Acceptance test plan

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

Cmcial documentation needed in the development phase includes end-user manuals, a unit test summary report, a user acceptance test plan, results of the database design, results and methods employed in the source code evaluations, and a trace-ability analysis. A source code traceability analysis verifies that all code is linked to established specifications and established test procedures. 

Site acceptance test plan and results are documented (if applicable)... 

Complete the Acceptance Test Plan with ICT-related tests. 

Acceptance testing is defined as the point at which the development team relinquishes its testing responsibility to an independent acceptance test team. The independent acceptance test team is to determine whether or not the system now satisfies the original system requirements. An acceptance test plan is developed, and the phase ends with successful running of aU tests in the acceptance test plan. 

Operating manuals and critical spares list Diagnostic procedures Calibration procedures and schedule Acceptance test plan and procedure... 

It is important that you inform the subcontractor through the contract of how the product or service will be accepted. Will it be as a result of receipt inspection at the specified destination or as a result of acceptance tests witnessed on site by your authorized representative These details need to be specified at the tendering stage so that the subcontractor can make provision in the quotation to support any of your activities on site. If you have invoked ISO 9001 in the subcontract, you are protected by clause 4.6.4.2. If you have not, you need to specify a similar provision in your subcontract, otherwise you may lose the right to reject the product later. There is no requirement for you to document your proposal to verify product at the subcontractor s premises but such a plan would indeed be a useful section in any quality plan that you produced. (See also Control of subcontractors in this chapter.)... 

Test plans should include definite, measurable acceptance criteria, in addition to the amount of testing to be done. The test plan should include the data sets to be used and the detailed instructions for testing. Errors encountered during testing must be documented, including how they were discovered, their description, and any action taken to remedy the error. Errors must be remedied prior to the release of the software or computer system. Test results must be documented clearly to allow for pass/fail determinations to be made. 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

Installation of fire water underground as early as possible Performance acceptance test Quality assurance inspections Emergency plan/drill... 

Expert systems can also be used off-line as advisory systems. If some leeway is left in the process specifications, operators can even be instructed to make simple variations in the process. Hajicek developed an expert system for troubleshooting injection molding, which was designed to be used by operators to adjust controls as needed whenever part quality suffered [20], These expert systems do not necessarily plan an entire cycle. As we will see in the section on in-process control, however, they can be used to do so. There are even specifications that include rules for altering the cure cycle in response to the results of quality acceptance tests such as flow and volatiles, a primitive set of heuristics. 

The test chapter section will include information about purpose, test documentation, review and approval, formal test plan, and test execution. Testing the spreadsheet should take all requirements into account. Tests using known cases and data including known results have to be developed. The data set used for testing should include representative data. If applicable, tests should also include data sets that will test values that exceed the anticipated range of normal operations and check for data close to the acceptance criteria limits. Data that make no sense (text in a numeric field) or are not allowed to be used in the calculation should be considered in the testing phase as well. The simplest test to validate a spreadsheet calculation is to perform a manual calculation and document it. All tests performed, results expected, acceptance criteria for the tests, and procedures for alternative calculation (e.g., manual calculation) will have to be documented. Persons who perform the testing have to be trained appropriately and must be mentioned in the documentation. 

Recommendation 2-4. The Army should prove, through testing, an acceptable technique for capturing emissions of heavy metals—particularly cadmium and mercury—from the metal parts furnace when processing mustard-filled projectiles. An acceptable disposal plan for accumulated heavy metals must be included in the modified baseline process or any other process. 

A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies process equipment, critical process parameters/operation ranges, product characteristics, sampling, and test data to be collected, number of validation runs, and acceptable test results [1],... 

The qualification protocol serves as a test plan to verify and document that a specific qualification has been satisfactorily completed. The qualification protocol and acceptance criteria are based upon the respective life-cycle specifica-... 

Qualification protocol A prospective experimental plan stating how qualification will be conducted, (including test parameters, product characteristics, production equipment, etc.) and decision points on what constitutes an acceptable test. When executed, a protocol is expected to produce documented evidence that a system or subsystem performs as required. 

The scope of the system generates many of the support requirements for the operations, usually provided by the system owner. The term requirement defines a bounded characterization of the scope of the system, and contains information essential to support the operation/operators. Some of these requirements include functional capacity, execution capability, operational usability, information needed to support validation, installation, commissioning, SLC documentation required, user s manuals, training, maintenance manual, system maintenance, system test plan, acceptance criteria, and regulatory compliance (e.g., Part 11). 

In this schedule, the performance (or acceptability) testing are planned in the second semester of 2012 and could go on up to the first semester of 2013. Thus, this schedule should match the objective of first tests of H2 production by 2013. 

As with the quality control plan for the formulator described above, acceptance tests on adhesives should be directed toward assurance that incoming materials are identical from lot to lot. However, this plan should also extend to the receipt and control of incoming adherends and other materials used in the bonding process. 

Validation Plan contained no instructions pertaining to what constitutes acceptable test results. [FDA 483, 2002]... 

Review quality plans and key validation documents (i.e.. Validation Plan, Requirements, Test Plan, Test Results, Acceptance, Record Retention (Archiving and Change Control)... 

Conversely, if the supplier s Quality Management System is very well written and there is documented evidence that the supplier adheres to it, the definition of risk levels might be relaxed a bit in the Function Risk Assessment. If the supplier s own acceptance testing is well documented and thorough, the Validation Plan should document the intent to reference some of the supplier testing in lieu of internal tests. It is not necessary to specify exact tests to be used at this point that can wait until the test plans are being prepared later on. 

Written in advance, the test plan defines all test procedures with their pass/fail criteria, expected test results, test tasks, test environment for equipment and computers, criteria for acceptance and release to manufacturing, and the persons responsible for conducting these tests. The test plan also specifies those functions excluded from testing, if any. Individual tasks cover functional testing, simulation of incomplete functions as integration proceeds, mathematical proof of results, records of discrepancies, classification of defects and corrective actions. 

Test plans with acceptance criteria and test cases... 

While the previously described tasks can be considered as rather straightforward, the issue of the suitability determination of apparatus, equipment and computerised systems may involve complex investigations, inquiries at the manufacturer or vendor, extensive acceptance testing and validations and/or vendor audits in order to render these systems GLP compliant. Most certainly the amount of work involved in these aspects will necessitate the prioritisation of the various systems in use at the test facility. In the assumed case of a test facility having been in operation for some time already, albeit not under GLP, these apparatus and systems may be credited to a certain extent with the assumption of suitability for their purposes. In a first round, therefore, only the relevant documentation already available on their performance need be collected, while a formal retrospective evaluation and acceptance testing may be deferred to a later time point. The policy document of test facility management dealing with the time plan for the introduction of GLP should include therefore also a timetable for such further activities to be performed after the successful implementation of GLP. 

Consistent and appropriate change controls, capable of tracking the software operations, are a vital element in the control process. All changes must follow carefully planned procedures, be properly documented, and, when appropriate, include acceptance testing. 

---