Difference between revisions of "4.1.3 External assessment"

From EQIPD
Jump to: navigation, search
(B. Guidance & Expectations)
 
(14 intermediate revisions by the same user not shown)
Line 1: Line 1:
== ​​​​​​​​A. Background & Definitions​ ==
+
== 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​ ==
+
== B. Guidance & Expectations ==
Depending on the resources, the External Assessment is performed by:
+
[[File:External Assessment 210906.png|right|400px]]
* Contractor with formal training as auditor
+
The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.
* Peers
 
  
The aim of the External Assessment is to:
+
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:
+
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
Line 19: Line 17:
 
* 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
 
* ​​Once per year
 
* When needed
 
  
 +
The process for the External Assessment is described as follows:
 +
# You can get in contact with EQIPD via Email (info@eqipd.online) to initiate your certification
 +
# EQIPD, represented by a partner, will
 +
## Provide you with additional information about the assessment and answer your questions
 +
## Clarify costs, NDA and contracting
 +
## Ask for several relevant documents to be assessed, e.g.:
 +
### Study plans
 +
### SOPs / Method protocols
 +
### Publications
 +
### EQIPD stand-alone documents (more information here: [[Documentation in EQIPD]])
 +
# Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents
 +
# Random selection of research units for onsite visit
 +
# Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
 +
# Final Assessment Report submitted to you
 +
# Award of the Quality Certificate to demonstrate compliance with the EQIPD requirements
  
'''PLEASE DO NOT FORGET​'''
+
 
* ​Make sure that the External Assessment is performed by qualified personnel
+
'''​PLEASE NOTE'''
* Ensure that the external personnel has no conflict of interest
+
 
+
* The certification will be assigned for 3 years with a short remote assessment after 1 and 2 years.
 +
* You will receive a printed certification and a digital logo
  
 
== C. Resources ==
 
== C. Resources ==
Line 35: Line 46:
 
----
 
----
  
back to [[Toolbox]]
+
back to [[Toolbox]]
 
 
​Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]​
 
  
+
Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]

Latest revision as of 11:11, 20 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

External Assessment 210906.png

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, represented by a partner, 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 (more information here: 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 research units 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 Certificate to demonstrate compliance with the EQIPD requirements


​PLEASE NOTE

  • The certification will be assigned for 3 years with a short remote assessment after 1 and 2 years.
  • You will receive a printed certification and a digital logo

C. Resources

to be added



back to Toolbox

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