po-1 evaluation process procedure (initial assessment … · 2020. 12. 4. · requirements in...

PO-1 EVALUATION PROCESS PROCEDURE

(Initial Assessment and Conformity of Production)

(Rev 22)

C/ Jose Gutierrez Abascal nº 2 28006 MADRID

FUNDACIÓN PARA EL FOMENTO DE LA INNOVACIÓN INDUSTRIAL

Evaluation process procedure of 13

PO.1 Rev 21

INDEX

1.- Subject 2.- Reference documents 3.- Initial assessment 4.- Conformity of production

4.1.- On-site audit 4.2.- Documentary audit

5.- Case of several manufacturing plants 6.- Temporary cessation of production 7.- Scope extension 8.- Certificate validity period 9.- Annex


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Evaluation process procedure 1.- Subject To describe the systematics so manufacturers request evaluation and the UCA carries it out in accordance with the Regulations and Directives of the automotive sector; both for compliance with the requirements of Initial Assessment as a previous step for the approval by the Approval Authority in Spain (hereinafter AA), as for compliance with the requirements of conformity of production stipulated in the international Directives and Regulations or national regulations. 2.- Reference documents

• Directive 2007/46/CE • Regulation (EU) 2018/858 • Directive 2002/24/CE • Regulation (EU) nº 168/2013 • Directive 2003/37/CE • Regulation (EU) nº 167/2013 • E/ECE/TRANS/505/Rev 3 • Regulation nº 0 of the United Nations • RD 750/2010

3.- Initial Assessment. According to the relevant Framework Directive requirements as well as by the EU and UN Regulations in the automotive sector and Royal Decree 750/2010, before the approval of a component, system or type, it is necessary to conduct an initial evaluation as a way of ensuring that the manufacturer has the necessary means and procedures to manage the manufacturing of the product, thus guaranteeing compliance with the control requirements in Conformity of Production per current regulations. The Fundación para el Fomento de la Innovación Industrial and, in particular, the Unidad de Certificación del Automóvil (hereinafter F2I2-UCA) is the technical service designated by the AA to carry out the initial assessment. F2I2-UCA shall evaluate the quality system, the Conformity of Production procedures and of the additional provisions laid down by the manufacturer so to comply with the requirements established in the directives, EU regulations, applicable UN regulations and RD 750/2010. The purpose of the evaluation is to obtain the initial assessment certificate issued by F2I2-UCA and the AA before the granting of the corresponding approval number. The evaluation by the F2I2-UCA consists in evaluating the manufacturer's ability to carry out a controlled manufacturing process in compliance with the regulatory requirements and provisions stipulated by the Approval Authority, and for this, the manufacturer must ensure:

1. To have a defined, documented and implemented quality system that ensures compliance with the minimum requirements set by the framework law applicable.

2. To have processes, procedures and a defined, documented and implemented planning that ensures the

controls and inspections of manufactured products to ensure the minimum technical requirements of the regulations in force and those established by the granted approval.


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3. To have defined, documented and implemented processes and procedures to ensure control of all necessary additional provisions stipulated by the Approval Authority.

Under certain conditions, F2I2-UCA will allow the acceptance of certifications according to ISO 9001 or IATF 16949, so that the evaluation of the quality system defined in section 1 is carried out by a third-party. The following conditions must be met to validate these third-party evaluations:

• The submitted certificate must be in force and be issued in the name of the manufacturer, ensuring that the same business name as the manufacturer applying for evaluation and approvals is maintained

• The certificate must include components or TIUs for which the evaluation is requested in the scope of the manufacturing activity for all categories of vehicles.

• The certificate must include all manufacturing plants, or these must be included in another certificate of the same characteristics.

• The certification authority issuing the certificate must be covered by the accreditation of an accreditation body that is a member of the IAF MLA (International Accreditation Forum).

• The applicant manufacturer shall provide the latest audit report by the certification authority.

When proving the availability of a quality system certified by a third-party according to ISO/IATF standards 9001/16949, which cover the plants indicated in the application and the type of product that the entity requested to approve is included in its scope, UCA will propose to perform a documentary audit in order to assess aspects that are not covered by the system evaluation, in particular those set in sections 2 and 3, i.e. the procedures of Conformity of Production and the complementary provisions; except when one or more type-approvals have been withdrawn recently from the manufacturer in one of the Member States due to an unsatisfactory conformity of production check. In this case, ISO/IATF certification will not be enough for granting the Initial Assessment. An evaluation at its facilities must be carried out in order to assess the application of all the necessary improvements to guarantee effective control, so that the vehicles, components, systems or separate technical units will be manufactured in accordance with the approved type. In cases where the manufacturer requesting the Initial Assessment does not have a certified QMS complying with the above requirements, he must additionally request the assessment of point 1, i.e. the certification of his quality management system according to the CSC-UCA Quality System Criteria. In this case, the evaluation of the three points that compose the Initial Assessment is carried out with an on-site audit according to the procedure PO-02. Once all the aspects of the Initial Assessment have been evaluated, either in a documented manner according to this procedure, or through an on-site audit according to PO-02, the Certification Committee will evaluate the global report issued as a result of the audit, and in case of a favourable evaluation, as a final result of the process F2I2-UCA will issue an Initial Assessment certificate in the name of the manufacturer The process set is defined in the flow chart next Figure


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3.1 Application process, audit conduction. The following steps will be followed: 1.- The manufacturer requests an initial assessment by providing the necessary data or completing the initial evaluation request form (FT-PO.1-1) provided by F2I2-UCA. Completed documents are sent by e-mail to [email protected]. UCA assigns a business code. 2.- F2I2-UCA studies the application, verifying the aspects contained therein, as well as the documentation provided. As a result, and according to FT PO format.01-18 established, the designated technician will indicate the result of the evaluation of this phase 1, giving several possible alternatives:

• It is considered that the necessary or adequate documents have not been provided, and new documentation or modification of the same should be requested before scheduling an on-site audit for initial evaluation.

• It is considered that necessary or appropriate documents have been provided, taking the following decisions:

A- The evaluation by a third-party according to ISO 9001 or IATF 16949 is satisfactory, meeting the requirements. In addition, there is a satisfactory evaluation of the procedures for product and complementary provisions. The report and the corresponding invoice are issued, and the issuance of the initial assessment certificate continues, per the established internal procedures (continuing with section 12 of the process)

B- The evaluation by a third-party according to ISO 9001 or IATF 16949 is satisfactory, meeting the requirements. Product provisions and supplementary provisions procedures are NOT accepted, as errors are detected and must be corrected.

C- It is determined to evaluate by on-site audit at the manufacturer's premises by verifying the definition and implementation of the procedures of the quality system, as well as the product provisions and complementary provisions. In this case, the manufacturer will have also requested the certification of its quality management system according to the requirements of CSC-UCA because it does not have another certification by 3rd party (Cases A and B)

3.- If option C is decided upon after evaluation, F2I2-UCA will make contact within 15 days and send an estimate with the fees and the audit schedule (FT-PO.1-3). The manufacturer must accept the estimate by email before the audit is carried out. The characteristics of the audit are determined from this moment onwards in terms of the categories of vehicles, components or ITUs and per the applicable legislation. If the estimate is not accepted, the trip to the manufacturer's premises will not be made. The acceptance of the audit automatically assigns a binding file code to the accepted audit. Any change concerning the initially agreed conditions implies the issuance of a new estimate and schedule. This process is documented in PO-02, through which the CSC-UCA certificate is obtained. 4.- In the case of options A and B, the manufacturer is informed that the assessment is carried out in a documented manner, as follows: 4.1.- A documentary evaluation estimate is generated and provided to the manufacturer before the evaluation, according to the FT-PO.1-3 Documentary. Once the estimate is accepted, the company is registered in the electronic system and a binding file code is assigned to the accepted audit. 4.2.- The designated technician carries out the documentary evaluation of the documents and procedures provided and issues the Phase 1 report. If the decision indicated in the Phase 1 report is “A” and a favourable report is issued without deviations, the dossier passes as a candidate for certification to be evaluated by the Certification Committee, as regulated in PGC-11. The deadline set for sending the report from the date of the audit is a maximum of 15 working days.

mailto:[email protected]


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4.3 If deviations are detailed in a Phase 1 report, they are recorded in the software application and the manufacturer has a maximum period of three months to reply to the deviations reported. This response (PAC) will be sent preferably by mail to the address [email protected] or by ordinary mail to the address:

Fundación para el Fomento de la Innovación Industrial (Unidad de Certificación del Automóvil)

C/ José Gutiérrez Abascal nº 2

28006 Madrid (España) 4.4 With the reception of the PAC by the established means, the process of analysis of the responses to the open deviations in the audit report begins. The audit technician is responsible for its correct evaluation and subsequent processing. 4.5 The designated F2I2-UCA audit technician records the receipt of the AACC Plan along with the evidence provided by the manufacturer and performs an analysis of the evidence, preparing and signing a PAC response report notifying the conclusions to the AACC study taken by the organization (FT-PO.1-5) (*) The deadline set as a target for the analysis of the AACC provided by the manufacturer and the issuing of the UCA response report is a maximum of 15 working days. In the event of a favourable report, the process of issuing certificates is initiated per established internal procedures (PGC-11). 4.6 If after 6 months from the completion of the Initial Assessment audit the manufacturer has not obtained his certificate, the file is closed for all purposes. If the manufacturer wants to obtain the initial evaluation, it will be necessary to start the process from the beginning. 4.7 In the event that approval is obtained from the internal committee established by UCA for the analysis of the dossier and that all relevant administrative procedures are fulfilled, F2I2-UCA will issue and send the initial assessment certificate to the manufacturer. F2I2-UCA shall communicate to the Spanish Approval Authority the completion of the initial assessment process, releasing the approval when the other requirements are met. (*)Note: the response report to the Corrective Action Plan (FT-PO.1-5) may have positive or negative results depending on the evaluation of each of the detected non-conformities. For each non-compliance, a satisfactory, unsatisfactory or partially satisfactory conclusion can be obtained. In the event that the evaluation of any non-conformity is not satisfactory, the result of the response report to the CAP will be negative. If the evaluation of all nonconformities is satisfactory or partially satisfactory, the outcome of the CAP response report will be positive. However, in the latter case, there may be “pending actions” that will be reviewed in the next audit process.

mailto:[email protected]


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APPLICATION Assessment

Reduced assessment of quality arrangements (CSC) (Product & complementary arrangements)

valid ISO 9001 or IATF 16949

Complete assessment of quality arrangements (CSC)

(QMS+Product & complementary arrangements)

Scheduling a date

Audit teamAudit preparationAUDIT

Budget-Program

preparation

BUDGET - PROGRAM

CAP assessmentAdequate CAP or

Documentary assessment?

UCA Appoval

Invoice paid?

Send certificate to manufacturer and inform Approval

Authority

Corrective Action Plan

(CAP)

REPORT AND INVOICE

Evaluation report

Positive evaluation

Negative evaluation

Man

ufac

ture

r Acceptance of Budget-Program

Auditor and Manufacturer Communication

Max. 15 days

Max. 15 days

NO

YES

Max. 6 months &2 Negative CAP

Evaluación INICIAL

INITIAL ASS

4.- Conformity of production As a continuation of the procedure, control of the Conformity of Production on the granted approvals will begin. If the manufacturer has not obtained any approvals during this period, the file shall be closed without the need for communication to the Approval Authority To evaluate the Conformity of Production of the manufacturers with approvals granted and in force, F2I2-UCA establishes an audit process ensuring the compliance with the regulatory requirements and with the provisions stipulated by the Approval Authority. To do so, the F2I2-UCA will inspect the manufacturer to ensure:

1. Maintain a defined, documented and implemented quality system that ensures compliance with the minimum requirements set by the Approval Authority and defined in the document CSC. This process can be carried out by accrediting the third-party evaluation of the QS in compliance with the established requirements or being audited on-site by UCA.

2. Maintain processes, procedures and a defined, documented and implemented planning that ensures the

controls and inspections of manufactured products to ensure the minimum technical requirements of the regulations in force and those established by the granted approval.

3. Maintain defined, documented and implemented processes and procedures to ensure control of all

additional provisions stipulated by the Approval Authority


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This inspection is carried out on-site at the manufacturer's location or online per the criteria set in paragraph 8 of the procedure. The F2I2-UCA, and in particular the established internal committee, shall evaluate the report issued as a result of the audit. As a final result of the established process, the F2I2-UCA will issue a certificate of Conformity of Production on behalf of the manufacturer. The established process is equivalent to the previous case with the following mean differences in:

• The process begins about two months before the expiration of the certificate. • The inspection may be carried out either on-site or online, depending on the specifications in the relevant

section. • The kind of on-site inspection will depend on whether the manufacturer is ISO 9001 certified • The deadline for accepting the continuation of the procedures is limited to 2 negative responses per file

and the process of withdrawal of approvals begins with the expiry of the certificate itself, regardless of the status of the process in which the file is located.

The process is defined in the flowchart in next Figure

Reduced in situ assessment of quality arrangements (CSC) (Product & complementary

arrangements)

Valid ISO 9001 or IATF 16949?

Complete in situ assessment of quality arrangements (CSC)

(QMS+Product & complementary arrangements)

Scheduling a date

Audit team appointment

Audit preparationAUDIT

Budget-Program

preparation

BUDGET - PROGRAM

CAP assessmentAdequate CAP or

Documentary assessment?

UCA Appoval

Invoice paid?

Send certificate to manufacturer and inform Approval

Authority

Corrective Action Plan

(CAP)

REPORT AND INVOICE

Evaluation report

Positive evaluation

Negative evaluation

Man

ufac

ture

r Acceptance of Budget-Program

Auditor and Manufacturer Communication

Max. 15 days

NO

Preparation of CertificateCoP Certificate

Conformity of Production

CoP expiration date

(On Site)


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5.- Case of several manufacturing plants The manufacturer must declare the manufacturing plants in both the corresponding approvals and F2I2-UCA , as they are subject to conformity of production. F2I2-UCA establishes that it is not necessary to carry out audits in all manufacturing plants, provided that minimum management conditions are maintained, as detailed below:

• Plants must maintain a homogeneous and demonstrable quality management system. • There is a department or responsible person designated to ensure the coordination of the CoP

requirements between the different plants. • Access is available, within a reasonable time, to the CoP records of the different plants. • The manufacturer/authorized approval manager ensures to maintain the responsibility of the CoP, and

therefore, compliance with the legislation on all approved and manufactured products.

Nevertheless, and given that there are different types of manufacturers and number of guaranteed plants, F2I2-UCA establishes criteria for carrying out on-site audits when there are multiple manufacturing plants, these are:

1. In case of any doubt that the above-mentioned criteria are being ensured, an on-site audit is determined for the manufacturing plant in the period established in the normal evaluation procedures.

2. In the event that the manufacturer has declared several manufacturing plants covered by the CoP certificate, the need to evaluate the file to assess the necessity to perform a complementary on-site audit in any of the plants declared is established (as a general rule it is established to perform an audit for every three plants included in the certificate). For this, aspects to be taken into account will be evaluated, such as the type of approved product (vehicles or components), the ISO certification of the plants, etc. This internal criterion can be met by replacing some of the documentary audits initially established with on-site audits.

3. The selection of the plants for performing the on-site audit is done by criteria of manufacture, logistics and

the number of approvals affected by each plant, keeping a certain sample approach in the selection and ensuring that it is rotated between plants in the successive evaluation procedures.

6.- Temporary cessation of production In certain situations, within the process of renewing CoP certificates, there may be cases of manufacturers not producing in the specified time. Given that providing evidence of the performing CoP controls on the production manufactured in that period is essential during the renewal process, and the inconsistency of not being able to provide evidence in this regard could happen. It is therefore necessary to foresee a temporary situation of the manufacturer where production is not carried out. This procedure is treated as follows: 1.- The manufacturer has a CoP certificate expiring shortly. 2.- F2I2-UCA is in contact with the manufacturer to request evidence for the renewal of the certificate, as discussed in points 3 and 4 of this procedure. 3.- The manufacturer declares that no production has been carried out in the requested period and it is not expected to reactivate it in the short term. It can also be the case that the manufacturer has obtained the initial assessment, but has not obtained approvals two years later and therefore has not produced. The production is understood as the application of the regulatory acts granted in some of the products manufactured and placed on the market (For example, the manufacture of a new vehicle with application of the regulatory acts that apply, the modification of a vehicle applying a “Informe H”, the manufacture of a catalyst, etc...) 4.- In order to admit this situation, F2I2-UCA requests a justifying document where the following aspects are clear:

o Production of the categories of affected vehicles and/or of the approved components has not been carried out in the requested period, nor is it expected to be reactivated in the short term.


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o Indicate the VIN number of the last vehicle produced and/or serial number of the component, system or separate technical unit approved, as well as the date of its manufacture, for all the approval numbers registered. In the case of carrying out major modifications in accordance with Royal Decree 866/2010, the VIN number of the last vehicle produced on which a modification has been carried out and for which a regulatory act has been applied must be indicated. For both cases, the number of manufactured and/or modificated units in which the approvals that the manufacturer owns during the last two years have been used must be listed.

o Copy of the last list of issued ITV cards. (if applicable) o Commitment to keep UCA informed as soon as the reactivation of partially paralyzed production

takes place.

5.- Upon receiving the request for non-control of Conformity of Production due to temporary cessation of production, F2I2-UCA will carry out a study and, in case of its admission, will close the ongoing renewal audit, taking the following decisions and actions:

o UCAnet is updated with the acceptance of the provisional suspension of the CoP for temporary cessation of production.

o A one-year period is given for review of the temporary situation of the company. o The billing process is stopped, if started, because this action is not billable. o No CoP certificate will be issued. o Renewal of this state is allowed for another year, after two years (two consecutive approvals) since

the beginning of this temporary status, the withdrawal process will begin. o Communication is sent to the applicant company allowing the temporary situation.

6.- Once a year since the approval of the temporary status has passed, the process to evaluate if the situation is renewable or a CoP audit must be carried out starts again. 7.- Two years after the initial approval of the temporary status, the process restarts in order to evaluate if the situation involves the activation of the CoP certificate by performing a CoP audit or the password cancellation process must begin. 7.- Scope extension In certain circumstances, the manufacturer may request the modification of the scope of the certificates for categories of vehicles, components or manufacturing plants other than those already covered by the issued certificates. For these cases, the manufacturer must complete the FT-PO.1-17 format, available on the website www.ucanet.es. Once this format has been received by F2I2-UCA , an auditor is appointed and may request the manufacturer to send additional explanatory documentation to evaluate the extension request. In general, the extension of scope is assessed on a documentary basis, where an on-site audit may be required based on criteria such as the level of finish of vehicles (complete, incomplete, completed), the applicable framework legislation (e.g. 2007/46/EC, EU R 168/2013, EU R 167/2013, RD 750/2010), the manufacturing process or product typology. Depending on the case, the extension of scope can be carried out with:

• Documentary audit, without altering the schedule of on-site audits. • Documentary audit, but performing the next audit on-site altering the schedule of on-site audits established

by the manufacturer. • On-site audit, altering the schedule of on-site audits established for the manufacturer

In all cases, the manufacturer shall be informed of the decision made through the FT-PO.01-19 extension report in documentary evaluations and the FT-PO.01-4 audit report in the event that the on-site evaluation is determined.


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Regardless of the evaluation process (documentary or on-site), the manufacturer must provide all the documentation requested on the form in advance. If necessary, the designated technical auditor may request such additional information. After evaluating the documents provided and if the result is positive, the new certificate of initial evaluation or Conformity of Production is issued including the new categories according to what is specified in the internal procedure PGC 11: procedure for issuing and withdrawing certificates. 8.- Criteria for establishing on-site audit and certified validity deadlines In the case of acceptance of the quality system evaluation by a third-party, F2I2-UCA establishes a system of “reduced” evaluation to paragraphs 2 and 3 to ensure compliance with all the specific requirements established by regulation. The internal requirement to assess the audit typology and access to this “reduced” evaluation format is determined according to internal requirements where, based on the different factors, the audit typology is determined. As a general rule, the specifics of this decision are:

• Difference between companies with third-party certification ISO 9001 or IATF 16949 and those without ISO 9001 or IATF 16949 certification.

• Assessment of factors such as the number of manufacturing plants, the entity's staff or the scope of certification

The duration and frequency of on-site audits are determined by several characteristics of the organisation being evaluated. As a general criterion, it is established:

• Vehicle manufacturers shall have regular inspections each year, interspersing documentary inspections with on-site inspections. As a general rule, there will be three-year cycles between on-site evaluations so that two documentary inspections will be carried out in that period.

• Component manufacturers shall have regular inspections every two years, interspersing documentary

inspections with on-site inspections. As a general rule, there will be four-year cycles between on-site evaluations so that in that period a documentary inspection will be carried out.

• The duration of the on-site audit is set out by adding the calculated days for each of the modules in which the audit is detailed, these being the audit of COP, the audit of ISC, the audit of reuse, recycling and recovery or the audit of the technical center of tachographs. The duration per module is estimated as:

o Conformity of Production: variable, depending on factors discussed above o ISC: 1 day o Reuse, recycling and recovery: 1 day o T. C. Tachographs: 1 day

The period of validity of certificates shall be determined based on their characteristics and the categories concerned. The deadlines are directly linked to the deadlines indicated in the previous section and will comply with the following table:


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Certificates Validity

IA certificate Vehicles 1 year From the first year the validity of the IA certificate is assured with the updated COP certificate Components 1 year

COP Certificate Vehicles 1 year No more than two consecutive documentary audits

shall be carried out between two on-site audits.

Components 2 years No more than one documentary audit will be carried out between two on-site audits.

Certificate of reuse, recycling and recovery 2 years

Certificate of T.C. Tachograph 1 year 9.- Annex FT-PO.1-1 EVI application letter form and manufacturer's file

FT-PO.1-3 Audit budget and program format FT-PO.1-4 Audit report format FT-PO.1-5 Assessment report UCA to PAC format FT-PO.1-9 Manufacturer exceeding deadlines communication letter format FT-PO.1-10 Renewal letter format (documentary) FT-PO.1-11 Response report UCA to PAC format (documentary) FT-PO.1-14 Audit plan format FT-PO.1-15 EVI file closing letter due to lack of certificate format FT-PO.1-16 File closing letter due to lack of E9/e9 format FT-PO.1-17 Extension of Scope Request. FT-PO.1-18 Evaluation Report, Stage 1 FT-PO.1-19 Evaluation Report, Scope Extensión. FT-PO.1-20 Evaluation Report, NC in Scope Extension.

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