Takeda Ireland Ltd Grange Castle · 2018-03-08 · Takeda Ireland, Grange Castle, Dublin, Ireland....

Takeda Ireland Ltd Grange CastleSurveillance Assessment ReportISO 50001:2011Assessment Date: 23rd May 2017

Confidence, Assurance and Certainty

Prepared for: Takeda Ireland Ltd Grange Castle

Prepared by: Dermot Gibbons

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Takeda Ireland Ltd Grange Castle - Surveillance - ISO 50001:2011

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ASSESSMENT DETAILS

Client Details

Company Name Takeda Ireland Ltd Grange Castle

ManagementRepresentative

Aileen Stack

Company Address Grange Castle International Business Park, Nangor Road, Dublin 22, Ireland

Date of Assessment 23-05-2017

Location ofAssessment

Takeda Ireland, Grange Castle, Dublin, Ireland.

Objective ofAssessment

To confirm the extent of conformity of the system to the ManagementSystems ISO 50001:2011, to evaluate the capability of the managementsystems, to ensure conformity to statutory, regulatory and contractualrequirements, to identify potential OFI and to evaluate the effectiveness ofthe system to achieve organisational objectives.

Assessment Details

Type of Assessment Surveillance

Standard(s) used inassessment

ISO 50001:2011

Scheme specificrequirements

None

Scope of certification The manufacture of active pharmaceutical ingredients (API)

EA Code ISO 50001 - 13 NACE Code

Current Exclusions None

No. of Employees inScope

80

Assessment Team Dermot Gibbons

Distribution list forAssessment Report

Donal Brady – [email protected] Stack - [email protected]

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Assessment Summary

Opening meetingThe assessment commenced with a review and confirmation of the assessment plan, the objectives,criteria, and scope of the assessment. The assessor provided an overview of Certification Europe’scomplaints and appeals procedures, acceptable use of certification documents and marks andconfirmed the basis of Certification Europe's confidentiality policy. The audit methodology andcategorisation of non-conformities was summarised, and the assessor checked relevant procedures forworking on site.

FindingsThe assessment is based upon a sample of the company’s activities, as they were observed by theassessor, and therefore the findings detailed in this report do not purport to include, nor do theyinclude, all possible non-conformances which may exist within the system, either during or at any timeprior to, or subsequent to, the assessment.The findings of the assessment are detailed in the Tables below.

Limitations to completing assessment including deviations from audit planNone, The audit guides are thankd for their hospitality and professional approach to the audit process.

Review of scopeThe scope of certification was reviewed and was deemed not appropriate for the organisation. Basedon the requirements of ISO 50003 and as a result of the output of the most recent energy review, theorganisation have decided to amend the scope of its certification.

The new scope of certification as outlined in the energy review and management system manual is:

The electricity and gas usage within the site boundaries of the Takeda Grange Castle facility.

Assessment ObjectivesThe objectives of the assessment were fulfilled.

Auditees

The following staff acted as assessment guides, attended meetings or were interviewed during theassessment:

Attendees at opening meeting:Donal BradyAileen StackMasuJi HamasumiMichael O'DonnellAuditees:Aileen StackAttendees at closing meeting:Donal BradyAileen StackMasuJi HamasumiMichael O'Donnell

Accompanying Persons

None

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EXECUTIVE SUMMARY

Summary of Nonconformities

Clause/Control Category NC No.

4.4.3 - ISO 50001 - Energy planning (Energy review) NC2 TT959

Assessment ConclusionOn the basis of the evidence identified above, the assessor has determined that the client’s managementsystem continues to meet the needs of the organisation and conforms to the requirements of ISO50001:2011, although non-conformities have been identified which require corrective action.Please complete the attached OPF10-1 (Corrective Action Plan) form and return [email protected] within 10 days of receipt of report.

Next Assessment Details

Next Assessment Type Surveillance

Next Assessment Date 8th May 2018

No. of Days of NextAssessment

1

Location(s) of NextAssessment

Takeda Ireland, Grange Castle, Dublin, Ireland.

Signed on behalf ofCertification Europe

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BUSINESS UPDATE & REVIEW OF PREVIOUS FINDINGS

Activity Assessed: Business Update & Review of Previous Findings

The energy review has been updated considerably since 2016 to take into consideration the 24 houroperations of the facility. The current energy review is better and more appropriate to theorganisations needs in many respects to the 2016 energy review. A new nonconformity was raised withregard to the current energy review. Several of the items required in the current energy review arepresent in other parts of the management system. However, to meet the requirements of the standardthese must be documented in the energy review.

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SUMMARY OF CONFORMITY

Activity Assessed: General Requirements, Scope & Policy

Clause: 4.1 - ISO 50001 - General requirements, 4.2.1 - ISO 50001 - Management responsibility (Topmanagement), 4.3 - ISO 50001 - Energy policy

Narrative:

The general requirements of the management system are outlined on the energy system file section 4.1.These were reviewed by the auditor and are adequately outlined. The energy policy POL025 asdisplayed on the EDMS document control system & notice board was reviewed against therequirements of the standard without issue. The roles and responsibilities for the management systemare adequately outlined on the energy system file, where the Engineering Director has been identifiedas the management representative.

Activity Assessed: Training

Clause: 4.5.2 - ISO 50001 - Implementation and operation (Competence training and awareness)

Narrative:

The training requirements for the management system and those affecting significant energy use areidentified on the EnMS overview document for each SEU. The training needs requirements andcompetency assessment is based on training on the P1 Gas & HVAC SOP (SOP - Eng - Util - 032 r4)were reviewed for Utilities technician, BMS Controller, and the Maintenance Engineer. The trainingneeds requirements can be seen on the Training Report.

Activity Assessed: Management Review

Clause: 4.7 - ISO 50001 - Management review

Narrative:

The management review process as outlined in the energy systems file and the presentation andminutes dated March 2017 were reviewed where the organisation has shown a 3% improvement inenergy performance in 2016.

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Activity Assessed: Design & Procurement

Clause: 4.5.6 - ISO 50001 - Implementation and operation (Design), 4.5.7 - ISO 50001 - Implementationand operation (Procurement of energy services products equipment and energy )

Narrative:

The Purchasing process of for assessing energy usage over the planed expected lifetime is outlined inthe Energy Management System manual section 4.6.5. The design process for the Ninlaro new productintroduction for the P2 production building was discussed with the audit guides as outlined in theProject scope template document and project files. There is also an energy efficient design projectexecution plan PR-422 in place for the project. The procurement requirements for the project areoutlined via the manual document section 4.5.7 and the EDMS project scope document.

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INSTANCES OF NONCONFORMITY REQUIRING ACTION

Code Index: NC1 = Major nonconformity; NC2 = Minor nonconformity

NC No.: TT959

Activity Assessed: Energy Review

Clause: 4.4.3 - ISO 50001 - Energy planning (Energy review)

Date of Nonconformity: 23-07-2017

Proposed Corrective Actions to be Submitted by: 23-07-2017

Findings:

The current energy review document does not outline following required outputs from the energyplanning process.

Evidence:

The items missing from the current energy planning process include:

The predicted energy usage for the upcoming period (retained in the monitoring andmeasurement spread sheets).The energy baselineThe Energy performance indicators in place.The SEU listing as outlined in the energy review is different than those outlined on the EnPIspread sheet. The spread sheet requires updating.The SEU spreadsheet needs to be updated to include the HDD variables into the HVAC & GasEnPI’sThe HTF relevant variable is not currently stated. (The HTF relevant variable was included in lastyear’s energy review).

Category: NC2

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SUMMARY

Conclusion

On the basis of the evidence identified above, the assessor has determined that the client’s

management system continues to meet the needs of the organisation and conforms to the

requirements of ISO 50001:2011, although non-conformities have been identified which require

corrective action.

Please complete the attached OPF10-1 (Corrective Action Plan) form and return to

[email protected] within 10 days of receipt of report.

Confidentiality

Certification Europe maintains strict confidentiality with regard to client technical and commercial

information and all details relating to the assessment and certification process, including all Assessment

Reports. Please ask for our confidentiality policy statement should you require further details.

Signed on behalf of Certification Europe

Dermot Gibbons

Lead Assessor

Date: 4th July 2017

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ASSESSMENT PLAN

Assessment Plan (V1.0)

Type of Assessment Surveillance

Standards (Criteria) ISO 50001:2011

Objective

To confirm the extent of conformity of the system to the Management

Systems ISO 50001:2011, to evaluate the capability of the management

systems, to ensure conformity to statutory, regulatory and contractual

requirements, to identify potential OFI and to evaluate the effectiveness of

the system to achieve organisational objectives.

Location(s) Takeda Ireland, Grange Castle, Dublin, Ireland.

Date of Assessment 8th May 2018

Number of Days of

Next Assessment1

Assessor Dermot Gibbons

Technical Expert n/a

Clause Activity Time Auditee

Opening Meeting 9:30

Business Update, review of findings from theprevious audit.

10:00

General Requirements, Scope & Policy 10:30

Energy Review / Monitoring & Measurement

11:00

Lunch 13:00 - 13:45

Internal Audit, Corrective & Preventive Action. 13:45

Procurement & Design 14:45

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Clause Activity Time Auditee

Management Review 15:30

Closing Meeting 16:45 Management Team

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Optien Ltd Internal Audit Report 16/10/2017

Internal Audit Scope P1 HVAC system Audit Attendees:

Aileen Stack

Richard Morrison

Completion Date:

11/10/2017

ISO:50001 Clause Area of focus Audit Trail Comments Action

4.4.2 Legal and other

requirements

Are there any legal or other

requirements identified for

this significant energy user?

Legal register

and evaluation

of compliance

SI 346 of 2006 was not located in the

legal register which deals with Air

conditioning regulations the site have

good HVAC maintenance practices due

to the GMP nature of the HVAC

systems but the legislation should be

included in the legal register.

Include SI:346 in the Pegasis legal register

and complete an evaluation of compliance to

the statutory instrument

4.4.3 Energy Review

Is there a comprehensive

understanding of the energy

usage and energy drivers of

this significant energy user

Energy Technical

file and Energy

Systems file

Breakdown of SEU's completed and

follows the process for the

identification of SEU's. The HVAC

electricity is 19% and is deemed a

significant energy user and includes

actual and annualised energy

performance chart for analysis None

4.4.3 Energy Review

Opportunities for

improvement

Energy

Opportunities

list, Energy

technical file

There is an opportunity for heat

recovery included in the register but

this has not been deemed cost

effective. The site could consider

setback of the HVAC during plant

turnaround

Consider including the setback of HVAC

equipment in the P1 building during periods

of turnaround

4.4.5 Energy

Performance Indicators

Are the EnPI's related to the

energy drivers?

Energy Technical

file

HVAC EnPI included Actual and

Annualised energy consumption, EII

and CUSUM. There has been a greater

than expected energy consumption for

July and August 2017 where the metric

showed 10% and 15% greater than

expected usage. This is to be discussed

following the last energy team meeting

Raise a Non conformance for the HVAC

energy consumption for July and August in

order to understand the driver behind the

increased energy consumption of HVAC

4.4.6 Energy

Management System

Action Plans

Is there an improvement

project in place for this SEU?

Energy System

File None None

4.5.5 Operational

control

Is there a process in place to

control this SEU

Daily rounds and

readings

Daily rounds and readings take place

for the HVAC. Brendan Timmons was

interviewed to discuss HVAC

operational controls. There are 115

HVAC work orders throughout the site

including condition monitoring. On

AHU-03, it appears that there is a

probe error on TT-03-01 which is a

similar issue identified last year.

Raise a Non Conformance for HVAC to

determine the root cause of the repeat

failure of the valve CVM-03-01 which had

been identified in 2016 as an issue and

resolved through the non conformance

system previously

4.5.5 Operational

control

Are there operating

parameters outlined in the

SOP?

TM-09-011

HVAC training

module

There is a comprehensive training slide

deck in place to train personnel on

HVAC and includes operating

parameters. There is also an SOP ENG-

UTIL-032 Operation and Maintenance

of HVAC Systems None

4.5.2 Competence

training and awareness

Are the personnel identified in

the energy aspects review

trained in this SOP

Training material

and training

records

The training matrix was reviewed and

the training record for TM-09-011 was

reviewed for Patrick Murray. He was

trained on the 8th January 2016. It was

noted that there is no training records

for the training manuals as they are

not covered by the training

management system (EDMS)

Consider updating the ISO50001 training

matrix to have the training manuals as

support materials for site staff (for reference

only) as there are no training manuals

maintained for these manuals. This will

resolve the current issue of not having

training records for these manuals.

4.5.7 Procurement

Is there a focus on energy in

the service contract N/A None None

4.6.1 Monitoring,

measurement and

analysis

Are the energy drivers used as

part of the performance

indicators to identify energy

performance slippage

Monthly Energy

Report

Yes the EnPI report incorporates

operating hours as a driver as

identified in the energy review None

4.6.1 Monitoring,

measurement and

analysis

Is there an opportunity to

improve measurement of the

significant energy user? N/A None None

4.6.1 Monitoring,

measurement and

analysis

Has there been any

excursions in performance of

the SEU?

Energy Technical

file

Yes for July and August 2017 and the

reason for this is currently not known.

As identified earlier, Need to raise non

conformance for HVAC as July and August

energy performance was greater than

expected and need to investigate why.

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Optien Ltd Internal Audit Report 16/10/2017

ISO:50001 Clause Area of focus Audit Trail Comments Action

4.6.1 Monitoring,

measurement and

analysis

Has there been an assessment

of the effectiveness of the

action plans in achieving the

objectives and targets?

Management

Review None None

4.6.3 Internal Audits

Are there any open items

from the previous internal

audit

Previous Internal

Audit Report

All items from the previous HVAC audit

were reviewed and the actions were

all addressed. An SEAI audit of

operational control of HVAC is

currently ongoing and could be

included in the audit schedule None

4.6.4 Nonconformities,

correction, corrective

action and preventive

action

Are there any open non

conformities

Non-

conformities log

Previous non conformance had been

addressed and closed out None

4.6.5 Control of

Records

Are the records associated

with energy management

easily retrievable

Observation

throughout the

audit

The documents and records are easily

retrievable and hard copies are also

available in the EnMS folder None

Other Comments: The management system is managing the HVAC system quiet well. There are three opportunities to improve as follows:

1. The legal register needs to be updated to include SI346 of 2006 and complete an evaluation of compliance to the statutory

instrument.

2. Raise a non-conformance for the temperature transmitter TT-03-01 on AHU 3 which was suspected of being faulty during the audit

in 2016 and again in 2017 following the closure of the issue in 2016. The non conformance should address the root cause of the

recurring probe or valve failure.

3. Raise a Non conformance for the HVAC energy consumption for July and August in order to understand the driver behind the

increased energy consumption of HVAC.

4. Consider changing the status of the training manuals as support or reference materials as these are not included currently in the

EDMS system.

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Takeda Ireland Ltd Grange Castle · 2018-03-08 · Takeda Ireland, Grange Castle, Dublin, Ireland....

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