EuroFIR Generic SOPs

1
EuroFIR Generic SOPs

• Susanne Westenbrink, Marine Oseredczuk, Mark Roe,
  Gaida Lapitajs
• Florence 07-05-2009

2
Results

• Compilation process
• 22 steps
• 11 critical steps
• 9 SOPs written and reviewed by compilers
• 2 steps are combined (14/15)
• 1 SOP not written lack of experience in Europe
  (18)
• 4 SOPs reviewed by UAG
• 9 SOPs on EuroFIR website

Thanks to authors and reviewers of SOPs
3
Work to be done

• Discuss and agree on content of generic SOPs
• Finalise contents based on discussion of generic
  SOPs by June 2009
• Harmonize SOPs (lay out, definitions used) by
  June 2009
• Integrate SOPs in EuroFIR QMS (document control,
  updates, approval)

4
What is required to achieve the objective of
generic EuroFIR SOPs?
Decision / agreement on the fundamental process
steps Decision / agreement on EuroFIR standard
requirements Contributions from all compilers to
ensure validity Decision / agreement on the QM
framework conditions
5
EuroFIR SOPs are generic can be adapted to
compiler specific SOPs

• Basic principle of generic SOP
• General description of the standard compilation
  process ? Best practise exercise
• Conform EuroFIR guidelines EuroFIR standard is
  mandatory and is described in generic SOP
• To be used as basis for EuroFIR compiler
  certification
• Compiler specific SOPs need to be written
• When other approaches which are optional are used
• When details from generic SOPs can not be
  fulfilled by compiler organisation
• When specific detail is needed in QMS of compiler
  organisation

6
Practical lessons in SOP writing as indicated by
Gaida Lapitajs (IRMM)

• When writing a SOP bear in mind the principle
• Write what is done do what is written
• the more you write the more you need to comply
  with
• KISS Keep it short and simple
• SOP is not a detailed working instruction
• Refer to reference documents rather than copy
  them

7
How to review generic SOPs?

• Does the SOP cover the EuroFIR requirements/guidel
  ines?
• Does the SOP describe
• the work to be done
• the necessary preventive and corrective measures?
• while being generic enough to be used by all
  compilers as a basis?
• Can the SOP be accepted by the compiler network?
  If no, which aspects of the SOP need to be
  improved during finalisation?
• Generic aspects
• SOP specific aspects

8
Points for discussionsuggestions indicated in
SOPs

• Generic
• Applicable to each SOP
• Part of harmonisation of SOPs
• SOP specific
• Concern the procedure described in the SOP
• Consensus needed per SOP (e.g. requirements
  mentioned)
• Any changes need to be made per SOP

9
Outline of SOP session

• Introduction
• Discussion on 2 SOPs in 9 small groups
• Discussion in 3 large groups indicate generic
  points for discussion
• Break
• Presentation of results by 3 groups and plenairy
  discussion on generic (and specific) aspects of 9
  SOPs
• Conclusions
• Identify persons to work on changes within
  deadline

• 10 minutes
• 20 minutes
• 45 minutes
• 30 minutes
• 50 minutes
• 10 minutes

10
Aim of this session

• List generic SOPs that are
• Agreed
• Not agreed
• List topics that need to be changed / harmonised
  / adapted
• Generic
• Specific
• Identify persons to work on changes within
  deadline

11
Groups to discuss SOPs
SOP 3 Paolo Colombani, Desislava Gyurova, SOP 8
Isabel Castanheira, Paul Finglas SOP 5
Simonetta Salvini, Ian Unwin, SOP 11 Tue
Christensen, Luisa Oliveira SOP 6 Patrizia
Gnagnarella, SOP 13 Verena Nowak, Gül Löker
SOP 8 Bernd Hartmann, Heikki Pakkala, SOP 14/15
Emilio Martinez de Victoria Munoz SOP 11
Andreia Porto, Carine Seeuws, SOP 16 Effie
Vasilopoulou SOP 13 Olafur Reykdahl, Albertas
Barzda, SOP 20 Anders Moller, Benny Keshet
SOP14/15 Janka Porubska, Heli Reinivuo, SOP
3 Lucinda Black, Simone Bell SOP 16 Ase
Borgejordet, Maria Parpinel, SOP 5 Aida Turrini,
Jayne Ireland SOP20 Irene Mattisson, Maria
Glibetic, SOP 6 Wojciech Daniewski, Dace Santare
SOP 3 SOP 8 Paolo Colombani, Desislava Gyurova
Isabel Castanheira Paul Finglas SOP 5 SOP
11 Simonetta Salvini, Ian Unwin Tue Christensen
Luisa Oliveira SOP 6 SOP 13 Patrizia
Gnagnarella Verena Nowak Gül Löker
SOP 8 SOP 14/15 Bernd Hartmann Heikki Pakkala
Emilio Martinez de Victoria Munoz SOP 11 SOP
16 Andreia Porto Carine Seeuws Effie
Vasilopoulou SOP 13 SOP 20 Olafur Reykdahl,
Albertas Barzda Anders Moller Benny
Keshet SOP14/15 SOP 3 Janka Porubska/Heli
Reinovo, Lucinda Black Simone Bell SOP 16 SOP
5 Ase Borgejordet, Maria Parpinel Aida Turrini
Jayne Ireland SOP20 SOP 6 Irene Mattisson Maria
Glibetic Wojciech Daniewski Dace Santare
12
(No Transcript)
13
Users Advisory Group review of 4 SOPs on
EuroFIR website

• Generic
• Duplication of definitions and abbreviations
• Inclusion of appendices good
• Specific
• SOP14-15 guidance on significant digits helpful
• SOP16 check if water and macronutrients fit to
  the recipe
• SOP16 more guidelines for imputing values
  helpful
• SOP16 guidelines how to deal with
  oligosacharides helpful
• SOP16 checks needed for derived nutrients that
  are not calculated from each other