780 CMR, ch. 110.00, 780 CMR 110R3, 110.R3.3

Current through Register 1536, December 6, 2024

Subsection 110.R3.3 - Certification of Manufacturer

110.R3.3.1General. An entity which maintains a quality assurance program in conformance with a quality assurance manual in accordance with this section may apply to the Office for certification as a manufacturer. An entity seeking to become a manufacturer or a manufacturer seeking to renew a certification shall submit an application to the Office for approval. These applications will include, but not be limited to: a quality assurance manual and a fee. A certification shall be issued for an application that meets the requirements of 780 CMR 110.R3, or the Offices shall notify the applicant of the reasons for refusal. Certifications first issued and renewals of certifications shall be valid for a period of one year.

110.R3.3.2Quality Assurance Manual. The quality assurance manual of a manufacturer shall consist of the requirements contained in 780 CMR 110.R3. It is the responsibility of the manufacturer to execute every aspect of this manual. The manufacturer shall continue to be responsible for all corrective actions required and the contractual relationship between the manufacturer and the TPIA shall not diminish such responsibility. The manufacturer shall cooperate with the TPIA by providing all necessary reports, information, documents, records, facilities, equipment, samples and other assistance for assuring compliance with 780 CMR 110.R3. The manual shall be comprehensively indexed, and shall treat the material listed here in detail, as follows:

1. A procedure for periodic revision of the quality assurance manual;

2. An organizational structure for implementing and maintaining the quality assurance program and its functional relationship to other elements of the organization structure of the manufacturer, which structure shall provide for independence from the production department; company officers and employees in charge of the quality assurance program shall be identified, and their training and qualifications specified;

3. A uniform system of audit (in-depth analysis of program effectiveness and means to identify deficiencies) to monitor the quality assurance program periodically;

4. Complete and reliable records of manufacturing and site operations, if any (suitable means of storage, preservation and accessibility of copies of forms to be utilized shall be included);

5. A system to control changes in production or inspection procedures within the manufacturing facility;

6. A system to assure that working drawings and specifications, working instructions and standards, procurement documents, etc. conform to the approved building system;

7. A serial number system for buildings or building components; and

8. The method of safekeeping, handling and attaching labels and identification of those employees responsible therefore.

9. Materials Control.

a. Procedure to assure effective control over procurement sources to ensure that materials, supplies and other items used in production and site operations, if any, conform to the approved plans, specifications and quality requirements;

b. Procedures for inspection of materials, supplies and other items at the point of receipt;

c. Method of protection of materials, supplies and other items against deterioration prior to their incorporation in the certified buildings or building component; and d. Provision for disposal of rejected materials, supplies and other items.

10. Product Control.

a. Procedures for timely remedial and preventive measures to assure product quality;

b. Provision, maintenance and use of testing and inspection;

c. Provision for frequency of sampling inspections;

d. Provision of necessary authority to reject defective work and carry out compliance assurance functions, notwithstanding any conflict with production department goals and needs;

e. A schematic of the manufacturing operation showing the location of inspection stations or areas, and "hold" points for mandatory inspection characteristics;

f. Inspection and test procedures, including accept/reject criteria and mandatory inspection characteristics;

g. Standards of workmanship; and

h. Provision of disposal of rejects.

11. Finished Product Control.

a. Procedure for final inspection of all product before shipment to the site or storage point, including identification and labels;

b. Procedures for handling and storing all finished product, both at the manufacturing plant or other storage point and after delivery to the building site;

c. Procedures for packing, packaging and shipping operations and related inspections; and

d. Procedures for transportation, including all measures to protect product against damage while in transit, and setting forth the modes of transportation to be utilized and the carrying equipment and procedures.

12. Installation Control.

a. Installation procedures including component placement or set, equipment and procedures, field erection and finishing work, utility connection instructions and all appropriate on-site inspection criteria and test descriptions; and

b. Organizational provisions for field repair and disposal of rejects.

13. Permission for Inspection. The manufacturer shall provide the Office with written permission, signed and notarized, for the Office to inspect manufacturing facilities, products, and building sites under his or her control at any reasonable time without prior announcement.

14. Shall contain detailed plans for inspections by the Office or the TPIA.

780 CMR, ch. 110.00, 780 CMR 110R3, 110.R3.3

Adopted by Mass Register Issue 1532, eff. 10/11/2024.