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ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 1 of 24
QUESTIONNAIRE FOR SK INSPECTORS – 2013 Table 1 – GENERAL DATA
Inspector’s name / nickname / code ETR
Questionnaire number / code ETR-1
I would like to be acquainted with all output documents of the project: YES
I would like to participate in the project (to attend the discussions, etc.): NO
Table 2 – ASSESMENT OF FPC ASPECTS ACCORDING TO ANNEX E
Annex E Aspect NC
2.1
General
The FPC shall be operated according to a documented quality system. The manufacturer shall establish, document and maintain the FPC system to ensure that the products placed on the market comply with the declared performance of the characteristics. The records must be kept at least for a period of 3 years. All quality documentation shall be kept up to date.
OK
2.2
Responsibility and authority
The responsibility, authority, and the interrelationships between all personnel who manage, perform, or verify work affecting quality or product conformity, shall be defined. This applies particularly to personnel who need the organizational freedom and authority to:
a) Identify procedures to demonstrate conformity of the product at appropriate stages b) Initiate action to prevent the use and production of non-conforming product
c) Identify and record any product quality problems or non-conformities
OK
2.3
Management and representative for the FPC
At every place of production, a representative with the appropriate knowledge and production experience shall be appointed by the manufacturer and given responsibility for managing and supervising of the FPC procedures and for ensuring that the requirements of this annex are implemented and maintained
OK
2.4
Quality and Objectives
Top management shall ensure that quality objectives regarding the production process are established at relevant functions and levels within the organization. The quality objectives shall be measurable.
At least one example of a quality objective could be to lower the number of non-conforming products from year to year.
OK
2.5
Management review
Management shall review at least every year the FPC system to ensure its continuing suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The minimum input for management review shall be at least related to the conformity of the product and include the following:
a) Status of corrective and preventive actions b) Status of complains c) Follow up from previous management reviews d) Follow up of quality objectives e) Results of audits
OK
2.6
Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity.
Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 2 of 24
Annex E Aspect NC
3
Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items:
a) Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity;
b) Procedures for specifying and verifying the raw materials and other constituent materials;
c) Manufacturer’s production control and other techniques, processes and systematic actions that will be used;
d) Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures;
e) Procedures for handling, storage, packaging, marking and labelling the product; f) Procedures for all personnel to receive training in the activities affecting quality or
conformity of the product g) A procedure that will specify how non-complying products shall be dealt with. Any event
of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.
h) A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence.
i) A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
j) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.
OK
4.1
Inspection and testing - General
All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for control, calibration, and maintenance of testing, measuring, and inspection equipment, whether owned by or on loan to the manufacturer or a subcontractor.
Inspection and testing shall be performed by personnel qualified for such tasks on the basis of documented appropriate education, training and/or experience.
OK
4.2
Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall be performed using appropriate testing equipment and documented working instructions.
The test equipment shall be controlled regularly by calibration or verification following the manufacturer’s own instructions.
OK
4.3
Inspection and testing of raw materials and other constituent materials
The manufacturer shall ensure that raw materials and other constituent materials conform to his specified requirements. In determining the checks necessary consideration shall be given to the control exercised by the supplier and the documented evidence of conformity supplied (often referred to as supplier certified components or certified raw materials). There should be a proper traceability to the supplier’s documentation.
This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall be recorded:
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 3 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Pipe
Visual check and documentation check
No damage Each delivery
Measurement Purchase specification: pipe dimensions within tolerance
Each delivery (1)
Absorber sheet
Visual inspection No damage
Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
Absorber
Visual inspection No damage Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
and proper connection between absorber sheet and
pipes (this may be a mechanical test also)
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Pipe grid
Visual inspection No damage Each delivery
Document check
Purchase specification
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Reflector material,
reflector shape (if the finished
reflector is delivered)
Document check or direct test for shape (eg: master
shape )
Purchase specification: Solar reflectance, shape
Each delivery (document check) or less frequency
if it is tested
Heat pipes
Test for check performance (may be done by heat pipe
manufacturer)
Purchase specification Variable
Glass tubes(assembly of absorber and
glass cover)
Specific test method Purchase specification Variable
Glazing
Measurement
Purchase specification: dimensions and optical
characteristics(solar transmittance) Each delivery (1)
Document check or direct test
If only a document check is done, then there must be a
special agreement to assure optical characteristics
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 4 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Insulation
Visual Damage Each delivery
Document check Purchase specification:
density and thermal conductivity
Each delivery
Weight measurement
Manufacturer’s method
Each delivery (1)
Dimension measurement
Outgasing test (only for flat plate collectors)
Casing
Material of frame elements
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Material of rear panel
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Hydraulic connections
Visual Check
Measurement (verify product is inside
tolerance)
Purchase specification Each delivery (1)
Sealant Documentation and Visual check
Purchase specification Each delivery (1)
1
4.4
Inspection and testing during manufacture and on finished product
In order to manufacture products which conform to the product standard the manufacturer shall control his process and perform inspection and tests as described in his manual, and complying at least with the following table.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 5 of 24
Annex E Aspect NC
4.4
Process Method Requirement Frequency
Cutting of pipe Measurement Manufacturer
specification for dimensions
At the beginning of each
production order (2)
Cutting of absorber sheet
Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Cutting of frames Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Connection of pipe to absorber
Visual
Proper welding
Each absorber
(Recommended but not obligatory) mechanical test with manufacturer’s method
Manufacturer’s specification
Absorber Visual check No damage Each absorber
Reflector material Visual
No damage Each collector
Assembly Visual Proper assembly Each collector
Sealing Visual Proper sealing Each collector
Leakage Manufacturer method for pressure test
Manufacturer method Each collector
Release of each collector
Visual or manufacturer’s method
Manufacturer method Each collector
OK
4.3 & 4.4
Note 1: In this case, the frequency of checks may be decreased in result of reliability of the supplier (ISO 9001 certificate etc.) and history of deliveries (no complains, no non-conformities). In this case a written procedure shall exist, describing the rules for decreasing the frequency and return to full-check in case of non-conformities.
OK
4.5
Inspection and test records
The results of products inspection and testing shall be recorded
The record shall contain the product identification, the date and time of manufacture and for each property the test methods, the test results, the inspection result and the identification of the person carrying out the inspection.
OK
5
Actions in the case of non-conforming products
If the result of a test or the inspection of a product is a failure, the manufacturer shall immediately take the steps necessary to rectify the deficiency. Products which do not conform to the requirements of the product standard, shall be marked, isolated or controlled accordingly. When the deficiency has been identified and rectified, the test or inspection in question shall be repeated without delay accordingly to the quality documentation, to provide the evidence that the defects have been overcome. Corrective and preventive actions taken in case of non-conforming products shall be documented.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 6 of 24
Annex E Aspect NC
6
Handling, storage, packaging and marking of products
In accordance with the quality documentation the manufacturer shall:
a) Provide methods of handling that prevent damage or deterioration; b) Provide suitable storage areas or stock rooms or prevent damage or deterioration of the
product;
c) Control the packaging, storage and the marking processes
OK
7
Traceability of products
Individual collectors and their main components (if applicable) (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes) shall be identifiable and traceable with regard to their production origin.
2
8
Internal audit
The organization shall conduct internal audits at planned intervals of at least once a year to determine whether the quality management system
a) Conforms to the quality documentation b) Is effectively implemented and maintained
In case of internal audit, an audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A document procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained.
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow up activities shall include the verification of the actions taken and the reporting of verification results.
OK
Table 3 – DESCRIPTION OF NON-CONFORMITIES AND COMMENTS
Non conformities Comments
1 Regarding the insulation of the HS deposits: a) No periodic monitoring of injected polymer mass are presented. b) Contrary to the IT03 (Rev.2) polymer injection, it appears that you are operating at 21 ° C when the instruction given as working range 22 º C-25 º C.
A small company which grew up very fast. Production responsible has no time to check everything and forgot it.
2 There is no traceability procedure for the main raw materials for the production of the collectors and HS deposits.
A small company which grew up very fast. Production responsible has no time to check everything and didn’t introduce traceability because of lot of work.
///End of the questionnaire
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 7 of 24
QUESTIONNAIRE FOR SK INSPECTORS – 2013 Table 1 – GENERAL DATA
Inspector’s name / nickname / code ST
Questionnaire number / code ST-1
I would like to be acquainted with all output documents of the project: YES
I would like to participate in the project (to attend the discussions, etc.): NO
Table 2 – ASSESMENT OF FPC ASPECTS ACCORDING TO ANNEX E
Annex E Aspect NC
2.1
General
The FPC shall be operated according to a documented quality system. The manufacturer shall establish, document and maintain the FPC system to ensure that the products placed on the market comply with the declared performance of the characteristics. The records must be kept at least for a period of 3 years. All quality documentation shall be kept up to date.
OK
2.2
Responsibility and authority
The responsibility, authority, and the interrelationships between all personnel who manage, perform, or verify work affecting quality or product conformity, shall be defined. This applies particularly to personnel who need the organizational freedom and authority to:
d) Identify procedures to demonstrate conformity of the product at appropriate stages e) Initiate action to prevent the use and production of non-conforming product
f) Identify and record any product quality problems or non-conformities
OK
2.3
Management and representative for the FPC
At every place of production, a representative with the appropriate knowledge and production experience shall be appointed by the manufacturer and given responsibility for managing and supervising of the FPC procedures and for ensuring that the requirements of this annex are implemented and maintained
OK
2.4
Quality and Objectives
Top management shall ensure that quality objectives regarding the production process are established at relevant functions and levels within the organization. The quality objectives shall be measurable.
At least one example of a quality objective could be to lower the number of non-conforming products from year to year.
1
2.5
Management review
Management shall review at least every year the FPC system to ensure its continuing suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The minimum input for management review shall be at least related to the conformity of the product and include the following:
f) Status of corrective and preventive actions g) Status of complains h) Follow up from previous management reviews i) Follow up of quality objectives j) Results of audits
2
2.6
Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity.
Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required.
3
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 8 of 24
Annex E Aspect NC
3
Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items:
k) Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity;
l) Procedures for specifying and verifying the raw materials and other constituent materials;
m) Manufacturer’s production control and other techniques, processes and systematic actions that will be used;
n) Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures;
o) Procedures for handling, storage, packaging, marking and labelling the product; p) Procedures for all personnel to receive training in the activities affecting quality or
conformity of the product q) A procedure that will specify how non-complying products shall be dealt with. Any event
of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.
r) A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence.
s) A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
t) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.
4
4.1
Inspection and testing - General
All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for control, calibration, and maintenance of testing, measuring, and inspection equipment, whether owned by or on loan to the manufacturer or a subcontractor.
Inspection and testing shall be performed by personnel qualified for such tasks on the basis of documented appropriate education, training and/or experience.
OK
4.2
Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall be performed using appropriate testing equipment and documented working instructions.
The test equipment shall be controlled regularly by calibration or verification following the manufacturer’s own instructions.
OK
4.3
Inspection and testing of raw materials and other constituent materials
The manufacturer shall ensure that raw materials and other constituent materials conform to his specified requirements. In determining the checks necessary consideration shall be given to the control exercised by the supplier and the documented evidence of conformity supplied (often referred to as supplier certified components or certified raw materials). There should be a proper traceability to the supplier’s documentation.
This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall be recorded:
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 9 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Pipe
Visual check and documentation check
No damage Each delivery
Measurement Purchase specification: pipe dimensions within tolerance
Each delivery (1)
Absorber sheet
Visual inspection No damage
Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
Absorber
Visual inspection No damage Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
and proper connection between absorber sheet and
pipes (this may be a mechanical test also)
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Pipe grid
Visual inspection No damage Each delivery
Document check
Purchase specification
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Reflector material,
reflector shape (if the finished
reflector is delivered)
Document check or direct test for shape (eg: master
shape )
Purchase specification: Solar reflectance, shape
Each delivery (document check) or less frequency
if it is tested
Heat pipes
Test for check performance (may be done by heat pipe
manufacturer)
Purchase specification Variable
Glass tubes(assembly of absorber and
glass cover)
Specific test method Purchase specification Variable
Glazing
Measurement
Purchase specification: dimensions and optical
characteristics(solar transmittance) Each delivery (1)
Document check or direct test
If only a document check is done, then there must be a
special agreement to assure optical characteristics
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 10 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Insulation
Visual Damage Each delivery
Document check Purchase specification:
density and thermal conductivity
Each delivery
Weight measurement
Manufacturer’s method
Each delivery (1)
Dimension measurement
Outgasing test (only for flat plate collectors)
Casing
Material of frame elements
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Material of rear panel
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Hydraulic connections
Visual Check
Measurement (verify product is inside
tolerance)
Purchase specification Each delivery (1)
Sealant Documentation and Visual check
Purchase specification Each delivery (1)
OK
4.4
Inspection and testing during manufacture and on finished product
In order to manufacture products which conform to the product standard the manufacturer shall control his process and perform inspection and tests as described in his manual, and complying at least with the following table.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 11 of 24
Annex E Aspect NC
4.4
Process Method Requirement Frequency
Cutting of pipe Measurement Manufacturer
specification for dimensions
At the beginning of each
production order (2)
Cutting of absorber sheet
Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Cutting of frames Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Connection of pipe to absorber
Visual
Proper welding
Each absorber
(Recommended but not obligatory) mechanical test with manufacturer’s method
Manufacturer’s specification
Absorber Visual check No damage Each absorber
Reflector material Visual
No damage Each collector
Assembly Visual Proper assembly Each collector
Sealing Visual Proper sealing Each collector
Leakage Manufacturer method for pressure test
Manufacturer method Each collector
Release of each collector
Visual or manufacturer’s method
Manufacturer method Each collector
OK
4.3 & 4.4
Note 1: In this case, the frequency of checks may be decreased in result of reliability of the supplier (ISO 9001 certificate etc.) and history of deliveries (no complains, no non-conformities). In this case a written procedure shall exist, describing the rules for decreasing the frequency and return to full-check in case of non-conformities.
OK
4.5
Inspection and test records
The results of products inspection and testing shall be recorded
The record shall contain the product identification, the date and time of manufacture and for each property the test methods, the test results, the inspection result and the identification of the person carrying out the inspection.
5
5
Actions in the case of non-conforming products
If the result of a test or the inspection of a product is a failure, the manufacturer shall immediately take the steps necessary to rectify the deficiency. Products which do not conform to the requirements of the product standard, shall be marked, isolated or controlled accordingly. When the deficiency has been identified and rectified, the test or inspection in question shall be repeated without delay accordingly to the quality documentation, to provide the evidence that the defects have been overcome. Corrective and preventive actions taken in case of non-conforming products shall be documented.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 12 of 24
Annex E Aspect NC
6
Handling, storage, packaging and marking of products
In accordance with the quality documentation the manufacturer shall:
d) Provide methods of handling that prevent damage or deterioration; e) Provide suitable storage areas or stock rooms or prevent damage or deterioration of the
product;
f) Control the packaging, storage and the marking processes
OK
7
Traceabilty of products
Individual collectors and their main components (if applicable) (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes) shall be identifiable and traceable with regard to their production origin.
OK
8
Internal audit
The organization shall conduct internal audits at planned intervals of at least once a year to determine whether the quality management system
c) Conforms to the quality documentation d) Is effectively implemented and maintained
In case of internal audit, an audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A document procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained.
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow up activities shall include the verification of the actions taken and the reporting of verification results.
6
Table 3 – DESCRIPTION OF NON-CONFORMITIES AND COMMENTS
Non conformities Comments
1 2.4 There are no quality objectives documented A small company – it is primary for them to reach the lower number of non-conforming products. They consider it to be senseless to have to document objectives
2 2.5 There is no management review documented A small company – Management is directly involved in the production process. They pay attention to complaints, non conformities, corrective and preventive actions continuously.
3 2.6 There is no training procedure,plan and training record
A small company – staff is qualified, records relating to education and experience are kept. They don´t understand why training procedures and a plan should be drawing up .
4 3. Quality aims and a training plan are missing in the Quality Documentation
See comments above.
5 4.5 Not all of inspections are recorded. If inspections are recorded, time of manufacturing is missing.
Visual inspections are not recorded – they don´t consider it to be necessary, because in most of cases it is possible to solve non-conformity immediately – if not, the component/product is separated.
They don´t understand why time of manufacturing should be recorded – it is not necessary.
6 8. There is no evidence of internal audits taking place.
A small company - they have difficulties with internal audits. Who audits who?
///End of the questionnaire
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 13 of 24
QUESTIONNAIRE FOR SK INSPECTORS – 2013 Table 1 – GENERAL DATA
Inspector’s name / nickname / code JHP
Questionnaire number / code 078/000032
I would like to be acquainted with all output documents of the project: YES
I would like to participate in the project (to attend the discussions, etc.): YES
Table 2 – ASSESMENT OF FPC ASPECTS ACCORDING TO ANNEX E
Annex E Aspect NC
2.1
General
The FPC shall be operated according to a documented quality system. The manufacturer shall establish, document and maintain the FPC system to ensure that the products placed on the market comply with the declared performance of the characteristics. The records must be kept at least for a period of 3 years. All quality documentation shall be kept up to date.
OK
2.2
Responsibility and authority
The responsibility, authority, and the interrelationships between all personnel who manage, perform, or verify work affecting quality or product conformity, shall be defined. This applies particularly to personnel who need the organizational freedom and authority to:
g) Identify procedures to demonstrate conformity of the product at appropriate stages h) Initiate action to prevent the use and production of non-conforming product
i) Identify and record any product quality problems or non-conformities
OK
2.3
Management and representative for the FPC
At every place of production, a representative with the appropriate knowledge and production experience shall be appointed by the manufacturer and given responsibility for managing and supervising of the FPC procedures and for ensuring that the requirements of this annex are implemented and maintained
OK
2.4
Quality and Objectives
Top management shall ensure that quality objectives regarding the production process are established at relevant functions and levels within the organization. The quality objectives shall be measurable.
At least one example of a quality objective could be to lower the number of non-conforming products from year to year.
OK
2.5
Management review
Management shall review at least every year the FPC system to ensure its continuing suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The minimum input for management review shall be at least related to the conformity of the product and include the following:
k) Status of corrective and preventive actions l) Status of complains m) Follow up from previous management reviews n) Follow up of quality objectives o) Results of audits
OK
2.6
Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity.
Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 14 of 24
Annex E Aspect NC
3
Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items:
u) Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity;
v) Procedures for specifying and verifying the raw materials and other constituent materials;
w) Manufacturer’s production control and other techniques, processes and systematic actions that will be used;
x) Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures;
y) Procedures for handling, storage, packaging, marking and labelling the product; z) Procedures for all personnel to receive training in the activities affecting quality or
conformity of the product aa) A procedure that will specify how non-complying products shall be dealt with. Any event
of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.
bb) A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence.
cc) A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
dd) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.
OK
4.1
Inspection and testing - General
All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for control, calibration, and maintenance of testing, measuring, and inspection equipment, whether owned by or on loan to the manufacturer or a subcontractor.
Inspection and testing shall be performed by personnel qualified for such tasks on the basis of documented appropriate education, training and/or experience.
OK
4.2
Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall be performed using appropriate testing equipment and documented working instructions.
The test equipment shall be controlled regularly by calibration or verification following the manufacturer’s own instructions.
OK
4.3
Inspection and testing of raw materials and other constituent materials
The manufacturer shall ensure that raw materials and other constituent materials conform to his specified requirements. In determining the checks necessary consideration shall be given to the control exercised by the supplier and the documented evidence of conformity supplied (often referred to as supplier certified components or certified raw materials). There should be a proper traceability to the supplier’s documentation.
This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall be recorded:
1
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 15 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Pipe
Visual check and documentation check
No damage Each delivery
Measurement Purchase specification: pipe dimensions within tolerance
Each delivery (1)
Absorber sheet
Visual inspection No damage
Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
Absorber
Visual inspection No damage Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
and proper connection between absorber sheet and
pipes (this may be a mechanical test also)
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Pipe grid
Visual inspection No damage Each delivery
Document check
Purchase specification
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Reflector material,
reflector shape (if the finished
reflector is delivered)
Document check or direct test for shape (eg: master
shape )
Purchase specification: Solar reflectance, shape
Each delivery (document check) or less frequency
if it is tested
Heat pipes
Test for check performance (may be done by heat pipe
manufacturer)
Purchase specification Variable
Glass tubes(assembly of absorber and
glass cover)
Specific test method Purchase specification Variable
Glazing
Measurement
Purchase specification: dimensions and optical
characteristics(solar transmittance) Each delivery (1)
Document check or direct test
If only a document check is done, then there must be a
special agreement to assure optical characteristics
1
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 16 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Insulation
Visual Damage Each delivery
Document check Purchase specification:
density and thermal conductivity
Each delivery
Weight measurement
Manufacturer’s method
Each delivery (1)
Dimension measurement
Outgasing test (only for flat plate collectors)
Casing
Material of frame elements
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Material of rear panel
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Hydraulic connections
Visual Check
Measurement (verify product is inside
tolerance)
Purchase specification Each delivery (1)
Sealant Documentation and Visual check
Purchase specification Each delivery (1)
1
4.4
Inspection and testing during manufacture and on finished product
In order to manufacture products which conform to the product standard the manufacturer shall control his process and perform inspection and tests as described in his manual, and complying at least with the following table.
1
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 17 of 24
Annex E Aspect NC
4.4
Process Method Requirement Frequency
Cutting of pipe Measurement Manufacturer
specification for dimensions
At the beginning of each
production order (2)
Cutting of absorber sheet
Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Cutting of frames Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Connection of pipe to absorber
Visual
Proper welding
Each absorber
(Recommended but not obligatory) mechanical test with manufacturer’s method
Manufacturer’s specification
Absorber Visual check No damage Each absorber
Reflector material Visual
No damage Each collector
Assembly Visual Proper assembly Each collector
Sealing Visual Proper sealing Each collector
Leakage Manufacturer method for pressure test
Manufacturer method Each collector
Release of each collector
Visual or manufacturer’s method
Manufacturer method Each collector
1
4.3 & 4.4
Note 1: In this case, the frequency of checks may be decreased in result of reliability of the supplier (ISO 9001 certificate etc.) and history of deliveries (no complains, no non-conformities). In this case a written procedure shall exist, describing the rules for decreasing the frequency and return to full-check in case of non-conformities.
OK
4.5
Inspection and test records
The results of products inspection and testing shall be recorded
The record shall contain the product identification, the date and time of manufacture and for each property the test methods, the test results, the inspection result and the identification of the person carrying out the inspection.
OK
5
Actions in the case of non-conforming products
If the result of a test or the inspection of a product is a failure, the manufacturer shall immediately take the steps necessary to rectify the deficiency. Products which do not conform to the requirements of the product standard, shall be marked, isolated or controlled accordingly. When the deficiency has been identified and rectified, the test or inspection in question shall be repeated without delay accordingly to the quality documentation, to provide the evidence that the defects have been overcome. Corrective and preventive actions taken in case of non-conforming products shall be documented.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 18 of 24
Annex E Aspect NC
6
Handling, storage, packaging and marking of products
In accordance with the quality documentation the manufacturer shall:
g) Provide methods of handling that prevent damage or deterioration; h) Provide suitable storage areas or stock rooms or prevent damage or deterioration of the
product;
i) Control the packaging, storage and the marking processes
OK
7
Traceabilty of products
Individual collectors and their main components (if applicable) (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes) shall be identifiable and traceable with regard to their production origin.
2
8
Internal audit
The organization shall conduct internal audits at planned intervals of at least once a year to determine whether the quality management system
e) Conforms to the quality documentation f) Is effectively implemented and maintained
In case of internal audit, an audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A document procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained.
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow up activities shall include the verification of the actions taken and the reporting of verification results.
OK
Table 3 – DESCRIPTION OF NON-CONFORMITIES AND COMMENTS
Non conformities Comments
1 NC 4 Some of Incoming materials without evidence of controls carried on according D4.3 and D.4.4 (RP 78.01).
Lack of knowledge and training in product requirements.
2 NC 7 There is no evidence related to the traceability of Individual collectors and their main components (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes).
Lack of knowledge about application of this requirement.
///End of the questionnaire
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 19 of 24
QUESTIONNAIRE FOR SK INSPECTORS – 2013 Table 1 – GENERAL DATA
Inspector’s name / nickname / code JHP
Questionnaire number / code 078/000043
I would like to be acquainted with all output documents of the project: YES
I would like to participate in the project (to attend the discussions, etc.): YES
Table 2 – ASSESMENT OF FPC ASPECTS ACCORDING TO ANNEX E
Annex E Aspect NC
2.1
General
The FPC shall be operated according to a documented quality system. The manufacturer shall establish, document and maintain the FPC system to ensure that the products placed on the market comply with the declared performance of the characteristics. The records must be kept at least for a period of 3 years. All quality documentation shall be kept up to date.
OK
2.2
Responsibility and authority
The responsibility, authority, and the interrelationships between all personnel who manage, perform, or verify work affecting quality or product conformity, shall be defined. This applies particularly to personnel who need the organizational freedom and authority to:
j) Identify procedures to demonstrate conformity of the product at appropriate stages k) Initiate action to prevent the use and production of non-conforming product
l) Identify and record any product quality problems or non-conformities
OK
2.3
Management and representative for the FPC
At every place of production, a representative with the appropriate knowledge and production experience shall be appointed by the manufacturer and given responsibility for managing and supervising of the FPC procedures and for ensuring that the requirements of this annex are implemented and maintained
OK
2.4
Quality and Objectives
Top management shall ensure that quality objectives regarding the production process are established at relevant functions and levels within the organization. The quality objectives shall be measurable.
At least one example of a quality objective could be to lower the number of non-conforming products from year to year.
1
2.5
Management review
Management shall review at least every year the FPC system to ensure its continuing suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The minimum input for management review shall be at least related to the conformity of the product and include the following:
p) Status of corrective and preventive actions q) Status of complains r) Follow up from previous management reviews s) Follow up of quality objectives t) Results of audits
OK
2.6
Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity.
Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required.
2
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 20 of 24
Annex E Aspect NC
3
Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items:
ee) Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity;
ff) Procedures for specifying and verifying the raw materials and other constituent materials;
gg) Manufacturer’s production control and other techniques, processes and systematic actions that will be used;
hh) Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures;
ii) Procedures for handling, storage, packaging, marking and labelling the product; jj) Procedures for all personnel to receive training in the activities affecting quality or
conformity of the product kk) A procedure that will specify how non-complying products shall be dealt with. Any event
of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.
ll) A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence.
mm)A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
nn) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.
3
4.1
Inspection and testing - General
All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for control, calibration, and maintenance of testing, measuring, and inspection equipment, whether owned by or on loan to the manufacturer or a subcontractor.
Inspection and testing shall be performed by personnel qualified for such tasks on the basis of documented appropriate education, training and/or experience.
2
4.2
Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall be performed using appropriate testing equipment and documented working instructions.
The test equipment shall be controlled regularly by calibration or verification following the manufacturer’s own instructions.
OK
4.3
Inspection and testing of raw materials and other constituent materials
The manufacturer shall ensure that raw materials and other constituent materials conform to his specified requirements. In determining the checks necessary consideration shall be given to the control exercised by the supplier and the documented evidence of conformity supplied (often referred to as supplier certified components or certified raw materials). There should be a proper traceability to the supplier’s documentation.
This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall be recorded:
4
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 21 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Pipe
Visual check and documentation check
No damage Each delivery
Measurement Purchase specification: pipe dimensions within tolerance
Each delivery (1)
Absorber sheet
Visual inspection No damage
Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
Absorber
Visual inspection No damage Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
and proper connection between absorber sheet and
pipes (this may be a mechanical test also)
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Pipe grid
Visual inspection No damage Each delivery
Document check
Purchase specification
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Reflector material,
reflector shape (if the finished
reflector is delivered)
Document check or direct test for shape (eg: master
shape )
Purchase specification: Solar reflectance, shape
Each delivery (document check) or less frequency
if it is tested
Heat pipes
Test for check performance (may be done by heat pipe
manufacturer)
Purchase specification Variable
Glass tubes(assembly of absorber and
glass cover)
Specific test method Purchase specification Variable
Glazing
Measurement
Purchase specification: dimensions and optical
characteristics(solar transmittance) Each delivery (1)
Document check or direct test
If only a document check is done, then there must be a
special agreement to assure optical characteristics
4
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 22 of 24
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Insulation
Visual Damage Each delivery
Document check Purchase specification:
density and thermal conductivity
Each delivery
Weight measurement
Manufacturer’s method
Each delivery (1)
Dimension measurement
Outgasing test (only for flat plate collectors)
Casing
Material of frame elements
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Material of rear panel
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Hydraulic connections
Visual Check
Measurement (verify product is inside
tolerance)
Purchase specification Each delivery (1)
Sealant Documentation and Visual check
Purchase specification Each delivery (1)
4
4.4
Inspection and testing during manufacture and on finished product
In order to manufacture products which conform to the product standard the manufacturer shall control his process and perform inspection and tests as described in his manual, and complying at least with the following table.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 23 of 24
Annex E Aspect NC
4.4
Process Method Requirement Frequency
Cutting of pipe Measurement Manufacturer
specification for dimensions
At the beginning of each
production order (2)
Cutting of absorber sheet
Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Cutting of frames Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Connection of pipe to absorber
Visual
Proper welding
Each absorber
(Recommended but not obligatory) mechanical test with manufacturer’s method
Manufacturer’s specification
Absorber Visual check No damage Each absorber
Reflector material Visual
No damage Each collector
Assembly Visual Proper assembly Each collector
Sealing Visual Proper sealing Each collector
Leakage Manufacturer method for pressure test
Manufacturer method Each collector
Release of each collector
Visual or manufacturer’s method
Manufacturer method Each collector
OK
4.3 & 4.4
Note 1: In this case, the frequency of checks may be decreased in result of reliability of the supplier (ISO 9001 certificate etc.) and history of deliveries (no complains, no non-conformities). In this case a written procedure shall exist, describing the rules for decreasing the frequency and return to full-check in case of non-conformities.
OK
4.5
Inspection and test records
The results of products inspection and testing shall be recorded
The record shall contain the product identification, the date and time of manufacture and for each property the test methods, the test results, the inspection result and the identification of the person carrying out the inspection.
4
5
Actions in the case of non-conforming products
If the result of a test or the inspection of a product is a failure, the manufacturer shall immediately take the steps necessary to rectify the deficiency. Products which do not conform to the requirements of the product standard, shall be marked, isolated or controlled accordingly. When the deficiency has been identified and rectified, the test or inspection in question shall be repeated without delay accordingly to the quality documentation, to provide the evidence that the defects have been overcome. Corrective and preventive actions taken in case of non-conforming products shall be documented.
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 10.2.2014 – Page 24 of 24
Annex E Aspect NC
6
Handling, storage, packaging and marking of products
In accordance with the quality documentation the manufacturer shall:
j) Provide methods of handling that prevent damage or deterioration; k) Provide suitable storage areas or stock rooms or prevent damage or deterioration of the
product;
l) Control the packaging, storage and the marking processes
5
7
Traceabilty of products
Individual collectors and their main components (if applicable) (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes) shall be identifiable and traceable with regard to their production origin.
OK
8
Internal audit
The organization shall conduct internal audits at planned intervals of at least once a year to determine whether the quality management system
g) Conforms to the quality documentation h) Is effectively implemented and maintained
In case of internal audit, an audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A document procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained.
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow up activities shall include the verification of the actions taken and the reporting of verification results.
6
Table 3 – DESCRIPTION OF NON-CONFORMITIES AND COMMENTS
Non conformities Comments
1 NC 2.4 There are no documented quality objectives A very small company without culture of quality system – luck of knowledge about how to define and follow objectives
2 NC 2.6 There is no evidence about definition of education, training and/or experience need to qualify personnel
A very small company – luck of knowledge about documentation of needs that people should achieve.
3 REMARK Production process procedure should be reviewed considering in a specifical way controls to be carried on according D4.3 and D.4.4 (RP 78.01).
Luck of knowledge and training in product requirements.
4 NC 4.3 Incoming materials without evidence of controls carried on according D4.3 and D.4.4 (RP 78.01).
Luck of knowledge and training in product requirements.
5 NC 6 No evidence of marking on collector according std rules.
Luck of knowledge of information and data to include in labels.
6 8. There is no evidence of internal audits taking place.
A very small company without culture of quality system – luck of knowledge about how to do internal audits (identified with management review).
///End of the questionnaire
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 1 of 7
QUESTIONNAIRE FOR SK INSPECTORS – 2013 Table 1 – GENERAL DATA
Inspector’s name / nickname / code Uli Fritzsche
Questionnaire number / code UF-2
I would like to be acquainted with all output documents of the project: YES
I would like to participate in the project (to attend the discussions, etc.): YES
Table 2 – ASSESMENT OF FPC ASPECTS ACCORDING TO ANNEX E – Comments related to small manufacturer (< 1000 collectors per year) and where the management is directly involved into the production!
Annex E Aspect NC
2.1
General
The FPC shall be operated according to a documented quality system. The manufacturer shall establish, document and maintain the FPC system to ensure that the products placed on the market comply with the declared performance of the characteristics. The records must be kept at least for a period of 3 years. All quality documentation shall be kept up to date.
OK
Applicable for all company sizes!
2.2
Responsibility and authority
The responsibility, authority, and the interrelationships between all personnel who manage, perform, or verify work affecting quality or product conformity, shall be defined. This applies particularly to personnel who need the organizational freedom and authority to:
a) Identify procedures to demonstrate conformity of the product at appropriate stages b) Initiate action to prevent the use and production of non-conforming product
c) Identify and record any product quality problems or non-conformities
OK
Applicable for all company sizes!
2.3
Management and representative for the FPC
At every place of production, a representative with the appropriate knowledge and production experience shall be appointed by the manufacturer and given responsibility for managing and supervising of the FPC procedures and for ensuring that the requirements of this annex are implemented and maintained
OK
Applicable for all company sizes!
2.4
Quality and Objectives
Top management shall ensure that quality objectives regarding the production process are established at relevant functions and levels within the organization. The quality objectives shall be measurable.
At least one example of a quality objective could be to lower the number of non-conforming products from year to year.
1
Difficult to implement in small factories; if they re-work the products, there’s no remaining non-conformity
2.5
Management review
Management shall review at least every year the FPC system to ensure its continuing suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The minimum input for management review shall be at least related to the conformity of the product and include the following:
a) Status of corrective and preventive actions b) Status of complains c) Follow up from previous management reviews d) Follow up of quality objectives e) Results of audits
2
Difficult to implement in small factories; it will be just a formal document without real benefit
2.6
Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity.
Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required.
3
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 2 of 7
Annex E Aspect NC
Possible to implement in an adequate way; so far not realized!
3
Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items:
a) Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity;
b) Procedures for specifying and verifying the raw materials and other constituent materials;
c) Manufacturer’s production control and other techniques, processes and systematic actions that will be used;
d) Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures;
e) Procedures for handling, storage, packaging, marking and labelling the product; f) Procedures for all personnel to receive training in the activities affecting quality or
conformity of the product g) A procedure that will specify how non-complying products shall be dealt with. Any event
of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.
h) A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence.
i) A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
j) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.
4
Red marked points not easy to explain and implement for small manufacturers
4.1
Inspection and testing - General
All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for control, calibration, and maintenance of testing, measuring, and inspection equipment, whether owned by or on loan to the manufacturer or a subcontractor.
Inspection and testing shall be performed by personnel qualified for such tasks on the basis of documented appropriate education, training and/or experience.
OK
Applicable for all company sizes!
4.2
Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall be performed using appropriate testing equipment and documented working instructions.
The test equipment shall be controlled regularly by calibration or verification following the manufacturer’s own instructions.
OK
Applicable for all company sizes!
4.3
Inspection and testing of raw materials and other constituent materials
The manufacturer shall ensure that raw materials and other constituent materials conform to his specified requirements. In determining the checks necessary consideration shall be given to the control exercised by the supplier and the documented evidence of conformity supplied (often referred to as supplier certified components or certified raw materials). There should be a proper traceability to the supplier’s documentation.
This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall be recorded:
OK
Applicable for all company sizes!
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 3 of 7
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Pipe
Visual check and documentation check
No damage Each delivery
Measurement Purchase specification: pipe dimensions within tolerance
Each delivery (1)
Absorber sheet
Visual inspection No damage
Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
Absorber
Visual inspection No damage Each delivery
Document check
Purchase specification:
Parameters of optical characteristics (solar
absorbance and thermal emittance)
and proper connection between absorber sheet and
pipes (this may be a mechanical test also)
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Pipe grid
Visual inspection No damage Each delivery
Document check
Purchase specification
Pressure/leakage test shall be done
on 100% of absorbers- by
supplier or manufacturer.
Reflector material,
reflector shape (if the finished
reflector is delivered)
Document check or direct test for shape (eg: master
shape )
Purchase specification: Solar reflectance, shape
Each delivery (document check) or less frequency
if it is tested
Heat pipes
Test for check performance (may be done by heat pipe
manufacturer)
Purchase specification Variable
Glass tubes(assembly of absorber and
glass cover)
Specific test method Purchase specification Variable
Glazing
Measurement
Purchase specification: dimensions and optical
characteristics(solar transmittance) Each delivery (1)
Document check or direct test
If only a document check is done, then there must be a
special agreement to assure optical characteristics
OK
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 4 of 7
Annex E Aspect NC
4.3
Material Method Requirement Frequency
Insulation
Visual Damage Each delivery
Document check Purchase specification:
density and thermal conductivity
Each delivery
Weight measurement
Manufacturer’s method
Each delivery (1)
Dimension measurement
Outgasing test (only for flat plate collectors)
Casing
Material of frame elements
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Material of rear panel
Visual check
Purchase specification Each delivery (1) Measurement (verify
product is inside tolerance)
Hydraulic connections
Visual Check
Measurement (verify product is inside
tolerance)
Purchase specification Each delivery (1)
Sealant Documentation and Visual check
Purchase specification Each delivery (1)
OK
4.4
Inspection and testing during manufacture and on finished product
In order to manufacture products which conform to the product standard the manufacturer shall control his process and perform inspection and tests as described in his manual, and complying at least with the following table.
OK
Applicable for all company sizes!
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 5 of 7
Annex E Aspect NC
4.4
Process Method Requirement Frequency
Cutting of pipe Measurement Manufacturer
specification for dimensions
At the beginning of each
production order (2)
Cutting of absorber sheet
Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Cutting of frames Measurement Manufacturer
specification for dimensions
At the beginning of Each
production order (2)
Connection of pipe to absorber
Visual
Proper welding
Each absorber
(Recommended but not obligatory) mechanical test with manufacturer’s method
Manufacturer’s specification
Absorber Visual check No damage Each absorber
Reflector material Visual
No damage Each collector
Assembly Visual Proper assembly Each collector
Sealing Visual Proper sealing Each collector
Leakage Manufacturer method for pressure test
Manufacturer method Each collector
Release of each collector
Visual or manufacturer’s method
Manufacturer method Each collector
OK
4.3 & 4.4
Note 1: In this case, the frequency of checks may be decreased in result of reliability of the supplier (ISO 9001 certificate etc.) and history of deliveries (no complains, no non-conformities). In this case a written procedure shall exist, describing the rules for decreasing the frequency and return to full-check in case of non-conformities.
OK
Difficult to implement (the written procedure) for small manufacturer; what about existing, but not recorded history? It is common practice to reduce the inspection frequency according to the history, but it is another thing to write down the rules. Usually in small factories, these frequencies will be defined by the management itself for every product/ part.
4.5
Inspection and test records
The results of products inspection and testing shall be recorded
The record shall contain the product identification, the date and time of manufacture and for each property the test methods, the test results, the inspection result and the identification of the person carrying out the inspection.
5
A lot of manufacturer are working only with negative record within their production. Sometimes, the record is only a signature on the part. For small productions, there’s no need to record every positive test and inspection.
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 6 of 7
Annex E Aspect NC
5
Actions in the case of non-conforming products
If the result of a test or the inspection of a product is a failure, the manufacturer shall immediately take the steps necessary to rectify the deficiency. Products which do not conform to the requirements of the product standard, shall be marked, isolated or controlled accordingly. When the deficiency has been identified and rectified, the test or inspection in question shall be repeated without delay accordingly to the quality documentation, to provide the evidence that the defects have been overcome. Corrective and preventive actions taken in case of non-conforming products shall be documented.
OK
Applicable for all company sizes!
6
Handling, storage, packaging and marking of products
In accordance with the quality documentation the manufacturer shall:
a) Provide methods of handling that prevent damage or deterioration; b) Provide suitable storage areas or stock rooms or prevent damage or deterioration of the
product;
c) Control the packaging, storage and the marking processes
OK
Applicable for all company sizes!
7
Traceabilty of products
Individual collectors and their main components (if applicable) (cover sheet, absorber, insulation, reflector, polymer sealing and gaskets and heat pipes) shall be identifiable and traceable with regard to their production origin.
OK
Difficult to implement for small productions. For them, it is (roughly) traceable via the delivery note and first in- first out process.
8
Internal audit
The organization shall conduct internal audits at planned intervals of at least once a year to determine whether the quality management system
a) Conforms to the quality documentation b) Is effectively implemented and maintained
In case of internal audit, an audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A document procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained.
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow up activities shall include the verification of the actions taken and the reporting of verification results.
6
Difficult to realize for small productions, where the management is directly involved in the production. For these kind of productions, the management report as well as the internal audit may be combined into one short document. It’s not possible for them to document the procedure, but they could record their audit-work.
Table 3 – DESCRIPTION OF NON-CONFORMITIES AND COMMENTS
Non conformities Comments
1 2.4 There are no quality objectives documented A small company – it is primary for them to reach the lower number of non-conforming products. They consider it to be senseless to have to document objectives
2 2.5 There is no management review documented A small company – Management is directly involved in the production process. They pay attention to complaints, non conformities, corrective and preventive actions continuously.
3 2.6 There is no training procedure,plan and training record
A small company – staff is qualified, records relating to education and experience are kept. They don´t
ITC/Hros – Project SK-Annex E: Questionnaire for SK Inspectors -- 17.2.2014 – Page 7 of 7
understand why training procedures and a plan should be drawing up .
4 3. Quality aims and a training plan are missing in the Quality Documentation
See comments above.
5 4.5 Not all of inspections are recorded. If inspections are recorded, time of manufacturing is missing.
Visual inspections are not recorded – they don´t consider it to be necessary, because in most of cases it is possible to solve non-conformity immediately – if not, the component/product is separated.
They don´t understand why time of manufacturing should be recorded – it is not necessary.
6 8. There is no evidence of internal audits taking place.
A small company - they have difficulties with internal audits. Who audits who?
///End of the questionnaire