Difference between revisions of "4.1.3 External assessment"

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== ​​​​​​​​A. Background & Definitions​ ==
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== A. Background & Definitions ==
 
External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately
 
External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately
  
  
== B. Guidance & Expectations​ ==
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== B. Guidance & Expectations ==
Depending on the resources, the External Assessment is performed by:
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The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.
* Contractor with formal training as auditor
 
* Peers
 
  
The aim of the External Assessment is to:
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The aim of the External Assessment is to examine the compliance of structures and procedures of an organization with the EQIPD QS.
* Examine the compliance of structures and procedures of an organization with the EQIPD QS  
 
  
The External Assessment is performed with checklists and in two different steps, where the first is mandatory and the second by chance:
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The External Assessment is performed with checklists and in two steps, whereas the first is mandatory and the second by chance:
 
* Remote Assessment
 
* Remote Assessment
 
* On-site visits
 
* On-site visits
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* Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them
 
* Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them
  
Update cycle
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The process for the External Assessment is described as follows:
* ​​Once per year
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# You can get in contact with EQIPD via Email (info@eqipd.online) to initiate your certification
* When needed
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# EQIPD will
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## Provide you with additional information about the assessment and answer your questions
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## Clarify costs, NDA and contracting
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## Ask for several relevant documents to be assessed, e.g.:
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### Study plans
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### SOPs / Method protocols
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### Publications
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### EQIPD stand-alone documents [[Documentation in EQIPD]]
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# Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents.
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# Random selection of Service Providers for onsite visit
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# Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
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# Final Assessment Report submitted to you
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# Award of the Quality Label in the name of EQIPD
  
 
'''PLEASE DO NOT FORGET​'''
 
* ​Make sure that the External Assessment is performed by qualified personnel
 
* Ensure that the external personnel has no conflict of interest
 
 
  
 
== C. Resources ==
 
== C. Resources ==
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----
 
----
  
back to [[Toolbox]]
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back to [[Toolbox]]
 
 
​Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]​
 
  
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Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]

Revision as of 12:44, 6 September 2021

A. Background & Definitions

External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately


B. Guidance & Expectations

The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.

The aim of the External Assessment is to examine the compliance of structures and procedures of an organization with the EQIPD QS.

The External Assessment is performed with checklists and in two steps, whereas the first is mandatory and the second by chance:

  • Remote Assessment
  • On-site visits

Examples for a potential assessment:

  • Reconstruct data and check critical items (checklist) by selecting a sample and track it back to the methods, equipment and freezer storage
  • Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them

The process for the External Assessment is described as follows:

  1. You can get in contact with EQIPD via Email (info@eqipd.online) to initiate your certification
  2. EQIPD will
    1. Provide you with additional information about the assessment and answer your questions
    2. Clarify costs, NDA and contracting
    3. Ask for several relevant documents to be assessed, e.g.:
      1. Study plans
      2. SOPs / Method protocols
      3. Publications
      4. EQIPD stand-alone documents Documentation in EQIPD
  3. Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents.
  4. Random selection of Service Providers for onsite visit
  5. Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
  6. Final Assessment Report submitted to you
  7. Award of the Quality Label in the name of EQIPD


C. Resources

to be added



back to Toolbox

Next item: 4.2.1 Installation of solutions, actions and mitigation strategies