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Classification of inspectionmarket surveillance items

By Randall Armstrong,2014-03-26 16:52
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Specify which MS actions are specified in your national legal framework: Pre-market requirements as for e.g. EMC for mass production products are using

Questionnaire N? 2 on inspection/market surveillance

Detailed/quantitative information on MS systems at legal, procedural,

    organizational and communication level

    Draft 2

    Completed by or on behalf of:

     Name:

     Entity:

     Title:

     Date of completion:

     What are your responsibilities in relation to market surveillance?:

    2008-07-10 IH draft 2 1/11 Questionnaire 2

    I. Legal approaches in MS actions

    1. What is the legal basis in your country to perform MS actions?

    i. The general product safety legislation

     The references are: ...............................................................

    ii. Other legislation, please explain

     ..............................................................................................

    2. Is there a framework law on MS?

    i. Yes: the reference is…….....................................................

    ii. No we don’t have

    3. What are the sub-laws to structure a MS action?

     The references are:................................................................

    4. Specify which MS actions are specified in your national legal framework:

    i. Inspections

     references:.................................................................

    ii. Inspections and basic testing

     references:.................................................................

    iii. Inspections and 3

    rd party testing

     references:.................................................................

    5. Should the legal field be increased to protect the current state of compliance of

    products?

    i. The legal field is sufficient

    ii. Yes the field should be enlarged/strengthened, explain how

     ..................................................................................

    II. MS procedures/Operational field

    1. Is there a procedure for coordination of MS projects?

     Yes: references..................................................................................

     No

    2008-07-10 IH draft 2 2/11 Questionnaire 2

    2. Do you use 1 procedure per product category?

     Yes: references..................................................................................

     No

    3. Explain how standards are used within a MS project

    4. Do you provide estimates of the measurement uncertainty of a product

    characteristic to be measured?

     NO

     YES, we use following standard/document to determine this:

     ..........................................................................................................

    5. Statistical approach to MS

    Introduction:

    Pre-market requirements as for e.g. EMC for mass production products are

    using statistic techniques (AQL) to control the production output in an attempt

    to ensure that equipment are complying with EMC requirements (e.g. emission

    testing using the 80%/80% (probability) rule)

    Q. Do you think that for safety critical market surveillance actions including

    sampling, we could use:

    - to use no statistical method at all, YES/NO

    - to use the 95%/95% rule YES/NO

    ? to use another approach, please explain:

     .................................................................................................

    Q. Does your national MS database allows the use of statistic analysis’s in time

    (in an endeavour to learn from previous MS projects)

    - we use no MS database

    ? we use a MS database which incorporate data analysis tools, explain which:

     ..................................................................................................

    Q. For which category of equipment on the market do you use a statistical

    approach?

    ? we don’t use a statistical approach

    ? we use following statistical methods for following products:

     ...................................................................................................

    5. Use of risk analysis methods in MS actions

    2008-07-10 IH draft 2 3/11 Questionnaire 2

     we use risk analysis methods in MS actions:

     NO

     YES

     which?: ..................................................................

     Do you think that risk analysis methods have sufficient scientific backing

     to be used for MS purposes?

     YES/NO

     If NO explain why:

     ................................................................................................

6. When no applicable standards are available to be used by the MSA1 there are

    some options which the authority might take e.g. performing a risk analysis

    exercise or using a similar standard.

     Please explain your practice/experience

    we use risk analysis

     we opt to use a similar standard

     we use a different approach, please explain below

7. How do you use pro- and re-active methods in MS activities?

    we use a fixed ratio of pro- and re-active actions

     we opt for a more pro-active approach

     we use a different approach, please explain below

    1 Market Surveillance Authority

    2008-07-10 IH draft 2 4/11 Questionnaire 2

2008-07-10 IH draft 2 5/11 Questionnaire 2

III. Organizational level

    1. What is the annual budget for MS for your administration, for the whole

    country?

    Product category Budget (EURO/year)

    2. Number of staff involved in MS activities

    Product category Number of staff

    3. Is a business plan made?

     YES

    ? for 1 year

    ? for more years

     NO

    4. IT infrastructure

     What are the budget needs (per year) for your IT infrastructure (hard and

     software)

     ...........................EURO

    5. HR development

     Annual budget: .................................EURO

2008-07-10 IH draft 2 6/11 Questionnaire 2

     Areas: i. Research area

     Which areas: ........................................ Budget:...................

    ii. Technical studies

     Which areas: ........................................ Budget:...................

2008-07-10 IH draft 2 7/11 Questionnaire 2

    IV. MS and communication with stakeholders

    1. Describe which procedures you use for the communications with stakeholders

    i. Which stakeholders?

    ii. The budget

    iii. The procedures

    2. Do you (your administration) participate in standardization work?

     Please provide details:

    Area TC or WG Standardization Kind of

    organization participation2

    3. Involvement of CABs in MS activities?

    ? No, there is no involvement

    ? Yes, there is involvement but limited

    ? Yes, there is important involvement

     describe: ...............................................................

2 Active or passive

    2008-07-10 IH draft 2 8/11 Questionnaire 2

    V. Coordination issues

    1. Is your administration involved incoordinated actions with other national

    entities?

     NO

     YES Which? Product category

    2. Is your administration involved in coordinated MS actions with other countries

    (regional level) or internationally?

     NO

     YES Which? Product category

    3. What is the budget allocated for above mentioned coordination actions?

    4. What methods do you use in order to avoid the overlap phenomenon in MS

    activities?

    5. What methods of transparency do you use in MS activities? (e.g. do you think

    that the results of MS activities should be published?)

2008-07-10 IH draft 2 9/11 Questionnaire 2

    VI. Approach to MS for certain product families

     Electrical/electronic products

    1. What are the methods employed to monitor the compliance of products on the marketplace

    ? Annual plans

    ? Purchase of products from the marketplace to test their conformity ? Sampling from manufacturing premises ? Consumer complaints

    ? Economic operator complaints ? Others Which?

    2. What are the organizations involved in the activities mentioned in the previous

    question?

    ? The responsible authority for MS of electrical products

    ? Local government bodies

    ? Organizations authorized by the responsible authority

    ? Others Which?

    3. What are the possible corrective actions taken by the manufacturers if their

    products have been found to be not in compliance with the requirements during

    the MS activities?

    ? Withdrawal of the products from the market ? Recall of the products from consumers/users ? Repair of the products

    ? Others Which?

    ? N/A

    4. What is the range of penalties for products not in compliance with the

    requirements?

    5. What is the estimated annual budget for market surveillance activities

    mentioned in question 1 above?

    6. How is the awareness of consumers about the regulatory requirements for

    electrical and electronic products?

    2008-07-10 IH draft 2 10/11 Questionnaire 2

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