Quality Manual For Ayurvedic Company

 Fem Analytika

(Ayurveda)

    (As per requirements of ISO/IEC 17025:2005)

Copy No.

Name of Copyholder

Designation

© No part of the document shall be copied or disclosed without the authorization of Fem Analytika Products Pvt. Limited, GHAZIABAD (UP)

FEM ANALYTIKA PRODUCTS PVT. LTD. GHAZIABAD

   LABORATORY QUALITY MANAGEMENT SYSTEM MANUAL

               (As per requirements of ISO/IEC 17025 :2005)

ADDRESS

Fem Analytika Products Pvt. Limited,

Ghaziabad. (UP).

E-MAIL     : femanalytika@gmail.com                  

SECTION 01

  GENERAL

1.2 AMENDMENT RECORD

It is essential that each copy of the Quality Manual contain a complete record of amendments. This amendment page should be updated with each set of revised/new pages of the quality manual. An acknowledgement slip will be included for signatures and returned by all holders of controlled copies confirming the receipt of amendments and returning the obsolete copies/pages.

S. No.	Page No.	Section/ Clause/Para/Line (As Applicable)	Date of Amendment	Amendment Details (Deletion /Insertion/ Correction)	Reasons of Amendment	Rev No/Date	Sig. Quality Manager

                                               

TABLE OF CONTENTS

S.No.	Section		ISO/IEC Clause No.		Contents	No. of Pages.
1	00		----		Release Authorization	01
2	00		----		Amendment Record	01
3	00		----		Table of Contents	02
4	01		----		Abbreviations	01
5	02		----		Distribution List	01
6	03		4.1		Management Requirements, Organization	03
7	04		4.2		Management System	03
8	05		4.3		Document Control	03
9	06		4.4		Review of Requests, Tenders and Contracts	02
10	07		4.5		Subcontracting of Tests	01
11	08		4.6		Purchasing Services and Supplies	01
12	09		4.7		Service to the customer	01
13	10		4.8		Complaints	01
14	11		4.9		Control of Nonconforming Testing and/ Calibration	02
15	12		4.10		Improvement	01
16	13		4.11		Corrective Action	02
17	14		4.12		Preventive Action	01
18	15		4.13		Control of Records	02
19	16		4.14		Internal Audits	02
20	17		4.15		Management Reviews	02
21	18		5.1		Technical Requirements, General	01
22	19		5.2		Personnel	02
23	20		5.3		Accommodation and Environmental Conditions	02
24	21		5.4		Test  Methods and Method Validation	06
25	24		5.5		Equipment	03
26	25		5.6		Measurement Traceability	03
27	27		5.7		Sampling	01
28	28		5.8		Handling of Test and Calibration items	02
29	29		5.9		Assuring the Quality of Test and Calibration Results	01
30		30		5.10	Reporting the Results		04
31		31		4.1	Legal Identity – Annexure - 01		05
32		32		4.2	Organization Structure – Annexure - 02		01
33		33		5.2	Job Responsibilities, Annexure – 03		10
34		34		----	Scope of Accreditation, Chemical  Testing Annexure – 04		22
35		35		----	List of Laboratory System Procedures Annexure -05		02

ABBREVIATION

Doc.                : Document

I.D. No.           : Identification Number

I.E.C.              : International Electro technical Commission

I.S.O.              : International Organization for Standardization

Lab.                 : Laboratory

N.A.B.L          : National Accreditation Board for Testing and Calibration Laboratory

N.C.                : Non-Conformity

No.                  : Number

Q.M.                : Quality Manager

L.S.P.              : Laboratory System Procedure

Ref.                 : Reference

Rev.                 : Revision

S.O.P.              : Standard Operating Procedure

T.M.                : Technical Manager

FEM ANALYTIKA           : Fem Analytika Products Private Limited

NSEZ              : Ghaziabad .

PVT. LTD.      : Private Limited

MD                  : Managing Director

PPC                 : Production planning and control

LQM               : Laboratory Quality Manual

STP                 : Standard Test Procedure

HRD               : Human Resource Development

GCMS            : Gas Chromatography Mass Spectroscopy

HPLC             : High Performance Liquid Chromatography

HPTLC          : High Performance Thin Layer Chromatography

GC                 : Gas Chromatography

AAS               : Atomic Absorption Spectroscopy  

DISTRIBUTION LIST OF CONTROLLED COPIES OF QUALITY MANAGEMENT SYSTEM MANUAL

SL.NO.	NAME	DESIGNATION	COPY NUMBER
1.		Chairman & Managing Director	01
2		Executive Director	02
3		Quality cum Technical Manager	03
4		Manager PPC	04
5		Manager Quality Control	05
6	Accreditation  officer	NABL Secretariat, New Delhi -67	06

Distribution Details

This quality manual meets the requirements of ISO/IEC 17025: 2005. This manual is confidential and issued to designated copy holder as mentioned below-

Issued to- Chairman & Managing Director

                  Executive Director

                  Quality cum Technical Manager

                  Manager, PPC

                  Manager, Quality Control

      Accreditation officer, NABL. New Delhi -67

q  Controlled Copy

q  Uncontrolled Copy

References

Reference list

1.      ISO/IEC Guide 25- General terms and their definitions concerning standardization and released activities.

2.      VIM: 1993 – International vocabulary of basis and general terms in metrology.

3.      ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories.

4.      INTEGRATED MANAGEMENT SYSTEM MANUAL (ISO/IEC 9001, HACCP, ISO/IEC 22000, WHO GMP).

Documentation and References are being given at the end of the clause in terms of Laboratory system procedures. The listing is being done in the Annexure 05 by giving complete details of the contents.

  

Quality Policy

The management is committed to:

• Provide quality testing services related to customer specific norms and protocols   that conform to all regulatory requirements.
• Ensure the compliance with  ISO/IEC 17025 : 2005 and all associated standards
• To strive for continual improvement in quality of services related to laboratory functions by enabling the personnel involvement at all levels
• To ensure that all laboratory personnel’s concerned with testing familiarize themselves with quality documentation and implement the policies and procedures in their work
• To maintain high degree of professional ethics and operational integrity

Date:                                                                                                                                                                                                   Executive Director

Quality Objectives:

1. To familiarize all the laboratory staff with quality documentation as per the requirement of ISO/IEC 17025: 2005 by regular interactions through awareness program.
2. Regular participation in proficiency testing / inter laboratory comparison program.
3. Providing technical training to update knowledge and skills of persons working in the lab.
4. Compliance with policy and procedures stated in the manual and other reference documents.
5. Adopting latest available well-documented and validated methods.
6. Assuring of commitment to good laboratory practices.
7. Reducing turn around time of testing and subsequent reporting.
8. Ensuring provision of safe working environment.
9. Ensuring calibration of test equipments.

Date:                                                                                                         Executive Director

Authorization

Dr. NAME, General Manager Quality Assurance and Research and Development - has been designated as Quality Manager and is assigned the responsibility for planning, implementation and maintenance of laboratory management system.

He is authorized to coordinate all the management related activities within the lab and interact with external organizations for all management system related activities. He is authorized to prepare and issue the quality manual.  He will also plan the audit and review activities of the laboratory.

He is free to contact the undersigned regarding availability of resources to implement the policy and objectives.

In addition to the above he is also designated as Technical Manager and has given the responsibility and authority to take care of over all technical operations and making provisions for the resources to ensure the required quality of technical operations.

He is authorized to approve the quality system procedures, standard operating procedures, work instructions and format etc.

Mr. NAME, Manager Quality Control, will perform the activities of Quality /Technical operations in the capacity of deputy Quality cum technical manager. He will assist the Quality cum Technical manager and perform the all the relevant functions in the absence of Quality cum Technical manager.

Executive Director

                             

Approval and Issue

The laboratory has established the management system in line with the requirements of ISO/IEC 17025: 2005. The manual addresses the laboratory’s commitment towards quality for all the functional groups and is being maintained so as to be verifiable at any stage. This document is issued after approval and authorization from Executive Director and Managing Director respectively.

This manual is a property of Fem Analytika Products Pvt. Limited, Ghaziabad and must not be reproduced as a whole or in part without the prior consent of Quality Manager.

It is the responsibility of the authorized holders of this manual to ensure the implementation of the management system in their respective section/area as described in this manual and for keeping this document updated by incorporating the latest amendments issued from time to time.

                                                                                                         Quality/Technical Manager

  

Purpose

The purpose of this manual is to document the quality system of Quality Control Laboratory of Fem Analytika  Ayurveda Products Pvt. Limited with a view to ensure its compliance to ISO/IEC 17025: 2005 and clauses of NABL specific criteria 102 and 103 pertaining to scope of activity.

Scope

This documented management system is applicable to Physical, Chemical and Microbiological testing of all type of Ayurvedic products pertaining to in house testing.

SECTION 02

SCOPE AND COMPANY PROFILE

2.1 SCOPE OF THE MANAGEMENT SYSTEM MANUA

This manual conforms to the requirements of Laboratory Quality Management Systems as per the requirements of International standard (ISO/IEC 17025:2005)

The laboratory in addition is committed to comply with all applicable statutory and regulatory requirements being applicable from time to time.

As regards to testing the system is applicable in terms of in house testing of finished products only.

The testing activity being performed in the laboratory in general covers standard test methods only.

The manual may be used by the laboratory for the purpose of developing the quality management system as well as administrative and technical operations.

In addition, the manual may be used by laboratory customers, regulatory authorities and the respective accreditation bodies

2.2 COMPANY PROFILE

FEM ANALYTIKA PRODUCTS PVT. LTD. was established in 1987 for development and manufacturing of Ayurvedic formulations, food supplements, health care products, teas, beverages, cosmetic and toiletry products with a well-equipped manufacturing plant (facilities being spread over to plot No’s. 17 & 18, 32) based in the Ghaziabad ., Ghaziabad, India.

Human resource spectrum comprises of well-qualified, competent and experienced managerial cadre and highly motivated work force, to provide highest quality of products and best of services to our esteemed customers. It provides a vibrant work environment to its personnel in pursuit of excellence. Presently the company employs in excess of 450 personnel in different disciplines.

The product range of FEM ANALYTIKA PRODUCTS PVT. LTD. includes but is not limited to the followings:

¨      Tablet

¨      Powder

¨      Syrup

¨      Oil & Ghee

¨      Paste

¨      Tea & Coffee

¨      Asav & Arisht

¨      Kashayam

Apart from the above, there are five intermediate product groups as follows:

¨      Sp. Dried Powder

¨      Bhasm      

¨      Pishti

¨      Shodhan

¨      Kshar

In addition to above the product spectrum also includes a range of herbal tea and coffee substitutes, beverages, cosmetic and toiletry products, herbal extracts, and food items.

The plant has full-fledged Research and Development wing along with a quality control laboratory. The Research and development operations are duly approved by the Department of Scientific and Industrial Research, Govt. of India.

The company exports its products to more than 50 countries including, U.S.A. Holland, Switzerland, U.K., Italy, etc.

The company has acquired ISO/IEC 9001:2008, WHO GMP & HACCP certification by RVA accredited certification agency Det Norske Veritas (DNV), Norway, and GMP certification from Government of India and EU-GMP.

The company has also obtained the Ayush Premium Marking certification from department of AYUSH, Government of India, for 118 products.

The company has a full fledged, state-of-the-art quality control department equipped with latest analytical instruments like AAS, GC, HPTLC, HPLC, GCMS, etc. All relevant test as per international standards and requirements are carried out in house.

The measure and procedure for testing is adopted as per the nature of the material tested.

 All raw materials are tested for various physiochemical parameters like pH, solubility, viscosity, sugar content, alcohol content, mineral assays, etc.

All finished products are tested for microbiological contamination, toxic heavy metal contamination and residual pesticide content.

   SECTION 03

           MANAGEMENT

OF

           QUALITY SYSTEM MANUAL

3.0 Quality Manual details in terms of structure, maintenance and implementation

3.1 Scope and Field of Application

The scope of manual is to cover documented system based on ISO/IEC 17025:2005, covering the laboratory operations of the organization.

This section deals with the principles of preparation, distribution, revision and control of Quality Manual.

3.2 Responsibility

The Quality Manager is responsible for preparation, modification, maintenance, issue, updation, revision and withdrawal of the manual.

3.3 Preparation

The manual follows continuous numbering system. The manual is based on the company’s policies, systems, program and procedures. It is prepared with the intention of consistently satisfying the needs of customer/interested parties and to meet the requirements of international management system as per ISO/IEC 17025:2005. The Quality Manager in consultation with all concerned functions prepares it. Executive Director approves the manual. The manual is issued through Quality Manager after getting the authorization from Chairman and Managing Director.

3.4 Distribution

The Quality Manager has issued the controlled copies of the manual to the copyholders mentioned in distribution list. The manual is distributed within and outside the company as per the designated persons mentioned in the list. The controlled and uncontrolled modes are identified with suitable stamps.

Uncontrolled copies are issued for general information and for commercial purposes clearly showing their status. A manual with uncontrolled status has no contractual binding with the company for its updation.

Each controlled copy is identified by a distinct number and by the name of company/ division of the holder. Quality Manager maintains a record of the distribution list of the quality manual. This list is used as reference for issue of amended/updated pages of the manual.  It is the responsibility of the controlled copyholder to maintain the amendment sheet and update as and when amendment to any provision of the manual takes place.

3.5 Revisions, Updation and Amendment

Revision in the manual may be generated consequent upon changes in the policies and objectives of the Company, ISO/IEC 17025:2005 and in the company's internal structure. The revision may also be necessitated due to new developments, standardization activities, technological advancement and changes in system or procedures.

A new edition replaces the entire manual, in case too many amendments/revisions have been affected or major changes have been enforced due to policy decisions.

All revisions, amendments and changes are furnished to only controlled copy holders and an acknowledgement is taken.

It is the responsibility of the controlled copy holder to return obsolete copies to Quality Manager for their suitable disposition.

All amendments/changes/revisions are recorded in the amendment sheet and maintained by the recipients. Recipients in uncontrolled mode are not eligible to receive such amendments.

The controlled copy is freely accessible to all personnel in the department for their use.

The Quality Manager is responsible for preparation, maintenance, modifications and issue of new version of quality manual along with prompt withdrawal of obsolete copies.

3.6 Translations

The manual is available in English, the language of the international standard. In case of any doubt or in the court of law the English version shall prevail as the authentic version.

3.7 TERMS AND DEFINITIONS

Corrective Action - Any action, to be taken to eliminate the root cause to prevent its recurrence.

Preventive action - Any action, to be taken to eliminate potential problems in order to prevent its occurrence.

Deviation: Non fulfillment of a specified requirement.

Defect: Non fulfillment of a requirement or reasonable expectation with respect to the intended use/application.

Flow Diagram - A systematic representation of the sequence of steps or operations used in the testing services.

Monitoring - To conduct a planned sequence of observations or measurements to assess whether the system is under control.

Note: Customer means our internal departments of FEM ANALYTIKA

SECTION 04

MANAGEMENT REQUIREMENTS

4.0              Management requirements:

4.1       Organization

4.1.1        The laboratory is part of FEM ANALYTIKA PRODUCTS PVT. LTD. Ghaziabad (U.P.) and is an entity that can be held legally responsible (Annexure 01).

4.1.2        The laboratory is organized and operates in such a way that it meets the requirements of this International Standard while satisfying the needs of its internal customer and regulatory authorities while carrying out work in its permanent facilities.

4.1.3        The laboratory is carrying out all its operational activities in permanent facility situated in the premises of its parent organization.

4.1.4        The responsibilities of key personnel in the organization that have an involvement or influence on the testing activities of the laboratory have been defined in HRD manual in order to identify potential conflicts of interest. It is ensured that departments having conflicting interests, such as production, commercial marketing or financial do not adversely influence the laboratory’s compliance with the requirements of this International Standard.

4.1.5.   The laboratory has

(a)        Adequate managerial and technical personnel with the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the quality system or the procedures for performing tests and to initiate actions to prevent or minimize such departures;

(b)        Arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of their work. As the laboratory is only carrying out in house activity there is not any type of commercial pressure on the technical staff. The emoluments of the laboratory staff are being fixed as per prevailing market rates.

(c)        Policies and procedures to ensure the protection of its customer confidential information and proprietary rights, including procedures for protecting the electronics transmission of results;

(d)       Policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity;

(e)        Defined, with the aid of organizational charts, the organization and management structure of the laboratory, its place in the parent organization, and the relationships between management, technical operations services and the quality system (Ref: Annexure-02).

(f)        Specified the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests (Ref: Annexure-03).

(g)        Provided adequate supervision of testing staff, including trainees, by persons familiar with the test methods and procedures,  purpose of each test along with the assessment of the test results;

(h)        Appointed Quality cum Technical Manager who besides responsible for quality management functions has overall responsibility for the technical operations and the provision of the resources, needed to ensure the required quality of laboratory operations;

(i)         Appointed Manager, Quality Control as deputy Quality cum Technical Manager,  who irrespective of other duties and responsibilities, has defined responsibility and authority for ensuring that the system is implemented and followed at all times; the Quality cum Technical Manager has direct access to the Executive Director the position at which decisions are taken on laboratory policy or resources.

(j)                 Ensured that its personnel are aware of the relevance and importance of their activities and how they have to contribute to the achievement of objectives of the management system.

4.1.6      Top management has ensured that appropriate communication processes are established within the laboratory regarding the effectiveness of management system. Most of the communications take place via electronic mail and interdepartmental circulars besides putting up the information on notice board.         

DOCUMENTATION AND REFERENCES:

FEM ANALYTIKA/LSP/4.1-01      Storage and transmission of data in electronic system

 FEM ANALYTIKA/LSP/4.1-02      Protection and maintenance of confidentiality,             impartiality and operational integrity

4.2       Management System

4.2.1        The laboratory management has established, implemented and maintained a management system appropriate to the scope of its activities, including the type and range of testing activities it undertakes. The laboratory management has documented its policies, systems, programmes, procedures and instructions to the extent necessary to enable the laboratory to assure the quality of the test results it generates. All documents used in this quality system are communicated to, understood by, and implemented by the relevant authorized personnel. 

4.2.2        The laboratory’s management has defined and documented its policies and objectives to be achieved by implementing the quality system. The laboratory management has ensured that these policies and objectives are documented in the quality manual. The overall objectives have been set out in line to the quality policy statement defined in the manual stating the standard of performance to be obtained and maintained. The quality policy statement has been issued under the authority of the Executive Director. 

4.2.2.1 Quality Policy

The management is committed to:

• Provide quality testing services related to customer specific norms and protocols   that conform to all regulatory requirements.
• Ensure the compliance with  ISO/IEC 17025 : 2005 and all associated standards
• To strive for continual improvement in quality of services related to laboratory functions by enabling the personnel involvement at all levels
• To ensure that all laboratory personnel’s concerned with testing familiarize them selves with quality documentation and implement the policies and procedures in their work
• To maintain high degree of professional ethics and operational integrity

4.2.2.2 Quality Objectives:

• To familiarize all the laboratory staff with quality documentation as per the requirement of ISO/IEC17025: 2005 by regular interactions through awareness program.
• Regular participation in proficiency testing / inter laboratory comparison program.
• Providing technical training to update knowledge and skills of persons working in the lab.
• Compliance with policy and procedures stated in the manual and other reference documents.
• Adopting latest available well-documented and validated methods.
• Assuring of commitment to good laboratory practices.
• To reduce turn around time of testing and subsequent reporting
• Ensuring provision of safe working environment
• Ensuring calibration and validation of test equipments and reference standards respectively as per schedule

4.2.3    The Executive Director always ensures the commitment regarding development and implementation of the management system and to continually improving its effectiveness   through management review meeting

4.2.4    Top management communicates the importance of meeting customer requirements as well as statutory and regulatory requirements on regular basis to all concerned persons and departments.

4.2.5    The quality manual includes reference to the supporting system procedures including technical procedures at the end of the relevant clause. The structure of the documentation used in the quality system is outlined. The quality system is structured in four tiers of documentation and is being maintained as follows-

a) Level 1- Laboratory Quality Manual [FEM ANALYTIKA/LQM]

b) Level 2- Laboratory System Procedures [FEM ANALYTIKA/LSP]

c) Level 3 – Standard Operating / Test Procedure [FEM ANALYTIKA/SOP/STP]

d) Level 4 – Records such as formats, worksheet, logbook etc [FEM ANALYTIKA /F etc.]

The quality manual is maintained up to date.

4.2.6    The roles and responsibilities of technical management and the quality manager including their responsibility for ensuring compliance with this International Standard have been defined in Quality Manual(Ref:Annexure-03)

4.2.7    Top management always ensures that the integrity of the management system is maintained when changes to the management system are planned and implemented.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/HRD/01                                    HRD Manual

Annexure 02                                       Organizational chart

Annexure 03                                       Roles and Responsibility of Key Personnel

4.3                    Document Control

4.3.1        General

The laboratory has established and maintained procedures to control all documents (internally generated and from external sources) that form part of its quality documentation. The spectrum of documents in terms of its internal generation includes Quality Manual, System procedures, work instructions and formats etc.  The documents of external origin  comprises of  regulations, standards, other normative documents, test methods, as well as drawings, specifications, instructions, brochures and manual etc

4.3.2    Document approval and issue

4.3.2.1                          All documents issued to personnel in the laboratory as part of the quality system are   reviewed and approved as defined in procedure for use prior to issue. A master list identifying the current revision status and distribution of documents in the quality system is established and is readily available to preclude the use of invalid and/or obsolete documents. The issue of documents is controlled through a document control register.

4.3.2.2   The procedure(s) adopted ensures that:

a)      Authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

b)      Documents are periodically reviewed once in two years and where necessary, revised to ensure continuing suitability and compliance with applicable requirements.

c)      Invalid or obsolete documents are promptly removed from all points of issue or use, in order to ensure against their unintended use

d)     Obsolete documents retained for either legal or knowledge preservation purposes are suitability marked.

4.3.2.3    Quality system documents generated by the laboratory are uniquely identified. Such identification includes document number, date of issue and/or revision identification, the total number of pages and a mark to signify the end of the documents, and the authority for their approval, authorization and issue.

4.3.3. Document changes

4.3.3.1    Changes to documents are reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel have access to pertinent background information upon which to base review and approval.

         4.3.3.2    The nature of the change is identified in the document in terms of appropriate attachment in the form of amendment sheet.

4.3.3.3    The responsibility to make amendment of documents by hand pending the re-issue of that documents lies with Quality and technical manager respectively.  Amendments are clearly marked, initialed and dated. A revised document is formally re-issued as soon as practicable.

4.3.3.4    The control to maintain and amend the documents in computerized system lies with Quality Manager. The system is being controlled through password protection and having a suitable back up.

 

DOCUMENTATION AND REFERENCES:

FEM ANALYTIKA/LSP/      4.3-01             Guidelines for quality system documentation

FEM ANALYTIKA/LSP/      4.3-02             Control of Documents

FEM ANALYTIKA/LSP/4.3.03                    Change control

4.4 Review of requests, tenders and contracts

4.4.1 It is the policy of the lab to follow a documented procedure to review all requests related to testing activity as per its capability in terms of prevailing facilities and resources. The review establishes that the laboratory possesses the necessary capability and resources and laboratory personnel have the skill and necessary expertise to perform the test as prescribed in reference standard protocol such as Ayurvedic Pharmacopoeia of India & API/ AOC etc. Being an in-house activity the laboratory is not involved to review of any tender and contracts.

4.4.2 The Quality Manager is overall responsible for reviewing all type of requests received from customer (Production Department)

4.4.3    Normally the procedure comprises of the following steps:

                                                            i.      Receiving and making entry of sample details as per the requests submitted from production department.

                                                          ii.      Putting the request to the Quality manager for reviewing after documenting the customer’s test requirement. In terms of selection of appropriate methods.

                                                        iii.      Assessing laboratory capability and resources through appropriate means.

                                                        iv.      Resolution of any differences of opinion before acceptance of review.

4.4.4.      Oral communications are also considered, reviewed and formalized by making the appropriate entries in the sample receiving register. The person responsible for this is Quality Manager.

4.4.5.      In between the testing of sample, deviation and amendment are made only after the matter is discussed with the customer and making the proper records for the same.

4.4.6.      Quality Manager or its designee is only responsible for review of requests in normal routine and repetitive testing.

4.4.7.      Normally subcontracting work is not being undertaken.  However in exigencies it is undertaken and the relevant customer is kept informed and their concurrence is obtained.

4.4.8.      Appropriate records are made for all type of review of request,

4.4.9.      For complex or advanced testing tasks or projects a more comprehensive record is being made.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/4.4-01                   Review of requests for testing

4.5              Subcontracting of tests.

4.5.1        Subcontract work (e.g. because of unforeseen circumstances such as extra workload or non availability of required technical expertise etc), is placed with a competent subcontractor.

4.5.2        When the laboratory intends to subcontract to other laboratory specific tests or a part of a test approval in writing is taken from authorized person.

4.5.3        The laboratory has ensured that its subcontractor is competent to perform the activities in question and complies with the requirements of ISO/IEC 17025: 2005 for the work being subcontracted.   

·          In cases where customer or regulatory authority specifies which subcontractor is to be used by the Laboratory, the laboratory is not responsible for the results obtained.

·         The laboratory is always responsible to its customer for the work the subcontractor performs.

4.5.4        The laboratory has maintained a register of all subcontractors that it uses for tests and a record of the assessments it has made of them and of all subcontracted tests.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.5-01      Sub contracting of test activities

4.6              Purchasing services and supplies

4.6.1      It is the policy of the lab to procure all materials / supplies and services from reputed and established suppliers and preferably from the suppliers with proven track record and accredited / certified by national / international agencies. Procedures exist for the purchase, receipt and storage of consumable and materials relevant for the tests.

4.6.2      The laboratory uses only such services and supplies that are of the quality, needed to sustain confidence in the results of tests. Services and supplies used comply with specified requirements. Records of actions taken to check compliance are maintained.

4.6.3      Purchasing documents, for items affecting the quality of laboratory output, contains data describing the product ordered. These purchasing documents are reviewed and approved for technical content prior to release. The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, and other relevant technical data. 

·         The laboratory has ensured that purchased supplies and consumable materials that affect the quality are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the method for the tests concerned.

4.6.4      The laboratory is evaluating suppliers of critical services and supplies which affect the quality of testing and maintained records of these evaluations and listed those approved.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.6 -01                 Purchasing of services and supplies   

FEM ANALYTIKA/LSP/ 4.6 -02                 Evaluation, selection and re-evaluation of Suppliers 

FEM ANALYTIKA/LSP/4.6 -03                  Verification of Purchased product

4.7 Service to the customer

4.7.1        The laboratory is committed to provide customer or their representative’s full co-operation to facilitate clarification of the customer’s request and to monitor the performance of the laboratory in relation to the work performed. The laboratory informs its customer about inordinate delay or major deviation in the performance of test.

4.7.2   The laboratory is periodically seeking feed back from its customer  The feed back thus   received is reviewed on continuous basis and is discussed in management review meetings. Feedback obtained from customers is used to improve the quality system and testing activities and services.

·         As the laboratory testing is an in-house activity the cooperation towards its customer such as Manager, PPC is extended in an appropriate and adequate manner.

·         Besides clarifying doubts and queries the lab is always ready and is not hesitant to take their advice and guidance in technical matters.

·         In case a customer wants to witness the test being performed, a reasonable access is provided to him up to the relevant area of the lab for that purpose.

·         Quality Manager is over all responsible for providing services to the customer.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/4.7-01     Service to the customer

4.8 Complaints

4.8.1          It is our policy to deal / resolve the complaints by according top priority to the customer’s satisfaction by initiating prompt and appropriate action within the frame work of existing management system.

4.8.2        Quality Manager is responsible for recording all the complaints (written or oral).

4.8.3        After making necessary entries the complaint is then forwarded to the relevant analyst

4.8.4        The complaint is then investigated by performing the root cause analysis and making subsequent recommendations for the corrective actions to follow.

4.8.5        In case the nature of complaint raises doubt on the compliance of organizations policy and procedure, a special internal audit is carried out to stop its recurrence.

4.8.6        The customer is all the times being informed about the actions initiated on the part of the laboratory.

4.8.7        The complaint record includes the following information-

1.      Details of the complaints

2.      Investigation/root cause analysis

3.      Corrective action/Preventive action

4.      Follow up verification audit, if required

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/4.8-01       Dealing with Complaints related to testing.

4.9 Control of nonconforming testing work

4.9.1 The laboratory has a policy and procedures that is implemented when any aspect of its testing work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. The management at all the times is committed to ensure that all non conformances are documented, identified, evaluated and resolved with proper remedial actions.

The management of non conforming work ensures that:

a)        Responsibilities and authorities  are  designated and actions (including halting of work and withholding of test reports as necessary) are defined and taken when nonconforming work is identified;

b)       Evaluation of the significance of the nonconforming work is made;

c)        Remedial actions are taken immediately, together with any decision about the acceptability of the nonconforming work.

d)        Where necessary, the results of nonconforming work already released are recalled.

e)        The responsibility for authorizing the resumption of work is defined.

4.9.2        Identification of non-conforming work related to the quality system or with testing activities can occur at various places within the quality system and technical operations such as

1.      Customer feed back / complaints

2.      In-house quality check

3.      Equipment calibration

4.      Checking of consumable material.

5.      Day to day observations

6.      Supervision or control

7.      Checking of test results

8.      Internal or external audit

9.      Management review.

4.9.3    Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 are promptly followed.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.9-01      Control of Non-conforming work

4.10 Improvement

4.10.1 The organization continually endeavors to improve the effectiveness of the laboratory management system through use of the quality policy, quality objectives, audit results, analysis of data, customer complaints, customer feed back, corrective and preventive actions and management review.

4.10.2 The quality policy is reviewed for its continuous appropriateness / suitability and effectiveness during management review meetings. The achievement of established objectives is a concern of all the laboratory staff. Both are monitored and reviewed on regular basis. Information related to customer complaints and feed back are analyzed and action taken are presented in management review meetings. Results obtained through internal quality control checks and proficiency testing/ inter laboratory comparison program are taken at the management review and subsequent corrective and preventive actions are followed up. The records are being maintained in appropriate manner.

4.10.3 The company, in the quest to continuously improve the laboratory management system and enhance customer satisfaction, has established a process to identify and manage improvement activities by using the improvement tools such as suggestion scheme, recognition and reward for improvement.

4.11 Corrective action

4.11.1 It is the policy of the laboratory to plan, implement and monitor the corrective action   without delay in case any nonconforming work or departure from policies and procedures in the quality system or technical operations have been identified.

The laboratory takes action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions taken are appropriate to the effects of the nonconformities encountered.

A procedure has been established to define requirements for:

a)      Reviewing non-conformities (including complaints);

b)      Determining the causes of non-conformities;

c)      Evaluating the need for action to ensure that non-conformities do not recur;

d)     Determining and implementing actions needed;

e)      Records of the results of action taken;

f)       Reviewing corrective action taken.

In pursuing corrective action, various sources of information and data are identified including customer complaint, nonconformity / internal audit report, output from data analysis, process measurements, and results of self-assessment.

4.11.2 Cause Analysis

Employees are trained in problem solving skills including root cause analysis to provide appropriate corrective action.  Actions taken are recorded and reviewed in the management review meetings.

4.11.3 Selection and Implementation of Corrective actions

Having identified the cause(s), the laboratory identifies the potential corrective actions. It selects and implements the action(s) most likely to eliminate the problem and to prevent recurrence.

Any corrective action taken to eliminate the cause(s) of non-conformance or other departures is to a degree appropriate to the magnitude of the problem and commensurate with the risks encountered.

4.11.4 Monitoring of corrective actions

After having implemented the corrective action(s), the laboratory monitors the results to ensure that the actions taken have been effective in overcoming the problems originally identified.

4.11.5 Additional audits

When necessary, the laboratory ensures that the appropriate areas of activity are promptly audited.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.11-01                Corrective action

FEM ANALYTIKA/LSP/ 4.12-01                Preventive action

FEM ANALYTIKA/LSP/ 4.11-02                Conducting additional Audit

4.12 Preventive action

4.12.1 The company determines action to eliminate the causes of potential non-

conformities in order to prevent their occurrence. Preventive actions are   

 appropriate to the effects of the potential problems. A documented procedure

 has been established to define requirements for:

a)               Determining potential non-conformities and their root causes;

b)               Evaluating the need for action to prevent occurrence of non conformities;

c)               Reviewing preventive action taken and its effectiveness.

             d)      Identifying opportunities for improvement

4.12.1.1 All relevant data are evaluated to develop an effective and efficient plan for preventive action.  Data used include, review of customer need and expectation, management review, output from data analysis, process measurement, inspection and test results and results of self-assessment.

4.12.1.2 Opportunities for needed improvement and potential sources of non-conformances, either technical or with the quality system are identified. If action is required, action plans are developed, implemented and monitored, to reduce the likelihood of occurrence of such non-conformances and to take advantage of the improvement opportunities.

4.12.2 Procedures for preventive actions include the initiation of such actions and application of controls to ensure that they are effective.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.12-01                            Preventive action

MANAGER MILK PURCHASE

4.13 Control of Records

4.13.1 General

4.13.1.1 The laboratory has established and maintained procedures for identification, collection, indexing, access, storage, maintenance and disposal of quality and technical records. Quality records include reports from internal audits and management reviews as well as corrective and preventive action records.

4.13.1.2  All records are made in legible manner and are stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage, or deterioration and to prevent loss. Retention times of records have been established and are mentioned in master list of records.

4.13.1.3  All records are held secure and in confidence.

4.13.1.4    The laboratory has established procedures to protect and back-up data held on computers at all times and to prevent unauthorized access to or amendment of data on computers.

4.13.2 Technical records

4.13.2.1   The laboratory retains original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report issued, for a defined period. The record for each test contains sufficient information to facilitate an audit trail thus enabling the test to be repeated under conditions as close as possible to the original. The test records include the identity of personnel responsible for sampling, performance of each test and checking of results.

4.13.2.2 The technical records comprises of:

a.       Work sheets containing original observations, derived data and calculations.

b.      Test request review etc.

c.       Customer notes and feed backs.

d.      Log books.

e.       Instrument printout (Graphs, Charts and Chromatograms etc.)

f.       Control graphs

g.      Test reports.

h.      Calibrations reports (internal & external)

i.        Internal checks/ verifications.

                       Observations, data and calculations are clearly and permanently recorded                   and are identifiable to the specific job at the time they are made.

4.13.2.3    When mistakes occur in records, each mistake is crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records are signed or initialed by the person making the correction. In the case of computer maintained data, relevant measures are taken to avoid loss or change of original data.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/4.13-01                 Control of Records

4.14 Internal audits

4.14.1    The laboratory conducts internal audits at least once in six months intervals to determine whether the Laboratory quality management system conforms to the requirements of ISO/IEC 17025:2005 and the system is effectively implemented and maintained.

An audit program is planned, taking into consideration the status and importance of the processes and the area to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process.

It is the responsibility of the Quality Manager to plan and organize audits as required by the schedule and requested by management. Such audits are carried out by trained and qualified personnel who are independent of the activity to be audited.

4.14.2   When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test results, the laboratory takes timely corrective action, and notifies customer in writing if investigations show that the laboratory results may have been affected.

4.14.3      The area of activity audited, the audit findings and corrective actions that arise from them are recorded. The laboratory management ensures that these corrective actions are discharged within an appropriate and agreed timescale.

4.14.4      Follow up audit activities are conducted to verify and record the implementation and effectiveness of the corrective actions taken.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.14-01                Conducting Internal Audit

4.15          Management reviews

4.15.1                Top management conducts review at least once in six months to ensure continuing suitability, adequacy and effectiveness of the Laboratory Quality management system as per ISO/IEC 17025 : 2005

4.15.2                In general review meeting takes account of the following:

·         The suitability of policies and procedures

·         Reports from managerial and supervisory personnel

·         The outcome of recent internal audits

·         Corrective and preventive action

·         Assessments by external bodies

·         The results of inter laboratory comparisons or proficiency tests

·         Changes in the volume and type of work

·         Customer feedback

·         Complaints

·         Recommendations for improvements

·         Other relevant factors such as quality control activities, resources and staff training

·         Any other relevant matter with the permission of chair

Result of management review are recorded and maintained by the Quality Manager being convener of the meeting.

4.15.3                Findings in the form of minutes of meeting and the actions that arise from them are recorded and forwarded to all concerned for taking necessary action within an agreed time frame.

4.15.4                The management ensures that those actions have been accomplished effectively within an appropriate and agreed timescale.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 4.15-01    Management Review

SECTION 05

TECHNICAL REQUIREMENT

5.0 Technical requirements

5.1 General

5.1.1    Top management is committed to ensure the correctness and reliability of tests and internal calibrations performed by the laboratory. The factors which are essential for achieving the implementation of laboratory policy and objectives, comprises of the following:

·         Human factors

·         Accommodation and environmental conditions

·         Test methods and method validation

·         Equipment

·         Sampling

·         Handling of test items

5.1.2    The extent to which the factors contribute to the total uncertainty of measurement differs considerably between the type of tests being performed The laboratory takes account of these factors in developing test methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

DOCUMENTATION AND REFERENCES: All the related documents and records.

5.2       Personnel

           5.2.1     The laboratory management ensures the competency of all staff personnel who operate specific equipment, perform tests, evaluate results and sign test reports. When using staff that is undergoing training, appropriate supervision is provided. Personnel performing specific tasks are authorized on the basis of appropriate education, training, experience and technical skills, as required. The authorization is reflected in their individual job descriptions. The laboratory is responsible for fulfilling specified personnel certification requirements being given through regulatory agencies.

5.2.2    Competence, awareness and training

The laboratory

a)      Determines the necessary competence of personnel performing work affecting product quality.

b)      Identifies the training needs and impart the relevant training keeping in view of present and anticipated task of the laboratory.

c)      Evaluates the effectiveness of the training actions taken.

d)     Ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;

e)      Maintains appropriate record of education, training, skills and experience.

          5.2.2.1   The training needs of employees are determined on periodic basis and training calendar is made accordingly. The training schedule is subject to change depending upon the skills requirement. The basis of the technical training topics selected depends upon the role of employees in case of non-conformance and the corrective and preventive action required to be taken in case of non-adherence to the set parameters and specifications.

5.2.2.2    Employees carrying out quality relevant activities are trained to deal with all work place situations in compliance to laboratory management system requirements.

5.2.2.3 All newly recruited employees are imparted induction training. Adequate and   appropriate supervision is provided accordingly.

5.2.3       The laboratory only uses personnel who are employed by the company. Presently the laboratory is not availing the services of any person who is under contract with the laboratory.

5.2.4               The laboratory maintains current job descriptions for managerial, technical and   key support personnel involved in tests. Job descriptions in general includes

§  Responsibilities with respect to performing tests

§  Responsibilities with respect to planning of tests and evaluation of results

§  Responsibilities for expressing opinions and interpretations

§  Responsibilities with respect to method modification and development and validation of new methods;

§  Expertise and experience acquired

§  Qualifications and training program attended

§  Managerial/supervisory duties.

The job descriptions are dated and signed to demonstrate that the relevant person has   read it and in compliance to the agreement.

5.2.5    Management has authorized specific personnel for each kind of activities as per skill required for the activities. Records of the relevant competence, educational and professional qualification, training, skills and experience of all technical personnel are being maintained in the relevant personnel files. The records are being held at administration department of Director Office.

DOCUMENTATION AND REFERENCES

 FEM ANALYTIKA/LSP/5.2-01                  Personnel selection, and appraisal.

 FEM ANALYTIKA/LSP/5.2-02                  Training needs identification,

 FEM ANALYTIKA/LSP/5.2-03                   Imparting of training and subsequent evaluation ( Ref: HRD Manual)

5.3       Accommodation and environmental conditions

5.3.1    The laboratory has determined, provided and maintained the infrastructure needed to achieve conformity to test and associated service requirements in order to facilitate correct performance of testing.

            Necessary infrastructure facilities are provided for carrying out day-to-day work required for efficient operations of the laboratory. These resources are reviewed from time to time in view of increased customer demand. Technical requirements related to accommodation and environmental conditions liable to affect the results, are being documented.

The laboratory is located on the second floor of the building and is designed in such a manner to provide sufficient space for sample receiving, storage, testing and reporting.

The microbiological section is effectively separated from chemical and Instrument section with a well designated space for washing, decontamination, media preparation, main inoculation including pathogen handling facility.

5.3.2    A documented procedure on control of work environment has been established to monitor general environment and clean room conditions in the laboratory. Due attention is paid, for example, to biological sterility, dust, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. Tests are stopped when the environmental conditions jeopardize the results of the tests.

5.3.2.1 As per the requirement effective separation is provided to prevent cross- contamination.

           

5.3.2.1.1  Access and uses of areas affecting the quality of the tests are controlled. Access   to main and microbiology laboratory is restricted to authorized persons only.

5.3.3        Measures have been taken to ensure good housekeeping in the laboratory. All efforts are being made to keep the laboratory tidy and clean. Special sanitization procedures have been prepared and followed.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/5.3-01                               Control of Work Environment

5.4 Test methods and method validation

5.4.1 General

The laboratory uses appropriate methods and procedures for all tests including sampling, handling, transport, storage and preparation of items. Where appropriate, an estimation of the measurement uncertainty has been done. Statistical techniques for analysis of test data have been adopted where required.

The laboratory has instructions on the use and operation of all relevant equipment and on the handling and preparation of items for testing.  All instructions, standards, manuals and reference data relevant to the work of the laboratory are maintained current and are made readily available to the concerned personnel. In case there is any deviation from test methods the same has been documented technically justified authorized, and has been brought under the knowledge of customer. In case any supporting information is available regarding standard method the same is supplemented with additional details to ensure its consistent application.

5.4.2 Selection of methods

The laboratory selects appropriate methods that have been published either in international, regional or national standards or referred through reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methods adopted by other laboratory are also used if they are appropriate for the intended use and are validated. For all standard methods latest valid editions are being used.

5.4.3      Laboratory-developed methods

A provision has been made regarding introduction of test methods developed by the laboratory for its own use in terms of making it a planned activity and is assigned to qualified personnel equipped with adequate resources. In any type of method development the plans are updated as development proceeds and effective communication is ensured amongst all personnel involved.

5.4.4   Non-standardized methods

So far the laboratory has not used any non standard method. In case when it is necessary to employ methods not covered under standardized methods, the method developed is validated appropriately before use, and is available for examination by the authorized recipients.

For new test methods, procedures are developed prior to the tests being performed and contains the following information:

·         appropriate identification

·         scope

·         description of the type of item to be tested

·         parameters or quantity and range to be determined

·         technical performance requirement of equipment

·         reference standard or reference material

·         environmental condition and stabilization period needed

·         description of procedure

·         criteria for approval

·         data to be recorded and method of analysis and presentation

·         procedure for estimating uncertainty or estimation of uncertainty

5.4.5 Validation of methods

5.4.5.1 The laboratory intends to validate the standard methods being used out side the range mentioned in the scope & amplification / modification of the standard method. The validation is performed to confirm that the methods are fit for the intended use.

Appropriate procedure has been made based upon below mentioned criteria:

·         Required standard specifications in terms of applicability and intended use

·         Determination of performance characteristics

·         Approval of equipment and qualification of personnel

·         Assigning responsibility in terms of its appropriateness and intended use

·         Approval and authorization of development plan

·         Method development through checking of requirements

·         Making appropriate records

·         Concluding the validity of method

·         Proper authorization from management

·         Ensuring use in terms of agreement with the customer

·         Defining  revalidation criteria

5.4.5.2    Validation and qualification processes adopted by the laboratory demonstrate the ability to achieve planned results. The laboratory intends to record the results obtained, & procedures used for validation & conclusion regarding the fitness of method for the intended use.

5.4.5.3    The range and accuracy of the values obtainable from validated methods (such as the uncertainty of the results, detection limit, method selectivity, linearity, repeatability  / reproducibility limit , robustness / cross-sensitivity against matrix interference  of the test item ) being assessed for the intended use are needs to be relevant as per customer’s needs.

5.4.6       Estimation of uncertainty of measurement

5.4.6.1   Laboratory has a procedure to estimate the uncertainty of measurement for internal calibrations and testing parameters pertaining to quantitative estimations. For test parameters the laboratory has adopted to estimate the uncertainty of measurement for all those cases that are following bases

·         Test method requirement

·         Customer’s requirement

·         Requirement for rigorous metrological conditions

·         Narrow specification limits on which decisions on conformance is made.

5.4.6.2.1  In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory attempts to identify all the components of uncertainty and makes the best possible estimation, and ensures that the form of reporting does not give an exaggerated impression of accuracy.

5.4.6.2.2  When estimating the uncertainty of measurement, all uncertainty components, which are of importance in the given situation, are taken into account using accepted methods of analysis. This includes reference standards and reference materials used, methods and equipment used the environmental conditions, the condition of the item being tested or calibrated and the operator.

5.4.7          Control of data

5.4.7.1 The laboratory is having an arrangement to ensure that all calculations and data transfers are subjected to appropriate checks in systematic manner. All activities consisting of recording of the raw data, observations, calculations are entered in the form of record book / register/ formats etc., are done manually and is preserved in the form of work sheet from which all the data is transferred in a computer for preparing the final test report which is released after checking by quality manager/section in- charge. The checking is done to determine the accuracy of calculations, conversions and data transfers.

5.4.7.2    When computers or automated equipments such as GC-MS are used in the laboratory for the acquisition, processing, recording, reporting, storage or retrieval of test data. The laboratory ensures that

1.      No laboratory developed computer software is being installed. The software developed by the supplier is ensured in terms of its genuinity and checked in terms of its adequacy before use.

2.      Procedures are established and implemented for the protection of data integrity.

3.      Computers and automated equipments are maintained to ensure proper functioning in terms of environmental and operating conditions.

4.      Data is securely maintained by preventing unauthorized access resulting into the amendment of recorded data and records.

5.4.7.2.1Data generated using computer software programs that are interfaced directly to instruments incorporates all dilutions and calculations, thereby eliminating the need for manual data reduction.

Commercially developed software in general use within its designed   application range is considered sufficiently validated.

DOCUMENTATION AND REFERENCES:

FEM ANALYTIKA/LSP/5.4-01       Method validation

FEM ANALYTIKA/LSP/5.4-02       Estimation of measurement of uncertainty

FEM ANALYTIKA/LSP/5.4-03                   Control of Data

5.5 Equipment

5.5.1       The laboratory is furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests (including sampling, preparation of test items, processing and analysis of test data). The laboratory does not use equipment outside its permanent control.

           5.5.2     Equipment and its software used for testing and calibration are capable of achieving the accuracy required and comply with specifications relevant to the tests concerned. Calibration programs are established for key quantities or values of the instruments where these properties have a significant affect on the results. When received, equipment is checked to establish that it meets the laboratory’s specification requirements, complies with the relevant standard specifications. For all equipments the performance in terms of its calibration /checking is ensured before use.

5.5.3    Equipment is operated by authorized personnel. Up-to-date instructions on the use and maintenance of equipment in the form of operating procedures or relevant manuals provided by the manufacturer of the equipment are readily available for use by the appropriate personnel.

5.5.4    Each item of equipment used for testing is uniquely identified in terms of ID numbers.

5.5.5    Records are maintained of each item of equipment significant to the tests performed.  The records include the following information

a)                      Name of the equipment

b)                     Manufacturer's name, type identification, and serial number or other unique identification;

c)                      Checks that equipment complies with the specification (Range and Accuracy);

d)                     Current location;

e)                      The manufacturer's instructions,  or reference to their location;

 dates, results and copies of reports and certificates of all     calibrations, adjustments, acceptance criteria, and due date of next calibration;

f)                   Maintenance carried out to date and the maintenance plan;

g)                  Damage, malfunction, modification or repair to the equipment.

5.5.6        The laboratory has procedures and has an established plan for safe handling, transport, storage, use and maintenance of measuring equipment to ensure proper functioning and to prevent contamination or deterioration.

5.5.7        Equipment that has either been subjected to overloading or mishandling, or gives suspect results, or has been shown to be defective or outside specified limits, is taken out of service. That equipment is clearly labeled or marked as being out of service and appropriately segregated until it has been repaired and shown by calibration or test to perform correctly. The laboratory examines the effect of the defect or departure from specified limits on previous tests and if required then institutes the "Control of non-conforming work" procedure.

5.5.8    Whenever practicable, all equipment under the control of the laboratory and requiring calibration is labeled, coded or otherwise identified to indicate the status of calibration and the date when recalibration is due.

5.5.9   In case any equipment goes outside the direct control of the laboratory, it is being ensured that the function and calibration status of that equipment is checked and shown to be satisfactory before that equipment to normal operations.

5.5.10 In case intermediate checks are required they are carried out as per defined procedure.

5.5.11 If required, where calibrations give rise to a set of correction factors, the laboratory has procedures to ensure that any copies both in manual and in computer software form are correctly updated.

             5.5.12             Test or calibration equipment, including both hardware and software, are safeguarded from adjustments that otherwise would invalidate the test results.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 5.5-01                  Handling and maintenance of equipments

FEM ANALYTIKA/LSP/ 5.5 -02                 Control and calibration of measuring devices

FEM ANALYTIKA/LSP/5.5-03               Performing intermediate checks for equipment

5.6      Measurement traceability

5.6.1 General

The laboratory has an established program & procedure for the calibration of all equipment used for tests, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test. The management is committed to ensure that all external calibrations will be done through the NABL accredited laboratories providing traceability to national or international standards.

5.6.2 Specific requirements

5.6.2.1 Calibration: The clause is not applicable because the laboratory is not providing any calibration services

5.6.2.2 Testing

5.6.2.2.1     The requirements are applied for testing with measuring functions used. The laboratory ensures that equipment used can provide the accuracy of measurement needed. The equipment used for measuring and tests are periodically calibrated as per the schedule.

5.6.2.2.2    In case where traceability to national or International standard is not practicable the confidence in the analysis is provided by

a)            the use of suitable reference materials certified to give a reliable characterization of the material;

b)            mutual-consent standards or methods which are clearly specified and agreed upon by all parties concerned;

c)            participation in a suitable programme of inter laboratory comparisons or proficiency testing

5.6.2.2.3        The schedule and fixing of calibration due date is based on as per the requirement of analysis and in line with the specific criteria related to testing.

5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards

The laboratory has a programme and procedure for the calibration of its reference standards. Reference standards are calibrated by a body that can provide traceability. Such reference standards of measurement held by the laboratory are used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated. The laboratory intends to calibrate the reference standard before or after any such adjustment.

5.6.3.2 Reference materials

Reference materials, where possible, are traceable to certified reference materials. Internal reference materials are checked as far as is technically and economically practicable. All reference standard and cultures being maintained by the laboratory are traceable to certified reference material or strains.

5.6.3.3 Intermediate checks

Checks needed to maintain confidence in the calibration status of reference, primary transfer or working standards and reference materials are carried out according to schedule.

5.6.3.4 Transport and storage

The laboratory has procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/5.6 – 01            Checking and distribution of calibration certificates

FEM ANALYTIKA/LSP/5.6 - 02             Control of Reference standards and materials.

FEM ANALYTIKA/LSP/5.6 -03              Reference culture maintenance

5.7 Sampling

           5.7.1                 The laboratory has a sampling plan and procedures for sampling when it carries out sampling of substances, matrices, materials or products for subsequent testing. The sampling plan as well as the sampling procedure is available at the location where sampling is undertaken.

5.7.2    Where there are deviations, additions or exclusions from the documented sampling procedure, these are recorded in detail with the appropriate sampling data and included in all documents containing test results, and are communicated to the appropriate personnel.

             5.7.3  The laboratory has procedures for recording relevant data and operations relating to sampling that forms part of the testing that is undertaken. These records include the sampling procedure used, the identification of the sampler, sampling location and environmental conditions, if relevant.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/ 5.7-01                                          Sampling plan and procedure

5.8 Handling of test items

5.8.1    The laboratory has procedures for the transportation, receipt, handling, protection,    retention and/or disposal of test items, including all provisions necessary to protect the integrity of the test items.

5.8.2    The laboratory has a system for identifying test items in terms of providing reference    number. The identification is retained throughout the life of the item in the laboratory. The system is designed and operated so as to ensure that items cannot be confused physically, or when referred to in records or other documents.

5.8.3    Upon receipt of the test item, any abnormalities or departures from normal or specified conditions, as described in the relevant test method, are recorded. When there is any doubt as to the suitability of an item for test, or when an item does not conform to the description provided, or the test required is not specified, in sufficient detail, the laboratory consults the customer for further instructions before proceeding and records the discussion in sample request format.

5.8.4    The laboratory has procedures and appropriate facilities for avoiding deterioration, loss or damage to the test item during storage, handling and preparation. Handling instructions provided with the item are followed. For items that are to be stored under specified environmental conditions, the conditions are maintained, monitored and recorded. As there is a requirement to keep a portion of the test item as a control sample the same is being held secure in control sample room. The samples, for which the complementary tests are performed later, are being kept in separate manner. The arrangements for their storage conditions and security are made in a manner that integrity of the secured items or portions concerned.

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/5.8 - 01                 Handling of test items

FEM ANALYTIKA/LSP/ 5.8 - 02                Identification and Traceability                              

5.9 Assuring the quality of test results

5.9.1        The laboratory ensures the quality of results by monitoring the validity of tests undertaken. This monitoring is planned activity and reviewed in a periodic manner. Keeping in view of the type and volume of the test performed. Statistical techniques are applied as per the requirement of monitoring. Following measures are being adopted in terms of verification practices pertaining to test activities.

a)        Maintaining calibration status of all the equipments

b)       Participation in inter-laboratory comparison or proficiency testing

      programs

c)          Regular use of certified reference materials

d)         Performance of internal quality checks using working standard and cultures.

e)        Replicate tests using the same or different methods

f)        Re-testing of retained items

g)       Correlation of results for different characteristics pertaining to specific test             items.

5.9.2    Quality control data    are analyzed and where they are found to be outside the accuracy criteria, corrective actions are taken to correct the problem and to prevent the incorrect results from being reported.   

DOCUMENTATION AND REFERENCES:

FEM ANALYTIKA/LSP/5.9 – 01           Assuring the quality of test results

5.10 Reporting the results

5.10.1     General

The results of all the tests being carried out by the laboratory are reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test methods.

The results are reported, normally in a test report that include all the information necessary for the interpretation of the test results and required by the method used.

5.10.2    Test reports

                Each test      report includes at least the following information:

a)        A title (e.g. "Test Report).

b)       Name and address of laboratory and location

c)        Unique identification of the test report (such as serial number),

d)       Name & address of the customer

e)        Identification of the method used

f)        Page wise identification in order to ensure that the page is recognized as a part of the test report, and a clear identification of the end of the test report;

g)       Description and unambiguous identification of the item(s) tested.

h)       Date of receipt of test (s) and date(s) of performance of the test

i)         Test results with units of measurement;

j)         Reference to sampling procedure and test method used by the laboratory

k)       Name, function(s) and signature(s) or equivalent identification of person(s) authorizing the test report.

l)         Where relevant, a statement to the effect that the results relate only to the items tested.

5.10.3 Test reports

5.10.3.1  As per customer request, the test report in addition to the requirements listed above contain following information necessary for the interpretation of the test results:

a)          Description and condition of the test item(s);

b)         Identification of the standardized test method(s) used, or  description of any non-standardized method used;

c)          Identification of the standard(s) or specification(s) relevant to the test;

d)         Deviations from, additions to or exclusions from the test method, and information on specific test conditions, such as environmental conditions;

e)          Where relevant, a statement of compliance/non compliance with requirements and/or specifications;

f)          Where appropriate and needed opinions and interpretations;

g)         Where applicable, a statement on the estimated uncertainty of measurement;

h)         Additional information required by specific departments.

5.10.3.2     In addition to the already listed requirements test reports containing the results of sampling includes the following, where necessary for the interpretation of test results:

a)            Date of sampling;

b)            Unambiguous identification of substance, matrix, material or product sampled (including name of manufacturer, model or type of designation and serial numbers as appropriate);

c)            Location of sampling;

d)           Reference to sampling plan used;

e)            Details of any environmental condition during sampling that may affect the interpretation of the test results;

f)             Identification of the sampling method or procedure used;

g)            Standard or other specification for the sampling method or procedure;

h)            Deviations, additions to or exclusions from the specification concerned.

5.10.4 Calibration certificates

Not applicable.

5.10.5 Opinions and interpretations

In general opinions and interpretations are not given on the test report. In case any such need arises the opinion will only be expressed after proper documentation of the bases. Opinion and interpretation will clearly be marked in the reports.

5.10.6 Testing results obtained from subcontractors

Results of tests performed by sub contractors are clearly identified in test report in the form of their respective report numbers.

5.10.7 Electronic transmission of results

The transmission of test report is via soft copy as well as hard copy in a manner to comply the requirements of ISO/IEC 17025:2005.

5.10.8 Format of reports.

The formats are designed to accommodate each type of test carried out and to minimize the possibility of misunderstanding or misuse.

5.10.9 Amendments to test reports.

Amendments to a test report after issue are made only in the form of a further document in the form of supplement statement which includes the statement "Supplement to Test Report serial number”. Such amendments are made in a manner to meet all the requirements of ISO/IEC 17025: 2005

When it is necessary to issue a complete new test report, it is uniquely identified and contains a reference to the original that it replaces.

 

DOCUMENTATION AND REFERENCES

FEM ANALYTIKA/LSP/5.10 – 01                           Reporting of results

  ANNEXURE 05

LIST OF LABORATORY  SYSTEM PROCEDURES
1	FEMANALYTIKA/LSP/4.101	Storage and transmission of data in electronic system
2	FEMANALYTIKA/LSP/4.102	Protection and maintenance of confidentiality,  impartiality and operational integrity
3	FEMANALYTIKA/LSP/4.301	Guidelines for quality system documentation
4	FEMANALYTIKA/LSP/4.302	Control of Documents
5	FEMANALYTIKA/LSP/4.3.03	Change control
6	FEMANALYTIKA/LSP/4.401	Review of requests for testing
7	FEM ANALYTIKA/LSP/ 4.5-01	Subcontracting of test activities
8	FEM ANALYTIKA/LSP/ 4.6 -01	Purchasing of services and supplies
09	FEM ANALYTIKA/LSP/ 4.6 -02	Evaluation, selection and re-evaluation of Suppliers
10	FEM ANALYTIKA/LSP/4.6 -01	Verification of Purchased product
11	FEM ANALYTIKA/LSP/4.7-01	Service to the customer
12	FEM ANALYTIKA/LSP/4.8-01	Dealing with Complaints related to testing
13	FEM ANALYTIKA/LSP/ 4.9-01	Control of Non-conforming work
14	FEM ANALYTIKA/LSP/ 4.11-01	Corrective action
15	FEM ANALYTIKA/LSP/ 4.12-01	Preventive action
16	FEM ANALYTIKA/LSP/ 4.11-02	Conducting additional Audit
17	FEM ANALYTIKA/LSP/ 4.12-01	Preventive action
18	FEM ANALYTIKA/LSP/4.13-01	Control of Records
19	FEM ANALYTIKA/LSP/ 4.14-01	Conducting Internal Audit
20	FEM ANALYTIKA/LSP/ 4.15-01	Management Review
21	FEMANALYTIKA/LSP/5.2-01	Personnel selection, and appraisal
22	FEM ANALYTIKA/LSP/5.2-02	Training needs identification
23	FEM ANALYTIKA/LSP/5.2-03	Imparting of training and subsequent evaluation ( Ref: HRD Manual)
24	FEM ANALYTIKA/LSP/5.3-01	Control of Work Environment
25	FEM ANALYTIKA/LSP/5.4-01	Method validation
26	FEM ANALYTIKA/LSP/5.4-02	Estimation of measurement of uncertainty
27	FEM ANALYTIKA/LSP/5.4-03	Control of Data
28	FEM ANALYTIKA/LSP/ 5.5-01	Handling and maintenance of equipments
29	FEM ANALYTIKA/LSP/ 5.5 -02	Control and calibration of measuring devices
30	FEMANALYTIKA/LSP/5.601	Checking and distribution of calibration certificates
31	FEMANALYTIKA/LSP/5.602	Control of Reference standards and materials.
32	FEMANALYTIKA/LSP/5.603	Reference culture maintenance
33	FEM ANALYTIKA/LSP/ 5.7-01	Sampling plan and procedure
34	FEM ANALYTIKA/LSP/5.8 – 01	Handling of test items
35	FEM ANALYTIKA/LSP/ 5.8 – 02	Identification and Traceability
36	FEM ANALYTIKA/LSP/5.9 – 01	Assuring the quality of test results
37	FEMANALYTIKA/LSP/5.10 – 01	Reporting of results