The Applicant agrees to the following:
These rules set forth procedures for The PRI-CMT Product Validation Program (The VP) and the issuance, and maintenance of the Seal and Certificate of PRI-CMT Validation Program.
The VP is to assist those enforcing model codes in determining whether a given subject complies with those codes. Both the Seal and the Certificate of the VP are not meant to be construed as representing a judgment of other attributes not specifically addressed in the report, nor as an endorsement or recommendation for use of the subject of the Validation. Approval for use is the prerogative and responsibility of the Authority Having Jurisdiction.
2.0 BASIS OF EVALUATION
Evaluation of data is based on one or more of the published editions of the model building codes, state building codes, referenced standards or other industry standards as appropriate for the product under consideration. Additionally, evaluation of data will be based on applicable accepted engineering procedures, experience, and good technical judgement.
3.1) Applications for the VP and for revisions to existing Validations shall be communicated via here: Bwilson@pricmt.com. All applications and the following review shall communicate the following data:
-Identification of the product(s) to be certified
-What applicable published editions of the model building codes, state building codes, referenced standards or other industry standards as appropriate for the product under consideration for which the product(s) is to be certified?
-The physical location(s) of the plant where the product(s) are manufactured
-Any other information relevant to the scope of certification which is necessary for initial evaluation and surveillance.
This information may be collected in various forms and assembled by the Project Administrator into a single file for review.
An application may be filed only by the entity having rights to the materials, products, or methods of construction on which the Validation is sought. The applicant must have legal rights to all evidence and data.
A Validation may be revised when requested by the Certificate holder, when revision is required by the applicable code or standard or upon prior notice by PRI. When revision is required, PRI will provide prior notice and will include the date by which the Validation must be reissued.
The Validation holder may approve the issuing of a separate Validation under the name of a distributor (also known as a private label applicant). A Validation application prepared by the private label applicant shall be submitted. The private label Validation shall be inseparably linked to the original Validation. Any pertinent information in the original Validation shall be included in the private label Validation. The private label Validation shall have the same renewal date as the original Validation.
Applications for new Validations that are held for more than 30 days without receipt of supporting documentation may be closed out, unless extended by the Project Administrator.
4.0 EVALUATION PROCEDURES
The evaluation of the product will be clearly defined by the mutually agreed upon Services section on the fully executed Certification Agreement (CFCA2) between the VP and the Client.
All fees for the VP will be clearly defined mutually agreed upon Services section on the fully executed Certification Agreement (CFCA2) between the VP and the Client.
6.0 GRANTING OF VALIDATION
The VP will review the evaluation and all information and data collected for product(s) and grant an approval decision if it is determined the product(s) is found eligible for Validation.
7.0 MAINTENANCE OF VALIDATION
Validation for product(s) within the scope of the Certification Agreement shall remain in effect for the duration of the Agreement, so long as the manufacturing audits and/or validation testing demonstrate continued compliance with the Validation Program requirements. Upon expiration of the Agreement, product(s) may require full evaluation to renew and/or continue participation in the Validation Program.
8.0 CHANGES AFFECTING CERTIFICATION
8.1) The requirements for Validation are established through the evaluation of data is based on one or more of the published editions of the model building codes, state building codes, referenced standards or other industry standards as appropriate for the product under consideration. Additionally, evaluation of data based on applicable accepted engineering procedures, experience, and good technical judgement. When the any of the requirements above change, the VP shall be addressed and evaluated to ensure continued compliance with the certification scheme. Types of changes include:
-Revision to the one or more of the published editions of the model building codes, state building codes, referenced standards or other industry standards as appropriate for the certified product within the scheme. The Project Administrator will evaluate the changes to determine the time period for the manufacturer to meet the additional requirements if applicable.
-Requests for approval of changes to certified products. The manufacturer shall make a written request and provide documentation and/or proposed drawings showing these changes.
-Requests for approval of scale-up systems within the approved series. The manufacturer shall provide documentation and scale-up drawings which prove that the proposed product is directly proportional for the intended use.
-Unapproved changes to certified products. Unapproved changes discovered during surveillance are treated as non-conformances and shall follow the procedures outlined in Section 5.3.2. of Validation Program Manual
-Scope extensions. Requests for a scope extension under additional certification schemes shall follow the procedures for initial application for product certification Section 5.0 of Validation Program Manual.
9.0 REDUCTION, SUSPENSION, AND WITHDRAWEL OF CERTIFICATION
9.1) If the Validation Program discovers a non-conformance of a product or non-compliance by the client with the certification requirements, the VP shall determine, based on the severity of the non-compliance, the appropriate actions to be taken by the VP. Actions may include:
- Require the client to provide a reason for the non-conformance and a plan for corrective action taken within 30 days.
- Require the client to immediately ensure that any continuing production and finished inventory is complying.
- Increased surveillance intervals.
- Issue a recall or public notice regarding the affected products.
- Reduce the scope of certification.
- Suspend certification.
- As a last resort, withdrawal of certification.
If the action includes reduction in the scope, suspension, or withdrawal of certification, the Review & Decision Committee shall provide their approval before the action is carried out.
9.2) If the non-conformance is a change in which the client would like to be approved in the certification, The Validation Program shall follow the procedure for change requests outlined in Section 5.7.
9.3) Upon suspension, withdrawal, or a termination in the scope of a certification the VP immediately notifies the client of the decision in writing and modifies all formal certification documents to indicate as such. See Section 5.4. Any revised certification documents are provided to the client. The client shall be required to make the necessary changes to their production process regarding marked product as stipulated in the Agreement
9.4) It is the responsibility of the Project Administrator to assemble a plan for actions needed to end the suspension and restore certification in accordance with the certification scheme or any other required actions.
9.5) If the plan for reinstatement involves complete re-testing of the product, all applicable processes in Section 5.0 of the Validation Manual for product certification shall be followed.
Upon reinstatement of the certification status or a change in the scope of certification, the procedure for notifications and document modification and reissue in Section 5.8.3 of the Validation Manual shall be followed. The client shall be allowed to resume use of the Seal on the certified products.
Procedures for handling complaints, appeals and disputes
Any interested party may submit a complaint, appeal or dispute to PRI-CMT. Complaints, appeals and disputes shall be submitted to the Quality Manager by U.S. mail or via email (preferred method). Submissions should provide as much information and background data as possible in order to help CMT address and evaluate the issue. Contact PRI for a complaint form.
Upon receiving a submission, the Quality Manger investigates the issue and makes a decision on the complaint, appeal or dispute. The person making the final decision for the appeal or complaint shall not be a person involved in the initial certification of the product. Additionally, the person making the decision shall not have provided consultancy for or been employed by the client for which the complaint or appeal is subject for a period of at least two years.