
3.State your Quality objectives

Represents the Vision, mission, ownership
and commitment to Quality for the
organization
1.OwnershipOwnership-------------- “Our, we, the
organization”
2.Missionission----------- “Improve the Quality of
patient care”
3.Vision3.Vision---------------- “Around the world”
4.Commitment to Quality---- “Through
Robust product and process designs.
Supporting objectives-Supporting objectives-----”Through
customer involvement and continuous
process improvement”
86

4.Specify how your organization will
meet Quality objectives
5.Review statements 1 through 4
6.Draft a statement from each
statement
7.Identify the following from drafted
statements:

8.Identify the vision
9.Identify commitments to ownership
10.Identify Quality objectives
11.Identify the relationship with the
end-user of your product.

12.Combine vision, commitment to
Quality, and objectives in your policy
statement.
13.Route your statement to
stakeholders for review
14.Route the final policy statement for
approval

EXAMPLE:EXAMPLE:
“Ashton Medical’s mission is to
improve the Quality of patient care
around the world through robust
product designs, and commitment to
Quality through customer involvement
and continuous product and processprocess
improvement.improvement.””

s
MODULE ACTIVITY
1.Summarizeproperties of a Quality policy
2.Draft a Quality policy for your
organization

THE QUALITY MANUALTHE QUALITY MANUAL
MODULE THREEMODULE THREE
WRITE YOUR QUALITY MANUAL

THE QUALITY MANUALTHE QUALITY MANUAL
It is the second most important document
in your Quality system
It is controlled by the Quality executive
and the president, or CEO of the
company.

WRITE THE QUALITY MANUALWRITE THE QUALITY MANUAL
To start:
Know your organizational chart
Know your Quality policy
Know the Quality model your QMS is
based on
Draft the content sections of the
manual

CONTENT SECTIONCONTENT SECTION
Purpose: Describes the Quality system layout
1.0 Quality policy
2.0 The organizational structure
3.0 Control of the Quality Manual
4.0 Document structure
5.0 Document numbering system
6.0 Quality system regulations and standards
followed
7.0 Quality system model
96

CONTENT SECTIONCONTENT SECTION
8.0 Management controls
9.0 Material controls
10.0 Corrective Action and preventive
Action(CAPA)
11.0 Equipment and Facilities controls
12.0 Document and change control
13.0 Design controls
14.0 Production and process controls
15.0 Quality system Document Matrix
97

1.0 QUALITY POLICY1.0 QUALITY POLICY
Here insert your Quality policy:
Mission,vission and commitment to Quality
98

2.0 ORGANIZATIONAL STRUCTURE2.0 ORGANIZATIONAL STRUCTURE
Insert the Org chart:

2.0 ORGANIZATIONAL STRUCTURE2.0 ORGANIZATIONAL STRUCTURE
Describe how the organization is
organized:
2.1 The Quality Unit
2.2 Manufacturing
2.3 Design unit

3.0 CONTROL OF THE QUALITY MANUAL3.0 CONTROL OF THE QUALITY MANUAL
Here describe how the Quality manual
is controlled:
3.1 The number of copies available
3.2 Revision control
3.3 Location of copies
3.4 Suitability for current use

4.04.0 DOCUMENTDOCUMENT
STRUCTURESTRUCTURE
102
Quality Policy
Quality Manual
Standard operating
Procedures(SOPs)
Work Instructions
Records
Templates and job
Aids
Tier 1
Tier 2
Tier 3
Tier 4
Tier 5

5.05.0 DOCUMENTDOCUMENT
NUMBERING SYSTEMNUMBERING SYSTEM
Describe how your documents are
numbered:
103
Work Instructions
Document
Type
Prefix Numbering
system
EXAMPLE
Quality
Manual
QM 100XXX QM1001
Policy PL 200XXX PL2002
Standard
operating
procedure
SOP 300XXX SOP3003
Work
Instructions
WI 400XXX WI4004
Record RD 500XXX RD5005
Job Aid JB 600XXX JB6001

6.06.0 Quality system requirementsQuality system requirements
Describe reference standard and
regulation for your Quality system:
This Quality system is based on the
following standards and regulations:
6.1 21CFR 820.00:Quality system
Regulation
6.2 ISO 13485:2005 Quality standard for
Medical Device
6.3 ISO9001:2005 Quality system
standard http://www.cgmpuniversity.com 104
104

7.0 QUALITY SYSTEM MODEL7.0 QUALITY SYSTEM MODEL
Describe subsystems in your Quality system
105

7.0 QUALITY SYSTEM MODEL7.0 QUALITY SYSTEM MODEL
Describe:Describe:
The subsystems in your Quality system
Specify the requirements met
Describe purpose of each subsystem

8.0 Management controls8.0 Management controls
Describe your management controls
subsystem:

8.0 MANAGEMENT CONTROLS8.0 MANAGEMENT CONTROLS
The idea is to describe how management knows
what is going on in the Quality system. This
includes the review of :
Defined CAPA indicators
Design changes
Process changes
Equipment downtime
Management review meetings
NCR data
Customer complaints
Audit Findings
Post market surveillance review

9.0 MATERIAL CONTROLS9.0 MATERIAL CONTROLS
Here describe
Material and service control processes
including:
9.1 Supplier Qualification
9.2 Supplier Quality Management
9.3 Material Qualification
9.4 Material Traceability
9.5 Nonconforming material control: NCR
process
9.6 MRB process
9.7 Separation, disposition. and segregation
of nonconforming material process

10.0 CORRECTIVE ACTION AND PREVENTIVE10.0 CORRECTIVE ACTION AND PREVENTIVE
ACTION/CAPAACTION/CAPA
Here describe Your CAPA system including:
10.1 CAPA initiation: Inputs including adverse
trends, complaints, OOS and OOT.
10.2 Investigation
10.3 Containment
10.4 Implementation
10.5 Effectiveness check
10.6 Change control
10.7 Closure
10.8 CAPA metrics

11.0 EQUIPMENT AND FACILITY CONTROLS11.0 EQUIPMENT AND FACILITY CONTROLS
Here describe Your processes for facilities
and equipment controls:
11.1 Environmental controls process: clean
room(gowning, particle count etc)
11.2 Equipment traceability process
11.3 Priventive maintainance process
11.4 Corrective maintainance process
11.5 Equipment calibration process
11.6 Equipment Qualification process
11.7 Facility Qualification and
commissioning process
11.8 Utility controls: Quality of water

12.0 DOCUMENT AND CHANGE CONTROLS12.0 DOCUMENT AND CHANGE CONTROLS
Here describe Your change control processes.
Including:
12.1 Change initiation.
12.2 Impact assessment
12.3 Risk assessment
12.4 Change review board
12.5 Change Request Approval process.
12.6 Design change evaluation and approval
12.7 Process change review and approval
12.8 Deviation process
12.9 Document change review and approval

13.0 DESIGN CONTROLS13.0 DESIGN CONTROLS
Here describe Your design control processes.
Including:
13.1 Design development planning: How to develop a
design plan.
13.2 Design Quality plan
13.3 Design input verification
13.4 Design output verification
13.5 Design review process.
13.6 Design verification
13.7 Design validation process
13.8 Design Transfer
13.9 Design change control
13.10 Design History File(DHF) process

14.0 PRODUCTION AND PROCESS CONTROL14.0 PRODUCTION AND PROCESS CONTROL
Here describe your production processes and their
controls Including:
14.1 Manufacturing, labeling,Packaging,storage and
distribution.
14.2 Environmental controls
14.3 Personnel Training
14.4 Contamination control process
14.5 Equipment Qualification and traceability
14.6 Material Qualification
14.7 Process validation: MVP, criteria for re-validation
14.8 Control of Test equipment: Calibration
14.9 Test method validation
14.10 Facility Design and commissioning
14.11 Production change control process

15.0 QUALITY SYSTEM DOCUMENT MATRIX15.0 QUALITY SYSTEM DOCUMENT MATRIX
The output of writing a Quality Manual is the Quality system document
Matrix:
subsystem Policy process SOP Task WI Record Number
All Quality
Manual
ALL ALL ALL ALL ALL QM001
All Quality
policy
ALL ALL ALL ALL ALL PL001
0.8 Management
controls
N/A Annual
review
Annual
review
process
N/A N/A N/A SOP006
N/A Annual
review
N/A Annual
review
meeting
Holding
Annual
Review
meetings
N/A WI009
N/A Annual
review
N/A Annual
review
meeting
Holding
Annual
review
meetings
Meeting
Agenda
RD007
N/A Managem
ent
review
Managem
ent
review
meetings
N/A N/A N/A SOP005
N/A Managem
ent
Review
N/A Manage
ment
review
meeting
Holding
meeting
N/A WI0053

Properties of the Quality manual
Sections of the Quality manual

WHAT DOES IT LOOK LIKE?
1.Review template provided
2.Write a Quality Manual for your
Organization
3.Introduction to process mapping
4.Introduction to process flows

STANDARD OPERATINGSTANDARD OPERATING
PROCEDURESPROCEDURES
MODULE FOURMODULE FOUR
WRITE YOUR STANDARD OPERATING PROCEDURES

PROCEDURESPROCEDURES
Are cross-functional documents that describe
how work flows across departments: “Who
does what”.
Written in second person voice
Example: “The Quality department reviews
and approves the corrective Action Request
form”
Initiated using a cross-functional map
120

WRITING STANDARDWRITING STANDARD
OPERATING PROCEDURESOPERATING PROCEDURES
Identify ALL processes in each
Quality subsystem on your
Quality System Document Matrix
Review the matrix with
stakeholders
Get buy-In from stakeholders

PROCEDURES(SOPs)PROCEDURES(SOPs)
Remember SOP are process document.
Properties:
Cross-functional documents:
Answers the Question: “Who does
what ?” i.e. “Who performs what task?”
Describe workflows across departments
and functions
Are written in a passive / second person
voice.
Are Quality subsystem based
122

QUALITY SYSTEM DOCUMENT MATRIXQUALITY SYSTEM DOCUMENT MATRIX
The output of writing a Quality Manual is
the Quality system document Matrix:
subsystem Policy process SOP Task WI Record Number
All Quality
Manual
ALL ALL ALL ALL ALL QM001
All Quality
policy
ALL ALL ALL ALL ALL PL001
0.8 Management
controls
N/A Annual
review
Annual
review
process
N/A N/A N/A SOP006
N/A Annual
review
N/A Annual
review
meeting
Holding
Annual
Review
meetings
N/A WI009
N/A Annual
review
N/A Annual
review
meeting
Holding
Annual
review
meetings
Meeting
Agenda
RD007
N/A Managem
ent
review
Managem
ent
review
meetings
N/A N/A N/A SOP005
N/A Managem
ent
Review
N/A Manage
ment
review
meeting
Holding
meeting
N/A WI0053

STEPSSTEPS
Step one: Identify all required processes
in your Quality subsystems
Step two: Identify all required SOPs per
processes
Step three: Identify All stakeholders
Step four: Talk to stake holders about
how work flows across functions.

STEPSSTEPS
Step five: Convert what stakeholders say
into a CROSS-FUNCTIONAL process map
Step six: Review the process map with stake
holders
Step seven: Convert the process map into a
standard procedure
Step eight: Review the SOP with
stakeholders and route for approval.

MODULE ACTIVITY
1.Think of a process at work
2.Who are the key players?
3.Draw a cross functional process map
4.Convert the map into an SOP
NOTE: Tool of choice for process mapping
is MicrosoftVisio

WORK INSTRUCTIONSWORK INSTRUCTIONS
MODULE FIVEMODULE FIVE
WRITE YOUR WORK INSTRUCTIONS

WORK INSTRUCTIONSWORK INSTRUCTIONS
Provide step by step instructions to perform a
task.
Written in an active voice
Example: 1.“ Push the red button on the
panel”
2. “ Slowly, add 50ML of 2.0M
Sulfuric acid to the copper sulfate in the
flask”
Initiated by drawing a process flow
130

STEPSSTEPS
Step one: Identify all required tasks per
processes in your Quality subsystems
Step two: Identify all required work
Instructions per processes
Step three: Talk to process owners about
process steps
Step four: Draw the process flow.

STEPSSTEPS
Step five: Review the process flow with
the process owner
Step six: Convert the process flow into a
work Instruction
Step seven: Review the work Instruction
with the process owner and route for
approval

Work Instructions (WIs)Work Instructions (WIs)
Properties:Properties:
 Task oriented
 Answers the Question: “how is it done ?” i.e. “How
is this task performed?”
 Describe workflows
 Are written in an active voice.
 Are task based
134
MODULE SUMMARY

MODULE ACTIVITY
1.Look at some tasks at work
2.Draw a process flow
3.Convert the process flow into a work
Instruction

RECORDSRECORDS
MODULE SIXMODULE SIX
DEFINE YOUR RECORDS

StepsSteps
1.Define what type of information you want
to capture
2.Decide where to capture the information
3.Decide who to capture the information
4.Decide when to capture the information
5.Decide how to keep the information
6.Define the record retention policy

STEPSSTEPS
Remember records are proof of a task
having been performed
Step one: Establish ownership (who)
Step two: Define the Task(what)
Step three: Document the Time(when)
Step four: Document results obtained
(what)
Leading Question : “ who did what, when,
and what?”.
139

RecordsRecords
( Proof that a task was performed)( Proof that a task was performed)
Properties:
Could be a form
Could be a report
Could be a printout
Could be electronic media
140

EXAMPLEEXAMPLE
TRAINING RECORDTRAINING RECORD FRM 872 Rev 2
ATTENDEE DATE SIGNATURE
Trainer: Date:

RECORDSRECORDS
Purpose:Purpose:
Prove that a task was performed.
It captures the following information:
 Who ----------------Ownership (name)
 What---------------Task performed
 When----------------Date
 What-----------------Results
142

RECORDS
Write your records retention policy
Contents of a records retention policy:
1.0 Purpose
2.0 Scope
3.0 Responsibility
4.0 Records
5.0 Retention policy

Quality attributes of a record
Types of records
Requirements of a records retention
policy
Requirements for DHF and DMR
Medical Device records

MODULE ACTIVITY
1.Current FDA warning letters on Quality
records
2.Compliance issues on records in India

MODULE SEVENMODULE SEVEN
HOW TO DESIGN TEMPLATES.
WHAT? HOW? WHAT.

TEMPLATESTEMPLATES
Types of templates:Types of templates:
Official SOP layout
Official WI layout
The organization’s Official forms
Official presentation layout
Training record
Protocol template
Report template
148

StepsSteps
1.Decide the purpose of the
template
2.Decide on the structure of the
template
3.Decide on the layout of the
template
4.Draft the template
5.Route the draft for approval.

GOOD DOCUMENTATION
PRACTICES(GDPs)
All Quality System documents:

Must be reviewed through a formal
review process

Approved through a formal review
process

Maintained at current revision levels
through change control

Retired through change control

ELECTRONIC RECORDS ANDELECTRONIC RECORDS AND
SIGNATURESSIGNATURES
MODULE EIGHT: REQUIREMENTS FOR ELECTRONICMODULE EIGHT: REQUIREMENTS FOR ELECTRONIC
SYSTEMSSYSTEMS
PART 11PART 11

PART 11 REQUIREMENTSPART 11 REQUIREMENTS
Electronic systems(Open systems,and
closed systems) must meet two sets of
compliance requirements:
1.0 Electronic records
2.0 Electronic signatures

1.0 ELECTRONIC SIGNATURES1.0 ELECTRONIC SIGNATURES
Limiting system access to authorized individuals

1.By use of operational system checks
2.By the use of authority checks
3.By the use of device checks
Determination that persons who develop, maintain, or
use electronic systems have the
education, training, and experience to perform their
assigned tasks

4. Establishment of and adherence to written policies
that hold individuals accountable for actions initiated
under their electronic signatures
5. Established appropriate controls over systems
documentation

2.0 ELECTRONIC RECORDS2.0 ELECTRONIC RECORDS
These requirement must beThese requirement must be
met:met:
1.Audit trail1.Audit trail
2.System validation2.System validation
3.Revision control for3.Revision control for
softwaresoftware

QUALITY FEEDBACK LOOPS
Once designed and implemented the Quality
management system is maintained through:

The internal Feed-backloop

External Feedback-loop
Internal feedback loop:
Quality information from within the
Quality system initiated by the
organization

INTERNAL FEEDBACK LOOP
Information maintained by this loop includes:

Internal Quality Audits

In-process inspection

Management Review

Annual document reviews

Change requests: product,process and
document

EXTERNAL FEED-BACK
LOOP
The external feedback loop is Quality
information from third party users of your
Quality system. This includes:

Customer complaints

Post market surveillance data

Customer returns

Regulatory Audits

Notified body/third party Audits

Customer returns

QUALITY RISK MANAGEMENT
Once an adverse is established,or a non-
conformity is discovered the risk is assessed
The risk level dictates:

Whether a CAPA is to be opened or
not

The priority level of the
nonconformity,or adverse trend
Note:
Not every nonconformity is a candidate
for CAPA.

REQUIREMENTS
EN ISO 14971 gives three options to manufacturers
for how to reduce and control risks for their
devices:
 Design an inherently safe device: DFMEA
 Use of protective measures in the device itself:
Hazard mitigation

In the manufacturing process: PFMEA

REQUIREMENTS
ISO13485: Clause 7.1 requires, “. . . risk
management throughout product
realization.”
– In addition, “Records arising from risk
management shall be maintained”

QUALITY RISK
MANAGEMENT TOOLS
There are several Quality Risk Management
tools:

PFMEA

DFMEA

Fault Tree Analysis

Probability Risk Assessment (PRA)

IMPROVE AND CLOSE THE
LOOP
Once the potential nonconformity,or
nonconformity has been prioritized based
on risk a decision is made as to whether to
open a CAPA,or not.
Second step:

Validate,or verify the solution

Implement the validated solution

Monitor for success

Close the CAPA based on data collected

WHAT WE HAVE LEARNED?WHAT WE HAVE LEARNED?
SEMINAR SUMMARYSEMINAR SUMMARY

TEACH THE TEACHER.TEACH THE TEACHER.

POINTS COVEREDPOINTS COVERED
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NOTESNOTES
Others:

Post your QuestionsPost your Questions
LinkedIn: cgmpuniversity
Facebook: cgmpuniversity.com
E-mail: support @cgmpuniversity.com
E-mail the instructorE-mail the instructor:
david@cgmpuniversity.com

How to Design a Quality system that meets compliance requirements 2014

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