Kinetix Quality Services personnel have experience in developing and maintaining Nuclear Quality Assurance Programs for utilities and vendors. The process of developing a program to meet NQA-1 requirements is a journey that commonly takes about six months, depending upon the QA Programs and Procedures currently in place. The process that Kinetix follows is outlined below and can be customized based on a customer's specific needs.

Conduct Gap Analysis

This is normally the first step in the process. We can conduct a comparison of your existing quality program to that of an NQA-1 Program. This will allow us to identify areas of your quality program that need to be enhanced.

Prepare NQA-1 Quality Manual

The NQA-1 Quality Manual is the top level document that comes into play when a purchase order is received with nuclear requirements. We can develop the NQA-1 Quality Manual to reflect the systems and documentation necessary to meet NQA-1 requirements. This can either be a stand alone document, or NQA-1 requirements integrated into your current quality systems manual(s).

Develop and Tailor Level II Procedures/Systems

NQA-1 requires documented procedures for all applicable elements of the quality system (18 Criteria). We can work with you to design and document the required systems and procedures. We can also provide the forms necessary to provide the records detailed within each procedure.

Identify and Review Level III Documentation

Level III documentation refers to product or process specific instructions, i.e. work instructions, test instructions, equipment specific calibration procedures, packaging instructions, etc. We can help you identify the instructions and procedures needed to support your processes and be compliant with NQA-1. These procedures typically require detailed product or process knowledge; thus it is proposed that you generate these procedures. We would then review the procedures for effectiveness and compliance with NQA-1. If desired, we can work with your personnel in developing the Level III documentation.

Provide NQA-1 Training for Personnel

Successful NQA-1 implementation requires personnel involvement, support and an understanding of their role in meeting the requirements. This joint training presentation by Kinetix and your management will provide an overview of NQA-1, as well as the plan for implementing an NQA-1 program. The objective is to ensure that all personnel acquire an understanding of the NQA-1 and commitment to "their" plan.

Implement New Procedures/Systems

After generating revised quality system procedures, the revised procedures must be implemented by your company. On rare occasions, "it looked good on paper" happens. Kinetix will work with your company to resolve all NQA-1 quality system implementation issues.

Provide NQA-1 Lead Auditor Training

The requirements for Lead Auditor certification are specifically delineated in NQA-1. These requirements include attending an NQA-1 Lead Auditor training course and participating on five audits prior to certification (one of which needs to be nuclear). Kinetix is a leader in providing this training and holds these courses several times a year. An alternative is to sub contract the various required audits in lieu of having your own NQA-1 Lead Auditors.

Nuclear Vendor Qualification

Your company will be required to qualify the vendors supplying nuclear materials and services. This will involve the conduct of on site NQA-1 audits or Commercial Grade surveys of suppliers and/or evaluation of third party audits or other documentation. We can lead the audits/surveys of your suppliers with your prospective lead auditors participating on the audit team, allowing them to obtain credit towards their lead auditor certification.

Conduct Internal Audit

Your company will be required to perform internal audits to the NQA-1 nuclear requirements. We recommend that an internal audit be conducted of the newly implemented program by an auditor not involved in the development of the program. Kinetix can provide this independent auditor and will assist in resolving any findings as a result of the audit.

On-Site During Nuclear Customer Audit

Kinetix can be on site during the first customer audit to assist with the audit and any corrective actions that may result. This will complete the NQA-1 quality system implementation.

We can develop an overall plan for your NQA-1 Program development providing whatever level of support meets your needs; anything from full blown development of your program, procedures and documentation, to phone consultations and review of procedures and documentation.