℮-marked prepackaged products control and monitoring
Post on 22-Feb-2016
54 Views
Preview:
DESCRIPTION
TRANSCRIPT
Organised in co-operation with Serbian Chamber of Commerce
℮℮-marked prepackaged products -marked prepackaged products control and monitoringcontrol and monitoring
Workshop on requirements for prepackaged Workshop on requirements for prepackaged productsproducts
Belgrade, Republic of SerbiaBelgrade, Republic of Serbia - - June 2010June 2010
Workshop on requirements for prepackaged products
e-marked prepackages control
General reasons to make a control
Checking of the actual quantity of product in prepackages is:
important part of compliance testing It is used to facilitate fair trade maintain a competitive marketplace and protect consumers against under-filled
prepackages.
Workshop on requirements for prepackaged products
e-marked prepackages control
e-marked prepackages use average system
contents must comply with three important rules
Workshop on requirements for prepackaged products
e-marked prepackages control
First ruleThe contents of packages must not on
average be less than the amount marked on the label.
This amount is known as the Nominal Quantity. (Qn)
Workshop on requirements for prepackaged products
e-marked prepackages control
Second ruleThe number of prepackages, in a
randomly selected sample, that are under-filled by more than a permitted quantity is less than or equal to a permitted number (not more than 2.5%)These prepackages are known are referred to as ‘defectives.
Workshop on requirements for prepackaged products
e-marked prepackages control
Third ruleNo packages may contain less than the
nominal quantity by more than twice the TNE
TNE – tolerable negative errorThese packages are sometimes referred to as “inadequates”
Workshop on requirements for prepackaged products
e-marked prepackages control
Metrology control
metrology officials are required to check whether prepackages in an inspection lot comply with these requirements by sampling prepackages at the point-of-pack, wholesale outlets and retail stores.
Workshop on requirements for prepackaged products
e-marked prepackages
Directive 76/211/EEC defines „prepackage‟ in article 2 as
being: “the combination of a product and the individual package in which it is prepacked”.
Workshop on requirements for prepackaged products
e-marked prepackages
The Directive also defines when a product is prepacked‟:
a product is prepacked when it is placed in a package of whatever nature without the purchaser being present, and
the quantity of product contained in the package has a predetermined value and cannot be altered without the package either being opened or undergoing a perceptible modification
Workshop on requirements for prepackaged products
e-marked prepackages
Article 1 of the Directive specifies the prepackages that are controlled,
they are prepackages containing products intended for sale in constant unit nominal quantities which are:
equal to values predetermined by the packer, expressed in units of weight or volume, not less than 5 g or 5 ml and not more than 10
kg or 10 l.
Workshop on requirements for prepackaged products
e-marked prepackages
The interpretation generally says that:
prepackages bearing an e-mark shall comply with the Directive
Workshop on requirements for prepackaged products
e-marked prepackages
The Directive states, in article 3, that prepackages may bear the EEC sign or
mark defined if they comply with the requirements of Annex I to the Directive, which covers labelling and quantity requirements.
Workshop on requirements for prepackaged products
e-marked prepackages
The Directive does not restrict the way the prepackages are sold
apply equally to business-to-consumer transactions as well as
business-to-business transactions
Workshop on requirements for prepackaged products
e-marked prepackages
Following prepackages are not considered to be e-marked:
They are weighed out while the purchaser is present, for instance at the delicatessen counter,
are in open packing material, for example a French loaf (baguette)
prepackages not made up to a predetermined quantity and are individually weighed. These prepackages are generally referred to as „catchweight‟ products, and
the marked quantity is outside the above ranges of weight or volume, or is expressed in terms of length, area or number
Workshop on requirements for prepackaged products
e-marked prepackages
Table of tolerable negative errors (tolerances)
Workshop on requirements for prepackaged products
System of prepackages control
Controls are performed by:
Competent departments Packers Importers Surveillance authorities
Workshop on requirements for prepackaged products
System of prepackages control
The supervision of the government is done through:
Controls performed by Competent departments
mostly at packer premises or on the premises of the importer or his agent established in the Community.
Workshop on requirements for prepackaged products
System of prepackages control
Competent department
checks to ensure that prepackages comply with the requirements of the Directive
Workshop on requirements for prepackaged products
System of prepackages control
The checks shall cover the adequacy of the quantity control system
This include: the labeling of the product, the accuracy and suitability of the equipment
and whether it was adequately maintained, the adequacy of the records, and their
accuracy by checking prepackages from the appropriate batch
the quantity in prepackages.
Workshop on requirements for prepackaged products
System of prepackages control
Control frequency
Checks on ‘e’ marked products and the quantity control system used for their production should be carried out at packers’ and importers’ premises generally at least once a year
Workshop on requirements for prepackaged products
System of prepackages control
Control frequency There are various ways of determining the
frequency of visits, which include assessing the number of prepackages, the value of the product packed, the quality system in use and complaints
received, the level of compliance found on visits.
Workshop on requirements for prepackaged products
System of prepackages control
Control frequency However frequency can depend on the risk the business poses and is related to:-
the area of distribution, the value of the product the difficulty of packing, and the result of previous checks, including
quantity control systems audits.
Workshop on requirements for prepackaged products
System of prepackages control
Control frequency A generic risking system is based on the following initial risk and frequency:
sold from packer‟s premises - low risk - every 5 years
regional distribution in a country - medium every 2 years
international distribution - high risk - annually.
Workshop on requirements for prepackaged products
System of prepackages control
Checks are done by means of statistical sampling check carried out in accordance with
the accepted methods of quality acceptance inspection. Its effectiveness shall be
comparable to that of the reference method specified in Annex 1 of Directive 76/211/EEC.
Workshop on requirements for prepackaged products
System of prepackages control
Methodology of testing
destructive testing or non destructive testing
Preferably non destructive tests are used.
Workshop on requirements for prepackaged products
System of prepackages control
Methodology of testing
Destructive testing is carried out only in special cases e.g.: empty wrappings are not available to determine a tare or mass of wrappings vary significantly and consequently the average value is not easy to determine.
Workshop on requirements for prepackaged products
System of prepackages control
Methodology of testingStatistical method of the control generally means that:
the number of samples taken from the butch to be controlled depends on the size of the butch which in practice determined from hourly production of a packing line.
maximum size of a butch is limited to 10 000 pieces. the average value is then corrected by a coefficient
depending on the method of statistic used
Workshop on requirements for prepackaged products
System of prepackages control
Advantages of sampling (statistical method)
Inspection of the sample instead of the total lot
reduction of costspossible choice of “test intensity” by a
suitable operating characteristic
Workshop on requirements for prepackaged products
System of prepackages control
Reference test (Annex II, Dir. 76/211/EEC)Two requirements:REQUIREMENTS FOR MEASURING
THE ACTUAL CONTENTS OF PREPACKAGES
REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES
Workshop on requirements for prepackaged products
System of prepackages control
Measuring the actual contentThe actual contents of prepackages may be measured directly by means ofweighing instruments or volumetric instruments or, in the case of liquids, indirectly, by weighing the prepacked product and measuring its density
Workshop on requirements for prepackaged products
System of prepackages control
Measuring the actual contentThe error made in measuring the actual contents of a prepackage shall not exceed one-fifth of the tolerable negativeerror for the nominal quantity in the prepackage
Workshop on requirements for prepackaged products
System of prepackages control
Checking batchesCarried out by sampling in two parts:
a check covering the actual contents of each prepackage in the sample,
another check on the average of the actual contents of the prepackages in the sample.
Workshop on requirements for prepackaged products
System of prepackages control
Checking batches
A batch of prepackages shall be considered acceptable if the results of both these checks satisfy the acceptance criteria.
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the actual content
The minimum acceptable contents shall be calculated by subtracting the tolerable negative error for the contents concerned from the nominal quantity of the prepackage.
Prepackages in the batch whose actual contents are less than the minimum acceptable contents shall be considered defective.
Workshop on requirements for prepackaged products
System of prepackages control
Non-destructive testing – sampling plan
Workshop on requirements for prepackaged products
System of prepackages control
Destructive testing – sampling planused only for batches of 100 or more
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the average actual contents
A batch of prepackages shall be considered acceptable for the purpose of
this check if the mean value
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the average actual contents
is greater than the value:
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the average actual contents
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the average actual contents
Criteria for acceptance or rejection of the batch of prepackages for checking the mean
Workshop on requirements for prepackaged products
System of prepackages control
Checking of the average actual contents
Criteria for acceptance or rejection of the batch of prepackages for checking the mean
Workshop on requirements for prepackaged products
System of prepackages control
Manufacturer or the importer responsibilities concerning the actual content of the prepackage
The manufacturer or the importer is responsible for ensuring that the prepackages meet the requirements
Workshop on requirements for prepackaged products
System of prepackages control
Importerin case of import from countries outside
the EEA
Workshop on requirements for prepackaged products
System of prepackages control
It means that checks are needed to confirm that the equipment used to make up the prepackages is legal and suitable and that records are available for competent departments to verify Checks shall be so organized so as to effectively guarantee the quantity of product in a prepackage
Workshop on requirements for prepackaged products
System of prepackages control
Measuring
During the filling the actual content of the prepackage is measured by means of a legal and suitable measurement instrument
Workshop on requirements for prepackaged products
System of prepackages control
recognizing procedures Methods of process control shall effectively
ensure that the prepackages meet the requirements.
The determination of whetherthis requirement is met is determined by the competent department based on anevaluation of the procedures.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
The characteristics of filling and packing process are highly dependent upon
the nature of the product which is packed the type of package and the way in which it is filled.
.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
Characteristics such as the average quantity packed, and the variation of the individual packages round this average, give important indications for the quality of the process, and how it should be controlled.
.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
The procedures have to ensure that, through control and correction of the packaging process, the e-marked prepackages that are put on the market satisfy the Directives’ requirements
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
Measurement results must be representative
At least once an hour the average content of the produced prepackages must be determined and evaluated.
The same applies for the number or percentage of prepackages with a content below the TU1 and TU2 limits.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
Identification of variations of the production process
Variations in the filling process that cause repackages to fail to meet the requirements must be identified
In general a deviation must be detected within an hour, since every hour’s production must meet the requirements.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
The measuring and sampling methods A packer must draw a sample of enough items of the
running production on a regular basis. The content of each item in the sample is determined.
Parts of this may be automated (for instance by using a checkweigher).
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitabilitySampling Frequency
The sampling frequency depends on the deviation of the filling process and the number of adjustments, but it should be at least once an hour and after adjustment. In certain situations (for instance bottle filling carousels that can not beadjusted) a lower frequency might be possible.
Checks must be carried out before the prepackages are distributed.
Workshop on requirements for prepackaged products
System of prepackages control
Procedures suitability
Sample sizeThe sample size can be calculated with
following formula
Workshop on requirements for prepackaged products
System of prepackages control
Workshop on requirements for prepackaged products
System of prepackages control
Workshop on requirements for prepackaged products
System of prepackages control
Example:
Workshop on requirements for prepackaged products
System of prepackages control
OverfillThe target quantity (nominal quantity + overfill) should be the greatest of :
the nominal quantityTU1 + 2 x STU2 + 3,72 x S
Workshop on requirements for prepackaged products
System of prepackages control
OverfillThe target quantity (nominal quantity + overfill) should be the greatest of :
the nominal quantity TU1 + 2 x S TU2 + 3,72 x S
If the standard deviation is larger than target quantity – TU1 the standard deviation must be monitored.
Workshop on requirements for prepackaged products
System of prepackages control
Import (from third countries)
The importer has the same responsibilities as a packerbut they may not physically come into contact with theprepackages being imported.
In the case of imports from non-EEC countries, the importer may instead of measuring and checking provide evidence that he is in possession of all the necessary guarantees enabling him to assume responsibility
Workshop on requirements for prepackaged products
System of prepackages control
Import (from third countries)
Acceptable guarantees:
a) evidence from a competent department in a Member State,
b) evidence from an EEA accepted competent department in the exporting country,
c) records of checks carried out by a competent sub-contractor at the place of first entry into the EEA,
d) to obtain records from the packer and to carry out checks to verify the data contained in them.
Workshop on requirements for prepackaged products
System of prepackages control
Import (from third countries)
Evidence shall state that the quantity control system had been assessed and that the controls and records guarantee compliance with the requirements.
Workshop on requirements for prepackaged products
System of prepackages control
Thank you for your attention
Ivan KřížČMI
ikriz@cmi.cz www.cmi.cz
top related