IFS CERTIFICATE - Tissunion...Audit Overview TISSUNION EUROP SRL UNIPERSONALE Page 2 of 68 Audit scope For the certification scope of the audit: Produzione di fazzoletti (mini e standard)

Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.

Any changes in the product shall immediately be reported to DNV GL Business Assurance Italia S.r.l. in order to verify whether this certificate remains valid.

ACCREDITED UNIT: DNV GL Business Assurance Italia S.r.l. Via Energy Park, 14, 20871 Vimercate (MB), Italy. Tel. 039.68 99 905. Website: www.dnvgl.com/assurance

IFS CERTIFICATE Certificate No.:

281583-2019-AIFS-ITA-ACCREDIA

Audit Date: 2019-12-18 Certificate expiry date:

2021-01-30

Re-audit due date:

from 2020-10-11 to 2020-12-20

DNV GL - Business Assurance being an ISO/IEC 17065 accredited certification body for the certification against IFS and having signed an agreement with the IFS

owners, confirms that

TISSUNION EUROP SRL UNIPERSONALE Via XXV Aprile, 11 LU - 55011 Badia Pozzeveri Altopascio, Italy

COID: 65713

Outsourced products and / or processes are available: None Exclusions: None

The Product defense chapter was not assessed. Product scope(s): 4 - Personal hygiene products

Scope: Production of handkerchiefs (mini and standard) and of cosmetic tissues

with balsams and perfumes. Beside own production, company has

outsourced processes and/or products.

Produzione di fazzoletti (mini e standard) e di tessuti cosmetici con balsami

e profumi. Oltre alla produzione propria, l'azienda ha esternalizzato processi

e / o prodotti.

Has been found to conform to IFS HOUSEHOLD AND PERSONAL CARE PRODUCTS, VERSION 2 APRIL 2016

HIGHER LEVEL

with a score of 98.78 %

Place and date:

Vimercate, 2020-01-31

For the Certification Body:

DNV GL Business Assurance Italia S.r.l.

______________________________________________________________________________

Sabrina Bianchini

Management Representative

003

Name and address of certification body

DNV GLDNV GL Business Assurance Italia S.r.l.Via Energy Park, Vimercate MB Italy

Tel +39 0396899905 - Fax +39 039 6899930 – e-mail: [email protected] – web page www.dnvgl.com

IFS HPC, Version 2, April 2016

Final Audit Report

Audited company: TISSUNION EUROP SRL UNIPERSONALE

Date of audit: 17-Dec-19 and 18-Dec-19

Accreditation number of the certification body

TISSUNION EUROP SRL UNIPERSONALE Page 1 of 68

Audit details

Lead Auditor:

Co-auditor:

Trainee(s):

Sergio Emanule Nestori

Date/time of currentaudit:

17-Dec-19 (08:30-18:15)18-Dec-19 (08:15-16:30)

DNV GL Sergio Nestori

CB and auditor ofprevious audit:

05-Dec-18

Date of previous audit:

Name and address of the company (or headquarter):

Via XXV Aprile, 11 LU Italy

55011 Badia Pozzeveri Altopascio

Italy

TISSUNION EUROP SRL UNIPERSONALE TISSUNION EUROP SRL UNIPERSONALE


Italy

Name and address of the audited site:


8033509720003EAN Code/ UCC GlobalLocation Number:

COID: 65713

Phone:

+393484780029

Fax:

+393484780029

Phone:

+390583278600

Fax:

+390583277017

IFS HPC, Version 2, April 2016

Audit Overview


Audit scope

For the certification scope of the audit:

Produzione di fazzoletti (mini e standard) e di tessuti cosmetici con balsami e profumiOltre alla produzione propria, l'azienda ha esternalizzato processi e / o prodotti

Production of handkerchiefs (mini and standard) and of cosmetic tissues with balsams and perfumesBeside own production, company has outsourced processes and/or products

Product scope(s): 4

Audit participants list

Name: Position: Openingmeeting

Documenta-tion review

On-site audit Closingmeeting

Luca Giorgi CEO

Paolo GiustinoGrazzini

Quality Resp

Alessandro Cei Purchasing Man

Massimo Binelli Consultant

Final Result of Audit

As a result of the audit performed on 17-Dec-19 and 18-Dec-19, “DNV GLDNV GL Business Assurance Italia S.r.l.“ found that the processes and activities of TISSUNION EUROP SRL UNIPERSONALE for the above mentioned scope of audit comply with the requirements set out in the IFS HPC, Version 2, at Higher Level, with a score of 98.78%.

Next auditbetween 11-Oct-20 and 20-Dec-20


Company Profile

Description about the key investments made by the company relating to the productionconcerning product quality and safety (construction changes, machinery, etc.)

Explanation:

In January 2019 the locker room work was completed. Line 7 robot inserted, line 6 robot changed. They changed a carton machine on line 6 for production efficiency. They have made dust containment boxes on line 2.

What is the year of construction of the audited site(s)? (mandatory explanation).

Explanation:

2004

Area of the site (manufacturing plus storage area) in square metres/feet.

Explanation:

Old factory 5000 square meters covered, new warehouse 2200 square meters plus 400 meters which is the connecting roof between the two buildings

Number of employees (FTE) and part time, work shifts.

Explanation:

38 people , 35 blue collars, 3 shifts/5days

What are the product groups and products per scope produced in the company?(mandatory explanation).

Explanation:

Scope 4Production of handkerchiefs (mini and standard) by embossing, cutting, folding and packagingProduction of cosmetic tissues by edge embossing, folding and packaging. Material involved paper, balsams and perfumes can be used

Number of production lines (mandatory explanation).

Explanation:

7 production lines: 1 for the tissues, 2 from standard handkerchiefs, the other 4 can make both mini and standard handkerchiefs

Complete view of the company´s processes (mandatory explanation).

Explanation:

The company manufactures :3 and 4-ply mini handkerchiefs with the ability to enter from 8 to 10 handkerchiefs inside each packet and forming sales units that vary from the pack of 6 up to the pack of 48 packets.standard 3 and 4-ply handkerchiefs with the possibility of adding 8 to 10 handkerchiefs inside each packet and forming sales units that vary from the pack of 6 up to the pack of 56 packets.2, 3 and 4-ply cosmetic tissues with the ability to enter from 60 to 200 tissue inside each case.They start from paper rolls and technoligies involved are embossing, cutting, folding and packagingPerfume and balsam can be used inside the product

Description of product exclusions, if applicable (yes/no). If so, provide explanations.

Explanation: Applicable:

No


Company Profile

Description of outsourcing processes, if applicable (yes/no). If so, provide explanations.


Having a single line for the production of cosmetic tissue, an outsourcer is used to manage the demand peaks and to have a backup production line. The outsourcer used has in short the goal of IFS HPC certification

Yes

Does the audited company trade products? If so specify these products.


No

Is it a multisite certification? If so, provide explanations in case of decreasing audit duration.


No

Name and contact data (phone, fax, Email …) of the contact person in case of emergency.

Explanation:

Paolo Giustino Grazzini tel +393484780029email [email protected]

Does the company not fulfill the requirements about the use of IFS HPC logo?If not, please provide explanations.


No

List if the site is certified according to other schemes. Specify scheme’s names.

Explanation:

ISO 9001:2015 , FSC , PEFC, Ecolabel ( there is a dossier but no products realised )

Reviewer: Sabrina Bianchini


Evaluation of requirements

Result Explanation Points

A Full compliance 20 points

B (deviation) Almost full compliance 15 points

KO requirementscored with a B

Almost full compliance 15 points

C (deviation) Small part of the requirement has beenimplemented

5 points

D (deviation) Requirement has not been implemented -20 points

Major non-conformity Major non-conformity can be given in non-respectof legislation, internal dysfunctions,customerissues or when the identified non-conformity couldlead to a serious health hazard.

15% of the possible totalamount of points issubtracted

KO requirement scoredwith a D

The KO requirement has not been implemented 50% of the possible totalamount of points issubtracted

N/A Not applicableRequirement not applicable for a company

N/A requirements will beexcluded from the finalscoring

Explanations regarding the audit report


Scoring and awarding of certificates

Audit result Status Action company Report form Certificate

At least 1 KO scoredwith D

Not passed Actions and newinitial audit to beagreed upon

Report gives status No

> 1 Major and/ortotal score < 75%

Not passed Actions and newinitial audit to beagreed upon

Report gives status No

Max 1 Major andtotal score ≥ 75%

Not passed unlessfurther actionstaken and validatedafter follow-up audit

Send completedaction plan within 2weeks of receivingthe preliminarilyreport. Follow-upaudit max. 6 monthsafter the audit date

Report includingaction plan givesstatus

Certificate atfoundation level, ifthe Major non-conformity is finallysolved as controlledduring the follow-upaudit

Total score is ≥ 75%and < 95%

Passed atfoundation IFS HPClevel after receipt ofthe action plan

Send completedaction plan within 2weeks of receivingthe preliminarilyreport.


Yes, certificate atfoundation level, 12months validity

Total score is ≥ 95% Passed at higherIFS HPC level afterreceipt of the actionplan

Send completedaction plan within 2weeks of receivingthe preliminarilyreport.


Yes, certificate athigher level, 12months validity


IFS HPC

Date of renewal audit: between the 11-Oct-20 and the 20-Dec-20.

98.78%

Higher Level

Result:The activities of company „TISSUNION EUROP SRL UNIPERSONALE“ met the requirements of the IFS HPC, Version 2.

The company passed with a score of 98.78% at:

Audit Report

Summary

Chapter 1

Senior ManagementResponsibility

Chapter 2

Quality and ProductSafety Management

System

Chapter 3

ResourceManagement

Chapter 4

Planning andProduction Process

Chapter 5

Measurements,Analyses, Corrective

Actions andManagement of

Incidents

A 18 26 24 103 47

B 0 0 2 3 0

C 0 0 0 2 0

D 0 0 0 0 0

NA 0 2 0 9 1

Major 0 0 0 0 0

KO 0 0 0 0 0


Observations regarding KO's and Majors


General summary table for all chapters


Overall summary of the audit

The organization has evolved very fast in recent times, with the intent of fulfilling the requirements of the standard. The construction of the new building has made it possible to rationalize the spaces available for production. The production appeared well organized and the conditions of cleanliness and order appeared to be adequate.The property has actively participated in all phases of the audit, showing full awareness of the standardThe organization has decided to entrust the logistical aspects to third parties, including the activities carried out in its warehouse. To verify the awareness of the people involved in the external society, the interviews were made by contacting the external operating staffThe organization uses an outsourcer for the production of cosmetic tissue to obviate the fact of having only one line at the limit of saturation. The outsourcer is subject to periodic audits and controls, and has also declared that he wants to access the IFS certification by January 2020Production of handkerchiefs (mini and standard) by technologies : embossing, cutting, folding and packagingProduction of cosmetic tissues by technologies : edging, embossing, folding and packaging. Material involved paper, balsams and perfumesDuring this year it was decided to adopt the BFR guidelines for the sanitary paper as guidelines for the characteristics of the paper. As a result, suppliers are being asked for statements.In view of the anomalies detected during the previous audit, an accurate and complete risk analysis had been carried out


Table of compulsory fields:

Part of the audit reportNumber ofIFS HPC

requirementCompulsory remarks to be added

Corporate policy 1.1 How does the company communicate the informationto the employees? (minimum description)

Senior Management Responsibility KO nº1 Minimum description (e.g. how does / ensure theSenior Management that the employees know theirresponsibilities, etc.)

Record keeping 2.1.2 Duration of record keeping for “product safety andlegality related” records.

Hazard analysis and riskassessment

KO nº2 List CCPs with associated critical limits. If thecompany does not have any CCP this shall bespecified.

Product specifications KO nº3 Minimum description (e.g. what is the evidence thatspecified recipe/formulation is followed?

Laboratories 4.5.4.1.9 -Which analyses are performed in the own laboratory?-Which analyses are performed by an externallaboratory?

Traceability 4.14 Summary of the traceability test result. In case of aproblem if found provide precise information relating tothe problem

KO nº4 Describe the traceability system from the raw materialsto distribution

Legislative framework 4.3 To list if applicable:

-the name of the person responsible for the productsafety/quality in the company,-the name(s) of independent assessor(s) working forthe company.

Procedure of withdrawal/recall KO nº5 The auditor shall provide the following information:-How many withdrawals and recalls have beenoccurred since the last audit?-Specify product(s) involved-Specify the cause of the withdrawal and productrecall.

Product analysis(including quality checks)

5.6 Specify if there is an internal microbiologist

Complaints management 5.8 Details concerning complaints raised from consumers,clients (e.g. retailers) and authorities.

Corrective actions KO nº6 Details of the last corrective actions taken.


Description of follow up of corrective actions from the previous audit

2.2.3.3 Modified the flow chart now Annex 1 to the risk analysis2.2.3.5.2 New comprehensive risk analysis issued2.2.3.6 New comprehensive risk analysis issued3.4.3 the dressing rooms are finished4.2.1.5 They have decided to use BFRs for sanitary products as a reference4.3.1.1 They have decided to use BFRs for sanitary products as a reference4.9.3 The responsibility for monitoring flying insects was entrusted to an external company4.10.2 built box to block dust that came from scrap recovery4.11.6 rules introduced for transporters5.1.1 an integrated internal audit program was implemented5.3.2 the IDL has been changed5.4.2 flexometer replaced and verification of the integrity of the others


Chapter 1: Senior Management Responsibility

Summary of all deviations and non-conformities found for each chapter:

No Reference IFS HPC requirement Evaluation Explanation

No non-conformities found.


Chapter 2: Quality and Product Safety Management System




Chapter 3: Resource Management


1 3.3.2

The documented training and/orinstruction programs shall applyto all personnel, includingtemporary workers andemployees from externalcompanies, employed in therespective work area. Uponemployment, and beforecommencing work, they shall betrained in accordance with thedocumented training /instructionprograms.

BThe records relating to the period ofcoaching of two operators that wereintroduced in July 2019 were not available

2 3.4.1

The company shall provide stafffacilities, which shall beproportional in size, equipped forthe number of personnel anddesigned and operated so as tominimize product safety risk.Such facilities shall be kept cleanand in good condition.

BAbove the locker of the male locker room,there were numerous objects, contrary towhat is defined in the company regulations


Chapter 4: Planning and Production Process


1 4.2.1.1

Specifications shall be availableand in place for all raw materials(raw materials/ingredients,additives, packaging materials,rework) and where relevant, forsemi-finished product. Thespecifications shall be up to date,unambiguous, available andalways in conformance with legalrequirements.

C

During traceability exercise seen examplesof conformity declarations and technical dataof raw materialsIn the case of the paper supplier CartiereCarrara the request for compliance with theBFR has not yet been sentView declaration of conformity of Tronchetti18/7/2019View of Rocca's declaration 3/9/2019

2 4.4.1

The company shall controlpurchasing processes to ensurethat all externally sourcedmaterials (raw materials,including packaging materials)and services, which have animpact on product safety andquality, comply with requirements.Where a company chooses tooutsource any process that mayhave an impact on product safetyand quality, the company shallensure control over suchprocesses and fulfill requirementsref. 4.4.8

B

View qualification of suppliersView supplier evaluation form (quality ,proximity, nomea)They introduced some value quality andrange, reliability and financial strengthAlso the strategic importance has beendefined (for example the paper supplier C.has a strategic value, while with the supplierL. almost there are no more reports)No suppliers were eliminated due toqualitative issues. No new suppliers were introducedDeviationThey did not find an economic agreementwith Labanti (box manufacturer) that waseliminated , but it was not removed from thelist of qualified suppliers.

3 4.4.6

The results of supplier´sassessment shall be reviewedregularly. There shall be recordsof the reviews and of the actionstaken as a consequence ofassessment.

B

No suppliers were eliminated due toqualitative issues. They did not find aneconomic agreement with Labanti (boxmanufacturer) that was eliminated june 2019(even if it was not removed from the list ofqualified suppliers updated September2019). No new suppliers were introduced

4 4.8.6

A glass and brittle materialmanagement shall beimplemented, taking into accountpreventive and correctivemeasures; the system shallinclude reference to proceduresin the event of glass or brittlematerial breakage.Where a risk assessment hasidentified a potential for productcontamination, the presence ofbrittle material (including glass)shall be excluded or, if this is notpossible, the risk shall bemanaged.

BOn line 5 a bulkhead of the boxing machinewas damaged



5 4.12.2

Product requirements andprevention of contamination shallbe ensured during and aftermaintenance and repair work.Records of maintenance andrepair work and of correctiveactions taken shall be kept.

C

Verified in production in more than one point,that the screws, bolts and washers used inthe tooling are not placed in containersmaking them become possible foreignbodies


Chapter 5: Measurements, Analyses, Corrective Actions and Management ofIncidents




Summary of all N/A evaluations

No Reference IFS HPC requirementEvalua-tion

Explanation

1 2.2.3.7 Establish critical limits for eachcritical control pointFor each critical control point,the appropriate critical limitsshall be defined and validatedin order to clearly identify whena process is out of control.

NA

No CCP identified

2 2.2.3.8 KO N° 2: Establish amonitoring system for eachcritical control pointSpecific monitoring proceduresshall be established for eachcritical control point to detectany loss of control. Records ofmonitoring shall be maintainedfor a relevant period. Eachdefined critical control pointshall be under control at alltimes. Monitoring and control ofeach critical control point shallbe demonstrated by records.The records shall specify theperson responsible, as well asthe date and result of themonitoring activities.

NA

No CCP identified

3 4.3.1.5 In accordance with the currentlegislation, the company shallmandate a qualified safetyassessor to consider thegeneral toxicological profile ofthe ingredients, their chemicalstructure and exposure level,and finally provide thecompany with a safetyassessment of the finishedproduct regarding humanhealth.

NA

not necessary by law

4 4.3.2.3 Without the authorization fromthe patent holder, the companyshall not use raw materials, orcomposition and shall notprocess finished products thatare already patented.

NA

no example



Explanation

5 4.3.2.5 Where relevant, shelf life testsshall be carried out taking intoaccount product formulation,packaging, manufacturing andstorage conditions. The shelflife (e.g. best before date) ofthe labeled goods shall becalculated accordingly, fromthe original production date.Where relevant, for productswith shelf lives, tests shall bedone at the end of the productshelf life on retained samples.

NA

It's not necessary to evaluate the shelf lifeusing test is a commercial shel life

6 4.5.4.3.1 All process waters (includingwater used as an ingredient)shall be tested regularly forcompliance with chemical,physical and microbiologicalspecifications. Special attentionshall be paid after periods of nowater consumption (e.g. after aweekend or holiday period).The risk assessment shalladdress this topic.The company shalldemonstrate the effectivenessof its water treatment andusage.

NA

water is not used

7 4.5.4.3.2 A water monitoring program(especially in the case of coldmixing operations) shall verifythat the water treatment isadequate and effective on arisk based plan.

NA

water is not used

8 4.5.4.3.3 Recycled water which is usedin the process shall not pose acontamination risk. The watershall comply with applicablelegal requirements for potablewater; records of compliancetesting shall be available.

NA

water is not used

9 4.8.3 Where metal and/or otherforeign material detectors arerequired, they shall be installedto ensure efficiency ofdetection, in order to avoidsubsequent contamination.

NA

no metal detector are used



Explanation

10 4.8.4 The accuracy of detectors shallbe specified. Checks of properfunction of detectors shall becarried out regularly. In case ofmalfunction or failure of foreignmaterial detector, correctiveactions shall be defined,implemented and documented.

NA

no metal detector are used

11 4.11.2 In case of transport ofdangerous goods, thecompany shall ensure that allthe relevant legislativerequirements are fulfilled.

NA

no dangerous goods involved

12 5.5.5 If relevant, all equipment usedfor final checking shall belegally approved.

NAthere is only a manual check


Detailed audit report


Explanation

1 1.1.1

The senior management shalldraw up and implement acorporate policy. The corporatepolicy shall include as aminimum reference to:- customer and consumerfocus,- environmental responsibility,- occupational health,- buildings,- machines and equipment,- product requirements(includes: product safety,quality, legality, process andspecification).The corporate policy shall becommunicated to allemployees.

A Quality and Safety Policy 14/3/2019

2 1.1.2

The content of the corporatepolicy shall have been brokendown into specific objectivesfor the relevant departments.The responsibility and the timescale for achievement shall bedefined for each department ofthe company.

A

Quality objectives for the year 2019 defined14/3/2019The goals for 2019 were down as regards aparticular customer. Expected sales increase5.4%. The value of the Nc related to suppliersis decreasing.Customer KPIKPI suppliersQuality checksIn terms of development, we hypothesise topack in paper instead of plastic, but theproblem is economic because it is notbearable. moreover, we must consider the factthat the price of raw materials has risen a lotover the last two years. companies in thesector have become under observation byinsurance companies

3 1.1.3

From the corporate policy, thequality and product safetyobjectives shall becommunicated to theemployees in the respectivedepartments and shall beeffectively implemented. Thecompany shall ensure that allrelevant information iscommunicated effectively andin a timely manner to therelevant personnel.

A



Explanation

4 1.1.4

The senior management shallensure that the achievement ofall objectives is regularlyreviewed, as a minimum theobjectives shall be reviewedannually.

AManagement review covering the period of2018

5 1.2.1An organization chart shall beavailable showing the structureof the company.

A

Company organization chart rev 20 of22/11/2018General Director Luca Giorgi and Liana GiorgiResp quality Paolo Giustino GrazziniResp. Production and purchase AlessandroCei

6 1.2.2

Competences andresponsibilities, includingdeputation of responsibilityshall be clearly specified.

A

7 1.2.3

KO N°1: The seniormanagement shall ensure thatemployees are aware of theirresponsibilities relating toproduct safety and quality.Senior management shall alsoensure that mechanisms are inplace to monitor theeffectiveness of the operationof the employees. Suchmechanisms shall be clearlyidentified and documented.

AAll employees contacted during the auditwereaware oftheir responsibilities

8 1.2.4

Employees with influence onproduct requirements shall beaware of their responsibilities,through job descriptions, andshall be able to demonstrateunderstanding of theirresponsibilities.

A

9 1.2.5The company shall have anIFS representative nominatedby senior management.

APaolo Giustino Grazzini t el + 39 3484780029email [email protected]

10 1.2.6

The senior management shallprovide sufficient and relevantresources to meet the productrequirements.

A

11 1.2.7

The department responsible forquality and product safetymanagement shall have adirect reporting relationship tothe senior management.

A



Explanation

12 1.2.8

The company shall ensure thatall processes (documented andundocumented) are known bythe relevant personnel and areapplied consistently.

A

13 1.3.1

A documented process shall bein place to identify fundamentalneeds and expectations ofcustomers.

A

14 1.3.2

The results of this processshall be evaluated andconsidered to determine qualityand product safety objectives.

A

15 1.4.1

Senior management shallensure that the quality andproduct safety managementsystems are reviewed at leastannually, or more regularly, ifchanges occur. Such reviewsshall contain at least:- results of audits,- customer feedback,- process compliance andproduct conformity,- status of preventive andcorrective actions,- follow up actions fromprevious management reviews,- changes that could affect theproduct safety and qualitymanagement system,- complaints from Authorities,- recommendations forimprovement.

A

Management review 15/1/2019 covering theperiod of 2018In 2018 they had received 8 complaints fromcustomer service. In 2019 there was anincrease in reports, due to the fact that thelogistical aspects that were previouslymanaged in a non-formal way are manageddifferently

16 1.4.2

This review shall include theevaluation of measures for thecontrol of the quality andproduct safety managementsystem and for the continuousimprovement process.

A



Explanation

17 1.4.3

The company shall identify andreview regularly (e.g. byinternal audits or factoryinspection) the infrastructureneeded to achieve conformityto product requirements. Thisshall include, for example, thefollowing items:- buildings,- supply systems,- machines and equipment,- laboratory equipment,- transport.The results of the review shallbe considered, with dueconsideration to risk, forinvestment planning.

A

18 1.4.4

The company shall identify andreview regularly (e.g. byinternal audits or factoryinspection) the workenvironment needed to achieveconformity to productrequirements. This shallinclude for example, thefollowing criteria:- staff facilities,- environmental conditions,- hygienic conditions,- workplace design,- external influences (e.g.noise, vibration).The results of the review shallbe considered, with dueconsideration to risk forinvestment planning.

A

19 2.1.1.1

The quality and product safetymanagement system shall bedocumented and implemented,and shall be retained in onelocation (it can be an electronicdocumented system).

A

20 2.1.1.2

A documented procedure shallexist for the control ofdocuments and theiramendments.

A

21 2.1.1.3

All documents shall be clearlylegible, unambiguous andcomprehensive. They shall beavailable to relevant personnelat all times.

A



Explanation

22 2.1.1.4

All documents which arenecessary for compliance withthe product requirements shallbe available in their latestversion.

A

23 2.1.1.5

The reason for anyamendments to documents,critical for the productrequirements shall be recordedand approved.

A

24 2.1.1.6Documents shall be removedfrom the job area anddestroyed if they are outdated.

A

25 2.1.2.1

All relevant records necessaryfor the product requirementsshall be completed, detailedand securely maintained (e.g.with backup system) and shallbe available on request.

A

26 2.1.2.2

Records shall be legible andgenuine. They shall bemaintained in a way thatsubsequent manipulation ofrecords is prohibited.

A

27 2.1.2.3

All records, including recordsshowing the effective control ofprocess, product safety andquality shall be kept inaccordance with legalrequirements and customerspecifications (this includes, forinstance and where relevant,the cosmetic productinformation file).These records shall be kept fora minimum of one year afterthe end of shelf life period. Forproducts which have no shelflife, the duration of recordkeeping shall be in line withcustomers' requirements.

A They decided to maintain records 5 year

28 2.1.2.4Any amendments to recordsshall only be carried out byauthorized persons.

A

29 2.2.1.1

Before developing a riskmanagement system, thecompany shall haveimplemented all necessaryGood Manufacturing Practices(GMP’s) which are commonlyused in its scope of activity.

A



Explanation

30 2.2.1.2

The basis of the company’sproduct safety control systemshall be a fully implemented,systematic and comprehensiverisk management system. Itshall take into account anylegal requirements of theproduction and destinationcountries which may gobeyond such principles. Therisk management system shallbe implemented at eachproduction-site.The risk management systemshall cover all raw materialgroups, products or productgroups, as well as everyprocess (included outsourcedprocess) from goods receipt toproduct dispatch, includingproduct development andproduct packaging.

A

31 2.2.1.3

The company shall ensure thatthe risk management system isbased upon scientific literature,or technical verifiedspecifications relating to themanufactured products andprocedures.The risk management systemshall be maintained in line withany new technical andscientific process development.

A

32 2.2.1.4

Risk management system shallbe reviewed and necessarychanges shall be made whenany modification is made in theproduct, process or anychange that could affectproduct requirements.

A

33 2.2.2.1

The risk management teamshall be multidisciplinary andinclude operational staff.Personnel appointed as riskmanagement team membersshall have specific knowledgeof hazards and risksassociated to products andprocesses.Where competent knowledge isnot available, external expertadvice shall be obtained.

A

Team assessment of risk analysisLuca GiorgiPaolo GrazziniMassimo Binelli ( external auditor )Tiziano Bertoccilast meeting relation to the internal auditconducted on october 2019



Explanation

34 2.2.2.2

Those responsible for thedevelopment and maintenanceof risk management systemshall have received adequatetraining in the application of therisk management principlesbased on the risk managementtool (Risk matrix, FMEA,HACCP, RPN, etc.) which thecompany uses.

A

35 2.2.2.3

The risk management teamshall have senior managementsupport and shall be wellknown and established withinthe company.

A

36 2.2.3.1

Describe the productThe assessment shall makereference to the full descriptionof the product including allapplicable relevant informationon product safety andregulation such as:- composition (raw materials,rework, reprocessing, etc.),- physical, chemical andmicrobiological parameters,- methods of treatment,- packaging, labeling,- durability (shelf life),- conditions for storage- method of transport.

A

The analysis of hazards and consequent riskshas been re-evaluated to better define theevaluation criteriaIt starts from the Risk Management ProcedurePOI-7.13 rev 00 of 04/12/2019. The risk isassessed with an Actual Risk Index with thedescription of the business transformationprocesses

37 2.2.3.2

Identify intended useThe intended use of theproduct shall be described inrelation to the expected use ofthe product by the consumer,taking into account vulnerablegroups of consumers.

A



Explanation

38 2.2.3.3

Construct flow diagramA flow diagram shall exist foreach product, product groups,raw material groups, etc., andfor all variations of theprocesses and sub-processes(including rework andreprocessing). The flowdiagram shall be dated, andclearly identify each criticalcontrol point with the numberassigned to it. In the event ofany changes the flow diagramshall be revised.

A

The analysis of hazards and consequent riskshas been re-evaluated to better define theevaluation criteriaIt starts from the Risk Management ProcedurePOI-7.13 rev 00 of 12/04/2019. The risk isassessed with an Actual Risk Index with thedescription of the business transformationprocessesAnnex 1 to the procedure "Principle Flowoperations, there are 5 CPs that have beenidentified in the process flowAttachment 2 Detail of tissues and tissuesproduction linesIn terms of layout there are several GMP rulesdepending on the area colors. more restrictiverules in the yellow areaThere is also a very limited red area wherethe card is not yet protectedCP01 control of the unloading of raw materials(integrity, correct storage of packages)CP02 control of incidence between what wasordered and what was received andidentification of the lotsCP03 technical verification of the paper in thelaboratory, packaging check, verification ofplastic thickness and graphicsCP04 coincidence check between productspresent at the end of the line and the bill ofmaterialsCP05 statistical checks by the operator on theline (the operator must set aside the productshe has checked, the shift supervisor will checkthe products and eventually reintroduce themto the production line)

39 2.2.3.4

On-site confirmation of the flowdiagramThe risk management teamshall review the processes atall operation stages against theflow diagram. Where relevant,amendments of the diagramwill be made.

A

40 2.2.3.5.1

A hazard analysis shall beavailable for all physical,chemical and biologicalhazards that may bereasonably expected.A hazard analysis and a riskassessment shall be conductedfor each step from rawmaterials to the finishedproducts includingdevelopment and packagingmaterial validation.

A

the final result is a tabular system, where thedangers are present in the columnsFinally, there are 4 registersgiven example Formation carried out on11/15/2019, a value is given to the singleshare (in this case 1% of incidence comparedto a maximum of 20%)



Explanation

41 2.2.3.5.2

Based on the hazard analysis,the risk assessment shalldemonstrate the actionsrequired if a hazard is a risk,taking into account theprobability of harm to theconsumer and the severity ofdamage (effect, potentialconsequences). Themethodology for assessing riskshall be documented.

A

a list of the macro processes has beendefined, the concept of State by Magnitude(gravity) introducedProbability of occurrence with value from 5 to1 (5 continuously, 1 once a month)Gravity based on consumer safety iswidespread throughout the product.Introduced difference between exposedproduct and packaged productThen assessment of actual risk (unacceptablerisk from 16 to 25)Then calculation of the residual risk index,after application of mitigation actionsthere are 4 categories: adequate training,operational control, maintenance andimprovement, surveillance

42 2.2.3.6

Determine critical control pointsBased on level of acceptabilityof risk, critical control pointsshall be identified anddocumented.

A

a list of the macro processes has beendefined, the concept of State by Magnitude(gravity) introducedProbability of occurrence with value from 5 to1 (5 continuously, 1 once a month)Gravity based on consumer safety iswidespread throughout the product.Introduced difference between exposedproduct and packaged productThen assessment of actual risk (unacceptablerisk from 16 to 25)Then calculation of the residual risk index,after application of mitigation actionsthere are 4 categories: adequate training,operational control, maintenance andimprovement, surveillance

43 2.2.3.7

Establish critical limits for eachcritical control pointFor each critical control point,the appropriate critical limitsshall be defined and validatedin order to clearly identify whena process is out of control.

NA No CCP identified



Explanation

44 2.2.3.8

KO N° 2: Establish amonitoring system for eachcritical control pointSpecific monitoring proceduresshall be established for eachcritical control point to detectany loss of control. Records ofmonitoring shall be maintainedfor a relevant period. Eachdefined critical control pointshall be under control at alltimes. Monitoring and control ofeach critical control point shallbe demonstrated by records.The records shall specify theperson responsible, as well asthe date and result of themonitoring activities.

NA No CCP identified

45 2.2.3.9

Establish corrective actionsFor each critical control point,corrective actions shall beestablished. In case themonitoring indicates that aparticular critical control point isnot under control, adequatecorrective actions shall betaken and documented.Such corrective actions shallalso take into account any non-conforming products.

A

46 2.2.3.10

Establish verificationproceduresProcedures of verification shallbe established to confirm thatthe risk management system iseffective. Verification of the riskmanagement system shall beperformed at least once a year.Examples of verificationactivities include:- internal audits,- analyses,- sampling,- evaluations,- complaints by authorities andcustomers.The results of this verificationshall be incorporated into therisk management system.

A

The company manager carried out a checkduring the night shift to verify the correctapplication of the hygienic GMP, finding somepeople who did not wear the hair caps that arenecessary by rule. Performed specific trainingwith refreshing concerning the GMP rules



Explanation

47 3.1.1

All personnel performing workthat affects product safety,legality and quality shall havethe required competence(demonstrated by education,work experience and/ ortraining) based on hazardanalysis and assessment ofassociated risk.

A

48 3.2.1.1

There shall be documentedrequirements relating topersonnel hygiene. Theseinclude, as a minimum thefollowing criteria:- protective clothing,- hand washing anddisinfection,- eating and drinking,- smoking,- actions to be taken in case ofcuts or skin abrasions,- fingernails, jewelry andpersonal belongings,- hair and beards.The requirements shall bebased on hazard analysis andassessment of associated riskin relation to product andprocess.

A

POI-6.02 Gestione delle risorse - Dipendenti ecollaboratori 03 4/12/2019POI 6-01 Gestione delle risorse Infrastrutturee Ambiente di lavoro rev 09 9/12/2019

49 3.2.1.2

The requirements for personnelhygiene shall be in place andapplied by all relevantpersonnel, contractors andvisitors. Compliance with therequirements shall be checkedregularly.

A

50 3.2.1.3

Visible jewelry (incl. piercing)and watches shall not be worn.Any exceptions shall havebeen comprehensivelyevaluated based on hazardanalysis and assessment ofassociated risk.

A

51 3.2.1.4

Cuts and skin abrasions shallbe covered by a coloredplaster/ bandage (different fromthe product color). Anyexceptions shall have beencomprehensively evaluatedbased on on hazard analysisand assessment of associatedrisk.

A



Explanation

52 3.2.1.5

Based on hazard analysis andassessment of associated risk,there shall be a program tocontrol effectiveness of handhygiene.

A

53 3.2.2.1

Company procedures shallexist to ensure that allpersonnel, contractors andvisitors are aware of the rulesregarding the management ofwearing and changingprotective clothing in specifiedareas in accordance withproduct requirements.

APOI-6.02 Gestione delle risorse - Dipendenti ecollaboratori 03 4/12/2019

54 3.2.2.2

In work areas where wearingheadgear and/or beard snood(covering) is required, the hairshall be covered completely, sothat product contamination isprevented.

A

55 3.2.2.3

Clearly defined usage rulesshall exist for work areas/activities where it is required towear gloves (colored differentlyfrom the product color).Compliance with these rulesshall be checked on a regularbasis.

A

56 3.2.2.4

Suitable protective clothing anddevices to ensure personnelsafety shall be available insufficient quantity for eachemployee, when required.

A

57 3.2.2.5

When required, all protectiveclothing shall be thoroughlyand regularly laundered. Basedon hazard analysis andassessment of associated risk,taking into consideration theprocesses and products, thecompany shall determine ifclothing shall be washed by acontract laundry, on-sitelaundry or by the employee.

A

58 3.2.2.6

Guidelines shall exist forlaundering of protectiveclothing and a procedure shallbe in place for checking itscleanliness, when required.

A



Explanation

59 3.2.2.7

The company shall review thatimplemented preventivemeasures to ensure personnelsafety related to hazardousworking conditions areeffective.

A

60 3.2.3.1

There shall be written andcommunicated measures forpersonnel, contractors andvisitors in case of anyinfectious disease which mayhave an impact on productsafety. In case of declaration ofinfectious disease, actionsshall be taken in order tominimize risk of contaminationof products.

AIDL 12 Obblighi relativi alla certificazione IFSrev 00 del 22/10/2018

61 3.3.1

The company shall implementdocumented training and/orinstruction programs withrespect to the productrequirements and the trainingneeds of the employees basedon their job which shall include:- training contents,- training frequency,- employee’s task,- languages,- qualified trainer/tutor,- evaluation methodology.

A

Specific training is carried out through thecellular communication system and theperson must confirm the readingGiven an example of training relating to a newemployee, S.I. operator task 31/10/2019,delivery of documents: organization chart, jobdescription, practical guide to safety at work,FSC and PEFC training, IFS HPCmanagement manual, code of ethics,company regulation. The person was recentlyreappointed until the end of January 2020.Similar documentation for MF 1/7/2019 andM.L. 07/10/2019Seen as an example of a coaching report forFG coaching period 3/12/2018 - 1/2/2019

62 3.3.2

The documented trainingand/or instruction programsshall apply to all personnel,including temporary workersand employees from externalcompanies, employed in therespective work area. Uponemployment, and beforecommencing work, they shallbe trained in accordance withthe documented training/instruction programs.

BThe records relating to the period of coachingof two operators that were introduced in July2019 were not available



Explanation

63 3.3.3

Records shall be available ofall training/instruction events,stating:- list of participants (this shallinclude their signature),- date,- duration,- contents of training,- name of trainer/tutor.There shall be a procedure orprogram in place to prove theeffectiveness of the trainingand/or instruction programs.

A

64 3.3.4

The contents of training and/orinstruction shall be reviewedand updated regularly and takeinto account company’sspecific issues, product safety,product related legalrequirements andproduct/process modifications.

A

65 3.4.1

The company shall providestaff facilities, which shall beproportional in size, equippedfor the number of personneland designed and operated soas to minimize product safetyrisk. Such facilities shall bekept clean and in goodcondition.

BAbove the locker of the male locker room,there were numerous objects, contrary towhat is defined in the company regulations

66 3.4.2

There shall be in place rulesand facilities to ensure thecorrect management forpersonnel belongings and foodand other materials brought towork by personnel and shallinclude, food from dining roomand from vending machines.The food and other materialsshall only be stored and/orconsumed in designated areas.

A

67 3.4.3

The company shall providesuitable changing rooms forpersonnel, contractors andvisitors. Where necessary,outdoor clothing and protectiveclothing shall be storedseparately.

Aworks concerning changing rooms have beenfinished



Explanation

68 3.4.4

Changing rooms shall beseparated from production areaand shall be sited so that theyallow direct access to the areaswhere products are handled.Based on hazard analysis andassessment of associated risk,exceptions shall be justifiedand managed.

A

69 3.4.5

Toilets shall not have directaccess to an area whereproducts are handled. Thesanitary facilities shall beequipped with adequate handwashing facilities. Sanitaryfacilities shall have adequatenatural or mechanicalventilation. Mechanical airflowfrom a contaminated area to aclean area shall be avoided.

A

70 3.4.6

Adequate hand hygienefacilities shall be provided nearpoints of entry to and withinproduction areas, as well as atstaff facilities. Based on hazardanalysis and assessment ofassociated risk, further areasshall be similarly equipped.

A

71 3.4.7

Hand washing facilities shallprovide as a minimum:- water,- liquid soap,- appropriate equipment forhand drying.

A

72 3.4.8

If necessary, followingadditional requirementsregarding hand hygiene shallalso be provided:- hand contact-free fittings,- hand disinfection,- adequate hygiene equipment,- signage highlighting handhygiene requirements,- waste container with handcontact free opening.

A



Explanation

73 4.1.1

The requirements which aredefined in the contract with thecustomer shall be established,agreed upon and reviewedconcerning their acceptabilitybefore a supply agreement isconcluded. All clauses relatedto quality and product safetyshall be known andcommunicated to each relevantdepartment.

A

During traceability exercise view technicaldata sheet agreed with the customer7/16/2018the product is a TCF (AOX <70), FSC Mix,basis weight, surface, brightness, sheet size,weight for tissue, tensile strength dry CD,water absorbtion, 100% recycled cardboardbox

74 4.1.2

Changes of existing contractualagreements shall bedocumented, communicatedand updated between thecontract partners.

A

75 4.2.1.1

Specifications shall beavailable and in place for allraw materials (rawmaterials/ingredients,additives, packaging materials,rework) and where relevant, forsemi-finished product. Thespecifications shall be up todate, unambiguous, availableand always in conformancewith legal requirements.

C

During traceability exercise seen examples ofconformity declarations and technical data ofraw materialsIn the case of the paper supplier CartiereCarrara the request for compliance with theBFR has not yet been sentView declaration of conformity of Tronchetti18/7/2019View of Rocca's declaration 3/9/2019

76 4.2.1.2

Identification of raw materialsincluding packaging materialsshall contain the followinginformation:- name of the product,- unique identification code,- date or number of receipt (ifrelevant)- supplier´s name,- expiry date, if existing- batch reference given by thesupplier and the one given atreceipt, if different.

A

77 4.2.1.3

A reevaluation of the suitabilityof raw materials shall be inplace, in cases where rawmaterials are close to the bestbefore date, or when they arereturned to storage or otherrelevant parameters given bythe supplier.

A

78 4.2.1.4

When raw materials includingpackaging materials arerepacked, the new label shallcontain the relevant informationas on the original label.

A



Explanation

79 4.2.1.5

Where relevant, raw materialspecifications identifyingallergens requiring declarationshall be available. Thecompany shall maintain acontinuously up to date listingof all raw materials containingallergens used at its premises,which also identifies all blendsand formulas to which suchraw materials containingallergens are added.

AThe organization, in the absence of specificsector legislation, decided to ask conformity toBFR guidelines

80 4.2.2.1

Specifications shall beavailable for all final productsand shall be agreed upon inwriting with customers. Thespecifications shall be up todate, traceable, unambiguous,available to relevant personneland always in conformancewith legal and customerrequirements.

A

81 4.2.2.2

KO N° 3: Current and approvedfinished product specificationsshall be the basis for thecomposition of products. Theyshall also be the basis for thecontrol of the productionprocess and to monitor thefinished products’ compliance.

A

Starting from traceability exercise seen finalproduct View technical data sheet agreed withthe customer 7/16/2018the product is a TCF (AOX <70), FSC Mix,basis weight, surface, brightness, sheet size,weight for tissue, tensile strength dry CD,water absorbtion, 100% recycled cardboardbox

82 4.2.2.3

Where customers specificallyrequire that products are “freefrom” certain substances oringredients, or that certainmethods of treatment orproduction are excluded,verifiable procedures shall bein place.

A

83 4.2.2.4

There shall be a procedure forthe creation, the modificationand approval of specificationsfor all parts of the process,which shall include thepreliminary acceptance of thecustomer, if specifications havebeen agreed with customers.

A



Explanation

84 4.2.2.5

The specification controlprocedure shall include theupdate of finished productspecification in case of anymodification requested by thecustomer and/ or defined bythe company, related to:- raw material,- formula/ recipe,- process with influence on thefinal product,- packaging with influence onthe final product.

A

85 4.3.1.1

The company shall comply withthe current applicablelegislation and shall be able todemonstrate its own role in thesupply chain.

A

The organization, in the absence of specificsector legislation, decided to adopt the BFR,Guidelines for Evaluating Sanitary Papers asa normative reference . They have sent aspecific request to all suppliers dated22/7/2019

86 4.3.1.2

The company shall have asystem in place to ensure thatit is kept informed of allrelevant legislation on productsafety and quality issues,scientific and technicaldevelopments and industrycodes of practice. Legislationshall be understood andapplied.

A

The organization, in the absence of specificsector legislation, decided to adopt the BFR,Guidelines for Evaluating Sanitary Papers asa normative reference . They have sent aspecific request to all suppliers dated22/7/2019

87 4.3.1.3

For all relevant raw materials,safety data sheets shall beavailable in the format requiredby the destination country andkept up to date.

A

88 4.3.1.4

Where relevant, the safety datasheet and/or composition forfinal products shall be providedand communicated to theappropriate organizations (e.g.national safety centers, publicwebsite, etc.), taking intoconsideration the currentlegislation of the destinationcountry.

A



Explanation

89 4.3.1.5

In accordance with the currentlegislation, the company shallmandate a qualified safetyassessor to consider thegeneral toxicological profile ofthe ingredients, their chemicalstructure and exposure level,and finally provide thecompany with a safetyassessment of the finishedproduct regarding humanhealth.

NA not necessary by law

90 4.3.1.6

A process shall be in place toensure that labelling complieswith current legislation ofdestination country andcustomer requirements.

A

91 4.3.1.7

The conformity of the productwith its labeling shall bereviewed each time before anew label is issued for use.Such review shall take intoaccount the productrequirements and particularrelevant legislation in thedestination countries.

A

92 4.3.2.1

The company shall have animplemented procedure forR&D that takes into accountrisks and patents and thatdemonstrates that all existingand new products are designedto meet legal requirements.

A

The Organization does not carry out designactivities, limiting itself to creating theproducts requested by the customer. In caseof a new reference requested by a customer,an industrialization check is carried out

93 4.3.2.2The progress and the results ofR&D shall be properlyrecorded.

A

94 4.3.2.3

Without the authorization fromthe patent holder, the companyshall not use raw materials, orcomposition and shall notprocess finished products thatare already patented.

NA no example

95 4.3.2.4

Product formulation,manufacturing processes andthe fulfilment of productrequirements shall have beenensured by factory trials,performance tests, stabilitytests, organolepticassessments (where relevant)and product testing.

A



Explanation

96 4.3.2.5

Where relevant, shelf life testsshall be carried out taking intoaccount product formulation,packaging, manufacturing andstorage conditions. The shelflife (e.g. best before date) ofthe labeled goods shall becalculated accordingly, fromthe original production date.Where relevant, for productswith shelf lives, tests shall bedone at the end of the productshelf life on retained samples.

NAIt's not necessary to evaluate the shelf lifeusing test is a commercial shel life

97 4.3.2.6

Where specific R&D tests areneeded, equipment shall beavailable and pertinent (suchas dosages for regulatedingredients, preservatives,biocides etc.). In case tests arenot performed on-site, resultsof these external tests shall beavailable.

A

98 4.3.2.7

Claims shall be supported byscientific evidence (e.g. sunscreen formulations,detergents, etc.) in order toensure that the product meetthe stated claim.

A

99 4.3.2.8

Where relevant, pilotequipment(s) shall be availableand used in order to warrantygood formulation´sindustrialization.

A

100 4.3.2.9

The consumer packaging shallbe designed and labelled toprevent non intended use inorder to protect the safety ofthe potential user. The riskassessment shall address thistopic.

A

101 4.3.2.10

If required by law and based onhazard analysis andassessment of associated risk,the company shall verify thecapability of the packagingmaterial for each relevantproduct (e.g. organoleptictests, storage tests, chemicalanalysis).

A



Explanation

102 4.4.1

The company shall controlpurchasing processes toensure that all externallysourced materials (rawmaterials, including packagingmaterials) and services, whichhave an impact on productsafety and quality, comply withrequirements. Where acompany chooses to outsourceany process that may have animpact on product safety andquality, the company shallensure control over suchprocesses and fulfillrequirements ref. 4.4.8

B

View qualification of suppliersView supplier evaluation form (quality ,proximity, nomea)They introduced some value quality andrange, reliability and financial strengthAlso the strategic importance has beendefined (for example the paper supplier C.has a strategic value, while with the supplierL. almost there are no more reports)No suppliers were eliminated due toqualitative issues. No new suppliers were introducedDeviationThey did not find an economic agreement withLabanti (box manufacturer) that waseliminated , but it was not removed from thelist of qualified suppliers.

103 4.4.2

Purchased products andservices shall conform tocurrent specifications andcontractual agreements.

A

104 4.4.3

The schedule of these checksshall take into account theproduct requirements, supplierstatus and the impact of rawmaterials on the finishedproduct.

A

105 4.4.4

There shall be a procedure forapproval and monitoring ofsuppliers (internal andexternal), outsourcedproduction and sub-processes.In case of any kind ofoutsourced production, thecustomer shall always beinformed.

A

106 4.4.5

The approval and monitoringprocedure shall contain clearassessment criteria such as:audits, certificates of analysis,supplier reliability andcomplaints, as well as requiredperformance standards basedon hazard analysis andassessment of associated risk.

A

107 4.4.6

The results of supplier´sassessment shall be reviewedregularly. There shall berecords of the reviews and ofthe actions taken as aconsequence of assessment.

B

No suppliers were eliminated due toqualitative issues. They did not find aneconomic agreement with Labanti (boxmanufacturer) that was eliminated june 2019(even if it was not removed from the list ofqualified suppliers updated September 2019).No new suppliers were introduced



Explanation

108 4.4.7

There shall be records toidentify which raw materialincluding packaging and semi-finished products are sourcedfrom each supplier.

A

109 4.5.1.1

Senior management shallensure that hazards related tosite security (fire, explosions,electrical devices, flooding) areidentified and preventivemeasures are managed.

A

access gates are controlled by access chipthat limits the possibility of entering, there isan access register, there is a notation for themanagement of visitors. The visitors aremanaged directly by internal peopleThey have installed the video intercom on theoutside in order to have an overview of who isenteringThey always have people in production exceptSaturday and SundayThey have surveillance service that performsthe nights when there is no productionThey asked for permission to use cameras onthe borders , on the side towards the fields puttwo cameras on the border

110 4.5.1.2

The production and storageareas of the site shall besecured effectively bycontrolled access in order toprevent unauthorized entry.

A

111 4.5.2.1

The company shall investigateto what extent the factoryenvironment (e.g. ground, air)may have an adverse impacton product safety and productquality.In each case, appropriatemeasures shall be established.The effectiveness of theestablished measures shall beperiodically reviewed(examples: extremely dusty air,strong smells).

A

112 4.5.2.2

The factory exterior shall besustainable maintained, cleanand tidy. The external conditionof the premises shall beconsidered within the internalaudit process.

A

113 4.5.2.3

All grounds within the site shallbe in good condition. Wherenatural drainage is inadequate,a suitable drainage equipmentshall be installed.

A



Explanation

114 4.5.3.1

Plans clearly describinginternal flows of finishedproducts, raw materialsincluding packaging materials,waste, personnel, water, etc.shall be in place. A site mapcovering all buildings of thefacility shall be available.

A

115 4.5.3.2

The process flow, from receiptof goods to dispatch, shall beorganized so that acontamination of raw materialsincluding packaging materials,semi-processed, rework andfinished products is avoided.The risk of cross-contaminationshall be minimized througheffective measures.

A

116 4.5.3.3

Where relevant, products shallnot be produced, stored andfilled on the same equipmentas products with anotherintended use, unless evidenceis available that there is nonegative effect on the products.

A

117 4.5.3.4

If production areas areidentified as microbiologicallysensitive (e.g. clean roomtechnology), a positive airpressure equipment shall beinstalled. Assessment of thelevel of the microorganismsshall be performed at riskbased intervals.

A

118 4.5.4.1.1

All buildings used in themanufacture or storage ofproducts shall be designed andconstructed in order to allowunobstructed installation, easeof maintenance, efficient pestcontrol and easy cleaning ofthe equipment, as well ascompliance with all relevantlegislation.

A

119 4.5.4.1.2

Rooms where the products areprepared, treated, processedand stored shall be designedand constructed, so thatproduct compliance andproduct safety is ensured.

A



Explanation

120 4.5.4.1.3

Walls shall be constructed toprevent the accumulation ofdirt, to reduce condensationand mold growth, and tofacilitate cleaning.

A

121 4.5.4.1.4

Floors shall be in goodcondition and shall bedesigned to meet productionrequirements (e.g. mechanicalloads, cleaning materials, etc.)and to facilitate cleaning anddisinfection, where required.

A

122 4.5.4.1.5

Ceilings (or, where no ceilingsare fitted, the undersides ofroofs) and overhead fixtures(incl. piping, cables, lamps)shall be suitable for theprocess and shall be designedand constructed to minimizethe accumulation of dirt, thedetachment of paints or othercoating materials,condensation and mold growth.Ceilings and overheads shallbe designed to facilitatecleaning and prevent productcontamination.

A

123 4.5.4.1.6

Windows and other openingsshall be designed andconstructed to avoid theaccumulation of dirt and shallbe maintained in goodcondition.

A

124 4.5.4.1.7Doors and gates shall be ingood condition and easy toclean.

A

125 4.5.4.1.8

Drainage equipment shall bedesigned to facilitate cleaningand to minimize the risk ofproduct contamination (e.g.adverse impact, ingress ofpests, environment impactetc.). The hygienic disposal ofwaste water shall be ensured.

A



Explanation

126 4.5.4.1.9

Where relevant, forlaboratories:-location of laboratories at thefactory shall not affect productsafety-microbiological laboratoryshall be physically separatedfrom chemical laboratory-suitable equipment andenvironment shall be availablefor all tests performed.

AThere is a very small laboratory in officebuilding

127 4.5.4.2.1All working areas shall haveadequate lighting.

A

128 4.5.4.2.2

Based on hazard analysis andassessment of associated risk,all lightning equipment andelectric fly killer units shall beprotected.The factory areas where thisclause shall apply:-handling of unpackagedproducts,-storage of raw materials,including packaging materials,-handling of raw materials,-changing rooms.This does not preclude thatother areas cannot haveprotected lighting equipment orelectric fly killer units.

A

129 4.5.4.2.3Adequate natural and/orartificial ventilation shall exist inall areas.

A

130 4.5.4.2.4

If ventilation equipment isinstalled, filters and othercomponents which requirecleaning or replacement shallbe easily accessible.

A

131 4.5.4.2.5

The use of air in the production(e.g. compressed air supply)shall avoid contamination andbe based on hazard analysisand assessment of associatedrisk.

A

132 4.5.4.2.6

Dust extraction equipment shallbe installed in areas whereconsiderable amounts of dustare generated.

A



Explanation

133 4.5.4.3.1

All process waters (includingwater used as an ingredient)shall be tested regularly forcompliance with chemical,physical and microbiologicalspecifications. Special attentionshall be paid after periods of nowater consumption (e.g. after aweekend or holiday period).The risk assessment shalladdress this topic.The company shalldemonstrate the effectivenessof its water treatment andusage.

NA water is not used

134 4.5.4.3.2

A water monitoring program(especially in the case of coldmixing operations) shall verifythat the water treatment isadequate and effective on arisk based plan.


135 4.5.4.3.3

Recycled water which is usedin the process shall not pose acontamination risk. The watershall comply with applicablelegal requirements for potablewater; records of compliancetesting shall be available.




Explanation

136 4.6.1

Based on hazard analysis andassessment of associated risk,cleaning and disinfectionschedules shall be availableand implemented. These shallspecify:- objectives,- responsibilities,- the products used and theirinstructions for use,- the areas to be cleanedand/or disinfected,- cleaning frequency,- documentation requirements,- hazard symbols (ifnecessary).These schedules shall bedocumented.

A

CleaningThey issued a new Procedure POI-6.01 rev09 9/12/2019vista IdL 13 Labor Instruction Management ofthe environment, production and warehousesrev 15/11/2018OPE CPR are responsible for daily cleaningPUL.PRO the cleaner is responsible forcleaning the common areas indicated in themapMEC is responsible for machine maintenanceHomogeneous areas for cleaning planninghave been definedThe IDL 13 view cleaning scheduleThe cleaning report PUL-MOD-06.21 seenexample 28/11/2108 , 29/11/2018, 30/11/2018On the production lines no detergents areused , if there were any particular cleaning tobe done, white oil would be usedLocal reports subjected to weekly cleaningView IDL 08 Cleaning the conditioner and / orperfume system 7/2/2017 contains indications:cleaning the anilox rollers off line with water,while the pipes are cleaned and kept filledwith ethyl alcoholChanging rooms and common areas arecleaned twice a week by an external externalcompany CDL company IRIS, seen as self-cleaning sheet

137 4.6.2

Where relevant, only qualifiedpersonnel shall be allowed toundertake cleaning anddisinfection. The personnelshall be trained and retrainedto carry out the cleaningschedules.

A

138 4.6.3

Based on hazard analysis andassessment of associated risk,the effectiveness and safety ofthe cleaning and disinfectionmeasures shall be verified,validated for equipment anddocumented according to asampling schedule by usingappropriate procedures.Resultant corrective actionsshall be documented.

A



Explanation

139 4.6.4

Cleaning and disinfectionmeasures shall be validatedaccording to any changingcircumstances (e.g.construction work, newproducts, new machines,changes of climate etc.).Where necessary, the cleaningand disinfection schedulesshall be adapted.

A

140 4.6.5

Current safety data sheets(SDS) and instructions for useshall be always available on-site for chemicals and cleaningagents. Personnel responsiblefor cleaning shall be able todemonstrate their knowledge ofsuch instructions.

A

141 4.6.6

Cleaning utensils andchemicals shall be clearlyidentified, used and storedappropriately, to avoidcontamination or unintendeduse.

A

142 4.6.7

The cleaning of productiontools shall, if relevant, becarried out at specific locationsor specific time periodsseparated from the productionprocess. If this is not possible,these operations shall becontrolled as to not affect theproduct safety and quality.

A

143 4.6.8

Where a company hires a third-party service provider forcleaning and disinfectionactivities, all requirementsspecified within section 4.6shall be clearly defined in therespective contract.

A

144 4.7.1

A waste managementprocedure shall exist and shallbe implemented to avoid crosscontamination.

A

Waste had only one case of destruction of theproduct with the name of the customer, butthe same gave authorization to the sale as asecond choice (it is a case of 2017)

145 4.7.2All current legal requirementsfor waste disposal shall be met.

A



Explanation

146 4.7.3

Waste collection containersand, where existing,compactors shall be clearlymarked, suitably designed, ingood state of repair, easy toclean, and disinfected wherenecessary.

A

147 4.7.4

Waste shall be collected inseparate containers inaccordance with the intendedmeans of disposal. Such wasteshall be disposed byauthorized third parties only.Records of waste disposalshall be kept by the company.Whenever possible, destructionof waste shall be intended toavoid re-use of unfit products.

A

148 4.8.1

Based on hazard analysis andassessment of associated risk,procedures shall be in place toavoid contamination withforeign material.

AIDL 12 Obblighi relativi alla certificazione IFSrev 00 del 22/10/2018

149 4.8.2

In all areas, i.e. handling of rawmaterials including packagingmaterials, processing andstorage, where riskassessment has identified thepotential for productcontamination, the use of woodshall be excluded. Where theuse of wood cannot beavoided, the risk shall becontrolled.

A

150 4.8.3

Where metal and/or otherforeign material detectors arerequired, they shall be installedto ensure efficiency ofdetection, in order to avoidsubsequent contamination.

NA no metal detector are used

151 4.8.4

The accuracy of detectors shallbe specified. Checks of properfunction of detectors shall becarried out regularly. In case ofmalfunction or failure of foreignmaterial detector, correctiveactions shall be defined,implemented and documented.

NA no metal detector are used



Explanation

152 4.8.5

Potentially contaminatedproducts shall be isolated.Access and actions for furtherhandling or checking for theseisolated products shall becarried out only by authorizedpersonnel according to definedprocedures. If product’scontamination is confirmed,those shall be treated as non-conforming products.

A

153 4.8.6

A glass and brittle materialmanagement shall beimplemented, taking intoaccount preventive andcorrective measures; thesystem shall include referenceto procedures in the event ofglass or brittle materialbreakage.Where a risk assessment hasidentified a potential for productcontamination, the presence ofbrittle material (including glass)shall be excluded or, if this isnot possible, the risk shall bemanaged.

BOn line 5 a bulkhead of the boxing machinewas damaged

154 4.9.1

The company shall have a pestcontrol system in place whichis in compliance with local legalrequirements, and as aminimum shall cover thefollowing criteria:- the factory environment(potential pests),- site plan with area forapplication (bait map),- identification of the baits on-site,- responsibilities (in-house/external),- used products/agents andtheir instructions for use andsafety,- the frequency of inspections.The pest control system shallbe based on hazard analysisand assessment of associatedrisk.

A

Contract with Rentokil 8 interventions areplanned ,As for pest control, they have contracted withRentokil and verifiable monitoring on the web.12 interventions are planned. there are 8lamps as per the map changed December2019. Seen for example report 12/12/2019In general terms, murine activity was detectedalso at the external walls. The pest controlcompany did not highlight any particularcritical issues. No example of complaint fromthe market had been received



Explanation

155 4.9.2

The company shall havequalified and trained in-housestaff and/ or employ theservices of a qualified externalprovider. Where an externalprovider is used, the activitiesrequired on-site shall bespecified in a written contract.

A They use external company

156 4.9.3

Pest control inspections andresulting actions shall bedocumented. Implementationof actions shall be monitoredand recorded.

AThe responsibility for monitoring flying insectcatches is now defined and They changed theglue every month

157 4.9.4

Baits, traps and insectexterminators shall befunctioning, in sufficientnumber and placed in anappropriate position. They shallbe constructed and positionedas not to cause anycontamination.

A

158 4.9.5

Incoming deliveries shall bechecked on receipt for thepresence of pests. Anyinfestation shall bedocumented and controlmeasures taken.

A

159 4.9.6

If windows pose a risk of asource of contamination suchas the ingress of pests,windows and roof glazing shallremain closed and sealedduring production.If they are designed to beopened for ventilationpurposes, they shall be sealedby easy removable pestscreens or other measures inorder to avoid anycontamination.

A

160 4.9.7

Based on hazard analysis andassessment of associated risk,external doors and gates shallbe designed to prevent theingress of pests; if possible,they shall be self-closing.

A



Explanation

161 4.10.1

All incoming goods, includingpackaging materials, shall beidentified and checked forconformity againstspecifications/other legallyrequired documentation and toa determined control plan. Thecontrol plan shall be riskbased. Test results shall bedocumented.

ASeen example of raw material control (example label 31/10/2018For every lot arrived a sample is maintained

162 4.10.2

The storage conditions andlocations of raw materialsincluding packaging materials,semi-processed and finishedproducts as well as workingmaterials shall in each casecorrespond to productrequirements, shall not bedetrimental to other productsand shall minimize crosscontamination.

AVerified, in stock raw materials, a cleaningcondition increased using a box to stop dust

163 4.10.3

Where relevant, for semi-finished products, maximumduration for storage shall bedefined.When this duration is reached,the semi-finished product shallbe re-evaluated before use.

A

164 4.10.4

Outdoor storage shall be keptto a minimum. Where goodsare stored outside, hazardanalysis and assessment ofassociated risk shall beundertaken in order to ensurethat there is no risk ofcontamination or adverse effecton quality and product safety.

A

165 4.10.5

When relevant, sampling ofraw materials and of bulkproduct shall be performed inan appropriate manner and byauthorized personnel.

A

166 4.10.6

Products shall be clearlyidentified on receipt and whenstored. Use of products shallbe undertaken in accordancewith the principles of FirstIn/First Out and/or FirstExpired/First Out, inaccordance with relevantindustry best practices.

A



Explanation

167 4.10.7

Periodic inventory shall beperformed to ensure stockreliability. Any significantdiscrepancy shall beinvestigated and correctiveaction taken.

A

168 4.10.8

Where a company hires a third-party storage service provider,the service provider shall besubject to IFS Logisticsrequirements. If the third partyservice provider is not certifiedto IFS Logistics, all relevantrequirements equivalent to thecompany’s own warehousingpractices shall be fulfilled andthis shall be clearly defined inthe respective contract.

AA CLT facility is used outsite that is under aperiodical control ( like another dept)

169 4.11.1

Before loading transportvehicles, their condition (e.g.absence of strange smells,high dust load, adversehumidity, absence ofcontamination, pests, mold)shall be checked and actionstaken, if necessary. At the rawmaterials and packagingmaterials receipt, checks shallbe made in order to assessthat transportation has takenplace under in good conditions.

ASeen example of truck control MOD 07.25Cconcerning DDT 38567 5/12/2018

170 4.11.2

In case of transport ofdangerous goods, thecompany shall ensure that allthe relevant legislativerequirements are fulfilled.

NA no dangerous goods involved

171 4.11.3

Adequate hygienicrequirements for all transportvehicles and equipment usedfor loading / unloading (e.g.hoses of silo installations) shallexist. There shall be records ofthe actions taken.

A

172 4.11.4

Where relevant, loading andunloading areas shall haveequipment in place to protecttransported products fromexternal influences.

A

173 4.11.5Security of transport vehiclesshall be appropriatelymaintained.

A



Explanation

174 4.11.6

Where a company hires a third-party transport service providerall the requirements specifiedwithin section 4.11 shall beclearly defined in therespective contract or theservice provider shall besubject to IFS Logisticsrequirements.

A defined transport needs

175 4.12.1

An adequate system ofmaintenance shall be in place.This system shall bemaintained and documented,covering all critical equipment(incl. transport) for compliancewith product requirements. Thisapplies both for internal andexternal maintenance activities.

A

As specified in procedure 6.01 there arescheduled maintenance operations which areweekly and monthlySeen examples of MOD 06.20M monthlyprogrammed maintenance plan of October2019 (eg automatic greasing system check, ortension check and state of the rotating ringseal lines Line 1)Then there is a diary of example machinesunfolding 02/04/2019 for the management ofanomalies that could be improved as asystem but is not incorrect

176 4.12.2

Product requirements andprevention of contaminationshall be ensured during andafter maintenance and repairwork. Records of maintenanceand repair work and ofcorrective actions taken shallbe kept.

C

Verified in production in more than one point,that the screws, bolts and washers used in thetooling are not placed in containers makingthem become possible foreign bodies

177 4.12.3All materials used formaintenance and repair shallbe fit for the intended use.

AFU vaseline is used for the lubrication of partsof the system that may come into contact withthe product

178 4.12.4

Failures of plant andequipment (incl. transport)covered by the maintenancesystem shall be documentedand reviewed so as to adaptthe maintenance systemaccordingly.

A

179 4.12.5

Temporary repairs shall becarried out so that productrequirements are not affected.Such work shall bedocumented and a short-termdeadline set for eliminating thefault.

A



Explanation

180 4.12.6

Where a company hires a third-party maintenance and repairservice provider, all thecompany specifiedrequirements regardingmaterial and equipment shallbe clearly defined, documentedand maintained.

A

181 4.13.1

Equipment shall be suitablydesigned and specified for theintended use. Beforecommissioning, it shall beverified that the productrequirements are compliedwith.Consumables used forequipment should not affect thequality of the product.

A

182 4.13.2

Equipment shall be designedand locationed so that cleaningand maintenance operationscan be effectively performed.

A



Explanation

183 4.14.1

KO N° 4: A traceability systemshall be in place which enablesthe identification of product lotsand their relation to batches ofraw materials, packaging indirect contact with product andpackaging intended orexpected to be in direct contactwith product. The traceabilitysystem shall incorporate allrelevant processing anddistribution records.Traceability shall be assuredand documented until deliveryto the customer.

A

We start with the finished product, lot number190723221, art Kokett Summer, products23808 boxes, 22 trucks were deliveredcompletely sold, delivered to differentwarehouses, the customer organized thetransportsThe customer had authorized the purchase ofboxes on 4/17/2019 of the approved graphicsView of approval by the customer 4/16/2019on proof of 3/29/2019The specific product was produced on07/23/2019 products 17 pallets, on the L2 lineCommodities involved:PP outer film lot A1907000671 reference lotsupplier 192065 PlastyleniaControl visa carried out on DDT 1152 of11/772019 (colors, color codes, barcode, printstep)Polyethylene A1907000677 lot supplier192112 PlastyleniaLot box A1907001024 lot 1530756 ScatolificioSandraLot card A1907001137 Cartiere Carrara eachreel is identified by a lot numberLabels A1904001194 lot supplier201935004957 supplier IRPLASTTo understand which coils are used, it isnecessary to select the single pallet andidentify the raw materials usedOn the incoming cards made checks of weightand dry strength and elongationProduction controls recorded on dymosoft17/7/2019: single packet printing, singlepacket welding, open and close die-cutting,number of packets per packet, handkerchieffolding, embossing centering, coupling seal,handkerchief size,On the cue: printing, welding, weight,readable production code,Boxbox closure, correct printingView technical data sheet of the product: 2-plyproduct and product featuresView technical data sheet agreed with thecustomer 7/16/2018the product is a TCF (AOX <70), FSC Mix,basis weight, surface, brightness, sheet size,weight for tissue, tensile strength dry CD,water absorbtion, 100% recycled cardboardboxLow migration inks

Visa DDT Cartiere Carrara TCF FSC paper Gr15 4V H84X3 TO 15% DDT 3722 of 4/6/2019,received 5/6/2019



Explanation

184 4.14.2

Downstream and upstreamtraceability records (fromproduction-sites to thecustomers) shall be available.The timeframe for producingthese records for review shallbe compliant with customer’srequirements.

A

185 4.14.3

Traceability shall be in place toidentify the relationshipbetween batches of finalproducts and their labels.

A

186 4.14.4

The traceability system shall betested on a periodic basis atleast annually, and each timethe traceability systemchanges.The test shall verifydownstream and upstreamtraceability (from raw materialsto delivered products and viceversa), including quantitychecking. Test results shall berecorded.

AThe company realised traeability test duringinternal audit from raw materials to finalproduct and viceversa

187 4.14.5

Based on hazard analysis andassessment of associated risk,on legal requirements and oncustomer specifications,traceability shall be ensured atall stages, including work inprogress, post treatment andrework.

A

188 4.14.6

Where relevant, it shall bepossible to identify at all timesall major equipment used forthe production of finishedproduct (containers of rawmaterials and of semi-finishedproducts, mixers, filling lines,etc.).

A

189 4.14.7

Identified samplesrepresentative of themanufacturing batch shall bestored appropriately and keptuntil expiration date of thefinished product and, ifnecessary, for a determinedperiod beyond this date(“sample bank”).

A



Explanation

190 5.1.1

Effective internal audits shallbe conducted according to adefined agreed audit programand shall cover at least allrequirements of the IFS HPCStandard. Scope andfrequency of internal auditsshall be determined by riskassessment. This is alsoapplicable for off-site storagelocations owned or rented bythe company.

AA complete program of the audits to be isperformed performed based on the riskanalysis : 19/1, 29/1, 27/2, 24/10

191 5.1.2Internal audits shall be carriedout at least once a year in alldepartments.

A

Internal audits conductedThere is a complete check list that has beenused by RGQ to understand the progress ofthe projectSeen report of internal audit 24/10/2019Seen auditor training report performed forexample 24/9/2018 but in general termsView check list that included 170 minorsurveys that were dealt with in real timeThere are a series of factories inspection :glass maintenance by weekly RGQ , cleaningby maintenance personnel

192 5.1.3The auditors shall becompetent and independentfrom the audited department.

A

193 5.1.4

Audit results shall becommunicated to the seniormanagement and toresponsible persons ofconcerned department.Necessary corrective actionsand a schedule forimplementation shall bedetermined, documented andcommunicated to everyrelevant person.

A

194 5.1.5

It shall be documented, howand when the correctiveactions resulting from theinternal audits shall be verified.

ASeen comunication to people after audit24/10/2019 . They have to answer durectly byphone

195 5.2.1

Regular factory inspectionsshall be planned and carriedout to assess criteria such asproduct control, hygiene,foreign material hazards,personal hygiene, andhousekeeping.Any deviation and theassociated corrective actionsshall be documented.

A



Explanation

196 5.3.1

The criteria for processvalidation and control shall beclearly defined. All processescritical to product safety andproduct compliance shall bevalidated.

A

In production check the following productions:Line 1 order B 2019 001882 cod prodV060303004.2Line 7 Order B 2019 002023 codM1515103012.2Line 6 Order B 2019 001949 artMFSC0624084001.1Line 5 Order B 2019 001252 CodS1024094023Line 4 order B 2019 001903 artSPEFC1024093026.1Line 3 order B 2019 001892 itemM36101030023

197 5.3.2

Processing operations shall becarried out in accordance withprocessing controldocumentation, and shallinclude:-suitable equipment,-composition of the product,-list of all raw materialsidentified according to relevantdocuments indicating batchnumbers and quantities,-detailed processing operationsfor each stage, such asaddition of raw materials,temperatures, mixing times,sampling and semi-finishedproduct transfer.Where applicable, a batchnumber shall be assigned.

A

Change the IDL 01 against the deviationissued during the previous audit rev 02 of12/19/2018 (mixing modification and spray forpacket), a check is required every 30 minutesto avoid producing items with the perfume inthe wrong position

198 5.3.3

In circumstances where thecontrol of process and workingenvironment parameters(temperature, time, pressure,chemical properties etc.) isessential to ensure the productrequirements are met, suchparameters shall be monitoredand recorded continuouslyand/or at appropriate intervals.

A

199 5.3.4

The company shall ensure thatin the event of changes toprocessing methods,equipment and productformulation (including reworkand packaging material),process characteristics arereviewed in order to assurethat product requirements arecomplied with. If relevant,customers shall be informedaccordingly.

A



Explanation

200 5.3.5

Where relevant, all reworkoperations shall be validated,monitored and documented.These operations shall notaffect the productrequirements.

A

201 5.3.6

There shall be appropriateprocedures for promptnotification, recording andmonitoring of equipmentmalfunction and processdeviations.

A

202 5.3.7

Process validation shall beperformed using the collecteddata that is relevant for productsafety and the processes. Ifsubstantial modifications occur,a revalidation shall be carriedout.

A

203 5.4.1

The company shall identify themeasuring and monitoringdevices required to ensurecompliance with productrequirements. These devicesshall be listed and clearlyidentified.

A

Measurement toolsSeen calibration report n ° 1185/1923/10/2019 of the BIL 2 used in quality labscales present on the tissue line and used tocheck weightsevery day a check is performed with sampleweights to verify the linearity using the sampleweightscontrol performed by laboratory external ClassI balance accuracy requestedPaper weight control performed in thelaboratory with BIL 2 scales I class reports1056/18B4 scale used in calibrated warehouse23/10/2019 class IIIDynamometer measuring range 0-30 kg or300 N seen calibration report 316/2019 usedin quality laboratory report 2/22/2019

204 5.4.2

All measuring devices shall bechecked, adjusted andcalibrated, under a monitoringsystem, at specified intervalsand in accordance with definedrecognized standard/methods.The results of these checks,adjustments and calibrationsshall be documented. Wherenecessary, corrective actionson devices and on processesand products shall be carriedout.

A

205 5.4.3All measuring devices shall beused exclusively for theirdefined purpose.

A



Explanation

206 5.4.4

The calibration status of themeasuring devices shall beclearly identified (labelling onthe device or on a list of testeddevices).

A

207 5.5.1

The frequency andmethodology of quantitychecking shall be determinedso that the legal requirementsand customer specifications, orif relevant, guidelines fornominal quantity are met.

A

208 5.5.2A procedure shall exist todefine compliance criteria forlot quantity checking.

A

209 5.5.3

Checks shall be implementedand recorded, according to asampling plan which ensures aproper representation of themanufacturing lot.

A

210 5.5.4

Results of these checks shallbe compliant with definedcriteria for all products ready tobe delivered.

A

211 5.5.5If relevant, all equipment usedfor final checking shall belegally approved.

NA there is only a manual check

212 5.6.1

There shall be proceduresensuring that all specifiedproduct requirements are met,including legal requirements,performance andspecifications. Results ofmicrobiological, physical andchemical analysis required forthat purpose shall be available.

A

The controls related to production arerecorded on the computer system , verifiedexample of product used for traceability testchecks every two hours , the checks were notmade every hour due to problems ofproduction interruption (the machine is stillundergoing settling)

213 5.6.2

Analyses, which are relevantfor product safety and legality,shall preferably be performedby laboratories havingappropriate accreditedprograms/methods (ISO17025). If the analyses areperformed by a factory internalor a laboratory not havingappropriate accreditedprograms/methods, thecompany shall be able todemonstrate that the resultsare reliable.

A

Tests are carried out at the University ofFerrara. Occlusive test patch on lot260319L7T32314, report 20/5/2019, classifiedas "non-irritating". Lottto patch test280319L4T22058. In order to comply with the"dermatologically tested" claimsSeen as an example of microbiologicalanalyzes carried out on the final product25/3/2019 in relation to product for customerC. 3 veils



Explanation

214 5.6.3

Documented evidence shallexist, which ensure thereliability of the internalanalysis results, on the basis ofofficial and non-officialrecognized analytical methods.

A

215 5.6.4

A control plan shall be drawnup for internal and externalanalysis, based on hazardanalysis and assessment ofassociated risk and based onadditional informationregarding product quality (e.g.complaints). This plan shallcover raw materials, semi-processed and finishedproducts and shall include thetypes of tests, their frequencyand critical limits, which arelinked to the specificationlimits. The test results shall bedocumented.

A

216 5.6.5

The analytical results shall bereviewed regularly and trendsidentified. Appropriatemeasures shall be introducedpromptly for any unsatisfactoryresults, or where such trendsindicate unsatisfactory results.

A

217 5.6.6

Where internal analysis isundertaken, qualified andtrained personnel shall be inplace, as well as appropriateequipment and premises.

A

218 5.6.7

Results of checks on finishedproducts including reworkmaterial shall be reviewed byauthorized personnel in orderto verify the conformity of thefinished and semi-finishedproducts with the acceptancecriteria.

A

219 5.6.8

Where relevant, for verificationof finished product quality,organoleptic tests shall becarried out regularly. Thesetests shall be in accordancewith specifications and relatedto the impact on respectiveparameters of productcharacteristic. The results ofthese tests shall bedocumented.

A



Explanation

220 5.6.9

Based on any internal orexternal information on productrisk which may have an impacton product safety and/ orquality, the company shallupdate its control plan and/ ortake any appropriate measureto control the compliance of thefinished products.

A

221 5.7.1

A procedure shall be in placefor the quarantine and releaseof all raw materials includingpackaging materials, semi-processed and finishedproducts, and processingequipment. The procedureshall ensure that only productsand materials conforming toproduct requirements areprocessed and dispatched.

A

222 5.8.1

A system shall be in place forthe management of productcomplaints and, when relevant,shall take into account specificprocedures (e.g. undesirableeffects).

A

Analysis of total customer complaints in 20188 complaintsconditionerPaper with wrinklesgoods wet at the draingoods damaged during transporthalved claims there are no repetitive elements

223 5.8.2

All complaints shall beassessed by competent staff.Where it is justified,appropriate actions shall betaken immediately.

A

Seen example of customer complaint24/10/2019 C.The customer "complains" that themechanical characteristics are too highcompared to the technical data sheet. Inreality the fact is not a problem for the finishedproduct in terms of performance. The producthowever was in the specifications

224 5.8.3

Complaints shall be analyzedwith a view to implementingpreventive and correctiveactions which avoid therecurrence of the non-conformity.

A no particular trends

225 5.8.4

The results of complaint dataanalysis shall be madeavailable to the relevantresponsible persons and to thesenior management.

A



Explanation

226 5.9.1

A documented procedure shallbe defined for management ofincidents and of potentialemergency situations thatimpact product safety, legalityand quality. This procedureshall be implemented andmaintained. This includes as aminimum: the nomination andtraining of a crisis team, analert contact list, sources oflegal advice (if necessary),contacts availability, customerinformation, and acommunication plan, includinginformation to consumers.

A

View of the client's communication D. that on25/9/2019 he is contesting, following ananalysis carried out in compliance with theEuropean Pharmacopoeia 2.6.12 version 9.The product involved is lot 4/1/2019, the lotwas sold 9/8/2019. An anomaly exists due tothe fact that the product was delivered inJanuary in a warehouse that is not the oneindicated. Open incident managementprocedure, complete product traceability,retrieve samples from the same productionshift (sample DIA Mini Mentolo 10x10 4 plyround 2), the perfume manufacturer excludedthe presence of water in their formulationMaking the traceability it results that toproduce those handkerchiefs 3 reels wereused (1 of Carraia and 2 of Tronchetti)Found the available counter samplesSend the samples to an external laboratory,Contacted the two paper suppliers whoexcluded contamination based on weeklyanalyzesTraceability of the pallets, discovered that thesix pallets had not been sent to differentwarehouses. One of these warehouses wasclosed and all the product was transferred tothe warehouse that was subject to collection.The SSCC pallet 080335097203659536They have commissioned product analysiswith a growing production lot.The laboratory delivered the report on8/10/2019 in accordance with thePharmacopea finding a value ten times lowerThey informed the customer and the productwas released

227 5.9.2

Updated emergency contactdetails (such as names andphone numbers of suppliers,customers and competentauthorities) shall be available.A person of the company, whohas the authority to initiate theincident management process,shall be permanently available.

A

228 5.9.3

The company shall assign theresponsibility (ies) for theexternal communication (crisismanagement, authorities andcommunication with media) tospecific personnel.

A



Explanation

229 5.9.4

KO N° 5: There shall be aneffective procedure for thewithdrawal and recall of allproducts, which ensures thatinvolved customers areinformed, as soon as possible.This procedure shall include aclear assignment ofresponsibilities.

AThere is a Crisis management proceduureupdated september 2018 .Organisationverified the system during the internal audit

230 5.9.5

The feasibility, effectivenessand timeliness ofimplementation of thewithdrawal procedure shall besubject to regular internaltesting, based on hazardanalysis and assessment ofassociated risk, but carried outat least once a year. This shallbe carried out in a manner toensure the effectiveimplementation and operationof the procedure.

A

231 5.10.1

A procedure shall exist for themanagement of all non-conforming raw materialsincluding packaging materials,semi-finished and finishedproducts and processingequipment. This procedureshall include always thefollowing criteria, but mayinclude other requirements:- isolation/ quarantineprocedures,- risk assessment,- identification (e.g. labeling),- decision about the further use(e.g. release, destruction,rework/post-treatment,blocking, customer information,rejection/ disposal).

A

Starting from 23/9/2019 they changed thesystem to manage NC , to describe correctlythe management of complaint . Seen exampleof NC issued against supplier Big Timeconcerning boxes example NC 11/2019Concerning internal NC , 2 NC issued duringjuly 2019 because not correct identification ofthe product . Shift resp , identified theproblems before deliveries . They introduceda control of the shift leader every hour andcontrol of quality manager every shift .Practically they increased controls inproduction how described IDL 07 Istruzioniper il corretto svolgimento dei controlli inproduzione rev 02 08/08/2019The second NC issued 5/7/2019 had beenconcerning an operator didn't realised thecontrols necessary ( the operator leaves

232 5.10.2

The responsibilities for themanagement of non-conforming products shall beclearly identified. Theprocedure for the managementof non-conforming productsshall be understood by allrelevant employees.

A

233 5.10.3

Where non-conformities arepresent, immediate correctionsshall be taken to ensure thatproduct requirements arecomplied with.

ARecords concerning NC are managed directlyusing mobile phones by operators , then thereis a management of QA manager



Explanation

234 5.10.4

Out of specification finishedgoods or finished goods that donot meet other legal and/ orcustomer requirements are notallowed to be placed on themarket. In case of privatelabels, exceptions shall beagreed in writing with thecontract partners.

A

235 5.11.1

A procedure shall be in placefor the recording and analysisof the non-conformities with theobjective to avoid recurrencesby the provision of preventiveactions and/or correctiveactions.

A

236 5.11.2

KO N° 6: Corrective actionsshall be clearly formulated,documented and undertaken,as soon as possible to avoidfurther occurrence of non-conformity. The responsibilitiesand the timescales forcorrective actions shall beclearly defined. Thedocumentation shall besecurely stored and easilyaccessible.

A

Seen examples of Corrective actions adoptedafter the Internal NC issued july 2017 THeychanged the system to records controls inproduction . They applied a visual scheme forevery anomalie identified , for instanceevidence of corrective action applied

237 5.11.3

The effectiveness of theimplemented corrective actionsshall be documented and shallbe validated.

A


Co-Auditor(s):

Audited company: TISSUNION EUROP SRL UNIPERSONALE



Italy

Date/time of current audit: 17-Dec-19 / 08:30 - 18:15 (Audit)18-Dec-19 / 08:15 - 16:30 (Audit)

Lead Auditor: Sergio Emanule Nestori

Trainee(s):

Requirementnumber

IFS HPC 2 requirement EvaluationExplanation (by theauditor)

Corrective action (by thecompany)

Responsability/Date/Status of implementation(by the company)

Release by theauditor

3.3.2

The documented trainingand/or instruction programsshall apply to all personnel,including temporary workersand employees from externalcompanies, employed in therespective work area. Uponemployment, and beforecommencing work, they shallbe trained in accordancewith the documented training/instruction programs.

B

The records relating to theperiod of coaching of twooperators that wereintroduced in July 2019were not available

Documents' paper archiveconcerning training activitieswill be completelyreorganized and registrationdocuments, including thesupport reports, will bescanned and associated tothe file of each employee, inorder to simplify theirtraceability.

Paolo Grazzini /05/01/2020/ started

S.Nestori 2019/12/24

3.4.1

The company shall providestaff facilities, which shall beproportional in size,equipped for the number ofpersonnel and designed andoperated so as to minimizeproduct safety risk. Suchfacilities shall be kept cleanand in good condition.

B

Above the locker of themale locker room, therewere numerous objects,contrary to what is definedin the company regulations

The anomaly emerged wasalready studied underadequate training which willbe repeated to awaken allthe operators to compliancewith the rules. Furthermore,in order to keep thesituation under control,appropriate weekly checkswill be introduced in thesurveillance plan.



Page 1 of 3

Requirementnumber





4.2.1.1

Specifications shall beavailable and in place for allraw materials (rawmaterials/ingredients,additives, packagingmaterials, rework) and whererelevant, for semi-finishedproduct. The specificationsshall be up to date,unambiguous, available andalways in conformance withlegal requirements.

C

During traceability exerciseseen examples ofconformity declarations andtechnical data of rawmaterialsIn the case of the papersupplier Cartiere Carrarathe request for compliancewith the BFR has not yetbeen sentView declaration ofconformity of Tronchetti18/7/2019View of Rocca's declaration3/9/2019

The distribution of requestsfor compliance to the BFRwill be completed andinterested suppliers whohaven't replied yet will bepressed.



4.4.1

The company shall controlpurchasing processes toensure that all externallysourced materials (rawmaterials, includingpackaging materials) andservices, which have animpact on product safety andquality, comply withrequirements. Where acompany chooses tooutsource any process thatmay have an impact onproduct safety and quality,the company shall ensurecontrol over such processesand fulfill requirements ref.4.4.8

B

View qualification ofsuppliersView supplier evaluationform (quality , proximity,nomea)They introduced somevalue quality and range,reliability and financialstrengthAlso the strategicimportance has beendefined (for example thepaper supplier C. has astrategic value, while withthe supplier L. almost thereare no more reports)No suppliers wereeliminated due toqualitative issues. No new suppliers wereintroducedDeviationThey did not find aneconomic agreement withLabanti (box manufacturer)that was eliminated , but itwas not removed from thelist of qualified suppliers.

The risk analysis system willalso be integrated withsupplier evaluation. Thesupplier qualificationprocedure will be adjustedaccordingly.

Paolo Grazzini / 28/02/2020/ to be started


Page 2 of 3

Requirementnumber





4.4.6

The results of supplier´sassessment shall bereviewed regularly. Thereshall be records of thereviews and of the actionstaken as a consequence ofassessment.

B

No suppliers wereeliminated due toqualitative issues. They didnot find an economicagreement with Labanti(box manufacturer) thatwas eliminated june 2019(even if it was not removedfrom the list of qualifiedsuppliers updatedSeptember 2019). No newsuppliers were introduced

The communicationbetween the purchasingdepartment and the qualitydepartment will beprocessed to be able tocarry out complete andconstant updates of the listof qualified suppliers.



4.8.6

A glass and brittle materialmanagement shall beimplemented, taking intoaccount preventive andcorrective measures; thesystem shall includereference to procedures inthe event of glass or brittlematerial breakage.Where a risk assessmenthas identified a potential forproduct contamination, thepresence of brittle material(including glass) shall beexcluded or, if this is notpossible, the risk shall bemanaged.

BOn line 5 a bulkhead of theboxing machine wasdamaged

"The damaged plexiglass willbe replaced immediately."

Meccanico / 05/01/2020 / tobe started


4.12.2

Product requirements andprevention of contaminationshall be ensured during andafter maintenance and repairwork. Records ofmaintenance and repair workand of corrective actionstaken shall be kept.

C

Verified in production inmore than one point, thatthe screws, bolts andwashers used in the toolingare not placed in containersmaking them becomepossible foreign bodies

"Special containers will beprovided to collect the smallmetal parts. In addition, tomonitor the situation,appropriate weekly checkswill be introduced in thesurveillance plan.



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