Technical Instruction

/ CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)

Technical instruction

CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM

(EXPLOSIVE FOR CIVIL USESAND PYROTECHNICAL ARTICLES)

These technical instructions provide basic information for obtaining a certificate, in accordance with the

Directive2014/28/EU on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses

and

Directive2013/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles

Agencija za prostore ugrožene eksplozivnom atmosferom – Ex-AGENCIJA
Industrijska 25, HR-10431 Sveta Nedelja
Tel/Phone.: ++ 385 1 36 67 260 Fax.: ++ 385 1 36 67 262
/ PQC-TU-PRe-ekspl/6
/ CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)

1.INTRODUCTION

The purpose of these instructions is to clarify the procedure of certifying the quality assurance system of a manufacturer who produces explosive for civil uses or pyrotechnical articles. This procedure applies to the certification of the quality assurance system, based on Modules C2, D or Eof Directive2014/28/EU and Modules C2, D or E of Directive2013/29/EU (in further text The Directive).

These instructions do not contain the procedure of type certification (per Module B of the Directiveswhich is described in the instructions on Certification od explosive for civil uses and pyrotechnical articles (TU-CERT-ekspl).

2.INITIAL AND RE-ASSESSMENT (Surveillance)

The quality assurance certification by Ex-Agencija consists of: examination of the documentation (with regard to conformity and preparation for assessment), on-site assessment of the quality assurance system and elimination of any nonconformity ascertained. Once these nonconformities have been successfully eliminated within the given deadlines, a Quality Assurance notification is issued with an expiration date of 1years (Modules D and E. The quality assurance certification procedureis repeated before the notification expires.

For Module C2 it is carried out batch tests for every production batch of explosives for civil uses/pyrotechnical articlesaccording the relevant parts of the harmonized standards and/or equivalent tests set out in other relevant technical specifications in order to verify the quality of the internal production control measures and conformity to type.Whenthe results of testing the test samples and conformity assessment with the requirements of satisfactory Certificate of conformity to typeis issued for that batch ofexplosives for civil uses/pyrotechnical articles..

Ex-Agencijaprepares an auditplan for independent on-site assessment of the quality assurance system. This plan and the time necessary to implement it are determined according to the complexity of quality assurance system and the production plant, the number of type certificates, as well as any other relevant information (e.g. the existence of other certificates for the quality assurance system, or number of locations if production is carried out at various facilities). If there are several manufacturing locations, the assessment of the quality assurance system is implemented at those locations deemed necessary. For Module C2 Ex-Agencija reviews documentation for products that will be tested and certifiedanddefines number of test samples for batch testing.

If the client wishes a revision or supplement to the scope of the notifiction already issued, the client must submit a request in writing. Ex-Agencija will evaluate the request and notify the client within 14 days regarding approval/denial of the request, and specify the activities and deadlines necessary for completion of work.

The re-assessment (surveillance)for Modules D and E is performed according to the following schedule:

-before the expiration date of the Quality Assurance notification,

-immidiately, if quality system has been changed and the change has influence to conformity with the Directive.

The re-assessment (surveillance)involves evaluation of any changes in quality assurance documents and a on-site assessment in the production plant. The purpose is to check the function of the system and its further compliance with the requirements of the quality assurance notification issued.

Periodic re-assessment(surveillance)is performedaccording to the same procedure as the initial assessment, along with the results and remarks from previous assessments which are now taken into consideration. Also, greater emphasis is placed on the efficiency of the quality system, the aim towards continuous improvement, realization of one’s own goals and expected results, as well as monitoring and adapting internal and external changes (e.g. legal or standard related), for the purpose of maintaining compliance of the certified scope of the quality system with the requirements of the corresponding standards and regulations.

3.SUBMITTING AN APPLICATION

To initiate the certification process, manufacturers or their representatives submit request and relevant information about its quality system and scope of assessment. The applicant can use form C-3-5 (available on Ex-Agencija’s website). The application is then assessed and if the inquiry is clear, the client is sent an offer and Agreement. If the offer is acceptable the client submits an order and the Agreement signed by manufacturer, and sends documentation on the quality assurance system, as specified in Modules of the Directives. Ex-Agencija confirms receipt of the order and initiates work.

In the same way is used to submit a request for a re-assessment (surveillance) or supplemental notification; that is, to expand the scope of the notification.

4.ASSESSMENT OF THE QUALITY ASSURANCE SYSTEM(Modules D, E i H)

The assessment of the quality assurance system is carried out in accordance with Modules D and E of Directive 2014/28/EU and Modules D,Eand H of Directive 2013/29/EU. If the results are satisfactory at the end of the procedure, Ex-Agencija issues the client a Quality Assurance Notification. This notification is issued with an expiration date of 1year. At the end of 1 year period re-assessment (surveillance)should be performed.

Assessment of the quality assurance documentation

Ex-Agencija evaluates compliance (according to EHS requirements or with the use of harmonized standards) of the quality assurance documentation with the Directive. The quality assurance documentation should be written in either English or Croatian. The use of a third language can also be agreed upon if this is acceptable to both parties.

If during the examination the documents find any deficiency (which are, or may become nonconformities), the user is then notified of those findings, which should be clarified and/or eliminated before the on-site assessment.

On-site assessment of the quality assurance system of the client/manufacturer

After the documentation has been assessed, in agreement with the client Ex-Agencija prepares a plan of on-site assessment at the manufacturer. The assessment plan, as needed, can also include an on-site assessment of the supplier, who may be considered relevant to the characteristic of explosive for civil uses or pyrotechnical articles that the client intend to produce, in accordance with the Directive2014/28/EU or Directive 2013/29/EU.

The client may request exclusion of any member of the assessment team or ask changes to the schedule. If the client does not provide any objections to the plan in writing, Ex-Agencija presumes the client has accepted the assessment planand members of the assessment team.

During the assessment Ex-Agencija observes implementation of the quality assurance system, and its compliance with the DirectiveModules D or E and other harmonized standards applied. The
on-site assessment includes the following mandatory procedures:

-checking compliance with all requirements of regulations and standards applied,

-assessing the implementation of the quality assurance system, with regard to anticipated effects in accordance with the requirements of regulations and standards applied,

-assessing the quality assurance system and its ability to meet the contractual, legal, normative and technical requirements (e.g. the company's registration with the court, requirements of the applied protection type, etc.), which are essential in verifying the compliance of the existing quality assurance system,

-monitoring processes within the company,

-executing internal audits and management reviews,

-management's responsibility for the policy and objectives of quality assurance,

-any other legal, technical and standard requirements (for applicable types of protection) relevant to validating compliance of the existing quality assurance system.

The results of the assessment are presented at the final meeting, led by the lead auditor. All significant findings and conclusions of the assessment team are presented at the final meeting, including any eventual non-conformities, remarks and/or opportunities for improvements, and brief meeting minutes are compiled. Non-conformities are presented in a manner that is clear to the client, and that reasonable deadlinesto eliminate the non-conformities are mutually arranged.

The final meeting as a rule also includes:

a)familiarizing the client wth the fact that an element of uncertainty always exists in the information and evidence gathered during the audit through methods of information sampling,

b)method and deadlines for the preparation of the assessment report,

c)further procedure and obligations of the client for eliminating non-conformities and deadlines for their elimination, as well as consequences in the event the non-conformities have not been eliminated,

d)deadlines in which the client must provide a proposal of corrective actions for non-conformities,

e)further procedure for Ex-Agencija,

f)information on the procedure of processing complaints and appeals.

A concise version of Minutes is presented during the final meeting, and if deemed acceptable, the document is signed by all parties. If an additional assessment is performed at the site of the supplier (considered essential for the explosion protection of Ex-products the client wishes to manufacture), those results are also recorded in the Minutes. Based on the results of the on-site assessment the client (if necessary) examines the cause of any non-conformity found and initiates corrective action. The client then notifies Ex-Agencija of these activities.

Evaluation of results of the conformity assessment and issue of Notification

Based on the data gathered once the on-site assessment is finished, the assessment team prepares an assessment report that contains all relevant information on the established quality system.

Once all nonconformities have been eliminated, Ex-Agencija evaluates compliance with the requirements. Based on the information gathered during the certification process and the corrective actions performed, a decision is made regarding certification of the client's quality assurance system. If the corrective actionsare satisfactory, the decision is positive and a quality assurance notification is issued.

If the results of the assessment do not comply with requirements, Ex-Agencija will notify the client accordingly, citing the reasons for denying issue of the notification.

5.ASSESSMENT OF CONFORMITY TO TYPE (Module C2)

6.SUSPENSION, WITHDRAWAL AND COVERAGE REDUCTION OF THE QUALITY ASSURANCE NOTIFICATION

There are four main reasons for suspending a quality assurance notification:

-if Ex-Agencija determines that the manufacturer is not adhering to conditions stipulated in the agreement,

-if the quality assurance system does not continuously fulfill the requirements of regulations and applicable standards,

-if the client does not permit the performance of a surveillanceassessment or does not wish another reassessment,

-if the client requests a suspension of the certificate.

A notification is temporarily invalid during suspension. If the notification has been suspended, per the Agreement the client is obligated to cease using the Ex-AgencijaNumber and discontinue all references to the Ex-Agencijanotification in any advertising media. Ex-Agencija will on its web site clearly declare that the notification is suspended.

Ex-Agencija will request an explanation from the manufacturer and try to resolve any problems within a reasonable time-frame, but no longer than 6 months. If the issue is resolved, the suspended notification/IECEx QAR will be returned to “valid” status. In case an agreement cannot be reached, Ex-Agencija will, in accordance with the Agreement, withdraw the notification or reduce its scope.

If the user’s quality assurance system is only partially non-compliant with the requirements of regulations and standards, and the part in question can be excluded from coverage without significantly affecting the rest of the quality assurance system, Ex-Agencija can reduce the scope of the notification to incorporate only those parts of the system that comply with regulations and standards.

7.OBJECTIONS AND COMPLAINTS

Any objections/complaints the client may have concerning the quality assurance notification issued, or any other unfavorable decision made by Ex-Agencija throughout the certification process, must be submitted to Ex-Agencija in writing. If the complaint is not in writing, Ex-Agencija will proceed in the manner it deems appropriate. Unfavorable decisions include:

-denial of applications,

-refusal to continue an assessment,

-requests for repair work,

-changes to the coverage of the quality assurance notification,

-denial, suspension or withdrawal of the quality assurance notification

-any other activities that prevent the client from acquiring and/or maintaining the quality assurance notification.

Ex-Agencija will process the objections/complaints according to procedure B-15, which can be provided on request.The complainant will be notified of Ex-Agencija’s position on the matter in writing. Ex-Agencija will attempt to resolve the issues by agreement within a reasonable time-frame, but no longer than 30 days. If the objection/complaint has not been resolved in a positive manner, the client may submit an appeal to the appropriate authority.

Before a decision is reached, the information in the complaint is reviewed and analyzed, and the client is informed of the results in writing. Records are kept on all complaints and actions implemented.

Any person or organization can express dissatisfaction to Ex-Agencija (where a response is expected) regarding its activities or the activities of the manufacturer whose quality assurance system has been certified by Ex-Agencija.

Ex-Agencija will assess the significance of the complaintand, if the complaint is justified, undertake the appropriate actions needed. The procedure of handling complaints is considered to be strictly privileged information, for the protection of both the complainant and Ex-Agencija clients.

If the complaint is not in writing, or is received from an unidentified source, Ex-Agencija will proceed in the manner it deems appropriate. If such need is indicated, Ex-Agencija will (with the permission of the complainant and the client) stipulate the conditions under which the content and resolution of the complaint may become public information. Ex-Agencija will attempt to resolve the issues by agreement within a reasonable time-frame, but no longer than 30 days.

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