Integrated Management

Systems Review 2021

 Table of contents
Integrated management systems annual review
2021 reporting and 2022 and multiannual objectives/roadmap
1- IMS-wide changes, findings and deliverables:
2021 results and
achievements

➢ standards and objectives

➢ hierarchy and repository of docs;
➢ EFSA architecture standards
➢ outcome of (re)-certifications, audits, NCs

2- IMS specific review and achievements

2.1 - Legality and regularity (Internal Control Assessment)
2.2 - Quality and performance (include evaluations & CI)4-
2.3 - HSSE

3- 2022 risk register and mitigation actions

2022 objectives

4-IMS-wide 2022 and multiannual roadmap objectives and activities / deliverables:

➢ standards and (re)-certifications;
➢ hierarchy and repository of docs;
➢ EFSA architecture standards

5- IMS 2022 specific objectives:

➢ Legality and regularity
➢ Quality and performance
➢ HSSE
General context – Major developments in 2021

EFSA
Major
Developments
in 2021

3
EFSA Integrated Management System

4
Scope of IMS Process Improvement Initiative

Define and map EFSA’s Management Systems

Develop a roadmap for IMS implementation

Phase I
(2021)
Implement some IMS roadmap actions

Identify opportunities for the individual MS

Identify and implement additional actions at

Phase II more granular level
(2022-
2023) Implement the IMS roadmap

5
 Introduction on Management Systems and
Integrated Management System
A Management System (MS) is considered a set of policies, processes and procedures utilized by an organization to
ensure the fulfilment of tasks required to achieve its objectives. In particular, the objectives can be related to several
topics such as legality and regularity, quality of products and services & organisational performance, environmental
performance and health and safety in the workplace.
MS standards are designed to be applicable across all economic sectors and to organizations operating in diverse
geographical areas with different cultural and social conditions.
Plan-Do-Check-Act Approach
One fundamental principle is that all standards can work together.
For this reason, management standards have been structured utilizing the
same high-level structure. In particular, Management Systems are based on the
ACT PLAN 4-element Plan-Do-Check-Act (PDCA) approach, which represents a dynamic
process cycle used by organizations to achieve continual improvement.
The abovementioned approach combines planning, implementing, controlling
and continual improvement, as the organization learns from the resolution of
any issue it may encounter. Below an overview of each element:
CHECK DO 1. Plan: establish objectives and process;
2. Do: implement the process as planned and ensure their operation;
3. Check: monitor and review processes and activities with regards to the policy
and the objectives set;
4. Act: take actions to continually improve the performance of MS.
Most importantly, the PDCA approach aims at supporting the
organizational performance in achieving MS objectives.

6
Introduction on Management Systems and
Integrated Management System

Integrated Management System

Improved Performance

An Integrated Management System (IMS) Streamlined process/Eliminating

Redundancies
integrates all objectives, requirements, and POTI
elements of an organisations management
standards into a single framework. Benefits Reduction in documentation
Having an IMS should ensure compliance to
the requirements of each management Consistent objectives and KPIs across
multiple systems
standard and allow units and actors throughout
the organization to work together with unified
objectives and efficiency. Improved clarity to the organization

ICF Reducing Management Systems

Maintenance

Integrated follow up of improvement

ISO actions
ISO
22301 9001
ISO
45001

7
 Introduction on Management Systems and
Integrated Management System
Below an illustration of the building blocks of an IMS with an explanation of the meaning of each block:

MANAGEMENT STANDARDS,
GOVERNANCE AND PROCESSES, PROCESS
OBJECTIVES AND
ORGANIZATION CHECKS & CONTROLS
REQUIREMENTS Tasks
ICF and ISO standards that set Entities (Units)/Actors responsible for Processes related to the IMS for
out requirements aimed at managing part of the IMS and for which common elements (e.g.
supporting an organization in ensuring accountability and integrated/coordinated audit) could
achieving MS objectives. transparency. be combined to create synergies.
Checks and controls to be
performed based on the relevant
management systems.

DOCUMENTATION AND INFORMATION TOOLS & IT TOOLS

Process Charters, EFSA's Repository of Registers (Risk Register, Register of findings

governance documents (which /recommendations, actions, etc.) and other
includes IMS Policies, Manual, SOPs, WINs) instruments that support the achievement
and records (including the ones and the implementation of the IMS.
encompassing checks and controls) to Software tools that enable to run correctly,
support and enable the implementation of oversight and manage the implementation and
management standards. maintenance of the IMS.

8
EFSA Management System Integration|
Standards & integrated objectives
EU/MS REGULATIONS, ICF
1) effectiveness, efficiency and economy of operations;
2) reliability of reporting;
3) safeguarding of assets and information;
4) prevention, detection, correction and follow-up of fraud and irregularities; and
5) adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account the
multiannual character of programmes as well as the nature of the payments concerned.

Quality Management HSSE

(ISO 9001)
Business Continuity

ISO MSs
OH&S Management (ISO
Consistently meeting customers’ 45001: 2018): eliminating and
Management (ISO 22301:
expectations through the products 2019): increasing ability to
Standards and services provided
minimizing OH&S risks, while
improving the performance
respond to and recover from
disruptive events
(objectives)
Information Security
Environmental Management Management (ISO 27001:
(ISO 14001: 2015 & EMAS): 2017): safeguarding data security
managing organization’s from security risks, threats and
environmental responsibilities impacts

Methodologies
Better regulation guidelines
Programme/project management PM2, COSO

Hierarchy of Documents & Repository of EFSA's governance documents (internal)*

*More details from slide 15

 EFSA Management System Integration|
Lines of accountability
EU (FR, staff, Founding) /MS REGULATIONS, ICF

Standards HSSEBusiness Continuity

OH&S Management

MSs
ISO
Management
Quality Management
(ISO 9001) Environmental Information Security
Management Management
(ISO 14001 & EMAS)

LEGALITY AND QUALITY AND SAFETY AND SECURITY

Objectives REGULARITY PERFORMANCE (ICF n. 1 (ICF n. 3; ISO 45001, 14001, 22301,
(ICF n. 4 and 5) and 2 - ISO 9001) 27001, EMAS)

Audit & RMIC

External
audits

3rd
Line of MB Audit
accountability Committee
(overall assurance,
meta Quality Management Safety and Converged Security
analysis/synthesis)
Accountability
Workplan/strategy Council –
Financial, contract Physical and chaired by the
planning and ED/Empower
2nd Line of mgt (G&P and staff), information security,
accountability monitoring, Budget/re HoD
competing interests, safety, business
(specific controls) sources (ftes/posts/co
PAD, confidentiality continuity... IMS Committee
mpetences) – chaired by
the Audit &
RMIC Process
1st Line of Manager
accountability All EFSA Processes, all process architects, owners, managers on their own processes

10
Objectives & Assurance Pillars reporting

LEGALITY AND REGULARITY QUALITY AND PERFORMANCE SAFETY AND SECURITY

(ICF n. 4 and 5) (ICF n. 1 and 2 - ISO 9001) (ICF n. 3; ISO 45001, 14001,
Objectives 22301, 27001, EMAS)

01 Audit Management
03 Risk Management
04 Internal Control

Legality & Regularity Compliance

Security & Business Continuity

Performance management

Information Management
Continuous improvement
Assurance

Quality Management
Financial Reporting
pillars

Health & Safety

Evaluation
NEW

06

10
09
07

11
08
05

12
02
Roadmap for the implementation|
EFSA’s Integrated Management System

Accountabilit
y Policy
IMS integration in GAP IMS Manual & IMS Register Integrated pre-
Single external new process charters Analysis SOP on IMS Objectives and workflow certification
ISO auditing
body,
HSSE integration
Risk based
internal quality
audits
Surveys/feedback
integration
Dec. 2021 Jan. 2022 Jan. 2022 Mar. 2022 Dec. 2022 May-June 2023

Nov. 2021 Dec. 2021 Jan. 2022 Feb. 2022

Jun. 2022 Jan. 2023 Oct. 2023

Recording of findings, Full Management IMS Coordinator Awareness

Internal Audit Integrated
recommendations & implementati Review and IMS Training
using integrated External Audit
actions on of the Meeting governance
audit checklist
Hierarchy and IMS Process
Corrective/ repository of 12
Implementation
Preventive Actions docs
 EFSA Management System Integration|
Actions/opportunities
EU Regulations & ICF MS
Quality Management HSSE
Standards (ISO 9001)
OH&S Management
Business Continuity

MSs
ISO
Management

Environmental Information Security

Management Management
(ISO 14001 & EMAS)

Objectives LEGALITY AND REGULARITY PERFORMANCE AND QUALITY SAFETY AND SECURITY

➢ Integrated MS Map ➢ Integrated Policy (accountability)

➢ Integrated documentation & single hierarchy of documents process ➢ Definition of a common SOP
(Quality management) ➢ IMS Coordinator
➢ Integrated indicators framework ➢ Management Review Meeting
➢ Integrated decision-making bodies (council & committee) ➢ Awareness training sessions
➢ Harmonized follow-up action template and non-conforming reporting in ➢ Integrated findings, recommendations, and actions register
ERW ➢ IMS Manual & Objectives

➢ EPA integration of quality, risk management ➢ Integrated audit templates

and business continuity, data protection ➢ Integrated audit documentation
Integration ➢ Integrated risk-based planning for the internal ➢ Conversion of the documents from other
roadmap quality audit programme management systems into the QMS format
➢ Single auditing body ➢ Integrated internal and external audits

• Register of the
➢ Quality Policy • Policies and Handbooks
interested parties
➢ Surveys alignment/centralisation • Form to record internal
Some items identified at this level will require further • Register containing the
➢ Annual alignment of EPA, Organization and external factors
analysis of the needs
analysis to see whether they need to be integrated at design, enterprise architecture, L&D plan • Register for the
and expectations of
a higher level (ISO or ICF) ➢ Further, competence – based linking of EPA assessment of the
interested parties
For a more detailed analysis, please refer to the IMS charters with Department/Unit Charters and internal and external
• Internal Documents
MS Map resource management with post management factors
register
13
Actions currently to be commenced/ongoing
Maintain the IMS|
Annual Cycle 2022 (IMS SOP)
Below it is provided an overview of the main checks described in the IMS Standard Operating Procedure that are recurring
in the view of continuous improvement:

February April-May September

Overview of main outcomes of the Check and approval of EPA,
Org Design in time for the Status of the IMS to be presented
previous year, risk register
planning cycle n+1 and plan to the Accountability Council prior
update and objective setting for the
for related POTI to external audits. This ensures
year for the Integrated Management
architeture/standars updates management that IMS is in
System. Internal and external IMS
to be performed (e.g. EPA, compliance with all standards.
audit plan and controls discussed
OrgDesign/DMF..). Changes Approval of EFSA’s corporate risks,
and agreed.
approved by Accountability to be integrated in the SPD.
Formalisation of the Management Review
Council end May.
meeting utilizing the Management Review
05
01
Report with Accountability Council 03

02 04 06
January- February June- September December
Review/Update of As part of the annual planning cycle, IMS Committee meets to discuss
Hierarchy/Repository of documents Process Managers review their outcome of completed audits
is done - ensuring that the respective EPA Charters. Risk (internal/external), discuss non-
documentation of each Management management exercise is conformities etc in preparation for
System is in compliance with EPA and performed. IMS Committee Management review meeting with
any recommendations/findings from Coordination performs a quality Council in Feb. Needs for trainings
audits. Relevant committee members + check.) on IMS are discussed/agreed.
owners of Document process.
IMS Committee Accountability Council and IMS Committee involved 14
IMS|
ISO IMS Hierarchy

Accountability policy

Quality Policy HSSE Policy Information

Management
Policy

IMS Manual

IMS SOP

Individual WINS
IMS wide|
Hierarchy & repository of EFSA documents
Entire triangle is the Hierarchy of
Documents.
All the levels with the exception of Policies 4 High # of docs
Records* will constitute the
Repository.
Further distinction within the categories
can be made between documents to be Implementing rules/ Rules of procedures 257 (136 SG)
managed centrally (Repository) vs
the ones that are under the
responsibility of the Units (outside
the Repository) Processes/procedures 102

New in the
Repository Administrative Acts/ Contractual Acts 49

101 docs cleaned from Working Instructions 153

Repository (outdated,
duplication etc)
Records
Architectures
EPA3 New Organigramme

P O

Technology Architecture T I
Work ongoing
Maintenance, updating
and alignment of
EFSA’s Architectures
to be part of the IMS
and piloted in 2022
 IMS 2021|Results and achievements
Audits overview
IAS Audit on Procurement and Grant Award Processes |
ECA Financial, Legality & Regularity Audit
0 critical / 1 very important observation
3 important recommendations*

ISO 9001:2015 ISO 45001: 2018 ISO 22301: 2019 ISO 14001: 2015
All EFSA’s ISO certification’s

Business
were confirmed in 2021

Quality OH&S & EMAS

Management Management Continuity Environmental
Management Management

Surveillance Surveillance 1st Re- Surveillance

Audit Audit Certification Audit
0 non-conformities 0 non- 5 Minor non-
conformities 0 non-
0 findings conformities
conformities
.

*More info on slide 13

 Internal control|
Nonconformities
During 2021, EFSA recorded 81 deviations A proactive approach has been adopted: for recurring issues, NCs have been
16 ex-ante inserted in the workflow by Unit/Department following general or specific
65 non-conformities scenarios, in order to better identify and follow up on the mitigating actions
14
12
10 L&R
8
6 ECA 2021 recommendation: Omission to register
4 the late publication of contract award notice in the
2
0 ERW (Financial, Legality and Regularity Audit)

Financial…

Amendm…
A-…

Expert…
IQA ISO…

EC…

Contract…
EC…

Commit…
Staff Reg
POL 002
ED CIM
SOP 005
SOP 006
SOP 007
SOP 009
SOP 010
SOP 012
SOP 013
SOP 014
SOP 017
SOP 020
SOP 033
SOP 039
SOP 045
SOP 049

Others
Internal Control Framework Principle 12

EFSA Policy on Independence, ED

on Competing Interest
Management and SOP
039_Management of Competing
SOP 007 Risk Assessment of Generic Mandates and SOP 012_Risk Interests:
Assessment of applications: Linked to the unfeasibility of recording tollgates 15 NCs related to DoIs’ submission
for the pre-Transparency mandates/dossiers on the Case Management tool and assessment were detected, due
to the malfunctioning of the new DoI
SOP_014_Publishing a scientific output in the EFSA Journal- Updated as IT tool
a result of the high number of non-conformities around the 14WD after adoption WG on Independence set up.
to be sent to EFSA Journal IMPRUL_110_CIM 28 09 2021
temporary processing of Declaration
Opportunity: HSSE non-conformities overview reported of Interest in contingent exceptional
separately since currently not inserted in ERW circumstances
Objectives & Assurance Pillars reporting

LEGALITY AND REGULARITY QUALITY AND PERFORMANCE SAFETY AND SECURITY

(ICF n. 4 and 5) (ICF n. 1 and 2 - ISO 9001) (ICF n. 3; ISO 45001, 14001,
Objectives 22301, 27001, EMAS)

01 Audit Management
03 Risk Management
04 Internal Control

Legality & Regularity Compliance

Security & Business Continuity

Performance management

Information Management
Continuous improvement
Assurance

Quality Management
Financial Reporting
pillars

Health & Safety

Evaluation
NEW

06

10
09
07

11
08
05

12
02
Legality and Regularity|
Internal Control Assessment | 2021 Achievements
Audits & Certifications
▪ ECA Financial, Legality and Regularity Audit 0 critical observations
▪ IAS Audit on Procurement and Grant Award 0 critical/very important observations
▪ IAS Internal Audit Plan 2022-2024
▪ Follow-up on very important outstanding recommendations Action plans on track or ready for
review
▪ EFSA Audit Plan 2022-2024
▪ Single provider Certification audits driver for integration
▪ ISO certifications All ISO certifications confirmed in 2021
Internal Control
Assessment Monitoring Criteria
Sources ▪ 2019 Discharge granted
▪ ECA's clean audit opinion on reliability of the accounts and legality & regularity of transactions
1. Audit ▪ Anti-Fraud Strategy New EFSA Anti-Fraud Strategy and Implementing Rules
2. Monitoring Criteria ▪ No transmission or follow-up of any suspicion of fraud to OLAF
3. Control Activities ▪ Risk Management exercise Carried out against newest EPA 3
4. Continuous Monitoring ▪ Number of exceptions and non-conformities within target
(Exception reporting) ▪ EDPS inspections and follow-up on track
▪ CERT-EU implementation of recommendations on track
▪ Managerial onboarding programs Ongoing

Control activities
▪ Independence No Conflict of Interest identified
▪ User Access Rights Management
- Access rights granted in ABAC in line with delegations
- Annual review DMS Access Rights extended scope
▪ Finance
- Public Procurement Committee Recognized in grant procurement and award process by IAS
- Financial verification on mass payments within threshold

Continuous monitoring (Exception reporting)

▪ Exception register | Outcome ECA review IUCLID exception

Legality and Regularity|
Internal Control Assessment | 2021 Weaknesses
Audits & Certifications
▪ ECA Financial, Legality and Regularity Audit 2021 1 very important recommendation
▪ IAS Audit on Procurement and Grant Award 2021 3 important recommendations
▪ Follow-up ECA one outstanding difference in opinion from 2017 position Accounting Officer
▪ Follow-up IAS four important recommendations not implemented within agreed timelines
Documentation of the monitoring of grant and procurement procedures (IAS 2021) Action plan
behind schedules
▪ Documentation of grant and procurement procedures
▪ Two recommendations on the EFSA staff DoI Management
Internal Control ▪ Implementation of the Oracle Fusion Performance management tool
Assessment
sources Monitoring Criteria
1. Audits ▪ Mandatory training Attendance rate
2. Monitoring Criteria ▪ Financial impact of exception NCs Above threshold
3. Control Activities
4. Continuous Monitoring
(Exception reporting)
Control Activities
▪ Independence One Competing Interest Management Compliance & Veracity Check in 2021
▪ Human Resources
▪ Monitoring time and leave management Reporting tool not available
▪ Remuneration cap for outside activities Ongoing

Continuous monitoring (Exception reporting)

▪ Independence
▪ Expert Declaration of Interest Technical issues IT solution
▪ EFSA Staff Declarations of Interest
▪ Finance
▪ IUCLID SLA between EFSA and ECHA Financial impact
▪ Omission to register the late publication of contract award notice ECA
 Legality and Regularity |
IAS/ECA 2021 recommendations overview
RATING AUDIT RECOMMENDATION INITIAL REVISED OWNER STATUS
TARGET TARGET
The summary table shows
2021 Q2 2022 NA FIN Open the state of play of all
1. DURATION TEMPORARILY OCCUPATION MANAGERIAL POSTINGS (ECA)
outstanding audit
Very recommendations.
2020 2. ACCUMULATED BATCHES OF WORK OF THE RE-EVALUATION OF SAFETY OF Q4 2021 NA FIP Ready
important
FOOD ADDITIVES AND ENZYMES (IAS)
2019 Q4 2020 NA HuCap/LA/ Ready
3. WEAKNESSES IN THE TIME MANAGEMENT PROCESS (IAS) TS
4. DOCUMENTATION OF THE MONITORING OF GRANT AND PROCUREMENT Q4 2021 Q2 2022 FIN Open
PROCEDURES (IAS) All are ready for review or
on track except for four
Q3 2021 NA FIN Ready
5. TIMING OF CONTRACT SIGNATURE AND DECLARATION OF HONOUR (IAS) recommendations
2021 that will not be
6. PROCEDURE AND DOCUMENTATION DECLARATION ABSENCE CONFLICT OF Q3 2021 NA FIN Ready implemented within
INTEREST AND CONFIDENTIALITY IN THE PROCUREMENT AND GRANT AWARD agreed timelines.
PROCESS (IAS)
Out of these, two
Q4 2021 NA FIP/HuCap Ready
Important 7. STAFF EXPERTISE, BACKUP ARRANGEMENTS AND TRAINING (IAS) recommendations are still
open beyond 6 months
Q4 2021 NA FIP/GPS Ready from the initial target
8. MONITORING (IAS)
2020 deadline of
Q4 2021 NA ISO/DMO/ Ready implementation and these
9. ACCESS RIGHTS AND PUBLIC INFORMATION (IAS) ART will be reported as such in
10. FOLLOW UP AND APPROVAL OF DECLARATIONS OF INTEREST FROM EFSA Q4 2021 Q2 2022 LA Open the Annual Activity
STAFF (IAS) Report.
Q4 2020 Q4 2022 HuCap/TS Open
11. WEAKNESSES IN APPRAISAL AND PROMOTION EXERCISE (IAS)
2019 12. MONITORING REMUNERATION CAP OUTSIDE ACTIVITIES AND Q2 2020 Q2 2022 LA Open
MANAGEMENT OF CONFLICT OF INTEREST (IAS)
Objectives & Assurance Pillars reporting

LEGALITY AND REGULARITY QUALITY AND PERFORMANCE SAFETY AND SECURITY

(ICF n. 4 and 5) (ICF n. 1 and 2 - ISO 9001) (ICF n. 3; ISO 45001, 14001,
Objectives 22301, 27001, EMAS)

01 Audit Management
03 Risk Management
04 Internal Control

Legality & Regularity Compliance

Security & Business Continuity

Performance management

Information Management
Continuous improvement
Assurance

Quality Management
Financial Reporting
pillars

Health & Safety

Evaluation
NEW

06

10
09
07

11
08
05

12
02
Quality and performance|
Status of 2021 QMS objectives
2021 Objectives- Status
# Objective Status Actions
1 Prepare for and run surveillance audit
Maintained ISO Implement internal quality audit cycle
9001:2015 Customer feedback interviews with SANTE / Customer/stakeholder survey
certification
Close gaps and lean process documentation (SOPs/WINs)

2 Update of EPA (EPA III) for the 2021 planning cycle

EFSA’s QMS updated in
line with TR measures Update Quality roadmap in line with the Strategy 2027
and strategic needs Adopt Quality Policy

3 Adopt Accountability policy by year end

Develop and implement EFSA’s integration of management systems roadmap
Integration of
management systems Operationalise hierarchy and repository of normative documents implementation

Integrated indicators framework: review of KPIs and PPIs in line with strategy

4 Run Process Improvement Initiatives (Lean), communicate results achieved

Implement Continuous
Improvement Process Deploy L&D plan on process management and lean

Achieved/on track Partially achieved Deprioritised/postponed 25

 Quality and performance|
Customer Feedback
DG SANTE Feedback: 2021 overview
A mix of written procedure and interviews was employed in order DG SANTE Feedback
to cover the same number of opinions, whilst minimizing the effort
2022
Positives
The interview template has been
Good collaboration of SANTE and EFSA Units updated for the current cycle to
General satisfaction with the timeliness and length of opinions receive feedback on the “Abstract”
at the request of EFSA Journal.
Continuous alignment between EFSA and SANTE on items opinion’s This addition was welcomed by
template was highlighted as very useful
SANTE colleagues
EFSA’s willingness and availability to answer questions, clarify doubts
and present information to interested parties EFSA Strategy Reputation
Survey 2022
Areas for attention:
Specific Actions for improvements were identified for 7 out of 14 Customer/stakeholder survey to be
outputs merged with the Reputation
barometer
General point for attention: The new EFSA Strategy Reputation
The importance of having a strong leadership and guidance survey to become one single
from the EFSA Panels’ chairs was highlighted. annual survey as of 2022.
This has been an observation that has come up in previous years, To be launched in the first half of
and for which some closer monitoring is needed. the year
Quality and performance|
Internal Quality Audits

Most of the non-conformities identified cover

2021 overview issues detected in the EPA Process Charters:
missing risk identification on respective
Process Risk Registers, lack of risk rating
and mitigating actions adopted.
➢Mix approach for auditing based on
interviews and document check
type audit in order to minimize
burden on Units.
➢Number of interview style audit: 8
2022 selection
➢Number of document check audit: 4 approach
➢New IMS template used
➢ 12 process variants audited Unit’s to be audited have been
➢ 5 Non-Conformities, 15 Opportunities selected avoiding those that will be
for improvement, and 7 Best Practices potentially audited externally (ISO
found or otherwise).
Should this approach be continued,
or should the Internal Quality Audits
be used as prep for other audits?
Quality and performance|
Overall EFSA performance 2021

Using the % of KPIs reaching or surpassing target as mean of analysis, EFSA registered a performance in line with the previous year. In
particular, SO1 registered the same performance as last year (with even an almost identical # of questions closed, 704 vs 697), whilst the other
SOs registered some minor deviations (around 5 p.p.), with the exception of SO2 (-9 p.p., mainly due to overplanning in terms of # of questions
closed).

28
Quality and performance|
Overall EFSA performance (2017-2021)

Performance within the “on target” area (77%-83%) between 2017 and 2019. A drop emerges in P1 2020, due to the impact of the SARS-CoV-2 pandemic, with also P2
2020 registering similar results. These two periods can be considered being the “acute phase” of the pandemic. Since September 2020, the performance moved away from the
red area but it remained behind the 2019 levels, also due to the impact of the TR on EFSA’s operations (resources needed to implement the provisions, effect of the adaptation to
new tools/procedures, delay of the efficiency gains expected from the ART programme).

To be noted that:
• despite the recent challenges and hurdles, SO1 and SO5 were safeguarded, with their performance at the end of 2020 (SO1:77%; SO5:90%) and 2021 (SO1:78%; SO5:85%)
within the “on target” area and in line with the average performance registered within the strategic cycle (80% and 83%, respectively).
• SO3 and SO4 registered a positive average performance but a drop can be seen in the past two years, also due to consequence of the re-prioritisation of activities to react to the
SARS-CoV-2 pandemic.
• SO2 saw the least positive average performance (68%). To be noted that this areas has very few indicators, and this can affect the robustness of the analysis
29
Graph is showing the % of KPIs reaching or surpassing targets over total, weighted by average amount of resources (budget+FTEs) spent in each SO between 2017-2021. Dotted lines represent the performance of each SO over the
reporting periods. Some adjustments have been carried out to minimise the impact of different measurement cycles among the various KPIs
Quality and performance|
EFSA performance by type of KPI
INTERMEDIARY IMPACT KPIs

Stable and positive performance across the

years. To note that some of these KPIs have a
OUTCOME KPIs
long (once a year or once every 2 years)
measurement cycle

OUTPUT KPIs
Performance registers a decrease over
time. However, the performance in absolute
terms can be considered positive (around
75% of the indicators reaching targets)

Clear drop in the past two years, with SARS-

CoV-2 and TR implementation impacting
EFSA’s operations

Graphs are showing the % of KPIs reaching or surpassing targets over total. Some adjustments have been carried out to minimise the impact of different measurement cycles among the various KPIs. Green bar shows the expected
performance as per targets in the SPD (80% for Intermediary Impact KPIs, 90% for Outcome KPIs, 95% for Output KPIs, which were stable targets over the years).
 Quality and performance|
Resources Management - Budget

Budget transfers

Commitment execution:
€ 19.1M (100%, target 100% met)

Payment execution:
€ 106.8M (89%)
Personnel
• Non-differentiated credits: € 91.3M (87% € 52.9M -> € 53.1M
out of target 90%)
• Differentiated credits: € 15.5M (100%, Operations € 2.4M € 0.4M
target 100% met)* € 61.6M

Carry forward to 2022

(C1 non-differentiated credits): € 13.7M
(13%, out of target <=10%)

Cancellation of C8 credits € 0.4M

(non-differentiated credits carried forward
from 2020): 4%
Infrastructure
€ 14.7M -> € 14.5M

* Differentiated payment budget has been increased following budget amendment (€ 1.5M) and transfers in
from non-differentiated credits
Internal transfers between chapters
31
Quality and performance|
Deep dive – RA main indexes
Timeliness of adoption and number of questions closed –
Performance over the years
The overall (all SOs) timeliness of adoption showed a decrease over the
years, due to the issues of increased workload (large batches of work and
the arrival of several new tasks since 2017) and increased complexity of
EFSA’s Risk Assessment. However, in 2021 an increase y-on-y was
registered, mainly due to the fact that COVID-related issues that emerged
in 2020 were not registered in 2021. The drop in P4 2021 is due some late
adoptions mainly in the areas of flavourings and MRLs

2021 performance 10% below target (785) but in line with 2020
figures. Compared to pre-COVID years, however, there is a decline in
terms of finalisation of outputs, with the impact of the pandemic
(in 2020) and the changes brought by TR (in 2021) adding up on the
issues of increased complexity and increased workload mentioned
above.
Quality and performance|
Process and Project Performance
Overall performance Overall performance
of EPA processes of EPA projects

2020 2021 2020 2021

(Targets adjusted after COVID
prioritization)

Process performance in 2021 showed some deteriorations compared to 2020. The delta y-on-y is mainly explained by teething
issues in the new/enhanced activities impacted by TR (foreseen volumes/timelines not in line with actuals) and impacts of
other changes (such as adaptation to new tools/procedure/providers). Moreover, last year’s assessment was done taking into
account the targets after COVID, which also contributes to explain the deterioration y-on-y.
The 9% of grey processes refers to processes part of the EPA 2.5 framework that were not active in 2021 (either because not
fully defined or not triggered).

The project performance, instead, shows minor improvements in all the dimensions, with the issues connected to delays in
finalization of projects and risks (mainly related to implementation, especially for the science-related development activities)
Quality and performance|
Performance
Activities carried out in 2021

Run Development
• Central insertion of all process metrics related to EPA 2.5 in units’ • Revision of the EFSA Performance Framework and revision of all
workplans to facilitate a more regular measurement process metrics to align them with EPA 3.0 processes
• Creation of an interactive dashboard on process metrics for units to
have an at a glance overview of their process performance / as a tool
to support the ISO 9001:2015 audit

On average, 6 metric/process have been put forward, with stronger

control in the area of RA (9 metrics/process).
When applicable, synergies with Strategy KPIs have been created.

In the context of the new Performance Framework, we have also created

(albeit the work is not finalized yet) dedicated fiches per each metric
to capture elements like scope and measurement method. The aim is to
systematize knowledge and increase the likelihood of a stable
measurement over the years.
 Quality and performance|
Performance of external providers
Contract terminations, reduction in payment & application of liquidated damages for delay

2020 2021
Termination 2 3
Liquidated damages 4 cases = 6,667 EUR 3 cases = 6,633 EUR
Payment reduction 3 cases = 92,087 EUR 8 cases = 176,756 EUR

There was overall good performance in line with previous years, any performance deviations did not have any considerable
impact when looking at the whole EFSA budget.
The overall increase in number (8 compared to 3 cases in 2021) is linked to take-over of IT services by a new contractor, for
which three separate cases of payment reduction were registered, albeit for low amounts, due to quality issues in the first
months of take-over and implementation. The high EUR amount overall for payment reduction is linked in particular to
three specific cases:
- 1 payment reduction of 75k in a grant for benchmark dose analysis where, despite the methodology described in the
specifications, the beneficiary insisted to apply their own methodology using only analogous models in the model
averaging framework. This was not in compliance with the specifications, nor acceptable to EFSA
- 1 payment reduction of 63k due to quality issues in the data migration under a specific contract under the previous IT
FWC.
- 1 payment reduction of 17k due to non-delivery of data under EU menu FWCs which was attributable to low quality
issues of the contractor
Quality and performance| Evaluations
b) external (third party) evaluations for c) internal evaluations for EFSA’s
a) external (third party) evaluation of
areas of work which entail significant “development” activities (projects),
EFSA as described in its Founding
spending and/or organisational covered ex-ante by project charters and
Regulation;
implications, whether individual (e.g., ex-post by project closing reports.
project) or cluster (e.g., EFSA strategy)
activities;

EFSA Strategy 2027

Ex-ante Ad Hoc external

3rd external Mid term Ex-post
PCO/ex-post evaluations:
evaluation - MB strategy 2020 evaluation -
end of project Closing
recommendation evaluation STEP 2018
reports programmes
Project Programmes

Recommendations and findings

To be integrated into IMS

Highlights 2021 To be carried out from 2022 onwards:

Closing STEP 2018 open recommendations: ❖ Third party external evaluations are envisioned to
❖ Centralisation - harmonise and streamline the role of the take place in 2023 (on closed programmes)
DBC vis-à-vis the coordinators across the departments ❖ The next external evaluation, to be carried out by the
❖ Enabling the Strategy to provide long-term benefits: EC, is planned to be finalised by March 2026.
Strategy (& work-programme) performance monitoring ❖ Mid term evaluation 2027 Strategy in 2024
(streamlining the number of KPIs and linking benefits to
strategic results)
Quality and performance|
Continuous Improvement Overview
Impact: 16 improvement projects in scope

✓ (9) FTEs saved on the Science Area

(improvement of the Food Enzyme Risk
assessment dossier evaluation process and
optimization of the time allocated in drafting
Reasoned Opinion Art. 12,) vs 0.42 FTEs
allocated; i.e. 0.1 GPS and 0.32 Process Owners
and other stakeholders

✓ 23 person days to hire experts (- 58%)

✓ 92 days for SOP dev. to inclusion in repository (-
43%)
✓ 13 days to write performance report (-38%)
✓ 205 days GMO applications cycle time (-13%)
✓ 4.5 expert days per opinion (-10%)

✓ New strategic sourcing process and model

✓ New onboarding process for newcomers

Managed in 2021

Enlarge scope of CI process New CI partners

Opportunity: collecting and managing Opportunity: leveraging on
all EFSA improvement opportunities in LSS skilled employees to build up a
the IMS improvement register CI partnership approach per Dep.
Objectives & Assurance Pillars reporting

LEGALITY AND REGULARITY QUALITY AND PERFORMANCE SAFETY AND SECURITY

(ICF n. 4 and 5) (ICF n. 1 and 2 - ISO 9001) (ICF n. 3; ISO 45001, 14001,
Objectives 22301, 27001, EMAS)

01 Audit Management
03 Risk Management
04 Internal Control

Legality & Regularity Compliance

Security & Business Continuity

Performance management

Information Management
Continuous improvement
Assurance

Quality Management
Financial Reporting
pillars

Health & Safety

Evaluation
NEW

06

10
09
07

11
08
05

12
02
HSSE|
Status of 2021 objectives
Domain Objective description Status
Biological, Chemical Risk monitoring Achieved
Health and
Electric System Inspection Achieved
Safety
ISO 45001 Contractors activities monitoring Partially achieve
Purchase of electric energy 100% produced Achieved
from renewable sources

Awareness campaign on environmental Partially achieved

sustainability (due to the COVID
pandemic)
Planning and organization of events according Partially achieved
Environment to environmental sustainable criteria (due to the COVID
ISO 14001 - pandemic)
EMAS
Transition to ISO norm version 2019 Achieved
Business
Integration with Corporate MS Postponed
Continuity
ISO 22301 Significant IT Disaster Recovery exercise Partially achieved

Achievements: Information security and Records Management Policy consolidated and merged
into Information Management Policy
HSSE|
Non-conformities
Description of minor non Solution already implemented or to be
conformity implemented in 2022
The autonomy of power Increase the generator fuel tank capacity (ongoing, to
generator is not consistent with be completed in 2022)
RTO

It is missing a dedicated Define the process and improve the monitoring

process that determines what already performed (ongoing, to be completed in
aspects of BC are considered 2022)
relevant and therefore to be
monitored and measured
Combustible material present in Remove combustible material and plan and execute
the data-centre periodical thorough checks (done, and checks on
going)
The “restore phase” of the IT Review of the “restore phase” of the IT Disaster
Disaster Recovery is weak Recovery and test it (ongoing, to be completed in
2022)
The organisation does not Implement IT suppliers audit – with particular regards
control effectively the ICT to those that are critical (ongoing, to be completed in
supply chain 2022 and re-run periodically in future)
 Risk areas identified in 2022:
Risk Management| - Budget execution
- IT tools and organization
EFSA Corporate Risks 2022 - Remaining pending EPA3.0 processes and
organisation
Way-forward: to be cascaded down to the EFSA risk
register
Objectives Risks Mitigating actions Mitigating actions: to be discussed with relevant Process
Transparency Regulation • ART programme Owners (some started)
(ICF n. 4 and
REGULARITY
LEGALITY

Fraud consideration • Anti-fraud strategy

AND

5)

Grants and Procurement • EFSA grants and procurement policies and guidelines
• Dedicated trainings on grants and procurement processes
• Control activities for grant agreements, procurement procedures and mass payments
• Annual financial, legality and regularity audits performed by the European Court of Auditors

Brexit • Preparedness for the UK withdrawal

• Identification of areas of EFSA’s operations likely to be affected by Brexit
(ICF n. 1 and 2 - ISO

SARS-CoV-2 • Monitoring of developments

• Assessment preparation on the impact of the changing context on EFSA’s operations and EFSA’s corporate services
PERFORMANCE
QUALITY AND

Independence • EFSA Independence Policy: clear framework for the way in which the Authority manages the interests of its scientific
9001)

experts and others with whom it works in the course of its activities
• Processes and guidelines detailing how to declare, assess and publish relevant interests
• Committee on conflict of interest advises on issues related to competing interests
• Mandatory training on ethics and integrity
• Annual compliance and veracity checks carried out by EFSA on a sample of declarations of interest

Scientific Expertise • Expertise Management programme (EMP)

• Guidelines to govern the process of selection of external experts
• External review of the evaluation of experts for panel renewal
• EFSA staff policies and guidelines

Information • Information Management Programme (IMP) coordinating all projects related to EFSA's information at 360 degrees
SAFETY AND

45001, 14001,
22301, 27001,
(ICF n. 3; ISO
SECURITY

Management • Information Security Policy focusing on EFSA's approach to information security management
• Dedicated trainings on Information Security Awareness
EMAS)

IT Security • EFSA's business continuity plan is based on a business impact analysis defining dependencies and recovery times for IT
systems
Risk management | Way forward
Integration with performance management
External/Top down
Process Performance
IAS Strategic Internal Audit
Measurements:
Plan 2022-2024 (example) Process Risk Registers
Feedback interview with SANTE
Risk 1: Fitness for purpose/Timeliness
Risk area identified: Risk 1:
Risk 3: Engagement
• 2. End to end risk assessment • EPA3 4.1 Generic Mandates: Risk
process partially addressed
KPIs
Risk 1:
- Timeliness of adoption
- Timeliness of publication
Risk 3:
• 1. Risk of ineffective processes - Methods preparedness to address
for the provision of general risk • EPA 2.5 (New process design RM’s questions
assessment based on mandates ongoing) E06.03.03 Public - Up-to-date scientific guidance
and ineffective application of consultation: MINOR RISK documents
the agreed methodology IDENTIFICATION Risk 3:
- Public consultation
- Customers/Partners/Stakeholders
• 3. Risks of insufficient satisfaction on risk assessment
engagement with stakeholders
and society in different parts of
the risk assessment process PPIs
Risk 1:
- Throughput time, Timeliness of
Are these risks identified in the Are these risks monitored adoption (4.1)
respective process charters? by process metrics? - Usability of cross-cutting guidance
documents by relevant Panels, # of
ad-hoc requests for advice on cross-
WAY FORWARD FOR INTEGRATION
cutting guidance implementation
addressed (6.1)
- Link between objective setting and risk reflection is currently missing
- KPI’s and risk reflection should be set at same time in planning cycle
- Integrated Process Documentation (integration of process risk registers and
charters)
- Roles and responsibilities, validation at unit and department level
IMS wide|
2022 Objectives
# Objective Action
Draft and finalise common documentation in line with roadmap(such as
common SOP, development of IMS manual, Accountability Policy)
Integration of Implement IMS-wide MT review meetings and report
0 management Implementation of Hierarchy of documents
systems Common IMS register & workflow
Coordination Audit Committee meetings
Coordination risk process, risk map and risk register
 IMS wide|
Audits overview (dates)
Internal Audit IAS/ECA TBC
ISO 45001

Internal Audit
Unit’s ISO 22301
Audit Prep ISO 27001(TBC)
April June October December

May November
September

Internal Audit Span of audits 9 months

ISO 14001 Internal Quality Audits
EMAS
Opportunity to
“condense” ISO audits
in 1-2 months
IMS wide|
Audits- process overview (2022)
ECA Financial, legality & External ISO Internal ISO * Entire ISO 9001 audit plan to
IAS audit
regularity audits Audit* audit be defined in March 2022

5. Services Delivery
6. Knowledge Management & 7. Engagement & Communication 8. Foresight
5.1 Services to applicants
Development
5.2 Support to managing RA evidence 6.1 Methodology management 7.1 Partnerships 8.1 Environment scanning
5.3 People services 6.2 Strategic competencies 7.2. Community management 8.2 Inn&Transf agenda
5.4 Logistics services 7.3. Strategic engagement definition
6.3 Knowledge Organization
5.5 Site & Facility services 6.4 Capacity building 7.4. Social research & Comm. planning
5.6 Digital services 6.5 Data management 7.5 Digital channels management
5.7 Financial Services 7.6 Coordinated comm. development

5.8 Public Access to Documents

7.7 Internal communication

5.9 Content Sanitization

9. Legal Counselling 1. Scientific preparatory activities 2. E2E Applications

9.1 Decisions review management 1.1 Generic Pre-submission Advice 3. E2E Pesticides
9.2 Legal partnering / advice 1.2 Renewal Pre-submission Advice
4. E2E Generic Mandates
1.3 Notifications of Study
2.1, 3.1 Dossier Intake
10. Procure-to-Pay 1.4 Sc. Workforce planning
2.2, 3.2, 4.2 Risk Assessment
10.1 Strategic outsourcing decisions 2.3, 3.3, 4.3 Confidentiality Assessment
10.2 Outsourcing launch, evaluation and award 2.4, 3.4, 4.4 Sc Output publication
10.3 Contract management
10.4 Accounting
12. Planning, Governance & Control 13. Develop & Improve
11. Hire-to-Retire
12.1 Strategy, Planning, Analysis 13.1 Enterprise Architecture
11.1 Talent pools
12.2 Audit & RMIC 13.2 Innovation Implementation
11.2 Onboarding 13.3 Continuous improvement
12.3 Quality Management
11.3 Competency development 12.4 Safety & Converged Security
11.4 Competing interest management 12.5 External governance actors coordination (MB
etc)
11.5 Performance management
IMS wide|
Internal quality audits & support proposal
Internal Quality Audit Document checks/self External Audit
Interviews assessment preparation

Performed by: Performed by: Advised by:

Internal quality auditors Relevant Unit & QM
▪ 2.1 Applications Dossier Intake GPS
▪ 2.2 RA of Applications(FEEDCO) ▪ 1.4 Scientific workforce planning ECA (Financial, legality & regularity
▪ 2.2 RA of Applications (NIF) ▪ 6.2 Strategic Competencies audits)
▪ 3.2 Peer-review of Pesticides / ▪ 6.3 Knowledge organisation ▪ 5.7 Financial services
Assessment of MRLs (PLANTS) ▪ 7.1 Strategic Partnership & Community ▪ 10.1 Strategic Outsourcing Decisions
▪ 4.1 RA of Generic Mandates building ▪ 10.2 Outsourcing Launch, Evaluation
(BIOHAW) ▪ 7.2 Community Management & Award
▪ 4.1 RA of Generic Mandates (MESE) ▪ 7.3 Strategic Engagement ▪ 10.3 Contract Management
▪ 5.1 Services to Applicants
▪ 6.1 Methodology mgmt.
▪ 8.1 Environmental scan ▪ 10.4 Accounting
▪ 6.4 Capacity Building ▪ 8.2 Innovation & Transformation IAS audit
agenda definition ▪ 6.5 Data management
▪ 11.1 Talent Pools ISO 9001:2015
▪ 13.1 Enterprise Architecture ▪ TBC
▪ 13.2 Innovation Implementation
New processes
IMS wide|
Hierarchy of documents
Repository
Team Repository Team:
Rolling out Hierarchy of documents suggested Responsible for maintaining the integrity of
in 2022: the Repository. Involved in all layers of the
composition
HoD (except Records). Their involvement is
GPS foreseen from the moment a need for a new
- New classification of docs Coordinates/advices/ document arises.
- Harmonised naming convention reviews
- When a need for a new document is
- Updated templates
LA identified, the team is responsible for
- 1 Catalogues with overview of identifying the nature of the
Advices/reviews
all document levels document (level)
- NEW/Updated SOP to be MESE - Checking whether there is any other
finalised Maintains Scientific existing documentation, and if so, if
guidances catalogue
there is a need for further
documentation
- Ensuring the correct naming
conventions/templates are being used
The process may need to be - Maintaining the various “catalogues”
implemented gradually due to limited up-to-date to ensure that staff have
resources between GPS/LA access to the latest up to date
documentation
 2022 objectives|
IMS specific objectives & actions
Legality & Regularity Quality & Performance
Internal Definition of Internal control monitoring criteria, Maintained Prepare and run surveillance audit, Implement
Control coordination control activities and internal control ISO internal quality audit cycle
1 9001:2015 Run customer feedback activities and integrated
assessment performed
1 Perform a control environment review (ex-ante and ex- certification survey
post) for IT financial, vendor management and G&P EFSA’s Definition of the new processes including their
expenditure Quality documentation (Process charters (including PPIs),
Audit Coordination, clearance and follow-up annual ECA Management SOPs/WINs) and the pending organisational
Manage financial, legality and regularity audits, ECA Special System evolutions (e.g. IT organisation)
ment Reports and Horizontal topics 2 updated in
2 Coordination, clearance and follow-up IAS audits on line with the
Information Security & Disaster Recovery and EPA3 process
Enterprise Data Governance and Management finalisation
and RFCs
HSSE Finalise theFinalisation of KPIs and cascading to processes
Maintain HSSE ISO Prepare and run internal and
Finalisation of the new programmes & IT roadmap
definition of
standards certification surveillance audit
1 ISO 14001, ISO 45001,
EFSA’sperforand new agile approach for handling DEV and PII
mance Create the basis for aligning IT tools with
EMAS, ISO 22301
Implement ISO 27001 Develop MS and implement the first
3 framework performance framework
2 cycle of ISO 27001
Improve and streamline the integration of the end
to end performance management in EFSA (covering
Ensure MS Design and run coordinated
workplan, FTEs/posts, Budget), and reinforce the
3 effectiveness Cybersecurity and Business Continuity
PDCA cycle
test/exercises
Strengthen Develop and implement fit for purpose
Implement continuous Cover the minor non conformities to 4 evaluations annual/multiannual evaluations plan
improvements improve the compliance with the norm
Ensure integration among MS Consolidate L&D- Continuing developing the capability of
continuous continuous improvement and support/partner with
4 procedures to ensure a more agile
management improvement staff to enforce process management and
5 continuous improvement knowledge and
Consolidate "Benefits and achievement
reporting responsibility
Consolidate “Benefits and achievements reporting”
 Quality and performance|
Performance – moving forward
a) Align IT tools with performance framework
Reason why:
Both at KPIs and at process metric level there is the opportunity to invest to have more automatic measurement. This is obviously a source of
efficiency (less FTEs spent, more harmonization, less manual mistakes) and frees more time for analysis. Also the reporting side (dashboards,…)
can be enhanced.

Create a stronger P-D-C-A cycle

Reason why:
Establish a codified process to handle deviations (compliance/performance) that integrated all the needed processes/actors, and establish
a stronger links between the various elements (such as between performance monitoring and risks management, integrating register and
process).
Performance deviations to be regularly escalated to Process Sponsor/PCO/Assurance/Continuous improvement functions in case of
consecutive moderate deviations (does the process have a sub-optimal design?), or relevant deviation (is the execution at risk?).

Create a measurement (and improvement) culture

Reason why:
This was a suggestion also coming from the FIP Lean Six Sigma exercise done some years ago.
Differentiate what is measuring (we need to measure what we do, ideally done with an increased degree of automatisation) and what is reporting
(report only what’s important/what’s concerning/what’s scrutinised). This should be, however, a pull and not a push (clarify role of central control
bodies and process hierarchy roles). Good examples from CI can help in this regard.

Risk of not acting: Lack of efficiency generation, Sub-optimal use of Performance monitoring
 Quality and performance|
Continuous improvement
EPA 13.3 Continuous Collected from all sources of
NEW Exception request
Improvement improvement actions workflow tool to be used as
Process scope enlarged central register (mid-2022)

ID DEPARTMENT UNIT EPA PROCESS 3.0 IMPROVEMENT DESCRIPTION SOURCE IMPROVEMENT TYPE

Consider to redesign the process since the current one has

Nutrition & reached his maximum productivity in his current form and
2.2 RA of
48 ASSESS Food the current demand of work from the team and the working EoYR PII
Applications
Innovation group is not anymore sustainable as already indicated in
previous reports
Format for the assessment of basic substances should be
changed in order to provide a more “fit-for-purpose”
product. However clear and consistent guidelines should be
3.2 Peer- given by and agreed with SANTE. 2020 DG Process Leader
review of The general limited database provided by the applicants for SANTE-EFSA
56 ASSESS PREV Pesticides / these active substances requires an action to increase their Customer BAU
suggests/indicates
Assessment awareness on why the dossier preparation is crucial to Feedback Improvement type
of MRLs avoid several data gaps. Implementing for basic substances exercise in liaison with
a similar approach to the Conclusions template which relevant Unit
indicate the “weight” of data gap for the final risk
assessment may be useful.
It was noted that SOPs 9 & 10 are linked, in that they both
deal with the approval process of the final deliverables, but
that SOP 9 is not mentioned in SOP 10 - creating a
EFSA
12.3 Quality misunderstanding about the steps to be taken. Lead
59 EMPOWER GPS Exception BAU
Management authors of the SOPs 009_S & 010_S to propose more
Register 2021
integration between both applicable procedures in the
process. The lack of integration caused the Non-
compliance event 76