TIME
The expert needs one or two expert days to prepare the pre-assessment.The pre-assessment can be carried out within one week. Two days are typically needed for the system requirement assessment.
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Area of application
A pre-assessment takes place before an assessment by an accreditation body. As result of the pre-assessment, the assessor identifies and addresses potential open questions or nonconformities to prepare the laboratory staff for the assessment by the accreditation body.
The pre-assessment has two main components:
- Document check;
- On-site assessment executed as remote assessment.
In addition, for most standards there are the “System Management Requirements” and the “Technical Requirements”.
The goal of the pre-assessment is to make sure that the documentation is according to the requirements of the standard which is the basis for the accreditation. During the on-site assessment, the focus is on the implementation of the requirements.
Interaction
First, a virtual kick-off meeting takes place to discuss the pre-assessment. On this basis, a pre-assessment plan is established. The draft of the pre-assessment plan must be approved by the assessed laboratory.
Second, the documentation is sent to the system / technical assessor. During the review of the documentation, the assessor contacts the laboratory staff to clarify any open questions, if necessary (via email or messaging applications).
In the third and most important step, the assessor checks the implemented system in relation to the quality management and technical documentation and the basic requirements of the applied standard. In case of a remote assessment, the assessor checks the evidence, which can be presented as scanned document per shared screen or visually via a smartphone logged to the video conference.
A virtual pre-assessment is conducted by establishing a video connection to the office through a laptop and an additional login for the assessment of the laboratory. Experience has shown that a smartphone with a mounting device is useful for the second channel. It is recommended that one person is assigned to be the camera operator to ensure that the assessed person is fully concentrated on the practical demonstration.
Lastly, there is a closing meeting for feedback and planning of next steps. The most important elements of the closing meeting are:
- the assessor addresses strengths, objectives for improvement (OFI), and minor or major nonconformities (NC);
- NCs must be confirmed by the assessed laboratory and a deadline for corrective actions must be set.
Within four weeks of the closing meeting, the assessor delivers a draft report. The report needs to be confirmed by the assessed laboratory. Furthermore, the laboratory develops a cause-and-effect analysis for the NCs.
Virtual mode
A pre-assessment can be carried out on site at the laboratory or virtually. The advantages of a virtual pre-assessment are cost-efficiency and protection of the environment as the expert does not need to travel. The challenge is conducting the on-site assessment remotely. For a remote pre-assessment, it is strongly recommended that the assessor knows the assessed laboratory staff. The establishment of a relationship of trust with people unknown to the assessor in the stressful assessment atmosphere is very difficult.
METHODS
Pre-assessments are conducted according to the guidelines for auditing management systems (ISO 19011:2018).
Resources
BUDGET
The main item in the budget is the remuneration of the technical expert.
Travelling cost within Germany should be considered for hybrid assessments with two experts.
TOOLS AND TECHNICAL ASPECTS
A videoconferencing software is necessary for the virtual meetings between the technical expert and the staff of the laboratory going through the pre-assessment. It is recommended that the expert and laboratory staff agree beforehand on the software to be used and have all the necessary information at the beginning of the pre-assessment.
This is also necessary for liability reasons.
It is highly recommended to use commercial tools to ensure the stability of the connection. The variety in the practical work should be reduced.
Furthermore, both the expert and the laboratory staff should have a reliable internet connection as well as headphones and a microphone.
HUMAN RESOURCES
The roles typically involved in a pre-assessment are:
- Expert:
conducts the pre-assessment. An important pre-condition is that the system and technical expert have assessment experience and knowledge of the relevant standards for assessment e.g. ISO 19011:2018. It is mandatory that the assessor has knowledge of additional rules of the accreditation body. An example is the DAkkS rule 71 SD 00 11 “Usage of the accreditation symbol”. A good knowledge of the ILAC and EA guidelines and policies is also necessary.