is accreditation expensive? a paper presentated to the test and measurement conference and

IS ACCREDITATION EXPENSIVE?

A PAPER PRESENTATED TO THE TEST AND MEASUREMENT CONFERENCE AND

WORKSHOP, 07 -10 NOVEMBER,2010, DRAKENSBERG-SOUTH AFRICA BY DOMINIC H MWAKANGALE DIRECTOR OF TESTING ,CALIBRATION AND PACKAGING SERVICES TANZANIA BUREAU OF STANDARDS

PRESENTATTION PLAN

1. INTRODUCTION2. WHAT IS ACCREDITATION3. WHY IS TECHNICAL COMPETENCE SO CRITICAL4. HOW DOES THE GOVERNMENT AUTHORITIES BENEFIT

FROM ACCREDITATION5. STRATEGIC PLAN ON ACCREDITATION IN TANZANIA6. GAP ANALYSIS FINDINGS7. ACHIEVEMENTS8. CHALLENGES FACED BY LABORATORIES9. SUPPORT FROM SADC/EU PROJECT

PRESENTATTION PLAN

7. TYPICAL ACCREDITATION COSTS8. IS ACCREDITATION EXPENSIVE?9. CONCLUSION

INTRODUCTIONTanzania is one of many countries, which exports her products at

regional and international level. As an exporting country it has to prove that a particular product complies with the prescribed

technical regulations, standard or testing and certification procedures.

In Tanzania, accreditation concept was conceived about ten years ago but the response has been slow due to the fact that the concept is new to many of the stakeholders. Another fact is that accreditation process requires a lot of resources like human, financial, equipment and other related infrastructures. To maintain such resources political will is required.

However, the trade barrier on the fish fillets exports to the European union imposed to the country ten years ago prompted the government and authorities to consider the importance of conformity assessment bodies.

Today accreditation is one of the components of the government trade policy.

MAP OF TANZANIACapital Dodoma

Largest city Dar es Salaam

Official language(s)Swahili (de facto)English (Higher courts, higher education)

Area

- Total945,203 km2 (31st)364,898 sq mi

- Water (%) 6.2

Population

- 2009 estimate 43,739,000[(30th)

- 2005 census 37,445,392

- Density46.3/km2 (124th)119.9/sq mi

GDP (PPP) 2009 estimate

- Total $57.400 billion

- Per capita $1,416

GDP (nominal) 2009 estimate

- Total $22.318 billion

- Per capita $550

ACCREDITATION

Accreditation is defined as the procedures by which an authoritative body gives formal recognition that a body or a person is technically competent to carry out specific tasks

Accreditation confirms

COMPETENCE

WHAT ARE THE FIVE COMPITENCES

The five Competences focused during theaccreditation process are:1. PERSONNEL2. METHODS3. EQUIPMENT4. MEASUREMENT TRACEABILITY5. ENVIRONMENT

ACCREDITATION IS BASED ON COMPETENCE

Criteria for competence is based on

Validated Methods, known measurement relationship(standards, inter-comparisons)

ISO/IEC 17025 Contains System Elements and Technical Elements

ACCREDITATION ASSESSMENT

An Accreditation assessment Team will assess to the Accreditation Schedule and confirm whether the system is implemented as per ISO/IEC 17025 and can support the competency aspects to ensure maintenance and sustainability of the laboratory`s ability to generate results in accordance with the accreditation schedule.

WHY IS TECHNICAL COMPETENCE SO CRITICAL?

Avoid Expensive Retesting Testing and/or inspection of products and

materials are expensive and time consuming.

If not done correctly, then the cost and time involved in re-testing and/or inspection can be even higher if the product has failed to meet specifications or expectations.

WHY IS TECHNICAL COMPETENCE SO CRITICAL? CRITICAL?

Minimise Risk Customers seek reassurance that products,

materials or services they produce or purchase meet their expectations or conform to specific requirements.

For the manufacturer or supplier, choosing a technically competent conformity assessment body minimises the risk of producing or supplying a faulty product.


Enhance Customer Confidence Confidence in a product is enhanced if clients

know it has been thoroughly evaluated by an independent, competent conformity assessment body.

This is particularly so if it can demonstrated that the conformity assessment body itself has been evaluated by a third party.


Reduce Costs and Improve Acceptance of Goods Overseas

Through a system of international agreements technically competent, accredited facilities receive a formal international recognition.

This recognition allows their data to be more readily accepted on overseas markets.

This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in the importing country.

HOW DOES USING AN ACCREDITED FACILITY BENEFIT GOVERNMENT AND REGULATORS?

Government bodies and regulators are constantly called upon to make decisions related to:

Protecting the health and welfare of consumers and the public

Protecting the environment Developing new regulations and requirements Measuring compliance with regulatory and legal

requirements Allocating resources, both technical and financial Government bodies and regulators have confidence in data

generated by accredited facilities to make their decisions.

STRATEGIC PLAN ON ACCREDITATION IN TANZANIA

In the year 2003, a strategic plan on accreditation of laboratories was initiated in Tanzania and received a support from DANIDA through a project on “ Product Quality Improvement ” The project focused on Food Laboratories preparing for accreditation and support conformity assessment infrastructure. The project ran for five years from July 2003 to June 2008.

The project was tasked with the assessment of critical needs and identifying problems hindering laboratories in achieving accreditation status and subsequently develop recommendations for laboratory support, training and strategic plans to ensure that laboratories are accredited to ISO/IEC 17025- General requirements for the competence of testing and calibration laboratories.

STRATEGIC PLAN ON ACCREDITATION IN TANZANIA

Export is critical to the growth of Tanzania economy. One of the basic requirements to be a qualified as an exporting country is being fulfilled at the laboratory level and therefore laboratories accreditation program is given a high priority.

SENSITIZATION SEMINARS

Tanzania Bureau of Standards(TBS) initiated a non-stop training workshops on Quality management, Quality assurance and Accreditation concepts to various sectors of the economy in the country as a way of creating Quality Awareness since 2003 .

The consequences to the quality awareness seminars prompted various laboratories to seek for accreditation.

SENSITIZATION SEMINARS The sensitization seminars targeted the followinggroups:1. Policy makers2. Chambers of commerce3. Confederation of Tanzania Industries4. Parastatal Organizations and Private Industries5. Testing and Calibration Laboratories6. Certification Bodies7. Inspection Bodies8. Tertiary Institutions9. Media people

GAP ANALYSIS FINDINGSHUMAN RESOURCE Many of the Laboratories surveyed, were endowed with core

technical human resource outlay possessing basic training in respective professional fields including scientists of higher degrees, technologists and technicians.

To achieve accreditation each laboratory showed a need of personnel training in general requirements of ISO/IEC 17025,method validation, calculation of uncertainty of measurements and other specific skills .

To date more than 200 personnel have been trained to ISO/IEC 17025.

GAP ANALYSIS FINDINGS

EQUIPMENTGood distributions of “state of the art”laboratory equipment existed amongstmost of the laboratories.

Laboratories had been trying to meet theirneeds through their own set budgets andthrough development partner's supports.

ACHIEVEMENT

Currently, Tanzania has seven laboratories beenaccredited to ISO/IEC17025 as follows:1. TBS Metrology Laboratory in December,20062. TBS Food Microbiology Lab. in December,20073. Fisheries Microbiology Lab. in January,20084. TIRDO Microbiology Lab. in 20085. SGS Environment Lab. in 20086. TBS Chemistry Lab in April,20097. TBS Condom Lab. in June,2009

INCOME GENERATED

0.00

20,000,000.00

40,000,000.00

60,000,000.00

80,000,000.00

100,000,000.00

120,000,000.00

140,000,000.00

2006 2007 2008 2009 2010

YEAR

TS

H FOOD LABORATORY

METROLOGY LABORATORY

PERIOD IN YEAR

FOOD LABORATORY


2006 46,232,575.00 34,404,000.00 2007 72,317,800.00 50,075,301.00 2008 116,662,300.00 58,678,923.00 2009 123,106,000.00 108,078,751.00 2010 56,569,000.00 53,466,483.00

NOTE: THE INCOME FOR 2010 COVERS FROM IS FROM 01 JULY, TO 30 SEPTEMBER, 2010

SAMPLE

0

200

400

600

800

1,000

1,200

1,400

1,600

YEAR

NU

MB

ER

OF

SA

MP

LE

TE

ST

ED

/CA

LB

RA

TE

D

FOOD LABORATORY


PERIOD

JULY/JUNE

NUMBER OF SAMPLE

TESTED

NUMBER OF EQUIPMENT CALIBRATED

2003/2004 1,317 299 2004/2005 1,206 513 2005/2006 1092 786 2006/2007 394 641 2007/2008 1425 1146 2008/2009 1350 1390 2009/2010 1,485 1192

NOTE: SAMPLES RECEIVED IN 2010 ARE FROM 01 JULY, TO

30 SEPTEMBER, 2010

CHALLENGES FACED BY LABORATORIES

Most of the laboratories do not have all the required reference materials to be able to check the competence of their personnel and equipment performance.

Certified reference materials are expensive to procure and very few laboratories can afford them.

In case of microbiological (organisms) it is more difficult to obtain due to procedures put by providing bodies because of the possibilities of microorganism being used as biological weapons.

CHALLENGES FACED BY LABORATORIES

FINANCIAL CONSTRAINTS. Laboratories do not have adequate equipment to

meet their scope of work.

After acquiring new piece of Equipment maintenance and service is a problem with regards to availability of spare parts and technical know how.

Accreditation cost is considered to be very high. Many laboratories lack adequate training on some

specific skills i.e. measurement uncertainties, method validation, evaluation of results and assessments.

SUPPORT FROM SADC/EU PROJECT

Since the start of the SADC EU PE 2 which started on 1 June2009 SADCMET Secretariat in collaboration with the SADC/EUTA Team has carried out a number of activities as follows: Activity 3103: Advanced training on length presented by NMISA

from 15-19 February 2010 and attended by 17 participant Activity 3110: Calculation of measurement uncertainty presented

by NLA from 3-7 August 2009 and attended by 23 participants Activity 3202: Awareness training on ISO/IEC 17025 presented by

SANAS from 10-14 August 2009 held in and participated by 24 technical staff and 16 quality managers from 13 countries.


Activity 3203: Technical training on ISO/IEC 17025 specifics including traceability, calibration intervals, estimation of uncertainty (Using model of technical assessors) presented by SANAS from 26-30 October 2009 held in Botswana and attended by 44 participants from 13 countries.

Activity 3204 Part a: Write QMS and submit to the SADCMET Secretariat for review – received QMS from 6 NMIs of which 5 have been recommended to apply for accreditation through SADCAS.


Activity 3206: Coaching for the preparation of documentation for the QMS presented by SANAS from 26-30 October 2009 and participated by 26 quality managers.

Activity 3301(a): Workshop on calculating CMCs with two experienced mentors for length and temperature participants presented by NMISA from 2-6 November 2009 and attended by 16 participants


Activity 3301(b): Workshop on calculating CMCs with two experienced mentors for Mass, Volume and Length participants presented by NMISA from 28 Sept –3 October 2009 and attended by 15 participants

Activity 3302: Establish database on regional CMCs and upload on SADCMET website

SUPPORT FROM SADC/EU PROJECT ON ACCREDITATION

TRAINING ISO/IEC 17025/17020/17021 ISO 15189 Technical and Lead Assessor Train of the TrainerATTACHMENTS SADCAS staff at SANAS On-site evaluation of assessors


After the review of quality manuals and procedures submittedby all the SADC NMIs, five of the twelve NMIs qualified to beassessed for their readiness to achieve ISO/IEC 17025accreditation in the following parameters: Country Parameter1. Botswana Temperature and Dimensional2. Seychelles Mass3. Mauritius Dimensional and Temperature4. Tanzania Dimensional5. Zimbabwe Temperature, Dimensional and Volume

TYPICAL ACCREDITATION COSTSTypical Accreditation costs are categorized asfollows:( SADCAS Accreditation Costs) Application Fee

– Includes one document review– Paid with submission of application documents– Non refundable if applicant withdraws– Approximately BWP 4 100

Initial Accreditation Fee– Initial assessment fee based on two assessor man

days approximately BWP 20 000– Assessor travel and subsistence costs also billed

TYPICAL ACCREDITATION COSTS

Annual Accreditation Fee– Based on 2 assessor units– Estimated at BWP11 600 for 2009– Additional assessor units will be charged at BWP

3 600 per assessor unit– Assessor unit is one visit by one assessor for one

day or part thereof

CONCLUSION

IS ACCREDITATION EXPENSIVE? From my presentation we can deduce that it is

the cost for putting the Management System in place which is expensive NOT the cost for the Accreditation Process.

It should also be borne in mind that even if the conformity assessment body is not applying for Accreditation, it has to have a system in place in order to compete in the competitive market.

CONCLUSION

IS ACCREDITATION EXPENSIVE?

ACCREDITATION IS NOT EXPENSIVE WHAT IS EXPENSIVE IS PUTTING AND SUPERVISING THE MANAGEMENT SYSTEM IN PLACE.

is accreditation expensive? a paper presentated to the test and measurement conference and

Documents

accreditation concept

accreditation schedule

accreditation assessment

technical competence

government trade

competence criteria

system elements

government authorities