The activities for which it is necessary to retain documented information relate to the results achieved with the design, to the design reviews, to the design verifications, to its validation and to all the actions undertaken.
Why is this requirement of the standard necessary? Without evidence of the activities carried out and the results of these activities, it would be difficult to perform accurate reviews and make decisions. Any decision to proceed to the next stage of development or production must, therefore, be based on the facts and records collected in this stage of the work.
The documented information on the results to be achieved through the design and development process is usually recorded in the design and development plan in the form of process objectives and indicators. The documented information relating to the design and development reviews, on the other hand, is usually documented in a report because it represents objective evidence that may be required later to determine compliance with requirements, examine any design problems and compare similar projects.
Even when no problems are detected, the records of this review provide a baseline that can be referenced if changes need to be made later.
In this case, the report should have the consensus of the entire review team and should include at least the following information:
- the criteria according to which the project was reviewed;
- a list of the documentation that describes the project under review and any evidence presented that demonstrates that the project meets the requirements;
- the evidence of a decision-making process regarding whether the project should move to the next phase;
- the database on which the approval of the project was based;
- a record of any uncompleted corrective actions that derive from previous reviews;
- any recommendations and the reasons behind a corrective action, if present;
- the list of members of the review team and their respective roles, with reference to the work performed.
And we come to the documented information relating to the verification of the project. The results of the project verification include at least the following information:
- the criteria used to determine the acceptability of the project;
- the data certifying the standard of the project being verified;
- the methods used for verification;
- the data attesting to the conditions, structures and equipment used to conduct the verification;
- the list of measurements taken;
- the reference to the analysis of the differences, if any, between planned and achieved results.
In planning the verification of the project, it is necessary to take into consideration the results, their format and the content. The content, basically, is regulated by the design specifications but the data that must be recorded before, during and after the verification must be listed. Some data can be generated electronically and others can be collected from an observation operation repeated over time.
It is often necessary to collect, file, and assemble many different pieces of evidence in a dossier that has a secure format and that guarantees the accessibility of data over time. All these factors must already be clear before starting the project verification phase, so that all the necessary information is collected at the right time. After the verification, a report of the activities carried out will be necessary to explain the results achieved, the possible causes related to any variation that has been found and the recommendations for any action to be carried out.
As for the documented information relating to the validation of the project, the results of this design phase are similar to those required for the verification, except for the fact that the duration of the tests is important to quantify the evidence. The results should not only indicate that the product meets the requirements for the intended use but also that it is able to meet the needs of the market.
As with the verification of the project, it is necessary to consider the output, its format and its content provided at the beginning of the design phase, so that the correct data is acquired during the validation tests of the project. Finally, we have the documented information on the actions taken in relation to the problems detected during the design.
The records of these actions should include at least:
- the actions to be taken to remedy any differences found between the requirements and the results of the review, verification, and validation of the project;
- the actual actions that were then undertaken;
- the confirmation that the actions taken have definitively resolved the problem that had been encountered.