004 301 training quality system management regulations, gmp (2)

Presented By
MUHAMMAD ZARRAR MEHMOOD

GMP
Good Manufacturing Practice
Regulations
developed and
enforced by the
Food and Drug
Administration,
an agency of
Federal
Government.

Introduction
 GMP
 (GOOD MANUFACTURING PRACTICES)
 A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a
quality product.
 Many countries have legislated that pharmaceutical and medical device companies must follow GMP
procedures.
 In U.S. A FDA enforce GMP through its rules and regulations.
 FDA considers a Device may be deemed adulterated if it has passed all of the specifications tests but
is found to be manufactured in a condition which violates current good manufacturing guideline.
Therefore, complying with GMP is a mandatory aspect in Device manufacturing and distribution.
 FDA regulates Medical Devices under the authority of the Federal Food, Drug, and Cosmetic Act and,
for products marketed on a retail basis to consumers, the Fair Packaging and Labeling Act.

GMP
 All guidelines follow a few basic principles:
 Manufacturing processes are clearly defined and controlled. All critical processes
are validated to ensure consistency and compliance with specifications.
 Manufacturing processes are controlled, and any changes to the process are
evaluated. Changes that have an impact on the quality of the devices are
validated as necessary.
 Instructions and procedures are written in clear and unambiguous language.
(Good Documentation Practices)
 Operators are trained to carry out and document procedures.
 Records are made, manually or by instruments demonstrate that all the steps
required by the defined procedures and instructions were in fact taken and that
the quantity and quality of the device was as expected. Deviations are
investigated and documented.
 Records of manufacture (including distribution) that enable the complete
history of a batch to be traced are retained in a comprehensible and accessible
form.
 The distribution of the devices minimizes any risk to their quality.
Quality possible by accident?
like if 100 monkeys were let loose without any training, guidelines or
direction someday they might create a really good quality product?

GMP
 A system is available for recalling any batch of devices from sale or
supply.
 Complaints about marketed devices are examined, the causes of quality
defects are investigated, and appropriate measures are taken with
respect to the defective devices and to prevent recurrence.
 GMP guidelines are not prescriptive instructions on how to
manufacture and distribute products. They are a series of general
principles that must be observed during manufacturing and
distribution. When a company is setting up its quality program and
manufacturing or distribution process, there may be many ways it can
fulfill GMP requirements. It is the company's responsibility to
determine the most effective and efficient quality process.

 QSR History, Purpose and Scope
 Regulatory Requirements
 FDA Inspectional Focus – QSIT
 Management Responsibility
 Design Controls
 Production and Process Controls
 Corrective and Preventive Action
• Integration of all QMS/QSR Systems

 U.S. FDA Quality System Regulation
 (QSR) – 21 CFR Part 820
 Harmonized with European Requirements
 ISO 9001
 EN 46001
 Medical Device Directive ( MDD)
 ISO 13485

• Current Regulation covers design
through commercialization of product
Controls for
Tracking Design
Medical Device
Amendments
1976 (Law)
Ensure Consistency
of Manufacturing
Approval for
Commercialization
Approval for
Commercialization
Ensure Consistency
of Manufacturing
Approval for
Commercialization
GMP Regulation 1978,
1982, 1990
ISO Regulation 1990
QSR Regulation
1997 (SMDA 1990)
ISO Regulation 1990
PAST CURRENT

GMP
 GMPs are enforced in the United States by the US FDA, under
Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21
USCS § 351). The regulations use the phrase "current good
manufacturing practices" (cGMP) to describe these guidelines.
 Courts may theoretically hold that a product is adulterated even
if there is no specific regulatory requirement that was violated as
long as the process was not performed according to industry
standards.
 Regulatory agencies (including the FDA , Labor Department,
EPA) are authorized to conduct unannounced inspections,
though some are scheduled. FDA routine domestic inspections
are usually unannounced, but must be conducted according to
704(A) of the FD&C Act (21 USCS § 374), which requires that
they are performed at a "reasonable time". Courts have held that
any time the firm is open for business is a reasonable time for an
inspection.

Benefits of knowing GMP
 How this presentation will benefit the team
 In terms of generating quick profit, low quality products can be a real quick win. GMP training really
benefits those who are looking for long-term sustained profit.
 Repeat custom is unlikely when someone experiences a low-quality product. It is very rare for
someone to return to a product if they were dissatisfied with their initial purchase. You will force
them into using your competitors.
 Research proves that if someone is satisfied with a product then they will come back and buy it again
and again. Only through this repeat custom can you expect your business and profits to grow.
 A product recall can be disastrous for an organization. A product recall is expensive in terms of time,
as well as money. Staff who have had GMP training will reduce the chances of this happening.
 The sky is the limit for Medical Companies who sell these products. If, however, their products are not
up to the par , then the chances of their products being generating profits are far less. If staff have
undertaken GMP training, they will be in a better position to adhere to the guidelines in the
manufacturing of products.
 As these reasons outline, outlaying money on GMP training will certainly pay its dividends in the
future. It would be naive to look past the benefits of GMP training.

GMP
 Presenter’s level of expertise
 Developed all the related Documentation & Procedures for the Organization.
 Attended GMP Training by MDI
 Attended Audits by Medline, FDA, MDI
 Liaison for complaints and regulatory affairs between Phoenix and Customers
 Responsible for Regulatory Compliance
 MSc Mathematics, M.S.Sc International Relations, MS Financial Management, Bachelors in Law &
Legislation, Graduate in Mind Sciences From TIMS
 PGD in Project Development
 Architect of the National Irrigation and Drainage Authority Act, which was enacted as PIDA ACT
1997 in Balochistan & PIDA ACT 1997 with some amendments in Sindh, Punjab And NWFP.

 Management Responsibility
 Quality Audit
 Personnel
 Design Controls
 Document Controls
 Purchasing Controls
 Identification and Traceability
 Production and Process Control
 Inspection, Measuring and Test
Equipment
 Process Validation
 Acceptance Activities
 Acceptance Status
 Nonconforming Product
 Corrective and Preventive
Action
 Labeling and Packaging Control
 Handling, Storage, Distribution
and Installation
 Records
 Servicing
 Statistical Techniques

FDA RequirementsTITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
Subpart H--Acceptance Activities
§ 820.80 - Receiving, in-process, and finished
device acceptance.
§ 820.86 - Acceptance status.
Subpart I--Nonconforming Product
§ 820.90 - Nonconforming product.
Subpart J--Corrective and Preventive Action
§ 820.100 - Corrective and preventive action.
Subpart K--Labeling and Packaging Control
§ 820.120 - Device labeling.
§ 820.130 - Device packaging.
Subpart L--Handling, Storage, Distribution, and
Installation
§ 820.140 - Handling.
§ 820.150 - Storage.
§ 820.160 - Distribution.
§ 820.170 - Installation.
Subpart M--Records
§ 820.180 - General requirements.
§ 820.181 - Device master record.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
Subpart N--Servicing
§ 820.200 - Servicing.
Subpart O--Statistical Techniques
§ 820.250 - Statistical techniques.
Subpart A--General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B--Quality System
Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C--Design Controls
§ 820.30 - Design controls.
Subpart D--Document Controls
§ 820.40 - Document controls.
Subpart E--Purchasing Controls
§ 820.50 - Purchasing controls.
Subpart F--Identification and
Traceability
§ 820.60 - Identification.
§ 820.65 - Traceability.
Subpart G--Production and Process
Controls
§ 820.70 - Production and process
controls.
§ 820.72 - Inspection, measuring, and
test equipment.
§ 820.75 - Process validation.
Subpart H--Acceptance Activities
§ 820.80 - Receiving, in-process, and
finished device acceptance.
§ 820.86 - Acceptance status.

FDA Classifications
 The Food and Drug Administration recognizes three classes of medical devices, based on the level of control
necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal
Regulations, Title 21, part 860 (usually known as 21 CFR 860)
 Class I: General controls
 Class I devices are subject to the least regulatory control. Class I devices are not intended to help support or sustain
life or be substantially important in preventing human health impairment to human health, and may not present an
unreasonable risk of illness or injury. Most Class I devices are exempt from the premarket notification.
 Class II: General controls with special controls
 Class II devices are those for which general controls alone cannot assure safety and effectiveness, Class II devices are
also subject to special controls. A few Class II devices are exempt from the premarket notification. Special controls
may include special labeling requirements, mandatory performance standards and postmarket surveillance. Devices
in Class II have a higher level of assurance than Class I devices, and are designed to perform as indicated without
causing injury or harm to patient or user.
 Class III: General controls and premarket approval
 A Class III device needs premarket approval, a scientific review to ensure the device's safety and effectiveness. Class
III devices are usually those that support or sustain human life, are of substantial importance in preventing
impairment of human health, or present a potential, unreasonable risk of illness or injury. Examples implantable
pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators etc.

 Specification
Development
 Testing
 Selection Of
Suppliers
 Transfer to
Production
 Tracking of
Design
Changes
Manufacture
 Establishing Production
Process
 Testing
 Developing Acceptance
Criteria
 Equipment Calibration
and Maintenance
 Labeling
 Tracking Changes
 Final Release
Inspection Criteria
 Segregation and
Storage
 Product Shipment
 Tracking of
Product
 Device
Tracking
 Handling of
Complaints
 Corrective
Action as
needed
 Servicing/
Replacing
Design
Distribute
Monitor
Performance

Quality Manual
 QUALITY MANUAL
 The manual describes the quality management
system of Phoenix Instruments Inc. consistent
to the FDA’s Quality System requirements (21
CFR820).
 The manual outlines the organization, policies
and principal of quality management system
applied to the companies as an ongoing
commitment to quality.
 A controlled copy of the manual shall be
distributed to specific personnel in the
company and the Management Representative
shall maintain record of distribution.
 Introduction

 Phoenix Instruments Inc. was founded in 1989
and is a family owned business that has a vast
experience of 50 years in the Surgical
Instruments Business. Phoenix Instruments
delivers complete sourcing capabilities. The
company carries thousands of standard and
specialty items from components to custom
trays to serve a variety of markets: General
surgery, Diagnostics, Orthopedic, Urology,
Obstetrics & Gynecology, Laparoscopy,
Cardiothoracic, Neuro & Spine,
Ophthalmology, ENT Sinus and Plastic etc.

Management Responsibility
 Establish policy and objectives for, and commitment
to, quality
 Establish Organization Structure
 Designate a Management Representative
 Conduct Management Review

QMS (Quality Management System)
 Management Responsibility
 Quality Statement
 Our aim is to have a system which
ensures high quality of instruments.
 In order to achieve the above defined
aim the quality system has been adopted
consistent to best quality international
standards. This provides documented
procedure for control of incoming
purchases and final inspection, training,
internal audit, process control
identification and trace-ability. It is
ensured that the quality policy is
understood implemented and
maintained at all levels of the
organization.
 Our Policy
 We are committed to delivering
outstanding customer value,
 by providing quality Surgical products
and services which consistently meet the
needs of our customers.
 We are committed to continuous
improvement of our products, our
services, our business processes and our
business relationships. We will
accomplish these objectives by creating
and maintaining a quality - focused
environment in order to serve with
valued customers, employees, and
community.

Management Responsibility (cont.)

 Establish a Quality Plan
 Additional Management Considerations
 Define appropriate responsibility, authority, and
interrelationships of all personnel who manage,
perform, and assess work affecting quality
 Provide adequate resources for management,
performance of work and assessment activities
(including internal audits)
 Display management commitment in decision-
making and involvement in management reviews

Management Review
Inventory.
 Provision of sufficient inventory based on
annual usage.
 Trained personnel for management and
verification activities including quality
audit.
Management Representative:
 The Management Representative has
responsibility for establishing,
implementing and maintaining the Quality
Management System.
Management Review
 The Quality Management System is
reviewed against International Quality
standards and management's own quality
policy & objective to ensure continued
suitability and effectiveness of the quality
system at the management review meeting
convened once a year or more often as
deemed necessary.
The Review Meeting is chaired by the President.
Vice president
QA Manager
Accounts Manager
Shipping /Warehouse Manager
A typical agenda considers all quality related matters
and the actions necessary to ensure the continued
efficiency of the Company Quality Management
System. Minutes of Management Review Meeting are
recorded. The President is ultimately responsible
ensuring that any corrective or remedial actions are
undertaken. The record of management review and
subsequent corrective actions will be maintained
according to "Control of Quality Record".

Management Review
 Management reviews:
 a. are performed at planned
intervals to ensure its continuing
suitability, adequacy and
effectiveness,
 b. assess opportunities for
improvement and the need for
changes to the quality management
system, including the quality policy
and quality objectives, and.
 c. are documented in management
review presentations and minutes,
including actions to be taken.
Review output from the
management review includes any
decision and actions related to:
a. improvements needed to
maintain the effectiveness of
the quality management
system and its processes,
b. improvement of product
related to customer
requirements, and,
c. resource needs.

Quality Management System
 QUALITY MANAGEMENT SYSTEM
 Quality Manual
 The quality manual describes the policies practiced by Phoenix Instruments Inc. to satisfy the requirements of quality
standards and to allocate responsibilities within the company. Quality Manual Section 1.0 outlines the quality
objectives, management organization and general quality system structure, Section 2.0 to 13.0 describes policies
relating to working practice employed in order to provide a satisfactory service to the customer.
 Quality Operating Procedures
 Standard Operating Procedures have been documented and effectively implemented to fulfill the requirement of our
quality policy. Where necessary the Standard Operating Procedure refers to the concerned work instructions, which
define how an activity is performed.
 Work Instructions
 Work instructions are issued where lack of such clear instructions would adversely affect quality work. Instructions
may be generally applicable to inspections, tests and quality etc. or may be specific to a particular order/contract.
 The purpose of such documentation is to ensure that each employee:
 2.3.1. Fully understands and is capable of carrying out his required task.
 2.3.2. Has the necessary skills and tools to complete the task.
 2.3.3. Is aware of the procedures and lines of responsibility.

 Device Master Record/Product Specifications (DMR)
 For device or family / category of devices Device Master Record/Product
specification (DMR) are created and maintained by the QA Manager which
either describes or provides reference to the components to be used,
labeling/packaging specification in-process inspections/tests and final
inspection and authority of release are created and maintained.

Internal Quality Audits
 Audits of all QS elements shall periodically conducted
to:
Demonstrate compliance of the quality system to
regulations, and/or
Identify nonconformities and areas for improvement in
processes
• Reports of audits must be documented and reviewed
by management of the areas that were audited

Internal Audit
 Phoenix Instruments Inc. conducts internal audits at planned intervals
to determine whether the quality management system
 Conforms to the planned arrangements to the requirements of this
International/cGMP Standard and to the quality management system requirements
established by the organization
 Is effectively implemented and maintained.

Personnel and Training
 Employees, Who’s Work affects quality, must have
appropriate education, background, training and
experience to do their jobs
 Records of education, training, background and
experience must be maintained

Quality System Element
 Design Controls
 Procedures to control and verify design of all products to ensure design requirements are
met
 Develop a design/development plan
 Develop and document design input
 Design input = Design requirements or specs
o Develop and document design output
 Design output = Finished product and DMR
(i.e., finished product specification)
o Plan formal reviews of the design throughout the development process
o Develop procedures for ensuring correct translation into routine production
o Document changes implemented in the design during development phase, and test as
needed ( including “regression analysis”)
o Maintain records of design process
o Conduct validation and verification testing

 Document Controls
 Establish and maintain a Quality System that is appropriate
for devices designed and manufactured and meets
regulatory requirements.
 Ensure documentation developed is adequate for its
intended purpose or requirement
 Make documents accessible to those who need them
 Ensure control of the accuracy and usage of current
versions of documents
 Maintain records of document changes

 DOCUMENT AND DATA CONTROL
 GENERAL
 Documents essential for performing or verifying quality related activities are maintained as CONTROLLED
documents. Standard Operating Procedures exist to implement effective control of those documents.
 These Standard operating procedures prescribe standard formats, order status, distribution and
amendment control. They include in their applicability:
 Quality Manual
 Operating Procedures
 Specifications and Technical Data/DMRs
 Forms
 Documents of external origin
 Work Instructions.
 Document & Data Approval and Issue
 Procedures ensure that these documents and data are reviewed and approved by authorized personnel prior
to issue and that copies of all such documents are available to all .
 Uncontrolled copies of the quality manual are made available to regulatory authorities, customers or their
representatives if requested and approved by management. Such copies are clearly identified as
(UNCONTROLLED).

Writing it Down!
Keeping Good Records
A GMP Training
for Document Control

Great Mounds of Paper?Some may think that
GMP stands for Great
Mounds of Paper!
There’s some truth to
that.

Our Paperwork is a Product
The paperwork we produce is
of equal importance to the
products we produce.
Product = Paperwork

Can we ship
this batch?
QC
Not until
the
paperwork
is released!
Lot no.
Phx A1/12

100 % Accuracy
Our customers trust
each of us to make sure
that our paperwork is
100% accurate.
Our customers don’t
want us guessing!

The FDA
The FDA represents
our customers, the
patients.
They inspect our
company to ensure
that our customers
can trust us.

Why is so much paperwork
required?
 To make sure we know exactly what
we did, and when we did it.
 To be able to correct mistakes if
they happen.
 To be able to PREVENT mistakes
from happening in the future.

Good Record Keeping Tips
Here are four record keeping tips for us to remember.

Record Keeping Tip #1
Use a non-water soluble pen for writing on any official
document.
No pencils.

Clearly record the data.

Take your time and write clearly.
• Slow down a
little.
• Take a deep
breath!
• Relax your body
before writing on
a document.

A few seconds of
composure helps
reduce stress too,
leading to a
healthier you!
Sloppy writing is
100% preventable.

There is a proper method for making corrections.
Veronica
Cuitino
26 Jan 2013

No erasures. No correction fluid. No “Post-it” notes.

Record Filling
 Do not leave any space blank, if nothing has to fill in a
space fill it in by N/A
Picked by:______________ Etched By:____________ Packed By:____________ Shipped By: ________
Picked by:_Muhammad Z Mehmood_ Etched By:___________ Packed By: ___H.P____ Shipped By:
_Asadullah
N/A

“I swear to tell
the truth, …”
Enter enough details so the
document can be understood in the
future.

Let’s keep good records!
Our
customers are
counting on
us.

 CONTRACT REVIEW
 General
 The company ensures that contracted requirements of the customer are fully understood and are within
quality capabilities, standard operating procedures exist in order to define
a. How these requirement are defined and documented.
b. How differing requirements to the inquiry are resolved.
c. How contracts, once accepted, are placed into getting the quality instruments
 Review
 The Office Manager reviews all inquiries/orders upon receipt in order to ensure that
a. The requirements are adequately defined and documented and are acceptable to Phoenix Instruments Inc.
b. The requirements of verbal orders are fully understood and are acceptable to Phoenix Instruments Inc.
c. Any differences between the contract or order requirements and those in the original inquiry are resolved
d. Company has the capability to meet the contract or order requirements.
 Quotes are reviewed before submission and contract/orders are reviewed before acceptance.

 Amendment to a Contract
 Any amendments to contract/order are indicated on all relevant documentation i.e. customer's order sheet
and or pick sheet. This would be done by the Shipping Administrator.

 Records
 Contract/order and quote with evidence of review are retained by the Office Manager in the customer file.

 Purchasing
 Document requirements, including quality
requirements that suppliers must meet
 Evaluate Suppliers, Contractors and Consultants on
ability to meet requirements
 Define type and extent of controls over products,
services and suppliers
 Maintain records for each supplier

 Purchasing
 Purchase product and services are controlled to ensure conformance with specified requirements. Standard Operating procedure
prescribes control measures relating to accuracy and completeness of purchasing data.
 Evaluation of Suppliers
 Suppliers must be able to demonstrate that they maintain the necessary facilities and systems of control to ensure the compliance of
their product/service with the purchase specification and that they have an acceptable quality performance and service record.
 This can be achieved in one or more of the following ways
a. Having been approved by a recognized body to an appropriate standard
b. Having a satisfactory history of supply
c. Having been assessed by Phoenix Instruments Inc.
d. Having been nominated by the customer
 Review of suppliers.
 Quality performance record is a major factor in determining purchasing policy. Suppliers who fail to maintain required standards of
performance lose their approved status and are either subjected to special controls stipulated by the Quality Assurance Manager or are
no longer considered for placement of future orders.
 Purchasing Data
 Purchase orders are issued purchase medical equipment, devices, sub-contracted services etc.
 Verification of Purchased Product
 Supplier Verification at suppliers premises

 Customer Verification of suppliers Product

 Purchasing Record.
 Copies of Purchase Orders issued to the suppliers, Reports/certificates of conformity if any provided by the supplier's incoming
inspection records are maintained

 Maintain procedures to identify product during all
stages of receipt, production, distribution, and
installation to prevent mix-ups
 Each unit or lot of finished device has a lot number
 Systems can be complex or simple
 FDA judges this system to be a measure of your control
over your system
Identification & Traceability

Product Identification
Phoenix Instruments Inc. maintains written procedure in order to establish the identification of any product.
 The identification clearly establishes the metal analysis of the instrument, its quality and inspection status. Where appropriate,
procedure exists for identifying devices by means of applicable labels, cards specifications or other documentation during
storage and delivery.

Trace-ability
Identification is maintained throughout all processes in order to ensure trace ability to original material identification and
quality status where applicable in order to facilitate corrective actions if needed.
 Should a customer’s contract request specific trace ability procedures this will be indicated on all relevant documentation and
appropriate procedure raised.
Procedure
 The purpose of this Procedure is to define the method used for the identification of all contributing materials that could affect
product quality used in the manufacture of product, and the final product, to ensure their full Traceability.
 Related Documentation
 Product ID and Traceability Procedure Doc. No. 006 SOP/PID/Trace
 Receiving Invoice
 Warehouse Receiving Sheet, WHR V 2.02
 Database
 Packing List
 Sales Order/Pick Sheet
PRODUCT IDENTIFICATION AND TRACEABILITY

Traceability
 Product Traceability is
the ability of an
organization to trace a
product through its
processing procedures
and to also have the
ability to re-trace a
product back to the
manufacturer.
 Product traceability is
monitored by the use if a
part or lot number

 Product traceability systems are commonly
implemented by the company’s Quality Control
department and give that department the
visibility to the products
 QC department can use these systems to provide
customers with processing data for the
compliance to set procedures and policies.
 These systems can be used when a product is
being recalled or has manufacturing problems.

 The ability to view
manufacturing process data
allows an Organization to
pull in other suspected
recall lots and also assign
responsibility to the
defective product

 In this procedure the product traceability is be based on a
lot.
 A lot is a quantity of devices with similar properties.
 A lot number or name is assigned to a lot at the beginning
of its processing life or when a product has been
purchased from a vendor and is entered into the system.

 In most cases this is not done
manually, but instead is done by a
lot traceability system that assigns
a lot number when an item is
received or from a purchase order.
 In some cases the lot number will
be directly linked to the purchase
order for the ability to track the
lot back to the original order.
 Lot numbers can also be specific
to the customer or vendor. Once
the lots are assigned a lot number
they are processed as required by
the manufacturing specifics and
tracked by the lot number that
was assigned to it.

 Product Traceability systems are being used to help improve the overall quality
in the manufacturing/ receiving/ stocking/distributing process as organization
use Statistical Process Control programs to include measurement data or
processing data.
 By doing this organization can monitor the processes and evaluate different
variables on a product.

 Whenever a quality defect is found, the lot traceability function
allows the organization to review the data and determine the cause
of the defect.
Some examples of the data that would be available are who
processed it, who inspected it, what tools were used, what were
the processing parameters, machine set ups, and when the lot was
ran.

The purpose of this is to be able to track down problems or defects and
prevent them from happening in the future.
Product traceability systems are being used in all types of Organizations
from the computer industry to the sterilized packing industry. These
systems allow organizations to maintain better inventory accounting,
inventory control, and product quality.

 In summary Product traceability
systems provide a company the
ability to store and retrieve the
events that took place during
processing and the ability to
monitor and change those
processes.
 By assigning a lot number/label to
their products a company has the
ability to single out quality related
issues, improve inventory
accountability, distinguish product
for individual customers, and
maintain inventory control.

1. Purpose
• To describe the methods employed and the personnel
responsible for controlling, documenting and
performing product identification and traceability,
where appropriate, through all stages of process and
operations
To identify a product from the receipt of inventory to its
final usage.
• To maintain historical records of the item.
• To be able to trace instruments and accessories
through serialization (Lot numbers).
• To define the methods which must be used to provide
product identification and traceability integrity by
means of labeling and serialization.
• To provide procedures for identifying and tracking
product during all stages of receiving, handling storing
and delivery.

Traceability Objectives
 Scope
 Responsibilities
 Procedure
 Lot Numbering
 Traceability to
Customer

2. SCOPE
THIS PROCEDURE APPLIES TO ALL INSTRUMENTS
BOUGHT, KEPT AND SOLD.
THIS PROCEDURE ENSURES THAT ADEQUATE
CONTROLS ARE DESIGNED IN THE RECEIVING,
HANDLING, STORAGE AND SELLING PROCESS TO
PROVIDE IDENTIFICATION AS REQUIRED
THROUGHOUT THE PROCESS.

Responsibilities
 Receiver/ QC Technician assigns Lot numbers to devices and maintains the completed record.
 QA Manager keeps track of Lot numbers by maintaining the database.
 QC Technician/Inspector ensures proper labels are present at each operation requiring a label.
 Receiver/ QC Technician ensures labels are properly stored and identified to prevent mix-ups.
 Office Assistant ensures that Receiver and pick sheets have all the relevant information before
entering into the data base.

Procedure
 4.1 Written Procedures
 Quality Control Technician/Receiver applies identification marking
according to the work instruction.
 4.2 Instruments/Component/Accessories
 Where required by contract, component parts are traceable to the
manufacturer.
 Receiving form WHR V 2.02 displays a record of traceability. The
Receiving form WHR V 2.02 indicates items received along with their
lot numbers, part numbers and accepted quantities. Office assistant
enters the information onto the receiving in MAS90.
 QC Technician applies identification number onto the product parts.
 QC Technician applies labels to accessories. The label indicates
accessory of main item or additional part. Component parts can be
tracked using the receiving documents and shipping documents. This
information is maintained in computer as well as a hard copy in the
files.
 The MAS90 tracks items received from the vendor by associating the
purchase order number an inventory location and pick.

Time Spent
IdentificationandTraceability
Get Familiar
Achieve
Mastery
Working Toward Mastery
Get
Experienced

Lot Numbering
 Lot Numbering
 All instruments arriving on the premises, intended
to be used carry permanent , unique lot numbers
allocated to different suppliers, Batch #s, Lot #s
and item numbers are also printed on labels and
affixed on the bags.
 Phoenix assign three kinds of lot numbers
depends on the frequency of shipments phoenix
receives from her suppliers.
 Each lot # is a five digit # in the format of
XY/YY, YY/YY or YYYYY .Lot numbers are in
the following formats

 For high frequency shipments
XY/YY (X is alphabet showing
the month and y is the numerical
denoting the number of shipment
received in that month and YY is
last two digits of the year

 Each incoming shipment is
assigned Lot #. QA Manager is
responsible for assigning Lot
numbers.
 QC Technician enters the lot
numbers into the receiving form
WHR V 2.02
 QA Manager gives the serial
numbers to QC Technician who
applies the lot number to the part.

Traceability to
Customer
 Finished product is traceable to the
customer through lot numbers
associated with customer record. The
packing list include the lot number of
the each instrument. Warehouse
Manager verifies the lot number on
the packing list matches the lot
number on the instruments or labels
on the devices.

 Production processes must be developed, conducted,
controlled and monitored to ensure the device
conforms to its specs
 Process control procedures are necessary where
deviations from the device specification could result
from the production process
 Significant changes to these procedures must be
verified or validated prior to implementation
Production and Process Controls

 Control environment when it can adversely affect
product
 Ensure equipment meets specified requirements and
is adequately maintained
 Process validation is required when results of process
cannot be fully verified by inspection/test
 Document validation activities and results
Production/Process Control (cont.)

 Maintain procedures for acceptance activities
 Upon receipt, incoming material is inspected, tested
and otherwise verified to demonstrate that it meets
specified requirements
 In-process material must:
 meet specified requirements, where appropriate
 be controlled until inspection and test is completed
 Each production run or lot of finished devices must
meet the stated acceptance criteria
Inspection and Testing

 Ensure that equipment is suitable for use and capable
of producing valid results
 Specific and detailed calibration procedures
 Calibration standards must be traceable to national or
international standards, if possible
Inspection , Measuring and Test Equipment

 Identification of acceptance status is required
throughout manufacturing, packaging, labeling,
installation and service
 Product must be clearly identified as conforming or
non conforming to the acceptance criteria
Inspection , Test and Acceptance Status

78
Inspection/Testing Points
• Receiving inspection
• In-process inspection
• Final inspection

79
Receiving Inspection
• Spot check procedures
• 100 percent inspection
• Acceptance sampling

80
Acceptance Sampling
Lot received for inspection
Sample selected and analyzed
Results compared with acceptance criteria
Accept the lot
Send to Stock
or to customer
Reject the lot
Decide on disposition

Acceptance Criteria
• DIMENSIONAL
• COSMETIC
• FUNCTIONALITY
• ETCHING
• GENERAL
• DOCUMENTATION
• a
81
QUALITY CONTROL DEPARTMENT
NCMR CODECS

 Maintain procedures for control of product that does
not conform to specifications
 Disposition of non-conforming product must be
documented
Nonconforming Product

 ISO 9001 (13485): 8.5.2 “The organization shall take
action to eliminate the cause of nonconformities in
order to prevent recurrence.”
 CFR: 21 CFR 820.100 (Medical Device) “(a) Each
manufacturer shall establish and maintain procedures
for implementing corrective and preventive action”
CAPA Required

 Unexpected, unwanted events with a Quality System.
 ASQ: The result of a nonfulfillment of a specified
requirement.
Non-Conformity (NC)

 A mature CAPA system can serve as a useful tool for analyzing past
events, correcting existing non conformities and preventing future
events.
 A mature CAPA system goes beyond regulatory compliance to
positively impact our customers by increasing the value of our products
and services.
CAPA

 CAPA Process - structured, formalized way to
investigate NC and determine appropriate corrections,
corrective actions and preventative actions and
measure their effectiveness. (With records)
Mature CAPA Process

 Each step can use quality tools
to standardize the approach and
document the outcomes.
 ISO 13485 and QSR require
records of each step
CAPA System step by step

 QMS has systems to detect NC
 Customer Complaints
 Equipment Monitoring
 Production Sampling
 Auditing
 Inspection
 Trending
 Accident Report
 Etc…
 Output = Specific Problem
Statement
Identification

 Where, Who, Risk, Compliance?
 Is/Is Not
 Contradiction Matrix
 Expert Interviews
 Data/Trends
 Data/Records
 Timeline
 Evaluation rubric may be defined
by your QMS (severity, probability
of harm, $$ exposure)
 Keep records
Evaluation

 Determine what happened, how it happened,
extent, identify true root cause(s)
 Seven classic quality tools (ASQ)
 Flowchart
 Checksheet
 Cause/Effect diagram (Ishikawa, fishbone)
 Pareto chart
 Control chart
 Histogram
 Scatter Diagram
 More tools
 5-whys
 Is/Is-not
 Contradiction matrix
 Keep Records
Investigation

 Lists corrective and preventive actions (if
applicable)•Clearly addresses root causes
 Commensurate with the risk of the issue
 Where effectiveness checks are defined
 Identification of task owners and task due dates
 Implementation due date
 Keep records
Action Plan

Refresher – C, CA, PA
Action (Etching is very dark, etching also has cloudy edges , center looks like a burn) C, CA, PA
•Rewrite procedure for Machine setup CA
•Rewrite procedure for inspection process CA
•Poke electrolyte soaking process for ensuring proper amount utilized CA
•Containment: identify potentially affected products and recall C
•Error-proof the monitoring process CA
•Verify revised procedure/ new settings and validate that no quality issue exists and
implement
PA

 Implementing a verified solution
 Testing during formation of
action plan
 Validate
 Tracking (where, how many, who)
 Keep records
Implement

 Monitor performance indicators à compare
“before” and “after”
 Achieve specific targets -- achieving a pre-
determined PPM level
 Statistical Data Analysis--Performance must
lie within a set of statistically derived control
limits
 Emphasis should primarily be on identifying
the most effective fix
 Verification and validation are completed
prior to implementing the action
 Keep records
Effectiveness

 Maintain procedures for implementing Corrective and
Preventive Action
 Analyze data to identify and investigate areas
requiring action – get to the root cause
 Process Analysis
 Quality Audits
 Service and Complaint Record Analysis
 Management Reviews
 Non- Conformities
Summary Corrective and Preventive Action
(CAPA)

 Identify the action(s) needed to address the root cause
of nonconformities in Quality System
 VERIFY or VALIDATE the action to ensure it is
effective & does not adversely affect product
 Confirm changes to documentation
 Follow up Audit
 Review of production or field reports
(cont.)

 Documentation shall include identified problem,
investigation, root cause, action plan and verification
results
 Report CAPA information relating to quality problems:
 To those directly responsible for assuring the quality of such
product
 As part of Management Review Meetings
(cont.)

 Maintain procedures for:
 Label Integrity: legibility and adhesive adequacy
 Labeling Inspection: accuracy of information
 Labeling Storage: identification and accessibility
 Labeling Operations: track label and labeling used for each
lot/batch of product
 Control Number: must accompany the unit through
manufacturing and distribution
 Packaging/Shipping containers: ensure proper construction to
protect device during processing and distribution
Labeling and Packaging Control

 Maintain procedures to minimize mix-ups, damage,
deterioration, contamination or other adverse effects
during handling
 Maintain distribution records
 Maintain installation and servicing procedures and
records
Handling, Storage, Installation and Delivery

 Maintain all records required by the Quality System in
an area reasonably accessible to the manufacturer and
auditors
 Records must be legible and stored to minimize
deterioration and to prevent loss
 Records stored electronically are backed up
Quality Records

 Maintain procedures for receiving , reviewing,
investigating, and responding to complaints
 Records shall be maintained for each complaints
 Document details of event, investigation, corrective action,
and response to complainant
 Must be reasonably accessible
Complaint Handling

 Establish, where appropriate, procedures for using
valid statistical techniques for establishing, controlling
and verifying the acceptability of process capability
and product characteristics
 Inspection samples
 Test quantities
 Sampling plans must be based on valid statistical
rationale ( e.g., ANSI/ASQC Z1.4, 1993, LTPD, Zero
based Sampling etc.)
Statistical Techniques

(Quality System Inspection Technique)

 FDA is responsible for inspecting firms who
manufacture or distribute devices cleared for use in
humans
 PMA Approval process
 510(k) Clearance Notices
 Registration and Listing Requirements

 FDA is responsible for inspecting firms who
manufacture or distribute devices cleared for use in
humans
 PMA Approval process
 510(k) Clearance Notices
 Registration and Listing Requirements
 FDA targets firms who have had previously
violative inspections and firms with whom they
have no history

 FDA has modified their inspection processes – became
more interactive
Pre-announcements: 3-5 days prior to beginning their
inspection
New techniques: QSIT/HACCP
 QSIT: Quality System Inspection Technique
 HACCP: Hazard Analysis and Critical Control Points
Discussion of their findings during the inspection
process so there should be NO surprises

 More similar to the ISO inspectional method
 Evaluates seven main subsystems by focusing on
four inspectional areas
 Significantly more interaction between the
investigator and all levels of the company to
determine objective compliance

 Four Inspectional Areas
 Management Responsibility
 Design Control
 Production and Process Control
 Corrective and Preventive Action
 Secondary Areas
 Facility and Equipment Control
 Material Controls
 Records/Document Controls

 Chart
Management
Reports of
Corrections &
Removals
Medical
Device
Reporting
Medical
Device
Tracking
Corrective &
Preventive
Action
Manufacturing
and Equipment
Control
Design
Control
Material
Control Records/
Documents/
Change
Controls
Process
Control
Etching
Process
Control

 Based on “Top Down” Approach
 Inspector reviews a sampling of records
 Statistically determine number
 Follows record trail to conclusion
 Monitors strict compliance to procedural tasks
 Evaluates raw data to confirm conclusions

 Typical Inspection Process
 Opening meeting 15-20 minutes
 Warehouse Tour 30-45 minutes
 Overview of Devices 60-90 minutes
 Meeting with Top Management: ½ day
 Design Controls: 1 day
 Corrective and Preventive Action : 1 - 1 ½ days
 Document and Data Control 1 ½ - 2 days
 Closeout Meeting

CAPA (50 %)
PAPC (30%)
Records (20 %)
PRODUCTION & PROCESS
CONTROL

CAPA (30%)
Mgmt (40%)
PAPC (20%)
Records
(10%)
QSIT
CAPA (30%)
Mgmt (40%)
PAPC (20%)
Records (10%)

Verify existence of
quality policy,
management review and
quality audit procedures
Confirm implementation
of quality policy and
objectives
Confirm establishment of
org structure.
Does it have provisions for
- responsibility and
authority?
- resources?
Confirm that management Rep
has been appointed? Does this
person have authority over and
responsibility for :
- Ensuring QS is effectively
established and maintained ?
- Reporting on the performance
of the QS to management with
executive responsibility
Confirm that management
review procedures ensure that
executive management
reviews the suitability and
effectiveness with sufficient
frequency
Confirm that quality audit
procedures ensure that audits
and re-audits of deficient
matters are conducted
Suspend inspection of
Management Controls .
Return to Management
Controls Subsystems after
completing inspection of
other subsystems
Evaluate whether
management with executive
responsibility ensures that
an adequate and effective QS
has been established
Management
Controls

Confirm that procedures
have been defined and
documented
Select a process and
confirm that process is
controlled and monitored
Confirm that process is
operating within the
specified limits
- per review of DHR or
other records
Confirm that:
- Non-conformances were
handled appropriately
- Equipment was adjusted ,
calibrated and maintained
- Process was adequately
validated
Confirm that management
review procedures ensure that
executive management
reviews the suitability and
effectiveness with sufficient
frequency
Confirm that if any software
is used in any process that
software is validated
Confirm that personnel are
qualified or trained to
implement the process
Production
and Process
Controls

Confirm that procedures
have been defined and
documented
Confirm that quality data
sources have been
identified and analyzed to
identify existing product
and quality problems that
require Corrective
action.
Confirm that sources of
product and quality
information that may show
unfavorable trends have
been identified and
analyzed to identify issues
that may require
Preventive Action
Confirm that data received by
the CAPA system are complete,
accurate and timely
- Appropriate statistical
methods used?
- Results compared across
different data sources
Confirm that failure
investigation procedures are
followed
- Is investigation level
commensurate with risk?
- Is investigation conducted to
root cause?
- is product controlled to
prevent distribution until
resolution?
Confirm that appropriate
action has been taken for
identified problems
Confirm that action taken is:
- effective
- Verified or validated prior
to implementation
- Not detrimental to the
finished device
- Implemented and
documented
Confirm that information has
been properly disseminated,
including reports at
management review
CAPA Controls

Audit Conduct
 Assign escort for Inspector(s)
 Typically QA personnel ( Quality Management Rep)
 Capture questions, comments from inspector and any
documents reviewed
 Intervene/clarify for “auditee”
 Seek departmental head for initial questions
 Prepare and coach department managers to
understand audit process
 Be truthful, but not volunteering
 Convince FDA that operation meets QS requirements

At the Conclusion of
Inspection . . . .
“ Evaluate whether
management with
executive responsibility
ensures that an adequate
and effective Quality
system has been
established and
maintained”

Corporate Culture
 Organizational culture is the collective behavior of humans who are
part of an organization and the meanings that the people attach to their
actions. Culture includes the organization values, visions, norms,
working language, systems, symbols, beliefs and habits. It is also the
pattern of such collective behaviors and assumptions that are taught to
new organizational members as a way of perceiving, and even thinking
and feeling. Organizational culture affects the way people and groups
interact with each other, with clients, and with stakeholders.
 Ravasi and Schultz (2006) state that organizational culture is a set of
shared mental assumptions that guide interpretation and action in
organizations by defining appropriate behavior for various situations. At
the same time although a company may have "own unique culture", there
is a diverse and sometimes conflicting cultures that co-exist due to
different characteristics of the management team. The organizational
culture may also have negative and positive aspects.

Wet Apes
Start with a cage containing 5 apes. In the cage,
hang a banana on a string and put stairs under it,
Before long, an ape will go up the stairs and start
to climb toward the banana.
As soon as the ape touches the stairs, spray all of
the other apes with cold water. After a while,
another ape makes an attempt with the same result
– all the other apes are sprayed with cold water.

Wet Apes
Turn off the cold water. If, later, another ape
tries to climb the stairs, the other apes will try
and prevent it even though no water spays on them.
Now, remove one ape from the cage and replace it
with a new one. The new ape sees the banana and
wants to climb the stairs. To his horror, all of the
other apes attack him. After another attempt and
attack, he knows that if he tries to climb the
stairs he will be assaulted.

Wet Apes
Next, remove another of the original five apes and
replace it with a new one. The newcomer goes to
the stairs and is attacked. The previous newcomer
takes part in the punishment with enthusiasm.
Again, replace a third original ape with a new one.
The new one makes it to the stairs and is attacked
as well. Two of the four apes that beat him have
no idea why they were not permitted to climb the
stairs, or why they are participating in the beating
of the newest ape.

Wet Apes
After replacing the fourth and fifth original apes,
all the apes which have been sprayed with cold
water have been replaced, Nevertheless, no ape
ever again approaches the stairs. Why NOT?

Wet Apes
“Because that’s the way it has
always been done here!”

Culture
The culture of an organisation is the
collection of behaviours and attitudes by
which it operates. It is made up of
people’s beliefs, values, ways of working
& assumptions and translates to norms,
the unwritten code of behaviour, or the
rules of ‘how we do things around here.’

Culture
When things are not up to the standards
then we know that we have to make
changes, and the first major step is by
changing the behaviour and aptitude
within the organization.

Corporate Culture
Healthy organizational cultures
Organizations should strive for what is considered a "healthy" organizational culture in order to increase productivity, growth, efficiency and
reduce counterproductive behavior and turnover of employees. A variety of characteristics describe a healthy culture, including:
 Acceptance and appreciation for diversity
 Regard for and fair treatment of each employee as well as respect for each employee’s
contribution to the company
 Employee pride and enthusiasm for the organization and the work performed
 Equal opportunity for each employee to realize their full potential within the company
 Strong communication with all employees regarding policies and company issues
 Strong company leaders with a strong sense of direction and purpose
 Ability to compete in industry innovation and customer service, as well as price
 Lower than average turnover rates (perpetuated by a healthy culture)
 Investment in learning, training, and employee knowledge
Additionally, performance oriented cultures have been shown to possess statistically better financial
growth. Such cultures possess high employee involvement, strong internal communications and an
acceptance and encouragement of a healthy level of risk-taking in order to achieve innovation.
Additionally, organizational cultures that explicitly emphasize factors related to the demands placed
on them by industry technology and growth will be better performers in their industries.

What you learned
 What you see depends on where
you stand
 Leader needs to be able to see
things from all perspectives
“Every man takes the limits of his own field of vision
for the limits of the world.”
Schopenhauer

What you learned
 The skills that you needed to be successful
in the early part of your career were very
different from the skills you would need to
be successful in the later stages of your
career
“We run carelessly to the precipice, after we have put
something before us to prevent us from seeing it.”
Pascal

Man who say it cannot be done should not
interrupt man doing it.
Chinese proverb
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