 
Project no.FP6 - 513944
EuroFIR
EUROPEAN FOOD INFORMATION RESOURCE NETWORK
Instrument: Network of Excellence
Thematic Priority: 5 – Food Quality and Safety
D1.3.2 Questionnaire on QA
Due date of deliverable: Month 7
Actual submission date: Month 6
Start Date: 01/01/2005 Duration: 5 years
Instituto Nacional de Saúde Dr. Ricardo Jorge (INSA) – Partner 24
Final
Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006)
|
Dissemination Level (please check appropriate box)
|
PU
|
Public
|
|
PP
|
Restricted to other programme participants (including the Commission Services)
|
X
|
RE
|
Restricted to a group specified by the consortium (including the Commission Services)
|
|
CO
|
Confidential, only for members of the consortium (including the Commission Services)
|
|
EuroFIR WP1.3 “Development of a quality framework for food composition data” Questionnaire for laboratories analysing food products
Name and acronym of the organisation:
Name of the person:
Introduction:
EuroFIR WP1.3 will establish the vital quality infrastructure necessary for the long-term viability of the EuroFIR network. One of the main objectives hereby is to ensure a common understanding and mutual confidence by EuroFIR partners of implemented quality requirements, quality control and quality assurance for food composition data.
EuroFIR WP1.3 developed two questionnaires with the aim of determining currently practised quality activities and aspects by either laboratories or compilers, as well as future required and/or desired quality aspects. This questionnaire has to be filled out by laboratories analysing food products, whereas the other questionnaire has to be filled out by compilers of food composition tables.
On the basis of the outcome of the answers of the two questionnaires WP1.3 will establish quality requirements and guidelines for the quality management systems (QMSs) to be implemented by EuroFIR partners. During month 18 – 60 of the EuroFIR project QMS-presentations by EuroFIR partners are foreseen (within WP1.3) in order to provide confidence that well-established QMSs are implemented according to the elaborated WP1.3 quality requirements and guidelines. With respect to e.g. analysis by laboratories, the quality requirements are already known as these are laid down in ISO/IEC 17025. For this reason the number of questions with regard to analysis aspects is limited. With regard to e.g. sampling and compiling however, no specific norms are yet available. So in these cases it is required to ask more questions in order to make it possible for WP1.3 to draft quality requirements and guidelines. The questionnaires consist of several parts: general questions, questions about sampling, about analysis, about compilation, about the computerized system, about user requirements and opinions, about opportunities and future needs. Most of the questions are ‘yes/no’ questions making it possible to fill out the questionnaire within a limited amount of time.
All EuroFIR partners will be requested to fill out the questionnaire, but the questionnaire is not restricted to EuroFIR partners only. In case for example a non-European food laboratory wishes to fill out the questionnaire, then this would be welcomed very much. In these cases the results will be reported seperately.
Note:
In case your organisation does data compilation and has a computerized system please answer also the questions with regard to these subjects in the questionnaire for compilers.
Good luck filling out the questionnaire(s)!
0.1.1General questions with regard to the quality system |
1.
|
How would you characterise your laboratory (more boxes can be ticked)?
□ as a commercial laboratory (including contract analysis laboratories);
□ as a food research laboratory;
□ as a food company routine laboratory;
□ a government laboratory;
□ an official food control laboratory;
□ other, please specify……….
………………………………….
|
2.
|
Is your laboratory accredited and/or certified?
□ yes
□ no
If yes, by which accreditation and/or certification body:
□ please specify………………………………
and according to which standard(s):
□ ISO/IEC 17025
□ ISO 9001 etc
□ other, please specify………………………
and does the scope for which you are accredited and or certified cover all your food analysis activities?
□ yes
□ no
And if you do not have an accredited or certified quality system, do you have an implemented quality system?
□ yes
□ no
If yes, according to which standard:
□ ISO/IEC 17025
□ ISO 9001 etc
□ other, please specify………………………
In case you are accredited you may skip questions 3 till 9 of this section.
|
3.
|
Is within your laboratory a person appointed who is responsible for the quality management system (such a person is often called quality assurance manager, quality coordinator etc)?
□ yes
□ no
If yes, what is his/her position in the organisation?
□ member management team reporting to director (or equivalent)
□ other, please specify……….
………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
4.
|
Does your laboratory have a quality manual?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
5.
|
Does your laboratory have a quality policy?
□ yes
□ no
If yes, is it documented in the quality manual?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
6.
|
Does your laboratory have a procedure for the handling of complaints made by customers ?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
7.
|
Does your laboratory have a procedure for the handling of non-conforming work?
(Note: a reference to definitions will be included here)
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
8.
|
Are internal audits carried out in your laboratory?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
9.
|
Are yearly management reviews carried out in your laboratory?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
10.
|
Does your laboratory have any difficulty in interpreting ISO/IEC 17025, ISO 9001, GLP or other relevant standards?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
11.
|
Please give your opinion by encircling per item the most appropriate figure
(1-Disagree strongly; 2-Disagree; 3- Neutral ; 4- Agree ; 5- Agree Strongly)
- +
The accreditation/certification process improves our organization 1 2 3 4 5
professionalism
The accreditation/certification process decreases bureaucracy 1 2 3 4 5
The accreditation/certification process contributes to the satisfaction
of users and stakeholders 1 2 3 4 5
|
12.
|
Please encircle per item the most appropriate figure with respect to the present state of implementation of ISO 17025/ISO 9001(1- Still to start; 5 – Fully completed)
ISO/IEC 17025 management requirements 1 2 3 4 5
ISO/IEC 17025 technical requirements 1 2 3 4 5
ISO 9001 requirements 1 2 3 4 5
GLP requirements 1 2 3 4 5
Other QS requirements 1 2 3 4 5
|
13.
|
Do the written instructions and SOP of your laboratory cover the scope of analyses□ yes
□ no
If yes, please copy your list of SOP’s into this questionnaire…….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
14.
|
Does your organisation follow any quality assurance plan for research and development and non-routine analysis?
□ yes ( Please specify ____________________________)
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………………………………………………...
|
15.
|
Please tick the most suitable method(s) for recognition of Quality Management System (more boxes can be ticked)
□ Formal recognition (e.g. National Accredited body like UKAS)
□ Second Party Evaluation (e.g. Peer-Review Experts from EuroFIR)
□ Self-Declaration ( e.g. presentation of Quality Management System to peers)
|
Questions with regard to sampling
|
1.
|
Does your laboratory follow a standard for the sampling of food products (e.g. Codex, ISO/IEC 17025, Southgate, national guidelines, etc.)
□ yes
□ no
If yes, please indicate the standard(s) ……………………….
…………………………………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
2.
|
Is your laboratory accredited and/or certified for this type of sampling activities?
□ yes
□ no
If yes, according to which standard(s) and which food products or analytes?
…………………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
3.
|
Does your laboratory have a requirement to develop a standard operating procedure (SOP) or work instruction (WI) for the sampling of food products?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
4.
|
If question 3 is answered with yes: does the SOP/WI prescribe where (e.g. region, country, city) samples must be collected?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
5
|
If question 3 is answered with yes: does the SOP/WI prescribe when (e.g. season, growth stage) samples must be collected?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
6.
|
If question 3 is answered with yes: does the SOP/WI prescribe or provide evaluation criteria for the number of samples?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
7.
|
If question 3 is answered with yes: does the SOP/WI prescribes, besides the points already mentioned in question 5, more issues with regard to the sampling method?
(e.g. random, selective)
□ yes
□ no
If yes, please specify……………………………..
………………………………………………………
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
8.
|
If question 3 is answered with yes: does the SOP/WI provide requirements for food identification?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
9.
|
Does your laboratory have sampling plans for different kinds of foods?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
10.
|
If question 8 is answered with yes: what are the contents of the sampling plan?
(if possible, please provide an example of a sampling plan):
……………………………………………………………………………………………………………………………………………………………………………………………………..............
|
11.
|
If question 8 is answered with yes: what type of guidelines do you refer to in order to design the sampling plan (internal, (inter)national):
……………………………………………………………………………………………………………………………………………………………………………………………………..............
|
12.
|
Does your laboratory have a SOP/WI for the packaging of sampled food products?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
13.
|
Does your laboratory have a SOP/WI for the sampling equipment to be used?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify
|
14.
|
Does your laboratory have a SOP/WI for the transport of the sampled food products to the laboratory?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
15.
|
Does your laboratory have a SOP/WI for the storage of sampled food products at your laboratory?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
16.
|
Does your laboratory have a SOP/WI for the identification and coding of the samples?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
17.
|
Does your laboratory have a SOP/WI for defining and ensuring homogenisation?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
18
|
Does your laboratory have a SOP/WI for defining and ensuring the stability of sensitive components e.g. treatment with liquid nitrogen?
If yes, which information is noticed on the sampling form (if possible, please provide an example of a sampling form)
…………………………
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
19.
|
Does your laboratory use a sampling form?
□ yes
□ no
If yes, which information is noticed on the sampling form (if possible, please provide an example of a sampling form)
…………………………
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
20.
|
Is personnel trained for the sampling of food products?
□ yes
□ no
If yes, are training records available?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
21
.
|
Does your laboratory carry out any quality control activities in the food sampling chain (from collection to storage)?
□ yes
□ no
If yes, please specify in short these quality control activities:
………………………………………………………………………………………………
………………………………………………………………………………………………
……………………..
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
I In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………
|
22.
|
Are precautions taken in your laboratory to prevent non-intentional losses of labile components, e.g. moisture, several of the vitamins, unsaturated fatty acids, antioxidants during sample collection, handling and storage until analysis?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
23
|
Are precautions taken in your laboratory to prevent contamination from laboratory equipment
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
24.
|
Which are the strengths and weaknesses of sampling routines currently in use for foods in your laboratory?
Strengths, please mention up to 5:
□ ……..
□ ……..
□ ……..
□ ……..
□ ……..
Weaknesses, please mention up to 5:
□ ……..
□ ……..
□ ……..
□ ……..
□ ……..
|
25.
|
How are sample details transferred to analysts and what kinds of data are provided?
……………………………………
|
Questions with regard to analysis
|
Note:
The quality requirements according to ISO/IEC 17025 are applicable and the list of questions is therefore limited to specific matters related to the analysis of food products.
|
1.
|
Does your laboratory have a standard operating procedure (SOP) or work instruction (WI) available for the selection of the appropriate analytical method required for the analysis of a nutrient in a food?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
2.
|
Does your laboratory apply requirements for the time span between sampling and analysis?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
3.
|
Do you consider analyte recovery in your measurements?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
4.
|
Does your laboratory have a procedure for capturing end-user requirements before tests start?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
5.
|
Does your laboratory maintain an audit-trail that would permit a suitably trained and experienced third party to repeat the analysis at a future date?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
6.
|
Does your laboratory also report on the estimation of measurement uncertainty?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
7.
|
With regard to the QA-system of your laboratory:
Does your laboratory follow a system for inclusion of reference materials?
□ yes
□ no
Does your laboratory have any difficulty in traceability of measurements results?
□ yes
□ no
In case yes, please specify for which type of standards, reference materials or others you need guidance ……………………….
………………………………………………………..
Does your laboratory have any difficulty in the calibration of advanced equipment?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
Does your laboratory follow a system for the control of purity and stability of standard solutions and other relevant consumables?
□ yes
□ no
Does your laboratory follow a system for the control of the stability of each analyte during the complete analytical performance, e.g. from homogenisation until analysis including storage conditions (time/temperature)?
□ yes
□ no
|
8.
|
Does your laboratory participate in proficiency testing schemes?
□ yes
□ no
If yes, in which ones?
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
9.
|
Please specify any food composition proficiency testing schemes that you would like to see developed and give a short reason why.
|
10.
|
Do SOPs /WIs cover all food composition analyses carried out by your laboratory?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes □ no
In case yes, please specify ……………………………….....................................................
………………………………………………………………………………………………………
|
11.
|
Please specify any food composition SOP/WI that you would like to see developed and give a short reason why.
………………………………………………………………………….
…………………………………………………………………………
|
Questions with regard to share and common management of equipment, installations, infrastructure
|
1.
|
Does your laboratory have SOP/WI for common rules on utilization and conditions of use of equipment & installations?
□ yes
□ no
If yes, please specify these SOP/WI aspects in short:
………………………………
………………………………
|
2.
|
Does your laboratory require temporary personnel (e.g. students, guestworkers) to have specific training before they are considered qualified to share equipment?
□ yes
□ no
If yes, please specify these SOP/WI aspects in short (please provide a copy):
………………………………
………………………………
|
Questions with regard to opportunities and future needs
|
1.
|
Can you recommend QMS aspects (with regard to e.g. sampling, analysis, exchange training, compiling) that are not covered by this questionnaire, but could be implemented in the current or future situation?
□ yes
□ no
If yes, please specify these QMS aspects in short:
………………………………
………………………………
………………………………
|
EuroFIR WP1.3 “Development of a quality framework for food composition data” Questionnaire for compilers of food composition tables
Name and acronym of the organisation:
Name of the person:
Introduction:
EuroFIR WP1.3 will establish the vital quality infrastructure necessary for the long-term viability of the EuroFIR network. One of the main objectives hereby is to ensure a common understanding and mutual confidence by EuroFIR partners of implemented quality requirements, quality control and quality assurance for food composition data.
EuroFIR WP1.3 developed two questionnaires with the aim of determining currently practised quality activities and aspects by either laboratories or compilers, as well as future required and/or desired quality aspects. This questionnaire has to be filled out by compilers of food composition tables, whereas the other questionnaire has to be filled out by laboratories analysing food products.
On the basis of the outcome of the answers of the two questionnaires WP1.3 will establish quality requirements and guidelines for the quality management systems (QMSs) to be implemented by EuroFIR partners. During month 18 – 60 of the EuroFIR project QMS-presentations by EuroFIR partners are foreseen (within WP1.3) in order to provide confidence that well-established QMSs are implemented according to the elaborated WP1.3 quality requirements and guidelines. With respect to e.g. analysis by laboratories, the quality requirements are already known as these are laid down in ISO/IEC 17025. For this reason the number of questions with regard to analysis aspects is limited. With regard to e.g. sampling and compiling however, no specific norms are yet available. So in these cases it is required to ask more questions in order to make it possible for WP1.3 to draft quality requirements and guidelines. The questionnaires consist of several parts: general questions, questions about sampling, about analysis, about compilation, about the computerized system, about user requirements and opinions, about opportunities and future needs. Most of the questions are ‘yes/no’ questions making it possible to fill out the questionnaire within a limited amount of time.
All EuroFIR partners will be requested to fill out the questionnaire, but the questionnaire is not restricted to EuroFIR partners only. In case for example a non-European food laboratory wishes to fill out the questionnaire, then this would be welcomed very much. In these cases the results will be reported seperately.
Note:
In case your organisation does sampling and/or analysis of food products please answer also the questions with regard to these subjects in the questionnaire for laboratories.
Good luck filling out the questionnaire(s)!
0.1.1General questions with regard to the quality system |
1.
|
How would you characterise your organisation?
□ as a commercial compiler;
□ as a Government organisation;
□ as a part of a university;
□ as a part of a research institute?
□ other, please specify……….
………………………………….
|
2.
|
Is your organisation accredited and/or certified?
□ yes
□ no
If yes, by which accreditation and/or certification body:
□ please specify………………………………
and according to which standard:
□ ISO/IEC 17025
□ ISO 9001 etc
□ other, please specify………………………
and does the scope for which you are accredited and or certified include food analysis?
□ yes
□ no
And if you do not have an accredited or certified quality system, do you have an implemented quality system?
□ yes
□ no
If yes, according to which standard:
□ ISO/IEC 17025
□ ISO 9001 etc
□ other, please specify………………………
In case you are accredited/certified you may skip questions 3 till 9 of this section.
|
3.
|
Is within your organisation a person appointed who is responsible for the quality management system (such a person is often called quality assurance manager, quality coordinator etc)?
□ yes
□ no
If yes, what is his/her position in the organisation?
□ member management team reporting to director
□ other, please specify……….
………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
4.
|
Does your organisation have a quality manual?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
5.
|
Does your organisation have a quality policy?
□ yes
□ no
If yes, is it documented in the quality manual?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
6.
|
Does your organisation have a procedure for the handling of complaints made by customers ?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
7.
|
Does your organisation have a procedure for the handling of non-conforming work?
(Note: a reference to definitions will be included here)
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
8.
|
Are internal audits carried out in your organisation?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
9.
|
Are yearly management reviews carried out in your organisation?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
10.
|
What are the qualifications required for your personnel involved in the compilation process?
………………………………………………………………………………………………………
|
11.
|
Does your organization have any work instruction/standard operation procedure (WI/SOP) on planning and organising training of personnel?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
12.
|
Does your organization participate in any round robin programme or any other kind of scheme to assess the compilation process?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
|
13.
|
Does your organisation have any difficulties in the interpretation of ISO 17025 or ISO 9001?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
14.
|
Please tick the most suitable method(s) for recognition of Quality Management System (more boxes can be ticked)
□ Formal recognition (e.g. National Accredited body like UKAS)
□ Second Party Evaluation (e.g. Peer-Review Experts from EuroFIR)
□ Self-Declaration ( e.g. presentation of Quality Management System to peers)
|
15.
|
Please give your opinion on by encircling per item the most appropriate figure ( 1-Disagree strongly; 2-Disagree; 3- Neutral ; 4- Agree ; 5- Agree Strongly)
- +
The accreditation/certification process improves our organization 1 2 3 4 5
professionalism
The accreditation/certification process decreases bureaucracy 1 2 3 4 5
The accreditation/certification process contributes to the satisfaction
of users and stakeholders 1 2 3 4 5
|
16.
|
Please encircle per item the most appropriate figure with respect to the present state of implementation of ISO/IEC 17025/ISO 9001 (1- Still to start; 5 Fully completed)
ISO/IEC 17025 management requirements 1 2 3 4 5
ISO/IEC 17025 technical requirements 1 2 3 4 5
ISO 9001 requirements 1 2 3 4 5
Other QS requirements 1 2 3 4 5
|
Questions with regard to compilation
|
1.
|
Does your organisation have a standard operating procedure (SOP) or work instruction (WI) for checking “original” data to detect atypical data before their use in the compilation process?
□ yes
□ no
If yes, please briefly describe these checks or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
2.
|
Does your organisation have a SOP/WI for the acceptance of food composition data directly from laboratory?
□ yes
□ no
If yes, please briefly describe the acceptance criteria or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
3.
|
Does your organisation have a SOP/WI for the acceptance of food composition data from literature?
□ yes
□ no
If yes, please briefly describe the acceptance criteria or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
4.
|
Does your organisation have a SOP/WI for the acceptance of food composition data from label information and/or other data from industry?
□ yes
□ no
If yes, please briefly describe the acceptance criteria or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
5.
|
Does your organisation have a SOP/WI for the acceptance of food composition data from other food composition tables?
□ yes
□ no
If yes, please briefly describe the acceptance criteria or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
6.
|
Does your organisation have procedures for the compilation of data from different data sources?
□ yes
□ no
If yes, please briefly describe the procedures or provide copyies of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
7.
|
Does the compilation process include calculation or specific rules to assess compiled data?
□ yes
□ no
If yes, please briefly describe the procedure or provide a copy of this SOP/WI
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
8.
|
Does your organisation have a procedure to validate the final compiled values?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
Questions with regard to the computerized system
|
Note:
The quality requirements according to ISO 9001 are applicable and the list of questions is therefore limited to specific matters related to food composition tables.
|
1.
|
Is the computerized system of your organisation certified?
□ yes
□ no
If yes, according to which standard and by which certification body?
……………………………………………….
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
2.
|
Is your organisation using own developed software for compiling FCDBs?
□ yes
□ no
If yes, is the software validated via a described validation programme?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
3.
|
Does your organisation apply a standard operating procedure describing the contingency plan in the event of partial or total failure?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
4.
|
Is a back-up system for the database installed (in case of disaster)?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
5.
|
Is your organisation using a routine surveillance system to control the data integrity and quality?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
6.
|
Does your organisation maintain an audit-trail with regard to changes of the data in the system?
□ yes
□ no
In case yes, is it maintained:
□ manually
□ automatically
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
7.
|
Are, after modifications of the database, old versions of the database archived?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
8.
|
Is your organisation using a restricted physical security access to the software programmes and data?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
Questions with regard to user requirements and opinions
|
1.
|
Does your organisation request users for feedback about their objective(s) and needs before providing them food composition data?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
2.
|
Does your organisation assess user’s satisfaction?
□ yes
□ no
If no, would you think it will be required in 3-5 years?
□ yes
□ no
In case yes, would you need guidance?
□ yes
□ no
In case yes, please specify ……………………….
………………………………………………………..
|
Questions with regard to opportunities and future needs
|
1.
|
Can you recommend QMS aspects (with regard to e.g. sampling, analysis) that are not covered by this questionnaire, but could be implemented in the current or future situation?
□ yes
□ no
If yes, please specify these QMS aspects in short
…………………
…………………
|
D1.3.2 Page of
Dostları ilə paylaş: |
