Product Sign-Off

For medium-risk components, the supplier will manage the quality process just as he would for a low-risk component. However, Chrysler will perform a formal Product Sign-Off (PSO) for the component, described in more detail later. 

All levels of development testing for the computer system must be fully documented and provide test records in the form of approved test procedures, signed-off test result sheets, and reports. For system parameters, data, and functions that are critical to product quality and GMP compliance it is beneficial that the test procedures align with qualification test requirements, and record... 

Batch production records are correct and suitably signed off. 

The XXXX form that documents approval to migrate the program to the production environment was not signed off by Quality Control. [FDA 483, 2002]... 

Applications to make changes to the PA should be addressed to the variations section of the 1MB. In principle they are handled in the same way as applications for a PA. When the application is received it will be assigned to the most appropriate member of the professional staff, and will be subject to the same process of review as a product application. If the application is fairly routine it can be signed off quickly and sent to the administrative section and the Board. In more complicated situations such as for a new therapeutic indication, it may be necessary to involve the advisory sub-committees. In the event that the variation is considered unacceptable, even after dialogue with the applicant, the same rejection procedure is invoked as for a product application. 

After the testing is complete and the code is corrected for errors, the software is released for production and distribution. The product is considered ready for release when it has met all the criteria specified in the quality plan and after formal sign-off by product line, quality assurance, and manufacturing management. A prerequisite for this is sufficient training of service engineers who must be able not only to install and operate the software but also to train users and answer users questions. Availability of user documentation in the... 

The report should be signed off by the person responsible for the evaluation and assessment of the product files. 

Empty chamber studies are sterilizer specific. Further process validation work is product specific (load specific) and may be done with dummy product if required. If this option is exercised, care must be taken to ensure that dummy loads are truly representative of genuine product. Scrap product is ideal for this purpose but may not be readily available for high cost products (e.g.. cardiac pacemakers). If good product is used in validation, it should nut be released as sterile until the validation program has been completed and signed off as satisfactory. 

For non-critical steps or series of steps in production, where there is no need to have each step signed off or to record data, the instructions and precautions may be given in brief together with a reference to a standard operating procedure. 

Boisjoly wrote that a quahty assurance manager had once advised him that when faced with a tough question of whether a product was acceptable he should ask himself, Would you allow your wife or children to use this product without any reservations If I could not answer that question with an unqualified Yes, he said, I should not sign off on the product for others to use. That is what ethical analysis of acceptable risk should be. Boisjoly (1987), p. 11. 

Before a project can be started, some preparation is needed. In the past, it was often the case that RE methods assumed that RE was performed for a specific customer, who could sign off a requirements specification. However, RE is actually performed in a variety of contexts, including market-driven product development and development for a specific customer with the eventual intention of developing a broader market. The type of product will also affect the choice of method RE for information systems is very different from RE for embedded control systems, which is different again from RE for generic services such as networking and operating systems. 

The person responsible for the preparation process will place a final signature before the product or batch is transferred for final check. The final sign off will be placed by the person responsible for the quality of the product. 

A safety professional will sign off on the change plans considering the provisions of our Design and Procurement of Equipment and Facilities Procedure and on the New Product Development process. 

Complete service SMP formally reviewed and signed off HL and safety analyses updated as matter of routine from variety of inputs (i.e. HL process integral to observation report (OR) process). Unit-level tools used consistently. Some formal safety analyses. Safety justification production partly automated. All staff aware of safety issues and responsibilities. PSE fiilly embedded in project and influential on all key staff Full higher management support. A formal service model used. 

The team is designed to break down any barriers that may exist between production, maintenance, employees, and the leadership team. To close this potential gap, the team uses a peer-to-peer approach to ensure that the safety-related hazard and associated risk is assessed. The intent is to involve the employee, ensure that the work order is valid, and that the hazard and associated risk is vaUd and needs to be corrected. When the work order is completed, a member of the follow-up team discusses the issue/conditions with the employee who requested a hazardous issue be corrected. If the employee agrees with the correction, then the work order is signed off and closed. 

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