Total Quality Managment Project

8/4/2019 Total Quality Managment Project

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COMPANY

The company we chose is pulse pharmaceuticals company (PVT) LTD.

Q.C Lab is specious, covering 900Sq/Ft area with three sections. The instrumentsection lab is well equipped with HPLC UV Spectrophotometer, Dissolution Testapparatus, Disintegration Apparatus, Refrectrometer, etcThe analytical lab is furnished with necessary chemicals required for testing. The inprocess quality control section is directly involved in all process section check. Themicrobiological section is at developing stage

SERVICE OVERVIEW

Pulse PharmaIndustries is manufacturing Tablets and syrup. Rasco is manufacturer of Human product keeping in view the quality services into ailing humanity. Thus providingthe standard medicine at reasonable prices.The antibiotic section of tablets, Capsule and Dry suspension has been approved fromministry of health and very soon production will be started.

LAB INTRODUCTION



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Functions of quality department

JOB DESCRIPTION OF QUALITY CONTROL MANAGER

REPORTING FUNCTIONS

Quality control Manager directly reports to the Plant Partner.

RESPONSIBILITIES AND AUTHORITIES

1. To arrange testing of raw materials.

2. To arrange testing of Bulk products.

3. To arrange testing of finished products.

4. To arrange calibration of instruments (internal and external both).

5. To trained the Analyst of the lab For Good Laboratory Practices.

6.To arrange microbiological testing of raw materials, products and finishedproducts.

7. To develop testing methods of the products.

8. To arrange sampling of packing components, their testing and release.

9. To make system of In-process activities in production and warehouse.

10. To arrange stability studies of the products.

11. To arrange method validation, process validation.

12. To prepare training program for Chemists and Pharmacists for GLP & CGMPin Lab.

13. To maintain chemicals/glassware store.

14. To make SOPs of raw material, F/Products.

15. To make SOP of instruments, calibration, etc.

16. To maintain record of Q.C. retain samples.17. Handling of complaints

18. Validation and calibration of production and Q.C. equipments.

19. Releases of the raw materials/packaging components/finished products.20. Purchases of new instruments of Q.C. with the help of Production

Manager



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JOB DESCRIPTION OF ASSISTANT QUALITY CONTROLMANAGER

REPORTING FUNCTIONS

Assistant Q.C Manager directly reports to the Q.C Manager.

RESPONSIBILITIES AND AUTHORITIES

1. To help the Q.C. Manager in analysis work.

2. To report to the officer concerned after completion of any job assigned.3. To collecting sample of Raw Material, Packing Material and Products atvarious stages.

4. To get all the equipment/utensils and work-desk in order after completion of aparticular job/test with the help of attendant.

5. To keep all of the reagents/chemical bottles/containers in order after completion of working with the help of attendant.

6. To work in other than routine duty if ask to do so.

7. To work in other than routine duty if ask to do so.

8. To make sure that whole of the section is in order regarding, cleanlinessswitch´ OFF´ and proper placing of all the equipment, chemicals and reagentsutensils books and record files at completion of daily working.

9. Perform any duty assigned by the Quality Control Management according theskill of assistant

10. To perform the assigned duties of the Quality Control Manager in his/her absence under guidance of Director Technical.



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I NTRODUCT I ON

ISO (International Organization for Standardization) is the world's largest

developer and publisher of International Standards.

ISO is a network of the national standards institutes of 162 countries, one

member per country, with a Central Secretariat in Geneva, Switzerland, thatcoordinates the system.

ISO is a non-governmental organization that forms a bridge between the

public and private sectors. On the one hand, many of its member institutes are

part of the governmental structure of their countries, or are mandated by their

government. On the other hand, other members have their roots uniquely in the

private sector, having been set up by national partnerships of industry

associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both

the requirements of business and the broader needs of society.

Because "International Organization for Standardization" would have different

acronyms in different languages ("IOS" in English, "OIN" in French for

Organisation internationale de normalisation), its founders decided to give it also

a short, all-purpose name. They chose "ISO", derived from the Greek isos,

meaning "equal". Whatever the country, whatever the language, the short form

of the organization's name is always ISO.



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History

The organization which today is known as ISO began in 1926 as the International

Federation of the National Standardizing Associations (ISA). This organization focusedheavily on mechanical engineering. It was disbanded in 1942 during the second World

War but was re-organized under the current name, ISO, in 1946.

Even the name of the organization is standardized. The name, "ISO" is not an acronym but was derived from the Greek word "isos" meaning "equal". (The relation to standards

is that if two objects meet the same standard, they should be equal.) This name eliminates

any confusion that could result from the translation of "International Organization For Standardization" into different languages which would lead to different acronyms.

ISO is a voluntary organization whose members are recognized standard authorities, each

one representing one country. The bulk of the work of ISO is done by the 2700 technicalcommittees, subcommittees and working groups. Each committee and subcommittee is

headed by a Secretariat from one of the member organizations. The American NationalStandards Institute (ANSI) is the United States representative to ISO. The ANSI ASC Z-

1/ASQ Standards Group coordinates the United States representation in the ISOTechnical Committees 176 and 207 which are concerned with the ISO 9000 and ISO

14000 standards respectively.



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QUALITY MANAGEMENT SYSTEM

ISO 9001 : 2000

General Requirements

Pulse Pharma establishes documents and maintains a Quality Management System and

continually improves its effectiveness in accordance with the requirements of thisInternational Standard.

Pulse Pharma:

a) Identify process needs for the Quality Management System and the applicationthroughout the Organization.

b) Determine the sequence and interaction of process

c) Determine the method and criteria to monitor the operation and processeffectiveness.

d) Ensure the availability of resources

e) Monitor, measure and analysis of process

f) Implement actions to achieve planned results and continue improvement of

process.Pulse Pharma identifies and maintains the control over process, which areconducted, outsource.

For reference, see process flow chart and work instruction.

Documentation Requirement

General

Quality Management System Documentation of Pulse Pharma includes,

a) Document statement of Policy and Objectives.

b) Quality Manual

c) Procedure



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d) Documents to ensure the planning, operation and control of its process,

e) Quality records required.

Quality Manual Pulse Pharma establishes and maintains a quality manual that includes:

a) Scope of Quality Management System, details or justification of any exclusion.

b) Procedure or reference

c) Description between process and Quality Management System

Control of Documents

Pulse Pharma controls all the documents required by Quality Management

System. This control is consists of:

a) Approve the documents for prior to issue.

b) Review and update s necessary and re ± approved

c) Ensure that changes and the current revision status are identified.

d) Ensure that relevant version of documents are available at point of use.

e) Ensure that documents are legible and identified

f) Ensure that documents of external origin are identified and distribution iscontrolled.

g) Prevent the obsolete documents.

h) Retention time, which is minimum to at least the life of services.

Control of Quality Records

Pulse Pharma establishes and maintains procedure for Quality Records to

provide evidence of conformity to requirements and of the effective operation of Quality Management System. This procedure defines the control for identification, storage, protection, retrieval, retention time and disposition of

quality records for each batch for traceability.



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Specific Requirements

SCOPE

PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented,implemented and maintained a procedure for the qualitymanagement system applied throughout the organization.

APPLICABILITY

This procedure is applied on all the sections, branches, departments and juristicarea of PULSE PHARMACEUTICALS (PVT.) LTD...

RESPONSIBILITY

It is the responsibility of all key persons of PULSE PHARMACEUTICALS (PVT.)LTD.. Organization specially the CEO to document, implement and revise this

procedure as required day by day.

ABBREVIATION

QP = Quality Procedure.

MRC = Management Review Committee.

SOP = Standard Operating Procedure.

PROCEDURE

MRC of PULSE PHARMACEUTICALS (PVT.) LTD.. has listed below her allthe processes for quality management system and their critical points for product conformity.

Resources

Purchase

Product Realization:

Tablets

Capsule

Dry Syrup

Identification:

Inspection & Testing:



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Lab. Equipment Calibration List of Equipments With MaintenanceSchedule

Weighing Machine

Reference Sample Till date of expiry

Communication + Documentation

Storage:

Packing + Labeling:

Delivery:

Marketing + Capability Analysis

Customer Feedback:

Records Keeping:

6 RELATED DOCUMENT

All Quality Documents



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Implementation and problems in implementation

pulse pharmaceutical company implemented the iso standard in its followingdepartments

a) production department

b) Quality control departmentc) Marketing department

d) Sales Department

They implemented the iso standards in the procedures and processes involved in thesedepartments since they are registered with the international standardorganization ,dated 21 march 2007.

Problems in implementation

The basic problems in implementation are the workers of the pulsepharmaceutical company.they resist to implement the iso quality standardbecause they paid low and they have to work hard to implement thesestandards.they have no know how about these standards.



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Cost and benefit and analysis of the isoimplementation

Cost

The cost for registration to iso is 60,000 PKR.

Benefits

1. IT helps to improve our image to export our products in Europeancountries

2. Customer satisfaction

3. Profit increases upto 120,000 PKR

4. Expansion in local market share upto 35%

5. Increase in number of contracts received

Analyisis

In overall analysis the company gain a lot of benefits as compared to cost bearedin implementing iso quality standarsds.



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C ONTROL OF DOC UMENTATION

SCOPE

PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented,

implemented and maintained a procedure for the documentation requirements,quality manual, and control of document and control of records.

APPLICABILITYThis procedure is applied on all quality documents, forms and records includingobsolete records.

RESPONSIBILITYIt is the responsibility of MR to maintain and control all the documentations .

ABBREVIATIONS

QP = Quality Procedure.

MRC = Management Review Committee.

SOP = Standard Operating Procedures.

CEO/DP = Chief Executive Officer / Director Production

M.R = Manager Representative / Q.C. Manager

ADMIN = Administrator

PROCEDURE

QUALITY POLICY STATEMENT

Our commitment is to produce excellent quality medicine at low price for

the customer satisfaction with effective resources through skilledprofessionals,, the excellence of work and continues improvement.

QUALITY OBJE C TIVES PULSE PHARMACEUTICALS (PVT.) LTD.. has two types of objectives:

1. Long term Objectives



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2. Short term Objectives

All these objectives are initiated during the MRC meeting. All these objective areplanned, executed, checked, verified and discussed during MRC meeting.Quality objective form is used for this purpose.

QUALITY MANUAL

The Quality Manual is current and up-to-date to reflect changes to the systemand approved by CEO by signing on title Page of Quality Manual. It is simplystated, easy to use, and fully approved by all affected functional groups. All therevision record & mentioned on 3rd page of Quality Manual.

PULSE PHARMACEUTICALS (PVT.) LTD.. has its policy for each element of ISO 9001:2000 Standards in the Quality Manual. For each element, asappropriate, PULSE PHARMACEUTICALS (PVT.) LTD.. has documentedprocedures that further describe how the specific policy objectives and goals aremet. The Quality Manual includes these documented procedures. Whereapplicable, SOPs are also included in the quality manual.

Quality procedures and SOPs are implemented as written. The procedures explain howPULSE PHARMACEUTICALS (PVT.) LTD.. implements the requirements of ISO

9001:2000 in accordance with its Quality Policy. These are revised, as necessary, toreflect the actual objectives, flow of tasks, and staff responsibilities

DOCUMENT STRUCTURE

LEVEL I Quality Policy Manual,

LEVEL II Quality Procedures,

LEVEL III Standard Operating Procedures/Work Instructions

LEVEL IV Forms (Records).

Approval: All the levels are discussed in MRC meeting and CEO / DP has signed for approval at title page of Quality Manual.

CONTROL OF DOCUMENTS PULSE PHARMACEUTICALS (PVT.) LTD.. maintains four-qualitydocumentation: Quality Manual, Quality Procedures, SOPs/work Instruction andForms (Records).

QUALITY MANUAL (LEVEL I)

Quality Manual is identified and controlled by its revision No, effective Date, Title

and Level. Distribution of Quality Manual is also recorded on title page of themanual and the Document Distribution List showing the distribution destination.

REVISION

a) When the number of changes exceeding 100 or when decided byManagement Review Committee, a new issue of the manual ispromulgated to all distribution points.



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b) A CPA (Occur by Audit, Customer Feedback, Management ReviewCommittee, Corrective / Preventive Action) is raised for any change madeat any page in Quality Manual changed matter is underlined.

c) Management Representative makes approval by signing the CPA.

QUALITY PR

OCE

DURES

(LE

VE

L II)

Quality Procedures are identified and controlled by its revision No, effective Date,Title and QP No. Distribution of Quality Procedures is recorded on theDistribution List showing the distribution destination.

SOP (LEVEL III)

SOPs / Work Instructions are identified and controlled by their Revision No,Effective Date, Title and SOP No./Work Instruction No. Distribution of SOPs isrecorded on respective SOPs and SOPs list and Distribution on first page of

level iii showing the distribution destination.REVISION

A single change in any SOP will change the revision no and Effective date.

FORMS (RECORDS) (LEVEL IV)

Forms are identified and controlled by their revision No, doc# and Title. All therecords are maintained on Document record Master List.

Numbering Scheme

Each form is assigned a unique Doc # showing the abbreviation of concernedprocedure / level of doc / serial No. e.g. CPD/04/01 where CPD shows concernedprocedure that is control of production, 04 shows level of document and 01 shows serialNo. of form used in that particular procedure.

ABRIVIATION.

Following abbreviations are used for different procedures.

Management Committee. MGT.

Control Of Documentation COD

Resource Management. RM

Customer. CRP

Purchasing PUR

Control of Production. CPD

Trace Ability TCR

Preservation. WH



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Calibration. Q.C

Analysis of Data ADT

Internal Quality Audit. IQA.

Monitor and Measurement. CLB.

Corrective Preventive Action. CPA.Improvements. IMP.

REVISION.

A single change in any forms will change the revision no.

CONTROL OF OBSOLETE DOCUMENTS

RETENTION

Obsolete documents are retained stapled with the concerned CPA or referenceof CPA no. and are retained for the period equivalent to the life of the Productswhich is defined on Document record Master List.

IDENTIFICATION

Any quality document or a portion thereof when obsolete is stamped ³Obsolete´

HANDLING

Obsolete documents are withdrawn from all concerned points by replacing thecurrent documents by MR himself and these obsolete documents are placed inObsolete Documents File duly attached with a copy of respective CPA.

EX T E RNAL OR IGI N.

Documents are identified with a stamp µExternal Origin¶ and distribution is

identified and controlled on Document Master List.

CONTROL OF RECORDS PULSE PHARMACEUTICALS (PVT.) LTD.. maintains Quality Records. All the

records are identified and controlled on Document record Master List details theretention site or location, Doc # if it is used for record and retention time for quality records. Quality records for each batch / lot are also maintained inseparate file for each batch / lot.).



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IDENTIFICATION

Quality Documents/ records are stored in a common location area (QualityRecords) as identified on the Quality Documents Master List. The commonlocation is communicated to each individual in the area and the location is clearlymarked as Quality Documents/ Records.

STORAGE

All the quality Documents records are stored in a common location area clearlymarked as Quality Records and no unauthorized person has the access to thestore.

PROTECTION

All quality records are maintained / locked by MR / Q.C. Manager.

No unauthorized person has the access to the store.

DOCUMENT CHANGE

Any kind of change in documents can be raised from any employee throughcorrective Preventive Action Report.

RETRIEVAL All quality system records once generated and completed, come to MR / Q.C.

Manager.

RETENTION TIME Retention time is mentioned on Document Record Master List.

DISPOSITION

All expired quality records are disposed (Recycling Agency) by MR / Q.C.Manager with concern of production Manager.

RELATED DOCUMENT

All Levels of Quality Manual

Corrective Preventive Action Report.

Document Record Master List.

All other quality documents

Quality Objective Form

Doc. Distribution List.

External Origin Document



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INTERNAL AUDIT

SCOPE

PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented,

implemented and maintained a procedure for Internal Audit, Monitor andMeasurement of process.

APPLICABILITY

This procedure is applied on analysis of production and quality system.

RESPONSIBILITY

Responsibilities are defined in procedure.

ABBREVATION QP = Quality Procedure

MR = Management Representative

PM = Production Manager

CPA = Corrective/preventive action.

INTERNAL AUDIT PROCEDURE

AUDIT PLAN

The internal quality audits are conducted once in 6 Months on the plandeveloped by the Management Representative. Each procedure area within theQuality Manual is included in the Internal Audit Plan. The individuals assigned toconduct the audits are determined by the Management Representative and areidentified in the audit plan. The identified auditors are independent of the areabeing audited. Production Manager when assigned to conduct an audit; he mayarrange trained external auditors/consultant.

INTERNAL AUDIT CHECKLISTInternal audit checklist is issued to conduct internal audit and is maintained by

MR. The designated auditor uses only the particular portion of the checklistintended for the areas by audited.

AUDIT FREQUENCY

Internal audit will be conducted twice in a year or when needed by management .

SECOND PARTY AUDIT.



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Customer has the access to audit production, equipment and training areas andother areas covered by this manual with the permission of M.P.

M.P. if not satisfied with internal audit can have the services of consultant for complete audit for the areas under the direct responsibility of MR.

CONDUCT AUDITS

ANDRE

COR

D CORRE

CTIVE

ACTIONS

The quality process audits are conducted in each area. The ManagementRepresentative reviews the non-conformities and he decides corrective action inconsultation with the relevant department. All non-conformities are reported andcorrective actions taken on the Non-Conformity Report (CPA).

CLOSING OF CPA¶S

All corrective actions are agreed between auditor and auditee. A targetcompletion date is also agreed for taking the c corrective/preventive actions within stipulated date. If a corrective/preventive action (CPA) is not taken and verified

with in target date, a new CPA is raised and a new target date is fixed for respective CPA. But root cause for not taking the corrective/preventive actionswithin agreed period is found and preventive actions are taken.

REPORT AUDIT RESULTS

Internal audit reports are used for reporting the audit results. Which is alsorecommended by Production Manager.

MONITOR AND MEASUREMENT OF PROCESS

PULSE PHARMACEUTICALS (PVT.) LTD.. conduct Internal Audit for monitor and measurement of process. This method demonstrates the ability of theprocesses to achieve planned results.

If results are not achieved, PULSE PHARMACEUTICALS (PVT.) LTD.. takesrelevant corrective action to ensure the conformity of product.

RELATED DOCUMENT

Internal Audit Plan

Internal Audit checklist

CPA

Internal Audit Report



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EXTERNAL AUDIT

Ex ternal audit done by a team composed of 5 members .they have found following lacks in quality department which are as follows.

1) Lack of emergency bo x( first aid bo x )

2) Lack of employees record

3) Lack of written proper records4) I nsufficient ventilation system

5) Lack of proper documentation of customer feed back

Auditor advised tha ne x t time try to improve these deficiencies

Audit conducted on31 dec 2009

Reference´ I nformation received by MR.ZAK I R who is QC manager of PulsePharamacuetical company´