Total Quality Management

Project:
Shaigan Pharmaceutical

ABOUT SHAIGAN Shaigan started as Pharmaceutical Distributor and Marketer in early 1983. After having gained enough knowledge of Pakistan Pharma Market in 1990, Shaigan procured land for pharmaceutical

unit and started its own manufacturing in 1993. The core of its objective since very beginning has been to market the products of novel quality with latest promotional skills. Organization: Shaigan Group of consists of the follow sister concerns. use. facility. a) Shaigan Pharmaceuticals (Pvt.) Ltd.: A company involved in the production b) Univet production pharmaceuticals for A human Pharmaceuticals: veterinary pharmaceutical

PRODUCTION Shaigan owns a high tech state of the art production unit, which plays a key role in producing the products of best possible quality. Shaigan takes pharmaceutical manufacturing as a great responsibility, hence they continuously put in several kinds of improvements and invest a great deal of capital in machinery, equipments, engineering, human resource and research. Shaigan has already shifted its production facilities in a newly constructed glorious building. of This latest building and is designed changing to meet the requirements rapidly manufacturing

processes and techniques. The following formulation sections are already functional. 1. Tablets 2. Capsules 3. Cream/Ointment

4. Dry Powder 5. Sachets

6. Syrups/Liquids/Suspension 7. Eye Drops 8. Injections Quality Assurance Quality Assurance is the department, which receives their special attention. Acknowledging Quality as a key to their success, they strive hard to ensure the quality of a product to its extreme level. Highly qualified and professionally trained personnel, supplemented with the most modern equipments, plays key role in achieving this objective. RESEARCH AND DEVELOPMENT As a commitment to continuous improvement both in new products and processes as well as in those existing already, Shaigan has established all Research of & Development research, Department. development They and maximize aspects global

marketing through the Research & Development tools.

CHIEF EXECUTIVE

FINANCE MANAGER

PRODUCTION MANAGER

DIR. HR & BUSINESS DEVELOPMENT

COMERCIAL & IMPEX COORDINATER

GM MARKETING & SALES

SECURITY OFFICER

As organizations are realizing the importance of to be in conformance with ISO standards to increase survive in the market, Shaigan market share and also gives the due importance

to it and has the privilege of being certified for ISO 9001: 2000. To fulfill the requirements of ISO, Shaigan has taken the necessary

steps and developed the required procedures. Shaigan has established, documented and maintains a quality management system, and is working for its continuous improvement. This system creates a framework for clearly defining the control of materials, processes, verification activities, thus providing their customer with confidence that the production, distribution and purchases in the organization are performed in well defined and controlled environment. Shaigan maintains the documentation of the quality management system in the form of quality manual, quality policy, quality objectives and required quality standard procedures. The quality annual of Shaigan specifies the quality management system of Shaigan Pharmaceutical (ltd). The system requirements of the manual aimed at achieving customer satisfaction by consistently providing conforming product and meeting or exceeding customer and applicable requirements through application of the system, continuous improvements and prevention of non conformity. Shaigan has a quality policy, which accurately meets their requirements. The company has established quality objectives at appropriate objectives functions are and in levels within organization. terms and These the defined measurable are

interpretation goals of policy, and consistent with the quality policy and the commitment to continuous improvement and meeting requirements for product. The company has prepared documented procedures that are consistent with requirements of the standard ISO 9001: 2000 and the companys stated quality policy. These documented procedures are as follow: 1. Quality System Procedure for Management Review. 2. Quality System Procedure for Internal communication. 3. Quality System Procedure for Human Resources. 4. Quality System Procedure for Document and Data Control. 5. Quality System Procedure for Purchasing. 6. Quality System Procedure for Continuous Improvement.

7. Quality provision.

System

Procedure

for

Product

8. Quality System Procedure for Control of Monitoring and Measuring Services. 9. Quality System Procedure for Customer Related Process. 10. Quality System Procedure for Control Non- Conforming Product. 11. Quality System Procedure for Graphic Design of Packaging Material. 12. Quality System Procedure for Product Development. 13. Quality System Procedure for Analysis of Data. 14. Quality System Procedure for Control of Quality Records. 15. Quality System Procedure for Internal Quality Audit. 16. Quality System Procedure for Monitoring and Measurement of Product and Processes. Our main focus will be on the following two quality procedures; 1) Quality System Procedure for Customer Related Process. 2) Quality System Procedure for Control Non- Conforming Product. 1. Quality System Procedure for Customer Related Process: Scope: This procedure applies to all customers/ distributors related processes for the products manufactured at SPL. Customer related activities include: Determination and review of requirements related to products including customers requirements and legal and regulatory requirements Communication channels with customers information related to products, customers feedback (including customer complaints and order/ agreement requirements) Purpose: To provide a system for: 5

Review of distributor,

institutional,

export and any other customer orders, Ensuring that the requirements are well understood, Ensuring that the company can satisfy the specified requirements Determining and reviewing requirements related to products, Establishing communication with customers, Responsibilities and authorities: CE, director marketing and sales and distribution manager are responsible for the effective implementation of this procedure. Director marketing and sales is responsible for: Interviewing and selection of distributors Recommend necessary actions incase of any deviation from expected performance or non-compliance of company policies issued from time to time by the distributors The Field Force Activity by coordinating and monitoring Area Sales manager and Sales force respectively Conducting customer surveys on regular basis Handling customer complaints with QMR/AMR

and deliver on time,

Distributor manager is responsible for: To process the order for dispatch To maintain liaison and communicates with all concerned departments in order to maintain optimum level of services Distribution manager receives all distributors orders,

processes them and ensures that all customer claims (credit processing) are settled within 45 days when all concerning matters have been settled Distribution manager prepares Monthly Sales Report (exfactory) and credit notes report and maintains order register

Monitoring

inventory

levels

of

distributors as per contract agreement Account officer checks the payment status of distributors and sends it to the Distribution Department at SPL. Marketing coordinator-I maintain the monthly sales report Marketing coordinator-II maintains all documentation record of Field Force. Marketing coordinator-III maintains the Tour Program and Promotional activity of the Field Force. Business Development Coordinator deals with the Institutional orders through Tenders. Distribution department/ marketing department are primarily responsible for determining requirements related to product and communicating necessary information to the customers. 4) Procedure: 4.1) Determinations of requirements related to products: Requirements related to products are determined through Customers inquiries and orders Customer surveys Legal and regulatory requirements

4.1.1) Types of customer orders; At SPL customer orders are of following types: Distributors orders Export orders Institutional orders

4.2) Customers inquire and orders: Orders are received along with the demand draft/pay orders through fax, mail, verbally on telephone or on demand form supplied to the distributors or the Distributors letterhead. The Distribution manger enquires the payment status against each order from the finance department. 4.2.1) Local orders;

All

local

orders

are

received

and

recorded in the Order Register and reconfirmed before processing. The distribution manger process the order in accordance with the payment received and affixes the stamp. Accepted/ or Amended in case of any adjustments. Such Amended or Accepted orders are then processed and invoices are raised against each order. The distributors are provided with standard Packing and price list. The orders received in the distribution /marketing department are critically reviewed and accepted /rejected amended in order to insure that they comply with the standard packaging and price list delivered to each distributor with SPL rules and regulations. Orders are accepted only if the payment enclosed demand Draft (DD) is in accordance with the value of the order or in special cases, approved for processing by the CE/Director M&S. Payment status is evaluated for each order for any out-standing amounts or credit that is adjusted against each order. The account Officer also verifies the payment status and sends it to the Finance Department at SPL. For specific periods, discounts and/or special bonuses may also be offered to the customers that are settled through replacement /credit notes. This is strictly controlled and is subject to the approval of CE and/or Director M&S. In case the payment is insufficient, the order is processed according to the payment received and the remaining order is considered as cancelled. The dispatched contents of the supply are verified by the Delivery Note, received in the Distribution Department from distribution as an acknowledgement. 4.2.2) Export orders: All export orders are received and processed. Invoice and other export order documents are prepared according to SOP for processing of export order. The target delivery dates after reviewing the customer requirements and the stock availability are defined.

Records of each export consignment are maintained in individual order files. SPL dispatches export orders on a 90 days credit policy. Orders are accepted only if the payment enclosed Demand Draft (DD) is in accordance with the value of the order or in special cases, approved for processing by the CE. Payment status is evaluated for each order for any outstanding amounts or credit that is adjusted against the order. 5) Receipt and review of clients inquiries: The company receives inquiries from customers through letters, fax, email or personal visit. Director M&S receives the inquiries. The information in inquiries includes: Product specification Mode of payment and delivery

Distribution manger reviews the inquiries as follows: In product specification the following things are reviewed: Correct name and strength of the product Legible quantity of the product For the mode of payments and delivery, the following things are reviewed: Advance demand draft of the required amount Delivery period should not be less than 93 working days

5.1) Preparation and review of agreement/order; Director M&S reviews the Distribution Agreement terms and conditions to ensure that all critical points have been reviewed before acceptance of agreement. After signature of contract, one copy of contract is sent to the customer and other filed in the Distributors File at the Distribution Department. 5.2) Amendments in contract/orders: Distribution Manager may make amendments in the original order with regard to payment status of the customer. Orders may 9

also be adjusted with regard to SPL products pack-size and stock position. Order changes may also be received from the distributors on their letterhead. Following actions are taken in case the customer initiates order amendment; The processing status of the original order is determined i.e. accepted, processed or dispatched The amended order is reviewed for completeness and clarity The feasibility of the requested change is also evaluated i.e. impact on cost and delivery date The amended order if accepted is stamped as Amended 6) Customer communication: The Director M&S and Distribution Manager may contact the customer under the following circumstances: If the product is not expected to be delivered in the requested time If the requirement are not adequately defined If there is any deviation in terms of agreed prices/ discounts etc Product specification Order and agreement requirement customer feedback (including customer complaints)

The communication channels include: Phone/ fax Letter Email Personal visit The Distribution Department/ Marketing Department is responsible for communicating with clients regarding the above mentioned information 7) Orders processing at SPL:

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Computerized

Inventory

Program

Account 98 processes customer orders. Distribution Manager 4 copies of each invoice through the program. The copies of invoices are dispatched as under Copy1: Copy2: Copy 3: Copy 4: To the distributor Master files of the distributors in the Distribution Master file of invoices maintained in the Distribution The finance Department

Department Department Each invoice has a unique identity number. The invoice is raised and is handed over to packer fro packaging and the stock is counted and checked by the Distribution Manager before sealing the shippers. The products are dispatched against the invoice with the delivery Note. The copy of DN and TCS receipt no. Is maintained in the Distribution Department. 7.1 Delivery policy: When the customer does not specify the delivery date, SPL has a delivery policy to dispatch all the accepted orders within 3 days of the working orders. The pending orders are dispatched within 2 days incase sufficient stock is available in the Market Store (Distribution Department) 8 Legal and Regulatory Requirements: All legal and regulatory requirements that apply to the companys product are identified. Distribution Manager maintains a list of all the applicable regulatory documents are maintained in the Commercial Department. 9 customer surveys: Customer survey is conducted annually on regular basis to monitor the customer satisfactions and identify customer needs and

11

expectations. Customer

Marketing surveys

Department are done

is the Survey forms/

responsible for conducting Customer Surveys. using Questionnaire and circulating the forms to the clients. After the customer fills these forms these forms are send back to Marketing Department at SPL. The survey areas are divided into 2 sectors throughout Pakistan. Sector I ranges from Peshawar to Lahore and Sector II ranges from Sahiwal to Karachi. 9.1 Analysis of customer feedback: The feedback from customers is compiled and reported by Director M&S at SPL. These survey results are presented as input in the management reviews and analyzed by top management. Based on the analysis corrective actions are taken. AMR records the survey observations. 9.2 Customer Complaints: Director M&S is responsible for handling the customer complaints. The complaints may be related to: Non-conforming product Poor packing and shipment Late delivery Late response Any other problem All the complaints are entered in the customer complaints log, which is maintained by the AMR who delivers these complaints to the respected department. 9.3 Improvement actions on Customer Complaints: QMR/AMR initiates a Corrective Preventive Action Request (CPAR) on the complaint, investigates the root causes of complaint, proposes a corrective action, and assigns a target date for implementation of corrective action and document the root cause and action on CPAR. On the assigned date, Director Marketing/ QMR/AMR follow up the implementation of corrective action. If there 12

is

sufficient

objective

evidence

that

the

corrective action has been effectively implemented, he closes out the CPAR. If the corrective action has not been implemented, he reviews the causes of delay and assigns a new target date for its complete implementation. All CAR/PAR relating to customer complaints and improvement action taken are discussed in MRM and are recorded in the MRM minutes. 9.4 Analysis of Customer complaints: Customer Complaints Data (if any) and Customer Survey Results are statistically analyzed by AMR and Director M&S reviews it. Based on this analysis, Director M&S initiates corrective actions or recommends preventive actions for improvement using the CPAR. 10) Field Force Activities: Sales Promotion officers call 10-15 doctors daily for the promotion of SPL products in their respective allotted territories by their fixed monthly tour program from ASM throughout the country. At the end of the day, each SPO prepares the daily report and sends it to ASM to review. ASM after reviewing sends it to Head Office for record.

2. Quality System Procedure for Control Non- Conforming Product: Scope: This procedure applies to review subsequent disposition of raw materials, packaging material, semi-finished products & finished products that do not conform to specified requirements. Purpose:

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The purpose of this procedure is to provide for a system & instruction & to assign responsibilities for the control of non-conforming product. Responsibilities: CE, Production & QA Manager are responsible to ensure the effective implementation of this procedure. QAI/QC Analysts &Production personnel are responsible for identifying non-conforming products in the course of their inspection activities. In addition, all other personnel are encouraged to watch for & identity non-conforming products, regardless of their other responsibilities. Production personnel are responsible to ensure that nonconforming products are properly quarantined & prevented from being issued to production. Production Pharmacist & QA inspectors are responsible to identify segregate & remove the non-conforming products from Production area. Production Manager ensures that non-conforming material does not accumulate in production area, conducts or delegates authority for surveillance, & notifies production &/or stores if unexpected occurrences of non-conforming materials are noticed.

Procedure: 4.1. Identification & Segregation: Following materials/items may be identified by labels/tags as non-conforming products by QA after performing certain inspection &/or testing. Products identifiers Receiving raw-material Receiving Packaging material In-process products during manufacturing Reject/Hold Reject/Hold Batch Control Slip Non-conformity

14

In-process

products

during

packaging Batch Control Slip

Batch Control Slip Finished products The relevant areas personnel may

also

identify

the

nonconformity. After the identification of non-conforming materials &/or products, they are properly segregated. Area Incharge is responsible for this. The organization ensures that labeling & segregation must be effective to prevent non-conforming products from being used or dispatched. 4.2 Documentation: As shown in table 4.4 below 4.3 Evaluation: All the non-conforming products are properly evaluated to find out the actual causes(s). If the non-conformity is identified at the receiving stage, commercial coordinator is responsible to evaluate the causes in consultation with the store personnel & QA, if required. If the non-conformity is identified during in-process/final stage, Production & QA Mangers in coordination with other concerned personnel evaluate the causes with the relevant area Incharge/Pharmacist. QA Manager is responsible for the disposition of the batch. 4.4 Review & Disposition: The following disposition decisions are possible as to the product non-conformity: Rework Reject

Reworks for packaging materials are done of the following manner: For any printed packaging material rework (100% inspection by sorting) may be arranged in-house but carried out by external

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source, that is, the same subcontractor from whom the materials are procured. For any other packaging material, are returned to source for external rework (100% inspection by sorting) In special cases, some times the packaging materials are Accepted As-Is with or without concession from the subcontractor, when the quality of the packaging material does not directly affect the quality of product in it. This decision is taken by the joint agreement of Production & QA Manager. Review & Dispositio n Authoritie s QA Material/ Analyst

Stages

Possible Dispositio n

Related Document

Record COA (Raw Material) & request for Analysis & GRW Packaging Material Test Report & GRN Tablet Compression COA, Sealing Test report, Info. Slip, Inprocess control checks Finish Pack, Inspection report, Info ship

Incoming (Raw Material) Incoming (Package Material)

Reject

Product File

Rework, Sampling QA Use-As-Is or SOP QC/SM Manager/ Reject 001 Analyst In-process Control QC/IC 001 QA Manager/ Analyst

In-process

Reject Rework

&

Final

Reject Rework

&

In-process Checks QC/IC 001

QA Manager/ Analyst

4.6. Notification of the non-conforming product: The concerned department/section is notified through info slip about the non-conformity with the help of the before mentioned does so that the same area may take the appropriate action to prevent its recurrence. The concerned department/section head is responsible to take corrective action.

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4.7 Re-Inspection: All the reworked Products/Materials are inspected again, as per SOP Inspection & Testing to verify that they comply with the same requirement as originally specified/required. QA maintains records of re-inspection on the same document on which it is normally recorded. 4.8 Product Recall: The organization retains samples from every finished batch for one extra year with respect to the expiry date of the same product for stability testing. Regulatory Authorities draw samples from the market & perform inspection & testing to ensure suitability of the product & if found otherwise non-conforming SPL in notified to bring the product back from the market on immediate basis. 5. Retention Period of Record: All records generated & used in the implementation of this procedure are retained for a minimum period of product expiry plus one year.

Table of Content

Topics
Introduction ... .

Page No
1

17

Organization..... .............................. Production..... . Quality Assurance. .... Research and development. Quality System Procedure for Customer Related Process... .. Scope... ................................................. Purpose. .............

1 1 2 2 4 4 5 5 6 13

Responsibilities authorities.......

and

Procedure......... Quality System Procedure for Control Non- Conforming

Product Scope... ................................................. Purpose. .............

Responsibilities authorities....

13 13 and 13 14

Procedure.........

18