Interpretation of requirements reflected in the Aide Memoire
For the assessment of Procurement Agencies
Based on the Model Quality Assurance System1
INSPECTION OF A PROCUREMENT AGENCY
1.
MQAS. WHO TRS 937
Assessment Tool: Procurement Agency. Version 1. 2013.
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Table of contents
1.
2.
3.
4.
5.
6.
Document history
Introduction
Purpose
Scope
Interpretation notes
Revision history
1. Document history
Action
Date
Preparation of first draft
May 2013
2. Introduction
This document reflects common interpretation of the recommendations as listed in the World Health
Organization (WHO) Model Quality Assurance System for Procurement Agencies (MQAS) and the Aide
Memoire used to assess Procurement Agencies. (This harmonized tool (aide memoire) and
interpretation document were developed by a working group consisting of representatives from the
following organizations: QUAMED, PFSCM, UNICEF, MSF, IDA, Crown Agents, GDF, MSH, UNION,
UNOPS, USAID, ICRC and CHMP).
3. Purpose
The interpretation document was developed by the working group with the objective to further
clarify the expectation of what has to be done to satisfy (or what is meant by) the recommendation in
the MQAS and aide memoire, to ensure compliance with the MQAS. The document only reflects on
some important aspects in these documents referred to and does not address all the
recommendations.
4. Scope
The MQAS and aide memoir consist of 6 Modules:
Module I
General requirements for Procurement Agencies
Module II
Prequalification
Module III
Purchasing
Module IV
Receiving and storage
Module V
Distribution
Module VI
Re-assessment
5. Interpretation document
This document attempts to clarify some of the recommendations; or to clarify what is expected from
a PA to achieve the objective of the recommendation in the MQAS.
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Module I: General requirements for Procurement Agencies (PA)
It is expected that a PA should have an infrastructure that supports its activities. That means having
suitable premises; working equipment and furniture; and the necessary transport (self or
contracted) to perform its functions appropriately. The PA must be operating within the provisions
of the national legislation (e.g. licensed). The organization chart, job descriptions, training records
should be current, have sufficient detail, and should be signed and dated.
There should be enough space for orderly storage of documents and products that will prevent loss
of data, prevent mix ups, support cleaning and operations carried out. The environmental conditions
(temperature and relative humidity) should be controlled as required on the labels of the products.
Vehicles should be available and in good conditions if the PA is responsible for delivery / transport of
products
The number of people employed should be sufficient to perform the activities claimed. The
individuals should have qualifications, training and experience in the relevant fields that they are
working in.
Quality assurance, prequalification and purchasing personnel should be independent of one another
to ensure that there is no conflict of interest.
There should be no conflict of interest meaning that any employee should not have any connection,
association, shares or other with a company supplying products to the PA. The code of conduct
prescribes behavior of employees should comply with including ethical and professional conduct.
No person should divulge any confidential information relating to any company or supplier to any
other party
Where computer systems are used for purchasing, stock control, data management, systems should
be followed to ensure authorized access, data integrity, and maintenance. Operators should be
trained according to SOPs and records should be available to show the assessment outcome after
training
The PA should be in good financial standing and must be using legitimate banking procedures and
facilities, with appropriate records in place for accounts, signatures, and financial statements
indicating debits and credits
All PA policies, guidelines, SOPs should be available in paper or electronic copy and accurately reflect
the quality systems. This includes a quality manual, risk management, SOPs, and site layouts.
Where necessary, documents (e.g. SOPs, layouts, job descriptions) should be reviewed for accuracy,
signed and dated by authorized personnel, and be current. Contracts (agreements) must be signed
and dated where activities are delegated to other parties
Relevant records of activities and transactions should be maintained in storage areas (access
controlled, and under appropriate storage conditions to prevent deterioration) for a period that
complies with national legislation
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Module II: Prequalification
When a PA performs prequalification, policies and procedures must be available for the activities
such as products assessment and site inspections
Personnel doing dossier assessments (evaluating data and information) and site inspections
(assessing compliance with GMP) should have qualifications and experience in this, follow SOPs and
remain within the scope of their job descriptions. Assessors of dossiers should communicate points
and information they observe from the dossiers to the inspectors to assist them when they inspect
sites, to verify data and investigate discrepancies. The assessors and inspectors should not be
responsible for purchasing
Module III: Purchasing
Procurement should be done with the aim of purchasing effective, quality assured products, and not
be focused on price alone. The term “procurement” in this Module relates specifically to the
purchase of health sector goods from manufacturers or suppliers. Purchasing should be from reliable
suppliers and transparent purchasing practices should be followed. Products should be selected
from the list/catalog of products (INN) and meet their specifications. Quantification of needs must
be accurate and quantities purchased based on reliable estimates
Once products are supplied, the PA should on a risk based approach – sample products for testing
purposes. Detailed procedures should be implemented for handling any out of specification results.
Other monitoring systems should include investigation of complaints, monitoring of adverse events,
reassessment of products and sites at defined intervals, monitoring of contracts and costs.
Donations should only be accepted if the principles are met as described in the WHO Guideline for
Donations
Module IV: Receiving and storage
Detailed SOPs should be followed for receiving and storage of products. Containers should be
checked and cleaned before taken for storage. Products have to meet their specifications. There
should be sufficient space for orderly storage of products according to their storage conditions
specified on the labels; and allowing cleaning of the areas and ventilation. Stock should be rotated to
ensure that earlier expiry stocks are issued first.
Rodent and pest control should be in place.
Environmental conditions should be monitored e.g. with a minimum maximum thermometer at
regular intervals; or with other suitable devices that will give results of the conditions over a period
of time.
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An appropriate system (e.g. electronic) for stock control should be used for receiving , dispatch,
reconciliation, obsolete materials, recalled products, returned goods, FEFO and waste
Records should be kept showing traceability of all batches of product
Module V: Distribution
The PA (or contracted party) should have a well-managed distribution system meeting the objectives
of ensuring constant supply of quality medicines. Packaging and transport of products must be
controlled to ensure that these are not damaged during transit, and that storage conditions are met
(e.g. including temperature monitors when needed). FMEA can be used in risk assessment exercises
when temperature excursions are noted. Products to be transported in a cold chain need to be
packed in containers with precautions and materials to assist in maintaining the storage conditions.
Products can only be supplied to those who are legally allowed to posses such products
Module VI: Re-assessment
Quality of products and services should be continuously monitored. This process includes reassessment of product data and information, as well as site inspections. If at any time, the PA
establishes that product(s) no longer meet their specifications, procedures should be implemented
to ensure that appropriate action is taken (and may include suspension of products and suppliers; or
withdrawal)
6. Revision history
Date
Version number
Reasons for revision
May 2013
1.2013
Original
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