Audit Report - Tielman · 2017-08-10 · Audit Report Global Standard Packaging and Packaging...

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P501: Packaging 5 template High Hygiene, Issue 3 Jan 2017 Report No.: 24032017001 Auditor: Pekka Sulkamo

This report shall not be reproduced in part without the permission of DNV GL Business Assurance Italia S.r.l of 22

Audit ReportGlobal Standard Packaging and Packaging Materials Issue 5: July 2015

Audit summaryCompany name Tielman Sweden AB BRC site code 4103275

Site name Tielman Sweden AB

Hygiene Category High Hygiene

Audit scopeScope of audit Manufacture of baking trays by flexo printing, punching and forming of grease proof

paper and carton for food industry.

Exclusions from scope None

Justification for exclusion Justifications

Voluntary modules includedModules Result Details

Choose a module Choose an item

Choose a module Choose an item

Audit results

Audit result Certificated Audit type Announced

Audit grade AA Previous audit grade A

Number of non-conformities Major against SOI of Fundamental 0Critical 0Major 0Minor 4

mailto:[email protected]

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Company details

Address Alkagatan 2, 582 77 Linköping

Country Sweden Telephone +46(0)13 12 97 30

CommercialrepresentativeName

Björn Tielman Email [email protected]

TechnicalrepresentativeName

Maria Boman Email [email protected]

Company profile

Plant size(square metres)

<10K sq.m No. ofemployees

51-500 No. of keyprocesses

1-3

Subcontracted processes Yes

Other certificates held FSC Chain of Custody

Regions exported to NoneEuropeNorth AmericaChoose a regionChoose a region

Major changes or auditorobservations since last BRC audit

No major changes

Company description Tielman Sweden AB is a privately owned company, by the Tielman family whois involved in the day to day work. Tielman Sweden AB was founded in 1993with a history dating back to the 1930’s.Customers are mostly industrial bakeries but also some stores. 85% of thesales are exported to approximately 15 countries mainly in Europe and NorthAmerica.The products are baking forms, cake forms, pie forms, muffin forms, mini traysfor baking and cake plates made from paper, grease proof paper and/or cartonboard.Development is part of the processes handled on site as well as production andsales. The production process is in general printing, cutting, forming andpackaging on several equipment’s.Production and storage areas cover approximately 4500 sqrm, and the no ofHACCP plans is one. The no of employees are appr. 65 working 3 shifts 5 daysper week and a night shift. Increased during the year due to increasedvolumes.Company bought Finform AS in Denmark.


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Company profile

Lead Auditor is Finnish but speaks Swedish fluently, therefore no extra time forlanguage difficulties was added as no translator was needed.


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Product and process characteristics

Field of Audit(GlassPaperMetalRigid plasticFlexible plasticWood and othermaterialPrintChemical processes)

02 - Papermaking07 - Print processesCategoryCategoryCategoryCategoryCategory

Products in production atthe time of the audit

Several types of baking trays and forms in different sizes; printed and with no print

Audit duration details

Finish date 2017-03-24

Re-audit due date 2018-04-19 Previous audit date 2016-04-19

On-site duration 12 Duration ofproduction facilityinspection

3Reasons for deviation from typical orexpected audit duration

No deviation

Next audit type selected Announced

Audit duration per dayAudit days Date Audit start time Audit finish time

1 (start date) 2017-03-23 08:30 16:30

2 2017-03-24 08:30 12:30

3

Auditor information

Auditor number Auditor Name Role053108 Pekka Sulkamo Lead Auditor

N/A


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Present at auditNote: the most senior operations manager on site should

be listed first and be present at both opening & closingmeetings (ref: clause 1.1.7)

Openingmeeting

Siteinspection

Procedurereview

Closingmeeting

Name / Job TitleBjörn Tielman / Managing Director x xMaria Boman / Quality Manager, HACCP team leader x x x xChristian Jakauby / Production Manager x xChrister Riddersporre / Maintenance xKenth Åkesson / Storage xLouise Lindström / Sales, new products xIngela Karlsson / Production x xAlexander Jonsson / Production x x


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This report shall not be reproduced in part without the permission of <insert certification body> of 22

Non-Conformity Summary

Major non-conformity against statement of intent of a fundamental requirementNo. Requirement

ref.Details of non-conformity Critical or Major ? Anticipated re-

audit date

CriticalNo. Clause. Details of non-conformity Anticipated re-

audit date

Major

No. Clause Details of non-conformity Correction Proposed preventive action plan(based on root cause analysis)

Evidence provided document,photograph, visit/other

Datereviewed

Reviewedby





Minor


Evidence provideddocument, photograph,visit/other

Datereviewed Reviewed by

1 1.3.1 Last revision of organizationchart was 2014-01-01, sincethen production manager hasleft company.

Updated organization chart. Incomplete and old organizationalchart. Set to year clock to check itin January.

Nonconfirmity No 1_RD 1.3Organisationplan.pdf

Updated organization plan2017

2017-04-07

PekkaSulkamo

2 4.11.5 Door #1 left open while forkliftwent to paper warehouse.

Changed opening times forthe storage door to 28,5seconds, then turns offautomatically.

Risk of pests or birds from enteringthe gate when it is open too long.Now the timing was set for too longtime.

Nonconfirmity No 2 Door.JPG

Photo

2017-04-07

PekkaSulkamo

3 4.11.8 No evidence on changing thelight bulbs on flytraps

Change of baits and lightbulbs documented in theservice report as well as therisk analysis.

Uncertainties regarding Anticimexactivities, pest and insect traps.Agreement is revised to includelregular yearly UV light tubechanges.

Nonconfirmity No 3Flytraps.pdf

Anticimex service report3.4.2017

2017-04-07

PekkaSulkamo

4 6.3.2 Shoes on floor underneathlockers in both changing rooms

Optional rack placed under thecabinets.

The hygiene training needs to beenforced, all persons will be given arefresser training on hygiene ruleswith in May month.

Nonconformity No 4 Shoes onfloor.JPG

Photo of shoes on the rack

2017-04-07

PekkaSulkamo





Voluntary Modules Non-Conformity Summary Sheet

CriticalNo. Clause Details of non-conformity Anticipated re-audit date

Comments on non-conformities – not tagged, just free text. This is to explain where a large number of NCs have been raised without a major

No





Major


Evidence provided: document,photograph, visit, other

Datereviewed

Reviewedby





Minor


Evidence provided document,photograph, visit/other

Datereviewed

Reviewedby



If you would like to feedback comments on the BRC Global Standard or the audit process directly to BRC, contact [email protected] call the TELL BRC hotline +44 (0)20 7717 5959.



Detailed Section

1. Senior management commitment

1.1 Senior management commitment and continual improvement

Senior management commitment is in place and resources seem to be provided (both in terms of employeesand capital expenditure available) to support ongoing certification to the Standard.There is a documented Quality and Hygiene policy which is signed by the CEO Mr Björn Tielman dated 2017-02-14, included within the staff hand book, addressing product safety and quality. The policy outlines e.g. toavoid contamination, commitment follow the requirements in BRC Packaging standard etc. After updatingthe policy in February all employees signed off to have read the policy.Objectives are documented and shared with staff.Objectives are: complaints – max 89 kSEK (B 200kSEK), Waste for recycling 37,3% both were showing greenindicator in monthly follow up. Also objectives on more new products/designes, likewise on green.Production staff interviewed during the audit was able to demonstrate awareness of these policies andtargets.Evidence of ongoing human and financial resources available to team who are responsible for theimplementation and maintenance of the requirements of the Standard seen throughout duration of theaudit. The QA manager is responsible for ensuring that the organisation is informed of all new legislation andregulatory requirements for the materials i.e. grease proof paper, ink etc. and finished products to ensureconformance with legal compliance. Compliance with legislation demonstrated by DoC (declaration ofcompliance) contents, ref to legislation, checked for article no 1051896 DAFGÅRD as part of the verticalaudit among other products on production during audit. Pdf copy of Issue 5 of the Packaging Standardavailable on site. Audit conducted within due dates and this time the audit time window was changed toavoid audits near the summer vacation. CEO Björn Tielman attended opening and closing meetings.5 minor non-conformities from the previous audit were closed out and have not recurred at this audit.Site is aware that for any NC raised and this and any subsequent audits, root cause analysis is required.

1.2 Management review

The management review is done by the CEO Björn Tielman and clear input and statistics is coordinated andpresented by the QA manager. There is an annual review with monthly progress review sessions with seniormanagement covering from 1 July to 30 June. Minutes of the annual management review meeting andaction plan from 2017 vk 21 reviewed and included all the required items. The monthly review meetings areused to review progress and QA manager reports statistics and progress to the management, protocol seenex. from week 10 2017. Minutes include timescales and confirmation of completion, progress towardagreed targets, e.g. customer complaints, which are then briefed to staff in the quality report displayed onboard in the production area.

1.3 Organisational structure, responsibilities and management authority

The management structure is documented within the quality manual “Organisationsstruktur, ansvar ochbefogenheter” 1.3/1 dated 2016-01-30, with designated deputies in job descriptions ex. Production manageris replaced by MD and production leader, QA manager is replaced by MD. The organisation chart has notbeen updated. The senior management team is comprised of Production/Development Mananager, QAManager (also held the role of production leader), Marketing/Sales manager and Financial manager reportto the MD.The production leader manages the 2 shifts, storage and maintenance.Job descriptions are available for managers and supervisors and a competence matrix cover staff. Jobdescriptions currently under review.


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Work instructions form part of the Quality Manual, ex checked “Styrning av grafisk design” 5.2/1 dated2016-02-20, “Produktinspektion, provning och mätning” 5.6/1 dated 2016-02-21 among others. Daily shifthandover meetings take place coordinated by the production leader.NC#1 1.3.1 Organisation chart was last updated 2014-01-01, changes have happened after this date.

Non-applicable clauses

2. Hazard and risk management system

2.1 Hazard and risk management team

A HACCP team has been established to review the hazard and risk management system.The team is made up of 5 members, MD, Production manager, storage responsible, maintenance responsibleand if needed operators.The team leader is the QA manager Maria Boman – who has received formal HACCP training as well asexperience also from the food industry.Details of the qualification and experience of members of the HACCP team are documented in “Grupp föranalys av hälsofaror och risker” 2.1/1 dated 2016-02-01. Last training for team on Issue 5 demands was01.10.2015. An overview of the experience of members of the HACCP team shows their experience andknowledge for areas of the factory. The system is well laid out, demonstrating competence. Since seniormanagement also is members of the HACCP team changes and customer requirements is well covered.

2.2 Hazard and risk analysis

The documented hazard and risk analysis is set out clearly, available in folders held by the QA manager.System lists scope of HACCP study, key members, training and experience of members, responsibilities, andpurpose of the study.The hazard and risk management plan is mainly modular in approach based on the different processactivities and work stations ex. printing cutting dated 2016-02-24 but some generic hazard analysis as wellex. staff hygiene and clothing dated 2016-02-24 all in excel file ref. RD 2.2QA manager is supported subscriptions to keep up to date on legislation and news as well as agents in theexport countries.Product descriptions were adequate and included all required items supported by a new databaseconnected to the business system Navision, checked for article no 1410166 (Baking Tray) as part of thevertical audit as well as for art. No 10519 (Oreo muffin form) DoC dated 2016-04-08 among others. Norecycled content.Flow chart viewed ref. RD 2.2/1 dated 2016-02-03, Verified by HACCP team latest 2017-02-15.Process steps: receipt of raw materials (ex. paper, grease proof paper, carton, chemicals, ink) inspection,storage, printing (not all products), storage, punching, storage, forming, storage, packaging, wrappingpallets, storage, dispatch.Processes shown on one flowcharts and an extensive excel file with risk analysis done as per step fromintake to dispatch.Subcontracted processes also covered by the flow chart and hazard analysis. Subcontracted process is thelaminating of printed paper to corrugated paper regarding one specific product, a baking form. Art work (subcontracted) and printing (in house) is likewise covered.The hazard and risk management plan included a review of potential hazards – chemical, physical,microbiological, allergens, quality or integrity, and potential for malicious intervention. Physical hazardsinclude foreign body contamination and out-of specification product (defects). Microbiological hazardsremoved by pre-requisite controls as well as are quality or integrity hazards.Each identified hazard was reviewed and given a risk rating to define the severity (scale 2-8) and likelihood


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(1-4) of a hazard occurring. E.g. physical contamination caused by oils and fats on equipment (food grade oilsused if pose a risk), quality hazards as wrong size, holes; or foreign body contamination. Assessment forallergen risks covered as well but none found.Suitable controls for each hazard were documented; in many cases these formed part of the prerequisiteprogrammes. E.g. hazard of equipment failure and subsequent physical contamination managed bydocumented preventive maintenance programme.Hazards linked to the use of raw materials are covered by supplier approval and purchasing requirements incontracts as well as DoC, certifications etc. ex. for grease proof paper, inks. Foreign body contaminationhazards are covered by pre-requisite programmes: personnel disciplines, cleaning, equipment condition, andmaintenance and pest control. The study identified no critical control points. Review takes place each yearlatest 2017-02-15 and report is input to the management meeting, all required points covered. Where asignificant issue occurs the team are reconvened to consider the hazard and risk management plan. Parts ofthe HACCP team meets every week at QA/Production meetings and records from the meetings are in placeas per a fixed agenda, covering also other topics.

2.3 Exemption of requirements based on risk analysis

No exemptions on the basis of risk were identified.

Non-applicable clauses 2.2.8, 2.2.9, 2.2.10. No CCP identified.

3. Product safety and quality management system

3.1 Product safety and quality management system

The system is now following the structure of the BRC Packaging standard (numbers) but also with companyspecific chapters.The company has a paper based manual and the QA manager update and distribute documents (system onserver covered by back up improved last year), which addresses the entire product safety and qualitymanagement system built up as folders with procedures (chapter 1-6) referring to related documents as thehazard analysis and job descriptions, and other folders with related records (chapter 1-6). This covers all ex.operation procedures, training, suppliers etc. No translations are required as the workforce is Swedish -speaking.The system is part of the management review agenda.All instructions and procedures are made available to the staff at line and accompany each work order asneeded. Supported by business system Navision creating product specific documents, “Produktkort”(product card), for each production run.

3.2 Documentation control

The company has a paper based manual and the QA manager updates and distributes documents (systemdocuments on server covered by back up). All documents issued with an issue date, reference andauthorisation. The system was found to be working effectively since all documents is updated since last auditwhen creating a new structure. The document reference library is in place in “Ledningssystem förproduktsäkerhet och kvalitet” 3.1/1 dated 2016-02-11, and changes is marked as red color. All documentschecked had issue date, reference and authorisation ex. Purchase procedure “Godkännande och bedömningav leverantörer” 3.6/1 2016-02-07. Relevant parts of the system are accessible by all employees throughfolders, production journals and the specific product cards for each production run . All reviseddocumentation signed off by authorized members of senior management to be incorporated into thesystem.


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Though the entire management system is updated and the structure changed, the work procedures andcontent in general are the same as previous.

3.3 Record keeping

Hard copy records are archived on site; electronic forms are backed up daily and weekly, strongly improvedlast year.Records are initialled or signed by the relevant team leader or senior management representative. Recordskept for 3 years as standard. All documents seen are appropriately approved and procedures for storage ofdocuments forms part of the quality manual ref. Dokumentstyrning 3.2/1 and Redovisande document 3.3/1.Alterations on ducuments was described in procedure and all checked records were filled appropriately.

3.4 Specifications

Specifications in place on raw material, intermediate and finished products.A new database is place for finished products specifications connected to the business system i.e also to thespecific product card for each product.Specs on finished products as product cards as per article containing all raw materials, process parameters(temp. size etc) as well as packaging.Specs on chemicals, paper, ink handled by QA manager.All specifications are documented and include typical properties ex numerous parameters on size, as well asintended use.Specifications on finished gods built up from specific specifications on composition as well as Normpackcertificate on finished products all available on computer. Ex. art no 1051896 DAFGÅRD as part of thevertical audit among others were reviewed and confirmed compliance with several regulations and industryguidelines ex. EU regulations on food contact material.Normpack cert dated 2016-05-07 seen as well as set of report dated 2016-04-11 and migration report dated2016-04-11. Renewed every second year.Specifications reviewed annually as part of the supplier review. Documented procedure 3.4/1 dated 2016-02-07.Contracts are in place concerning service suppliers (e.g. pest control, maintenance, cleaning).

3.5 Internal audits

Risk-based system of internal audits in place. Scope of audits covers the quality system, PRPs and otherprocesses and procedures with regular audits covering all areas audited over a 12 month period spread overthe year on 6 occasions. Audits carried out by a team of 6 qualified auditors but mainly by the QA mngr, whois trained externally for BRC as well as in house. Reports given to the Managers for the audited areas andtime set for corrective action and appropriate timescales agreed and actions followed up at next audit. Oncecorrective action forms have been completed by the responsible Manager the auditor is responsible forchecking off actions. All documented on server and paper and managed by QA mngr. Detailed follow up atmanagement meeting. Checked all six reports and all were clear. Also hygiene rounds twice per year by pestcontrol company and approximately twice per month quality rounds by QA-manager supported bychecklists. Rounds ambitious and well handled.

3.6 Supplier approval and performance monitoring

Documented procedure “Godkännande och bedömning av leverantörer” 3.6/1 dated 2016-02-07 andquestionnaire ref. RD 3.6. All suppliers of products and services are approved by the management andentered onto the list of approved suppliers by the QA manager before they can be used. Assessment isbased on hygiene and quality risk among other requirements with suppliers categorized A, B or C.


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All relevant suppliers of raw materials are required to fill in a questionnaire every two year and some areaudited or certified to a GFSI approved bench marked standard. Raw material assessments at intake formspart of the ongoing review of supplier performance. Annual performance review of suppliers.Checked questionnaires and certificates, in general good. Raw materials for the vertical audit was suppliedby approved suppliers ex. Nordic Paper and Billerud Korsnäs. Purchases sought from non-approved suppliersrequired to be approved by management involving QA mngr.

3.7 Management of subcontracted processes

Documented procedure ”Styrning av kontrakterade processer” 3.7/1 dated 2016-02-07.The process to laminate printed paper to corrugated paper aimed for a specific product (baking tray) is subcontracted to one company. Audit performed at the company as well as questionnaire. Records from lastvisit at Frontpac seen dated 2016-01-28 by the QA and Production managers. All gods inspected byoperators before use. Specifications are used as the basis for agreement of work for the subcontractor. Thesubcontracting of laminating forms is one of the modules of the hazard and risk management plan, as well aspackaging. Also art work is out sourced to an approved supplier with a shared web site used for cooperation.

3.8 Management of suppliers of services

Documented procedure Styrning av leverantörer av tjänster 3.8/1 dated 2016-02-07.Contracts are in place concerning service suppliers (e.g. pest control Anticimex, cleaning ISS, transportseveral accepted companies, waste Ragn Sells AB, laundry ISS). Viewed agreement of pest control agentAnticimex origin 2006-11-14 is until further notice and priceds updated yearly.The QA manager has a list of all approved suppliers as part of the management system ref. RD 3.6“Leverantörsbedömning” covering both raw material, subcontractors and services.Annual review by management.

3.9 Traceability

Auditor tested: prod nbr 1051896 DAFGÅRD CANDOR LF 70gr, size 90x25 papers 293566-2 and 315176-2colours batches 379, 407, and 433 were easily found also production recordings and maintenance recordingschecked during vertical audit. Successful and all raw materials traced within an hour and delivery tocustomer as well. All raw material id. registered in the business system or traceability excel file for inks, andcustomer delivery in business system. The traceability system in place is supported by order number in thebusiness system, and internal journals. Based on a unique manufacturing order and time - bar codes onpallets. Traceability of raw material including chemicals is based on delivery information from the supplierlot no or date. Precise traceability to batches of raw materials in place by using excel file filled in with lot noamong other information connected to the order no and to internal batch no. Annual test of the recallsystem done by the QA Manager includes test of traceability. Latest 21.03.2017 prod 1031389 Speedibaketray color 344 paper 310200-03 as well as on the raw material paper order no 306919-1 from supplierBillerudKorsnäs went totally 6 orders, time used totally 2 hours.No rework.

3.10 Customer focus and contract review

There is a new marketing and sales manager since last audit as well as some new sales persons. The salespersons communicate directly with some customers and via agents in some areas. For the North Americanmarket most contacts via the company representative in Canada. All active or potential customers have anappointed contact person within the sales department.Customer requirements are communicated to production using clear product cards in the business system,as packaging patterns etc. and reviewed as part of the review of specifications.


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No performance requirement so far.

3.11 Complaint handling

Documented procedure Reklamationshantering 3.11/1 dated 2016-02-10.All complaints logged on paper and in excel file by the QA manager, very thorough.Report made for all complaints as input to management meeting. Monthly statistics and discusses atmanagement meetings as well as on daily operation meetings. The number of complaints is on a low levelsince several years (appr. 30 to a cost of 0.235% of all sales) and no actual food safety related issues lastperiod. Mainly on size.To reduce complaints is still one of the company objectives.

3.12 Management of product withdrawals, and incidents and product recalls

Documented procedure cover withdrawals, incidents and recall and describes the process includingresponsibilities and contact list as well as return procedures and documentation; Hantering av incidenter ochåterkallande av product 3.12/1 dated 2016-02-10.The MD is responsible to call in the crises team, replaced by QA manager if not available.Customer data is available in the business system and other external emergency contacts in the folder at theQA office.Annual test using a specific template for documentation, initiated by the QA manager, latest as part of thetraceability test and included contact with the customer (clearly stating it was a test), successful and timingdocumented – Latest 21.03.2017 prod 1031389 Speedibake tray color 344 paper 310200-03 as well as on theraw material paper order no 306919-1 from supplier BillerudKorsnäs went totally 6 orders, time used totally2 hours.No withdrawals or recalls last year, and no recalls for several years.


4. Site Standards

4.1 External standards

The plant is located in Linköping surrounded by some light industry and stores. Buildings from 2006 and ingood repair and well maintained with investment regularly planned. No local activities that would affectproduct. The perimeter of the site is not fully fenced and gated but all doors locked with code at all times aswell as alarm system and security rounds. Condition of the site and buildings is checked by the maintenanceand QA regularly. Very orderly at the audit. No issues with drainage and site’s yard and driveways areconcrete and in suitable condition.No outside storage.

4.2 Building fabric and interiors

Floors are constructed of coated painted concrete, maintained as part of the maintenance program. Floorsin the 2 separate storage buildings is partly asphaltProtected fluorescent light tubes in use – no evidence of breakage. No evidence of water ingress. Glasswindows pose no risk since not near products.Ventilation provided through built in ventilation system.

4.3 Utilities


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Water used for catering facilities and personnel is provided by the country council Linköping county, potable.No water used in the process and cleaning is mainly dry cleaning. Oil free filtrated pressure air withspecifications is used. Ventilation managed by contractor via the land lord, filer type specified. Utilities arepart of risk assessment.

4.4 Security

No security issues were identified at the time of the audit and are part of the annual risk assessment.The perimeter of the site is not fully fenced and gated but all doors locked with code at all times as well asalarm system and security rounds by security company on weekends.Site access is regulated. A code system is use to regulate access to areas where authorized personnel onlyare permitted, not accessed without the correct code. All visitors sign in on entry and staff is encouraged toreport or challenge unidentified visitors.All references supplied must be followed up ex. on new employees by manager.External transport personnel are not permitted in production areas.No outside storage tanks or silos.

4.5 Layout and product flow

The flow is U-shaped and seems appropriate, from receiving raw material, during production to loading –Internal transports occur in a safe way between buildings. 2 storage magazines on the same lot mainlycontaining packed raw material paper and some machine tools/equipment. Packed finished productsstorage in the same building as production.Storage of work in progress was seen to be satisfactory near the production in the hygiene area. All itemswere uniquely identified.All items properly labelled and protected, and the site is roomy and adequate space available for alloperations and movements.

4.6 Equipment

All equipment is suitable for the intended purpose, and suitably clean. Procedure for the installation of newequipment in place as part of the investment procedure and includes notification to production and otherinvolved departments. In practice handle by the production manager and MD, but no new equipment lastyear. Documented procedure Utrustning och konstruktionsutveckling 4.6/1 dated 2016-02-14.Notice on production equipment rare but if used there cleanable.

4.7 Maintenance

Maintenance seems adequate. Paper based system covering all equipment. Planned maintenance mainlycover lubrications and other maintenance based on rounds and inspections. Two building rounds per year byQA and maintenance to inspect buildings since the building in practice not owned by the company.Rules are in place to prevent contamination from maintenance activities signed off in the maintenance log.There are two people working at maintenance full time, as well as contractors used.Wooden equipment all in good conditions, and no engineering workshops open directly into productionarea.

4.8 Housekeeping and cleaning

A generally good level of housekeeping and cleaning was found during the audit and the site personnel alltook responsibility for maintaining cleanliness.“Clean as you go‟ policies with an end of shift clean by operatives. More extensive cleaning every Thursdayby operators spending some hours to clean. Last year cleaning of production was outsourced but no back to


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be done by operators. Good standards of cleanliness at the time of the audit.Cleaning procedures ref. Rengöring och skötsel 4.8/1 dated 2016-02-14 include all required detail. Recordsmaintained to manage cleaning, checked journals for January-April 2016. Verified by QA manager weekly aswell as at hygiene rounds visually, but at times using plates to test for microorganisms.Mainly dry cleaning but some chemicals used for ex. printing equipment.Material for cleaning to toilets, are in a separate room from the production and done by ISS sub contractor.

4.9 Product contamination control

4.9.1 Glass, brittle plastics, ceramics and similar materials control

Glass breakage procedure viewed, Styrning av kontaminering 4.9/1 dated 2016-02-14 covering glass andbrittle plastics, sharps including tools.Cover also detailed procedure and reporting in case of breakage. No glass or brittle plastics breakagesrecorded in last 12 months.Use of glass minimized e.g. bulbs and strip lights protected against breakage.Checks done by operators when starting the shifts, and by QA mngr at rounds twice per month records seenfrom Jan-April 2016 . List of items updated by QA manager latest dated 2016-02-12 including check.

4.9.2 Sharps control

Sharps policy in place Styrning av kontaminering 4.9/1 dated 2016-02-14 covering glass and brittle plastics,sharps including tools.Knifes and blades managed by the production leader using a list of items (personal knives) and receiving oldblades and handing out new ones.Notice board with magnets used.

4.9.3 Chemical and biological control

Hazard and risk analysis gave no need for food grade lubricants due to the nature of the process andequipment except on a few places and food grade lubricants available. Also food grade silicone for transportbelt (checked Kem Silicone). List of chemicals including safety data sheets in place by subscription to aservice provided externally.Microbiological hazards identified through hazard and risk management system.

4.10 Waste and waste disposal

Satisfactory systems in place. Designated refuse bins emptied by dedicated staff throughout shifts, wasteintended for recycling collected and stored. Trademarked goods are all destroyed on site by compressing buta signed contract on no miss use also in place with the waste company. Established contractor used forhandling waste, Rangsells.

4.11 Pest control

The company continue to use the same pest control contractor as documented in previous audits –Anticimex.Covers rodents and insects, both internal and external baits are used but no poison bates if not needed.Contract dated 2006-11-14.The service purchased is 4 routine visits per year and 2 more extensive hygiene rounds.Checked reports from 2016-03-10, 2015-12-16 among others.The QA manager is the contact person and keep reports, trends, follow up on findings etc. available by log into the Anticimex web site.


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No evidence of infestation was found or had recently been reported. No issues highlighted through trendingreports. Trends checked by QA manager.Staff aware to report of pest activity.NC#2 4.11.5 Door #1 left open while forklift went to paper warehouse.NC#3 4.11.8 No evidence on changing the light bulbs on flytraps


5. Product and process control

5.1 Product development

There is a documented procedure and checklist covering product design and development also covering theevaluation of potential risks - Produktutveckling 5.1/1 dated 2016-02-20. Well established since at presentapproximately 2-5 new prints per week. At the weekly cross functional HACCP and quality meetings newproducts are evaluated and approved. Product card on all new products as specifications, and cover processparameters as temperatures, size, colour etc. Customer approvals kept at sales. Samples retained on allbatches as blue print. Reviewed product no 1031147 and 10519 among others.

5.2 Graphic design and artwork control

Procedure Styrning av grafisk design 5.2/1 dated 2016-02-20 specifies controls in place regarding graphicdesign and art work to minimise loss of information/malicious intervention, assuring information is fullylegible and meeting customer specifications. The company receive a specification from the customer andsend this to an external company (millers) who do the graphic design and art work, the company review thisand send it to the customer for approval – approvals always documented. No changes without customerapprovals. This includes receipt of masters and colour standards.

5.3 Packaging print control

Print activity is assessed regarding risks. Rarely wording on content, mainly different colors and patterns.Procedure in place and checks during printing documented in production journals and signed by operators.Personnel are suitably trained in the required areas, and samples retained as reference. No actual mixedprints but procedures in place on line clearance.See minor NC on documented print check.

5.4 Process control

Procedures in place to ensure effective control of operations throughout the process including qualityassurance as well as food safety hazards. Extensive control of size and performance in packaging equipment.Checks on colour and print as well, and on equipment settings as temperature.Production specifications are available for all products which include equipment settings as temperaturesetc. as part of the product card/produktkort printed out at every production.Control of intermediate and finished products done by operators during the production ex. on print, color,size, function, numbers packed. No lab on site.Every production is documented in the control journal as well as in the specific production card coveringcontrols, setting, cleaning and clearance etc. Paper based system archived at the production leader who alsoverify the documentation. Reviewed several records ex Jan.-April 2016.Observation of checks performed by operators on line were seen to be well performed and many checksdone every hour (weight, size, color, print) – staff knew the checks to be performed, had access to thespecifications (produktkort) to review the test results and understood the actions to be taken for making


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adjustments to equipment or informing the production leader in the event of issues.Process checks were performed at regular and frequent intervals to ensure conformance of product.Equipment used for these checks was available, appropriate for the activity and calibrated, ex scales.Checks were documented in the production journals.The clearance procedure is part of the control journal and production card. Lines and equipment are clearedwhen changing articles.All new products are grouped into the hazard and risk management plan, if appropriate. New modulescreated as required. At present all product covered by the same HACCP plan. Signed off by QA teamapproving specifications.

5.5 Calibration and control of measuring devices

Documented procedure Kalibrering och kontroll av mätutrustning 5.5/1 dated 2016-02-20 and list RD 5.5.Identified equipment (e.g. balances, Pantone Matching System (PMS), metal detector, callipers) and subjectto calibration/checks in general twice per year. Scales, metal detector and PMS latest 2017-02-10.Traceable weights latest 2013-01-23. Equipment such as balance is checked between formal calibrationsdaily by qualified staff using a traceable master. Items viewed suitably protected. No in-line testing is used(metal detector is off line and used manually only for one product).

5.6 Product inspection, testing and measuring

All regular checks done on-site. Control of intermediate and finished products done by operators during theproduction ex. on print, color, size, function, numbers packed. Ex color checked to PMS standard. No lab onsite. External lab. Innventia used for analysis on finished products (every two years) and accredited.

5.7 Control of non-conforming product

Documented procedure Behandling av avvikande produkt 5.7/1 dated 2016-02-21.Out-of-specification products seem well handled.Identified, labelled including coloured tape and documented in journals and quarantined. Kept in specifiedareas.QA is involved in decisions regarding out of spec products. Followed up on management meetings.No main issues but for some quality issues. Raw materials usually returned to supplier.

5.8 Incoming goods

Documented procedure Inkommande gods 5.8/1 2016-02-22.Raw material transport arranged by suppliers and procedure in place to visually check loads prior to intakeinto warehouse and sign off.Goods in procedure validates delivery notes against purchase orders. Checked documents for January toApril 2016 among others.

5.9 Storage of all materials and intermediate and finished products

No external storage. One storage for raw material and finished gods but in separate areas in the samebuilding as the production. On the same lot two buildings are rented also used for storage started in 2013.Storage of finished product on site normally for a short period due to produce as per customer order.Intermediate goods stored at appointed area in the production. Conditions in general good.Temperature/humidity controlled to some extent. Pallets wrapped in plastics.Appropriate identification, no unidentified products/raw materials seen in warehouse. Hazardous chemicalsare stored in a separate room or cabinet to minimise risk of cross-contamination. No off-site storage used.


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5.10 Dispatch and transport

The company has no own trucks. Mainly road transport used.Finished products transport is subcontracted to be managed by contractors, mainly DHL and Schenkerapplying to hygiene requirements as well as products protected by plastic wrapping.Sufficient identification and protection against hazards seen. Generally good condition of pallets seen. Nocompany owned vehicles but procedure in place to check hygiene of vehicles prior to loading, stamped andsigned delivery documents archived at storage office seen. Transport personnel have no access toproduction.

Non-applicable clauses 5.6.3 No in line equipment

6. Personnel

6.1 Training and competence

Documented procedure: Rutin för utbildning och kompetens 6.1/1 dated 2016-01-30. Good evidence ofappropriate levels of training and competence amongst all production employees at all levels. Inductiontraining programme for all new employees and temporary staff. Checklists used ex for new sales personLouise Lindström dated 2016-01-11. All visitors accompanied. Records indicate that adequate training is inplace for personnel involved in activities relating to product safety, quality and legality. E.g. training ofprinting staff (Alexander Jonsson, machine operatives (Ingela Karlsson) viewed. Training matrix maintaineddetailing competency for all staff ref. RD 6.1.Annual review by management for the need of retraining. Annual hygiene repetition training for alloperators latest 2015-09-16.

6.2 Personal hygiene

Documented procedure: Personlig hygien 6.2/1 dated 2016-01-30. No jewellery allowed except for weddingring and continuous loop earrings. All staff seem to apply. Hygiene policy also covers fingernails, eating anddrinking in production area, hand washing, and use of personal medicines in production area.

6.3 Staff facilities

Gender specific locker and changing rooms provided with appropriate lockers for segregation of personalclothing and work wear, including toilets. Two lockers each for men and with dividing wall in women lockers.No canteen but facilities for keeping, heating and eating food in place. 2 designated smoking areas availableoutside of the main building. No evidence of eating, drinking etc. in locker rooms. Hand washing facilitiesavailable at the entrance to the production areas for all staff and visitors with signage. No toilets opening toproduction.Minor NC#4 6.3.2 Shoes on floor underneath lockers in both changing rooms

6.4 Medical screening

Staffs informed of medical policy in introduction training and return to work form following sickness andtravelling, documented as part of the hygiene rules ref. 6.2/1. Plasters are blue, detectable and available inhygiene zones in special automates/stations filled by appointed persons. Visitors do a health declaration aspart of signing in procedure.

6.5 Protective clothing


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Company issued clothing cleaned on site by appointed person. Documented procedures and check in placeon temperature, cleaning agent, storage etc. Sufficient no of sets for all employees – no limit. Companyprovided clothing is shoes, trousers, T-shirts, shirts and different types of scalp hair protection as well asbeard snoods. Visitors coat provided and hair net.Protective clothing can be worn around the site, but must not be worn on travel to or from the site.All staff seen wearing suitably clean clothing.



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Audit Report - Tielman · 2017-08-10 · Audit Report Global Standard Packaging and Packaging...

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