report b06381 final 2015 · audit report global standard for packaging and packaging materials...

Exova (UK) Limited 121, Shady Lane, Great Barr, Birmingham, England B44 9ET

Email: [email protected] Web: www.exova.com Tel: +44 (0) 121 251 4000 Fax +44(0)121 251 4040

Auditor: Alan Gibson

P026 Issue 2: Dec 2011 of 22 Report No: B06381/10/15 Global Standard for Packaging and

Packaging Materials – Issue 4

This report shall not be reproduced in part without the permission of Exova UK Limited

Audit Report Global Standard for Packaging and Packaging Materials Issue 4 : February 2011

1. Audit Summary

Company Name: Sirane Limited Site name: Sirane Limited - Telford, UK

Audit Category: High Hygiene Risk BRC Site Code: 9067082

2. Results

Audit Result: CERTIFICATED Audit Grade: A

Audit Frequency : 12 months

3. Audit Detail

Audit Start Date: 2015-10-27 Audit Finish Date: 2015-10-28

Re-audit Due Date: 2016-11-06 Previous Audit Date: 2014-11-13

Auditor Number (one only : team leader)

Auditor Names Alan Gibson – Lead Auditor

221013

4. Scope Details

Packaging Field:

02 - Paper

04 - Plastics

Select a packaging field

Select a packaging field

Scope of Audit: The manufacture of paper and polymer based functional packaging products including absorbent products, microwaveable and barbecue packaging, bone guards, polymer-based oven compatible/microwaveable non-absorbent products

Exclusions from Scope:

Medical and horticultural products.

Non-applicable clauses:

2.3.2, 4.1.6, 4.2.5, 4.12.11, 5.2.2-5.2.10, 5.4.5, 5.5.1-5.5.4, 6.5.9

Products in production at the time of the audit:

Divider inserts, bags, Dri-Fresh absorbent materials (cellulose with PE coated paper), adhesive and thermal lamination, slitting, guillotining, die-cutting, packing of various packaging products.







5. Company Profile

Company established in 2003, privately owned. Company employs around 130 staff with approximately 20 production staff per shift working three shifts, permanent weekend shift, 24/7. Company continues to develop novel functional packaging concepts for food products and non-food use. Products predominantly manufactured from polyethylene, polypropylene and polyethylene terephthalate in non-woven blends with cellulose, with additional barriers laminated as required for product performance characteristics. PE coated paper also used. Metallised polyester used for absorbent fat pads. Printing of materials required sub-contracted to company located adjacent to site (TCL). Company continuing to grow including overseas, with site in Turkey nearing completion and due to get into full production soon, premises in South Africa (in production) and offices in Dubai, S.E.Asia, Poland, Finland. New factory built in Mexico; machines built and ready for shipping from Telford site.







6. Non Conformity Summary

Summary of Non-Conformity Raised

No. No.

Critical non-conformity 0 Major non-conformity 0

Major non-conformity against statement of intent of a fundamental clause

0 Minor non-conformity 8

Critical

No Requirement

ref. Detail of Non-Conformity

Proposed audit date

Reviewed by

Major non-conformity against the Statement of Intent of a Fundamental Clause

No Requirement


Proposed audit date

Reviewed by

Major

No Requirement


Corrective action taken (with consideration of root

cause)

Evidence provided Document

Photograph Visit/Other

Date

signed off

Reviewed by

Minor

No Reqt ref.

Detail of Non-Conformity Corrective action taken

(with consideration of root cause)

Evidence provided Document

Photograph Visit/Other

Date signed

off

Reviewed by

1 1.2.1

Product safety and quality objectives on document WR044 v2 are not directly measurable or stated with numerically basis allowing easy monitoring.

RCA: Items detailed within WR044 are measurable but do not detail any of the figures associated with monitoring. This was an oversight and has been rectified. CA: A new version of WR044 has been completed with the relevant figures included.

Updated document WR044, v3.

2015-12-01 ADG

2 2.2.5

HACCP - hazard definition does not clearly identify all hazards considered, for example, microbiological, foreign objects, chemical, component transfer, use of recycled components, defects critical to consumer safety, functional integrity hazards (where applicable). Only general hazards referred-to within risk assessment.

RCA: Although a concise update of the HACCP plan has taken place recently the physical, micro-biological and chemical attributes were not included within the final section. CA: This has now been heavily updated to include actual contamination types and associated risks.

Updated HACCP system, v13.

2015-12-01 ADG







3 4.7.6

Temporary engineering noted in several places, particularly at bag making machines Seamus and Sophie, with adhesive tape and cable ties. These were removed during the audit from Seamus and Sophie machines.

RCA: Initially the temporary engineering was removed from the machine. CA: A general instruction issued to the shop-floor to ensure that this is adhered to. Full hygiene review conducted on a daily basis from 29

th

October to 6th November. This

was then reduced to two hygiene reviews per week until 20

th November. This has now

been reduced to a weekly review and will continue as so until happy to reduce timescales further.

Various evidence of walk rounds and actions raised directly to the Production Manager.

2015-12-01 ADG

4 4.9.2

Housekeeping & Cleaning – some areas not subject to formally documented cleaning, for example, diagonal cylindrical metal beams in warehouse visible from mezzanine floor heavy with dust/dirt (dust was removed during this audit at areas accessible from mezzanine floor)

RCA: Certain areas of the factory were not reviewed or formal cleaning documented. CA: This has now been heavily updated to include all areas not previously documented.

Document WR203 - additional areas cleaning schedule, v1. Document WR204 – updated warehouse cleaning schedule, v3.

2015-12-01 ADG

5 4.10.4 No formal control system in place for controlled disposal/destruction of trademarked waste.

RCA: This has been overlooked due to the fact that up until a few months ago we were not dealing in any trademarked goods. CA: A letter concerning trademarked goods has been created and issued to all companies that we manufacture a product that falls into this category. There are three customers at present.

Master information letter for companies.

2015-12-01 ADG

6 4.11.6

Pest control report of 18/08/15 (Ecolab) reported standing water/blocked drain, no corrective action or comment made on report by company.

RCA: The issue recorded is one that cannot be rectified as the blocked drains are cemented into the ground - they cannot be cleaned without ripping up the concrete. The landlord has refused to do this work and not allowed us to do this work either. This should have been recorded at the time within the document. This was also a small oversight due to the fact that shortly after the Ecolab report we moved our contract to a different company. CA: Ecolab report completed.

Copy of Ecolab report. 2015-12-01 ADG

7 5.8.3.1 Blue dye water bottle for absorbance testing on line not labelled with contents.

RCA: Blue food colouring and tap water is used to test the Dri-Fresh Sea-Fresh pads on-line. The bottle is used on one machine and for one product. CA: Initially the bottle was issued via

Hygiene audit WR252 updated.

2015-12-01 ADG







the lab. It was deemed a good idea but they have been instructed this needs to be approved via the appropriate channels.

8 6.5.11

Blue disposable gloves not subject to formal control; no reference to blue glove controls in hygiene rules document WR024.

RCA: Gloves had not been reviewed previously. After review this was an oversight from our internal systems and rectified. CA: Personal Hygiene Regulations Procedure updated.

Updated WR024, v12. 2015-12-01 ADG







7. Company Details

Company Name : Sirane Limited

Site Name : Sirane Limited - Telford

Address : European Development Centre, Stafford Park 6, Telford

Country : England Postcode : TF3 3AT

Telephone : 01952 230055 Fax : 01952

Company Representative Name: Alan Stanworth

Email : [email protected]

8. Key Personnel

Name/Job Title Present at Audit (x)

Note: the most senior operations manager on site should be listed first and be present at both opening & closing meetings

Opening Meeting

Site Inspection

Procedure Review

Closing Meeting

Simon Balderson – MD x x

Alan Stanworth – Manufacturing Services Manager x x x x

Ian Shingler – Operations Manager x x (part) x

Manjula Ladwa – Quality & Hygiene Coordinator x x

9. Audit Duration Details

On-site audit duration 17 Man Hours

Duration of production facility audit 8 Man Hours

Reasons for deviation from typical (12 hours) or expected on-site audit duration or typical (3 hours) site inspection duration. None

10. Audit Duration per day

Start time Finish time

Day 1 09:00 18:00

Day 2 09:00 17:00







Detailed Audit Report BRC

Requirement No.

REQUIREMENT Conforms

Details Y, N

or N/A

1. SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT

1.1 Product Safety and Quality Management System

SOI

The company’s senior management shall develop and document a product safety and quality management policy, which is authorised, reviewed, signed and dated by an appropriate senior manager.

Y

Quality and Hygiene Policy available (WR174 v4) and indicated commitment with regard to safety and legality of product, last reviewed May 2015, signed by Managing Director. Signed and dated version displayed on staff notice boards at employee entrance and canteen.

1.1.1 Y 1.1.2 Y

1.2 Senior Management Commitment FUNDAMENTAL

SOI The company’s senior management shall demonstrate that they are fully committed to the implementation of requirements of the Global Standard for Packaging and Packaging Materials. This shall include provision of adequate resources, effective communication and systems of management review to effect continual improvement. Opportunities for improvement shall be identified, implemented and fully documented.

Y Company demonstrated clear commitment to implementation of BRC-IoP standard.

1.2.1

The company’s senior management shall ensure that product safety and quality objectives are measurable, established, documented, monitored and reviewed.

N

Quality objectives defined (WR044 v2) and included maintaining BRC, quality, client feedback etc. Non-conformance 1.2.1 - Product safety and quality objectives on document WR044 v2 are not directly measurable or stated with numerically basis allowing easy monitoring. Key performance criteria monitored at management review including complaint levels (target <4/month).

1.2.2

The company’s senior management shall provide the human and financial resources required to implement the processes of the quality management system and product safety programme.

Y Satisfactory personal and material resource observed for management of product quality and safety.

1.2.3

Clear communication and reporting channels shall be in place to report on and monitor compliance with the Standard. Y

Management reporting systems well defined and included formal annual management review meetings, daily production meeting and monthly quality meetings (example reviewed for 9

th October for period of for

September 2015).

1.2.4

The company’s senior management shall have a system in place to ensure that the company is kept informed of all relevant legislative requirements in the country of manufacture and, where known, the country in which the packaging material will be sold. The company shall also be aware of any scientific and technical developments and industry codes of practice applicable.

Y Company maintained membership of PIRA as source of technical and legal updates. Company also utilised FSA website and RSSL Food e-news. Customers and suppliers also supplied technical information where relevant.

1.2.5

The company shall ensure that the materials manufactured comply with the relevant legislation (including any legislation concerning the use of recycled content) in the country of manufacture and in which the products are intended to be sold and/or ultimately used, where known.

Y

Products supplied worldwide (65% of product supplied to UK, approximately 90% within EU, with emerging markets in South Africa, Turkey and Middle East). Product supplied via distributors for countries outside EU and advice sought as necessary from relevant customers.

1.2.6

The company’s senior management shall ensure that non-conformities identified at the previous audit against the Standard are effectively actioned.

Y Previous BRC audit non-conformances satisfactorily addressed ten non-conformances identified; corrective action reviewed at this audit remained effective.

1.2.7 The company shall have a current, original copy of the Standard available on site.

Y Pdf copy of BRC-IoP Global Standard issue 4 available (paper copy of issue 5 also available).







1.2.8 Where the company is certificated to the Standard they shall ensure that recertification audits occur on or before the audit due date indicated on the certificate.

Y Audit scheduled appropriately (current certificate expiry 18

th December 2015).

1.3 Organisational structure, responsibilities and management authority SOI The company shall have a clear organisational

structure and define the responsibilities, reporting relationships and job functions of those personnel whose activities affect product safety, legality, regulatory compliance and quality.

Y

Company organisation structure documented (WR004, version 11) in a chart on computer-based Sirane Operating Knowledgebase (SOK). Job descriptions in place for key positions. Deputy arrangements specified in document WR054 v3 27/05/15. Managing Director responsible for QMS; Manufacturing Services Manager reports to Managing Director and defined as deputy for QMS (including BRC Packaging standard compliance).

1.3.1 Y 1.3.2 Y

1.3.3 Y 1.3.4 Y

1.3.5 Y

1.4 Management Review SOI The company’s senior management shall ensure that a

management review is undertaken to ensure that the product safety and quality programme is fully implemented, effective and that opportunities for improvement are identified

Management review carried out at minimum annual intervals. Agenda for review, presentation to management team, and records of review maintained. Minutes from last review held 9

th January 2015 reviewed and indicated

required coverage defined in Global Standard. Daily Production meetings held. Quality Review meetings held every month and minutes maintained.

1.4.1 Y 1.4.2 Y

1.4.3 Y 1.4.4 Y

1.4.5 Y

2. HAZARD AND RISK MANAGEMENT SYSTEM

2.1 Hazard and risk management team SOI A multidisciplinary hazard and risk management team

shall be in place to develop and manage the hazard and risk analysis system and ensure this is fully implemented.

Y

Multidisciplinary HACCP team defined and led by Managing Director (Team Leader), with Manufacturing Services Manager (deputy HACCP Team Leader), Technical Manager, Engineering Manager, Quality & Hygiene Co-ordinator, Production Manager. Team members appropriately trained in HACCP including Manufacturing Services Manager and Technical Manager to Intermediate level (CIEH, 2003), other members trained in-house, most recently refreshed on 28/09/15 (certificates of training seen).

2.1.1 Y 2.1.2 Y

2.1.3 Y

2.2 Hazard and Risk Analysis FUNDAMENTAL

SOI A formal hazard and risk management system shall be in place to ensure that all hazards to product safety and integrity are identified and appropriate controls established. Y

HACCP fully documented and reflected nature of products and complexity of operations undertaken. One HACCP plan defined. Significant review and extension of study since previous audit to separate-out activities into generic product groups. Additional HACCP training provided to team members.







2.2.1

The scope of the hazard and risk analysis shall be clearly defined and shall cover all products and processes included within the intended scope of certification. Y

Scope of study clearly defined in HACCP plan and included all on site operations and sub-contracted printing operations (including Dri-Fresh odour absorbent (including anti-microbial) range, Sira Cook bags, Sira Crisp (susceptor), Tuff hold bone guard, Sira Flex barrier films, Sira Form board/barrier/absorbent, other products (medical and horticultural)).

2.2.2

The hazard and risk analysis team shall maintain awareness of and take into account:

historical and known hazards associated with specific processes, raw materials or end use of the product

relevant codes of practice or recognised guidelines

legislative requirements.

Y HACCP study complied with BRC Packaging standard requirements, based on Codex Alimentarius HACCP principles. Products, processes and production equipment had largely been designed by Sirane owners.

2.2.3

A full description of the product shall be developed, which includes all relevant information on product safety and integrity. As a guide this may include:

composition, e.g. raw materials, inks, varnishes, coatings and other print chemicals

origin of raw materials including use of recycled materials

intended use of the packaging materials and defined restrictions on use; for instance, direct food contact, physical or chemical conditions.

Y

Product description and recommended use defined extensively for each group and sub-group. Product description detail included range of materials used, processes including lamination and printing (sub-contracted) and whether materials food or non-food application.

2.2.4

A process flow diagram shall be prepared for each product, product group or process. This shall include each process step from the receipt of raw materials to despatch to the customer. The process flow shall as a guide include, as relevant:

• receipt and approval of art work

• receipt and preparation of raw materials such as additives, inks and adhesives

• each manufacturing process step

• the use of rework and post-consumer recycled materials

• any sub-contracted operations

• customer returns. The accuracy of the process flow shall be verified by the hazard and risk analysis team.

Y

Series of process flow diagrams documented (x36) according to product sub-type, enabling previously complicated process flow diagram to be simplified, with variations in process shown within stage 4 manufacturing for each product type. Diagrams included general processes for each product, such as 1. Sales enquiry/order taking, 2. Purchase of raw materials, 3. Main components goods-in. 4. Manufacturing (see above – specific details identified per product type), 5A. Packaging and despatch, 5B. Handling and storage, 6. Delivery to customer. Accuracy of process flow diagram verified by HACCP team, signed and dated (all current flows approved by HACCP team 18/03/15).

2.2.5

The hazard and risk analysis team shall identify and record all potential hazards that are reasonably expected to occur at each step in relation to the product and process. The hazards considered shall include, where relevant:

• microbiological

• foreign objects

• chemical contamination (e.g. taint, odour, allergen, component transfer from inks, varnishes and glues)

• potential problems arising from the use of recycled materials

• legality

• defects critical to consumer safety

• hazards that may have an impact on the functional integrity and performance of the final product in use.

N

Hazard and risk analysis encompassed all stages of operation including purchase and receipt of raw materials, processing (various stages detailed), packing and despatch. Hazards considered physical, chemical, microbiological and product performance characteristics. Non-conformance 2.2.5 - HACCP - hazard definition does not clearly identify all hazards considered, for example, microbiological, foreign objects, chemical, component transfer, use of recycled components, defects critical to consumer safety, functional integrity hazards (where applicable). Only general hazards referred-to within risk assessment. No recycled materials currently used.

2.2.6

The hazard and risk analysis team shall identify control measures necessary to prevent, eliminate or reduce each hazard to acceptable levels. Where control is through a prerequisite programme these shall be reviewed to ensure they adequately control the risk identified and where necessary improvements implemented.

Y

Appropriate prerequisite controls defined for identified hazards not considered as CCP's and included: raw material purchasing (OP004), traceability (OP007), goods-in/out vehicle inspection (OP008), product recall procedure (OP019), approved supplier procedure (OP024), glass/brittle plastic control (WR026), personal hygiene rules (WR024), pest control (WR033) etc.







2.2.7

For each hazard that requires control, other than by an existing prerequisite programme, the control points shall be reviewed to identify those that are critical. This process shall include an assessment of the risk level for each hazard based on the likelihood of the occurrence and the severity of the outcome. Critical control points shall be those control points that are required to prevent, eliminate or reduce a product safety or integrity hazard to acceptable levels. Where controls are not classified as critical and control may be achieved through a prerequisite programme, a programme shall be developed that is sufficiently specified to effectively control the identified hazards.

Y

Risk assessment of likelihood and severity of outcome undertaken using scoring matrix system (1 to 3 for likelihood and severity). Single CCP identified for lamination process - highlighted on process flow diagram(s), for example, process flow 1. Dri-Fresh Inflex, 3. Dri-Fresh Fresh-Hold, 36. Dri-Fresh Sea-Fresh. Control measures clearly defined for CCPs and other hazards.

2.2.8

For each critical control point, the appropriate critical limits shall be defined in order to identify clearly if the process is in or out of control. Critical limits shall be measurable where possible and the rationale for their establishment clearly documented. Relevant legislation and codes of practice shall be taken into account when establishing the limits.

Y Critical limit for CCP1 lamination identified as intact heater elements.

2.2.9

For each critical control point a monitoring system shall be defined in order to ensure compliance with critical limits. Records of the monitoring shall be maintained. Procedures relating to the monitoring of critical controls shall be included in internal audits against the Standard (refer to clause 3.3).

Y

Monitoring of heater element integrity identified as CCP; inspection of element carried out each time laminator hood raised (WR055), at start, reel change, machine shut-down, machine stop (minimum 4 times per shift). Results on day of audit indicated checks approximately every 2-3 hours.

2.2.10

The corrective action that shall be taken when monitored results indicate a failure to meet the control limit shall be established and documented. This shall include the procedures for quarantining and evaluating potentially out of specification products to ensure they are not released until their safety can be established.

Y Segregation of product and potential disposal identified as required in event of breakage.

2.2.11

A review of the hazard and risk management system shall be carried out at least once per year and following any significant incidents or when any process changes. The review shall include a verification that the hazard and risk analysis plan is effective and may include a review of:

• complaints

• product failures

• recalls

• product withdrawals

• results of internal audits of prerequisite programmes

• results from external third-party auditors.

Y

HACCP system reviewed annually. Last review of HACCP study carried out 16

th January 2015 and minutes of

meeting maintained. At last meeting significant changes made to content of HACCP. CCP audits carried out monthly covering control of thermal laminator heater elements.

2.3 Exemption of requirements based on risk analysis SOI The site has demonstrated adequate compliance with

the requirements of this clause Y HACCP suitably supported by prerequisite controls identified in sections 4 – 6 of Global Standard.

2.3.1 Y 2.3.2 N/A No exemptions had been identified. Although not considered as an exemption, in-line monitoring was not appropriate for the operation.

3. PRODUCT SAFETY AND QUALITY MANAGEMENT SYSTEM

3.1 Product safety and quality manual SOI The company shall have a manual which describes

how the requirements of the Standard are met. These requirements shall be fully implemented, reviewed at appropriate planned intervals and improved where necessary.

Y Well-documented quality manual maintained in electronic form, referred to as SOK (Sirane Operating Knowledge base). Second copy of SOK utilised for read-only factory access (Factory SOK).

3.1.1 Y 3.1.2 Y

3.2 Customer focus and contract review







SOI The company’s senior management shall ensure that processes are in place to determine customer needs and expectations with regard to quality and safety and ensure these are fulfilled.

Y

Dedicated and identified personnel responsible for customer contact, namely Sales Director and Sales Account Managers. Customer satisfaction questionnaires sent to clients each year (last undertaken in December 2014/January 2015) and results reviewed. Customer specific quality initiatives/access to technical libraries etc. available. Customer satisfaction review carried out at annual management review.

3.2.1 Y 3.2.2 Y

3.2.3 Y

3.3 Internal audits FUNDAMENTAL

SOI The company shall audit those systems and procedures which cover the requirements of the Standard to ensure they are in place, appropriate and complied with.

Y Formal internal audit system in place and included schedule for current year.

3.3.1

Internal audits shall be planned and their scope and frequency shall be established in relation to the risks associated with the activity. Audits shall be scheduled so that all aspects of the Standard are audited at least annually.

Y

Audits scheduled once per year (2015 schedule in progress). Operating procedure audits carried out once per year, monthly glass/factory contamination control, monthly HACCP/CCP audits, monthly hygiene and raw material trace audits carried out monthly.

3.3.2

Internal audits shall be carried out by appropriately trained competent personnel who shall be sufficiently independent from the department being audited to ensure impartiality.

Y Team of 8 auditors trained in internal auditing (x5 trained on 22

nd January 2015), drawn from Technical/Quality,

Warehouse, production, operation, purchasing. Certificates available in training files.

3.3.3

Deficiencies and details of non-conformities shall be notified to appropriate supervisory staff and corrective action implemented within a specified and appropriate time period.

Y Non-conformances raised during audits managed using Corrective Action system.

3.3.4 The completion of corrective action shall be recorded and verified.

Y Corrective action required to be recorded and verified.

3.3.5

Internal audit reports shall be sufficiently detailed to ensure that conformity as well as non-conformity can be clearly identified and verified.

Y

Reports of audits compiled and retained and indicated level of compliance. Example internal audit report reviewed, including OP027 Machine Training Procedure 13/10/15. Non-conformances raised and transferred to CA system.

3.4 Supplier approval and performance monitoring SOI The company shall operate procedures for approval

and monitoring of its suppliers. This shall include suppliers of materials and services to the company and ensure that materials and services procured conform to defined requirements. Y

Supplier Approval Procedure defined (OP024 v4). Suppliers considered approved if certified under BRC Packaging standard and self-audit questionnaire (WR002) completed by each supplier at annual frequency. Approved supplier list maintained. Documentation retrieved for a number of suppliers during traceability test.

3.4.1 Y 3.4.2 Y

3.4.3 Y 3.4.4 Y

3.5 Subcontracting of production SOI Where production processes are subcontracted this

shall be with the agreement of customers. Procedures shall be in place for the effective control of subcontractors and the work undertaken.

Y Printing (where required) sub-contracted company on same site as Sirane (TCL in adjacent unit). Printing company monitored through Supplier Approval procedure.

3.5.1 Y 3.5.2 Y

3.5.3 Y 3.5.4 Y

3.6 Documentation control







SOI The company’s senior management shall ensure that documented procedures and recording forms critical to the management of product safety, legality and quality are in place and effectively controlled.

Y

Document control procedure defined. Amendments generally well controlled. Refer also to section 3.8.2. Superseded versions of documents retained in archive (Old SOK). Records kept for at minimum five years although it was reported that this was indefinitely as electronic records used.

3.6.1 Y 3.6.2 Y

3.6.3 Y

3.7 Specifications FUNDAMENTAL

SOI The company shall ensure that appropriate specifications exist for raw materials, intermediate and finished products, and any product or service which could affect the integrity of the finished product and customer requirements.

Y Raw material specifications available in company’s own format and supplier`s format where relevant. Finished product specifications available.

3.7.1

Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant product safety and legislative requirements. Y

Raw materials technical specifications and legal contact compliance declarations available from suppliers. Examples assessed during audit for cellulose absorbent substrate and PE.

3.7.2

The company shall seek formal agreement of specifications with relevant parties. Where specifications are not formally agreed then the company shall be able to demonstrate that they have taken steps to put an agreement in place.

Y

Specifications and artwork agreed with suppliers and customers as appropriate. Pre-production check sheet (WR108) in place, requiring agreement and customer signature before new product can be manufactured. This also includes verification against company HACCP plan.

3.7.3

A declaration of compliance shall be maintained, which enables users of the packaging materials to ensure compatibility with the product with which the materials may be in contact. The declaration of compliance shall contain as a minimum:

• the nature of the materials used in the manufacture of the packaging

• confirmation that materials meet relevant legal requirements

• the inclusion of any post-consumer recycled materials

• this shall identify any limitations of use of the declaration of compliance.

Products shall meet at least minimum legal requirements in the country of manufacture and use, where known.

Y

Company maintained detailed specifications for finished products and raw materials. Specifications include generic documents for product range from which specific item specifications derived. Declaration of Food Contact Compliance provided to customers (upon request) for each specific product group and product technical specification (if requested). Documentation included relevant product details and confirmed only virgin material used. Non-food grade components encapsulated within food grade layers where food contact required. Reference made to legal requirements within compliance documents. Example adhesive laminated product reviewed during audit and sufficiently detailed.

3.7.4

Trademarks for application on packaging materials shall, where appropriate, be formally agreed between relevant parties.

Y Trademarks applied by sub-contract printers according to pdf from customer. Customer approval process formal. Project will not proceed without formal approval.

3.7.5

The company shall operate a specification review procedure. Y

Raw materials specifications reviewed annually, in-process specifications generated per order to ensure most up to date versions in use. Refer also to section 3.6.3.

3.8 Record Keeping SOI The company shall maintain records to demonstrate

the effective control of product safety, legality and quality.

Y Satisfactory records observed in factory. Records retained appropriately for minimum five years as defined in procedure.

3.8.1 Y 3.8.2 Y

3.8.3 Y 3.8.4 Y

3.9 Traceability FUNDAMENTAL







SOI The company shall have a system in place to identify product batches and to trace and follow all raw materials through processing to distribution of the finished product to the customer. Records shall be retrievable in a timely manner. Y

Effective traceability system in place based on PC (process control) number applied to each production batch. Satisfactory exercise undertaken during audit for Dri-Fresh 1500 product, specification code SIAE13 produced 28/04/15 (selected from warehouse). Traceability of component materials and process control records demonstrated within an hour, including retrieval of CCP monitoring records.

3.9.1

The company shall have a system that has the ability to trace and follow all raw materials from the supplier through all stages of processing to distribution of the finished product and vice versa. Where continuous processes are used or raw materials are in bulk, the traceability of silos shall be achieved to the best practical level of accuracy.

Y

Traceability systems in place to identify suppliers and customers and relevant material batch numbers (2 suppliers for Dri-Fresh 1500 product: Tech Folien and SCA/GP – production batch and reel numbers for incoming goods identified).

3.9.2

An appropriate system shall be in place to ensure the customer can identify a product or production lot number for the product, for the purposes of traceability.

Y Finished product cartons clearly labelled with product description and product code, production date, dimensions, customer name and box quantity.

3.9.3

The system shall be tested to ensure traceability can be determined from raw material to the finished product and vice versa. This shall take place on a predetermined frequency, at least on an annual basis, and results retained for inspection.

Y Traceability tested formally on an annual basis. Also raw materials trace audits carried out monthly.

3.10 Complaint handling SOI The company shall have a system for the effective

capture, recording and management of product complaints.

Y

Customer Complaints procedure documented (OP011 v5). Procedure included requirement for recording and investigation. Details for each complaint included suspected cause, classification, preventive action, cost etc. Complaints form WR052 generated and email notification issued to relevant personnel. Trend data summarised and graphs generated for complaints and resulting costs. Previously reported target of maximum of four complaints per month being maintained majority of months (10/12).

3.10.1 Y 3.10.2 Y

3.10.3 Y

3.11 Management of incidents, product withdrawals and recalls SOI The company shall have a plan and systems in place

to effectively manage incidents, product withdrawals and recalls, in order to ensure that all potential risks to the quality, hygiene and legality of products are controlled.

Y

Incidents managed according to documented procedures (reference OP018, v7 Incident Procedure and OP019, v9 Recall Procedure).Procedures defined incident/recall team based on senior management team. Procedures satisfactorily detailed and included categories of incidents likely to result in a recall/withdrawal based on risk level. System tested annually, last test undertaken 5

th

June 2015, report of test available. Manufacturing Services Manager designated person responsible for preventive actions.

3.11.1 Y 3.11.2 Y

3.11.3 Y 3.11.4 Y

3.11.5 Y 3.11.6 Y

4. SITE STANDARDS

4.1 External standards SOI All grounds within the site shall be finished and

maintained to an appropriate standard. Y

Roads and pathways around factory hard surfaced and well maintained. Secure containers provided for safe storage of chemicals, engineering materials, surplus stock of cardboard boxes in yard at rear of factory. External areas kept in a tidy state.

4.1.1 Y 4.1.2 Y







4.1.3 Y 4.1.4 Y

4.1.5 Y 4.1.6 N/A

4.1.7 Y

4.2 Building fabric and interiors SOI The internal site, buildings and facilities shall be

suitable for the intended purpose and shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination. Y

Building of a modern design and well-constructed using sectional steel walls and composite panel ceiling and smooth finished and painted walls at lower levels. No opening windows present. Ventilation satisfactory. Extraction provided at adhesive and thermal lamination lines.

4.2.1 Y 4.2.2 Y

No opening windows present. 4.2.3 Y 4.2.4 Y

4.2.5 N/A 4.2.6 Y

4.2.7 Y

4.3 Utilities SOI All utilities to and within the production and storage

areas shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.

Y

Potable mains water used on site. Water used only for personnel purposes (hand-washing etc.). Compressed air systems fitted with driers and filtration systems. Air-product contact reported on adhesive laminator machine. Air compressor oil food grade; air filtered for removal of particulates, oil and moisture. Quality monitoring and filter changes carried out by a compressor supplier/service agent.

4.3.1 Y 4.3.2 Y

4.4 Security SOI Security arrangements shall be assessed to ensure the

integrity of products and processes.

Site security policy defined (WR299 v2). Suitable security measures present at access points to building with coded locks on side door and door from reception to factory for staff entry. Staff trained in security procedures during induction. Some agency staff utilised from two agencies (On Call and Ethero) and also trained in security procedures. CCTV installed on site (external and internal). IT system data backed up daily, remotely.

4.4.1 Y 4.4.2 Y

4.4.3 Y 4.4.4 Y

4.4.5 Y 4.4.6 Y

4.4.7 Y

4.5 Layout and Product Flow SOI Premises and plant shall be logically designed,

constructed and maintained. Procedures shall be in place to control the risk of product contamination and to comply with all relevant legislation.

Y

Site comprised: large open plan production area with defined processes within designated areas. Given mixed nature of processes, linear flow not appropriate. Adjoining warehouse with mezzanine floor and racking available for storage of raw materials. Support functions including maintenance, offices and personnel facilities located off a corridor adjacent to main production area. Work in progress well controlled and suitably identified.

4.5.1 Y 4.5.2 Y

4.5.3 Y 4.5.4 Y







4.5.4 Y

4.6 Equipment SOI Equipment shall be suitably designed for the intended

purpose and shall be maintained and used so as to minimise the risk to product safety, legality and quality.

Y Equipment in good condition overall and suitable for operations undertaken. Majority of production machines designed and built in-house in adjoining workshop.

4.6.1 Y 4.6.2 Y

4.6.3 Y

4.7 Maintenance SOI A documented system of planned maintenance shall

be in place, covering all items of equipment and plant that are critical to product safety, legality and quality.

Y

Programme of preventive maintenance including routine lubrication operated for machinery by engineering department. Records of maintenance documented. Equipment designed for purpose and maintained in satisfactory condition throughout plant. Equipment included in-house designed and manufactured production lines. Records of maintenance compiled, and inspection of condition and if necessary cleaning undertaken and recorded by Engineering using dedicated form WR198 v2, and signed-off by production to demonstrate agreement. Workshop located off main production area with controlled access and maintained in a suitably tidy condition. Swarf mats provided at access door.

4.7.1 Y 4.7.2 Y

Non-conformance 4.7.6 - Temporary engineering noted in several places, particularly at bag making machines Seamus and Sophie, with adhesive tape and cable ties (these were removed during the audit from Seamus and Sophie machines).

4.7.3 Y 4.7.4 Y

4.7.5 Y 4.7.6 N

4.7.7 Y 4.7.8 Y

4.7.9 Y

4.8 Staff Facilities SOI Staff facilities shall be sufficient to accommodate the

required number of personnel, and designed and operated to minimise the risk of product contamination. Such facilities shall be kept in a good and clean condition.

Y

Suitable staff facilities provided prior to entry to production areas. Facilities clean and in good condition. Wash hand sinks provided with warm water, foam soap and paper towels. Toilets located off main corridor and separate from production areas. Wash hand facilities available at toilets and reminder signs displayed. Dual compartment lockers raised off floor and fitted with sloping tops provided to employees for separate storage of personal and protective clothing. Refrigerator provided in staff rest area for personal food and checked daily. Vending machines provided for snacks and drinks. Smoking not permitted on site.

4.8.1 Y 4.8.2 Y

4.8.3 Y 4.8.4 Y

4.8.5 Y 4.8.6 Y

4.8.7 Y 4.8.8 Y

4.8.9 Y

4.9 Housekeeping and Cleaning FUNDAMENTAL







SOI Housekeeping and cleaning systems shall be in place, which ensure that appropriate standards of hygiene are maintained and that risk of contamination to the product is minimised. Y

Cleaning schedules and recording forms documented for all relevant areas and equipment. Procedure for ‘Barbi’ machine reviewed and indicated use of dry cleaning methods consisting of brush and cloths on weekly or per shift basis.

4.9.1

Good standards of housekeeping shall be maintained, which shall include a ‘clean as you go’ policy.

Y

Generally, satisfactory standard of cleaning and housekeeping observed during visit. Hygienic standard of adhesive laminator improved; some adhesive residues noted, but no obvious product hazard.

4.9.2

All internal surfaces of buildings, equipment and vehicles shall be subject to documented scheduled cleaning. Cleaning schedules shall include the following information:

• responsibility for cleaning

• item/area to be cleaned

• frequency of cleaning

• method of cleaning

• cleaning materials to be used

• cleaning record and responsibility for verification.

N

Employees responsible for cleaning equipment and surrounding areas. Cleaning schedules defined area to be cleaned, frequency, responsibility. Minimal cleaning chemicals used (floor cleaning only). Cleaning record forms signed off by shift manager. High level cleaning and deep cleaning carried out at scheduled intervals. Non-conformance 4.9.2 - Housekeeping & Cleaning: some areas not subject to formally documented cleaning, for example, diagonal cylindrical metal beams in warehouse visible from mezzanine floor heavy with dust/dirt (dust removed during this audit at areas accessible from mezzanine floor).

4.9.3 Cleaning equipment and materials shall be kept in a secure designated location such as a locked cupboard. Y

Designated secure areas provided for storage of cleaning chemicals and utensils. Colour coding used to facilitate control.

4.9.4 Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers and used in accordance with manufacturers’ instructions.

Y Minimal chemicals used and suitable for purposes employed.

4.9.5 Chemicals that are strongly scented or could give rise to taint and odour contamination shall not be used. Y

No problems observed during visit; food grade lubricants used in production areas.

4.9.6 Materials and equipment used for cleaning toilets shall be segregated from those used elsewhere. Y

Designated and locked store provided for separate equipment and chemicals for cleaning personnel areas.

4.10 Waste and waste disposal SOI Suitable facilities shall be provided for the storage

and disposal of process and other waste. Y

Waste materials separated by type (wood, cardboard and general waste) and removed from the site by contractors Veolia CB/EP3195BG, expiry 04/04/16.

4.10.1 Y 4.10.2 Y Non-conformance 4.10.4 - No formal control system in place for controlled disposal/destruction of trademarked waste.

4.10.3 Y 4.10.4 N

4.10.5 Y

4.11 Pest control







SOI The company shall be responsible for minimising the risk of pest infestation on the site.

Y

Pest control contracted to Acute Pest Control (APC, BPCA members, certificate expiry 29/02/16). Contract included 12 routine inspections, 2 Field Biologist visits per year covering all pests, all areas. Additional 6 EFK services/catch counts per year (last tube change 01/09/15). Call-out facility included in event of identification of infestation (last call-out 07/10/15 for pigeon in warehouse – removed). No evidence or records of infestation noted during routine visits of 01/10/15 or previous visit on 01/09/15. Last Field Biologist visit on 18

th August 2015 (under

Ecolab, previous contractor). Last EFK visit 1st September

2015. Records of inspection and treatment maintained on file. Proofing and hygiene issues raised under previous contract managed using Sirane corrective action system. BPCA membership certificate and records of training for pest control staff and material safety data information for baiting materials available on file.

4.11.1 Y 4.11.2 Y Non-conformance 4.11.6 - Pest control report of 18/08/15 (Ecolab) reported standing water/blocked drain, no corrective action or comment made on report by company.

4.11.3 Y 4.11.4 Y

4.11.5 Y 4.11.6 N

4.12 Transport, storage and distribution SOI The transport, storage and distribution of raw

materials and finished products shall be undertaken in a manner to minimise the risk of contamination or malicious intervention.

Y

Storage of raw materials and finished goods undertaken on site, with additional material storage at a 3

rd party run

facility approximately 12 miles away (Harman warehousing not audited during audit) but audited by company annually, last on 16

th June 2015). Conditions within on-site storage

areas good overall. Vehicle Inspection For Goods In and Out procedure followed (OP008 v6). Contract hauliers used for distribution of finished product. A number of preferred contractors, with 2 primary local hauliers – Rhenus and W J Capper. Signed transport agreements (WR032 v3) completed by approved contractors. Recycling waste suitably covered in yard area (wood). Vehicle Inspection completed before each load (in and outbound). Inspection recorded on relevant transport documents using a rubber stamp.

4.12.1 Y 4.12.2 Y

N/A - No company-owned vehicles.

4.12.3 Y 4.12.4 Y

4.12.5 Y 4.12.6 Y

4.12.7 Y 4.12.8 Y

4.12.9 Y 4.12.10 Y

4.12.11 N/A 4.12.12 Y

4.12.13 Y

5. PRODUCT DESIGN AND PROCESS CONTROL

5.1 Product design and development







SOI Product design and development processes shall be in place to ensure the production of safe and legal products to defined quality parameters.

Y

New product development operations comprised design of new concepts and variations of existing products in accordance with defined procedure and checklist (OP31 v3, WR200 - NPD Checklist, and WR108 - Pre-Production Checklist WR108 – for existing customer taking additional product). Development work coordinated by Technical Manager and Directors and involved completion of factory trials, development of new production equipment where required and completion of specifications. Due regard made to hazard analysis during NPD process and recorded. Dedicated development area located off production area. Printing sub-contracted; artwork formally approved by customers before printing (recorded on WR100). Relevant. Due to changes within Regulations (particularly 10/2011 EC regarding migration limits) multi-layer composite products no longer tested (no testing standards available for multi-component packaging materials), so migration testing data from individual/single component suppliers obtained and details reproduced within Sirane Declaration of Compliance. Migration testing previously carried out by PIRA or RAPRA in accordance with 1935/2004 EC.

5.1.1 Y 5.1.2 Y

5.1.3 Y 5.1.4 Y

5.1.5 Y 5.1.6 Y

5.2 Packaging print control SOI Where packaging is printed with allergen/safety/legal

information, procedures shall be in place to ensure that the information is fully legible and correctly printed to the customer’s specification.

Y

Printing sub-contracted to nominated and approved sub-contractors. Printer located at adjoining site to Sirane. Artwork generated by customers, supplied to Sirane and forwarded to sub-contract printer, developed into print-proof and returned for approval. Formal customer approval and sign-off of artwork obtained before ordering print production.

5.2.1 Y 5.2.2 N/A

5.2.3 N/A 5.2.4 N/A

5.2.5 N/A 5.2.6 N/A

5.2.7 N/A 5.2.8 N/A

5.2.9 N/A 5.2.10 N/A

5.3 Process control FUNDAMENTAL SOI Procedures shall be in place to ensure effective

quality assurance of operations throughout the process.

Y Procedures defined and documented for key operating activities.

5.3.1 The company shall undertake a review of the manufacturing and, where applicable, printing process to identify critical manufacturing process control points that could affect the quality of the products produced.

Y Production processes well controlled in accordance with documented procedures and instructions. Refer also to section 3.6.3. Critical manufacturing processes covered by HACCP.

5.3.2 For each critical manufacturing process control point, machine settings or process limits shall be established and documented – the process specification.

Y Single CCP identified for control of integrity of thermal laminator heater elements. Control measures defined as condition checks i.e. intact state of thermal laminator heater elements.







5.3.3 Documented process checks shall be undertaken at start up, following adjustments to equipment, and periodically during production, to ensure products are consistently produced to the agreed quality specification.

Y Pre-start procedures followed at each machine. Product quality inspection was carried out in accordance with each PC (production order). CCP audits carried out by Quality department monthly.

5.3.4 A clearance procedure shall be in place to ensure that at start up, the line is clear of all previous work and production documents.

Y Pre-start checks of lines recorded on WR064 Product Line Integrity & Safety Check Sheet.

5.3.5 Suppliers of incoming materials, as appropriate, shall provide evidence of conformity. Y

Food contact declaration information provided by suppliers for relevant raw materials. Examples assessed during the traceability exercise.

5.3.6 Quality checks shall be carried out to demonstrate that the finished product is within the tolerances laid down in the agreed product specification and conforms to any critical technical/legal requirements.

Y Routine quality checks undertaken on line and by quality staff to verify that the products met specification requirements.

5.3.7 In the event of changes to product composition, processing methods or equipment, the company shall, where appropriate, re-establish process characteristics and validate product data to ensure product safety, legality and quality are achieved.

Y Trials undertaken in event of change to product, process etc. This was reported to be very rare and only in event of like for like raw materials substitution from alternative supplier.

5.4 Product inspection and analysis SOI The company shall use appropriate procedures and

facilities when undertaking or subcontracting inspection and analyses critical to product safety, legality and quality.

Y

Product assessment included on-line visual inspection for dimensions, defects and contamination. Checks made for every box and recorded on PC record sheets. Migration testing no longer carried out (see section 5.1). Quality test for absorbency was witnessed using blue dye (food grade). Leak and Seal Testing procedure defined TM010 v3 for pouch products.

5.4.1 Y 5.4.2 Y N/A –company did not undertake any critical analysis. If external testing undertaken, would use ISO17025 accredited laboratory.

5.4.3 Y 5.4.4 Y

5.4.5 N/A

5.5 In-line testing and measuring equipment SOI The company shall use hazard and risk analysis

principles to determine the need for in-line product testing equipment to ensure the integrity and quality of products.

Y

Risk assessment had been undertaken and there was no in-line test or measuring equipment used or identified as necessary.

5.5.1 N/A 5.5.2 N/A

N/A - No in-line test or measuring equipment used. 5.5.3 N/A 5.5.4 N/A

5.6 Calibration SOI Measuring equipment used to monitor critical

manufacturing process points and product safety and legality shall be calibrated.

Y

No critical measurements undertaken so - no programme for specific calibration. Dead weights used for verification of weighing scales subject to periodic external calibration. Measuring equipment limited to weighing scales and metre rules. Accuracy of scales verified annually in-house using calibrated test weights. Condition of metre rules checked during hygiene audits.

5.6.1 Y 5.6.2 Y

However, no requirement for formal traceable calibration. 5.6.3 Y 5.6.4 Y

5.6.5 Y

5.7 Control of non-conforming product







SOI The company shall ensure that out-of-specification product is clearly identified, labelled and quarantined.

Y

Non-conformance managed according to a defined procedure (reference: OP010 v4). NCRs were transferred to Corrective Action form WR013 and log WR014. Quarantine (hold) area provided in warehouse. On-Hold Items log maintained on computer, including reason for hold and comments (system successfully interrogated for hold 1380). Corrective Actions (CAs) raised in event non-conformance (for example, product issues, pest control internal audits, external audits etc.) Timescale for completion of corrective actions determined according to severity, A = immediate, B = 5 working days and C = 20 days.

5.7.1 Y 5.7.2 Y

5.7.3 Y

5.8 Foreign body contamination control SOI All practicable steps shall be taken to identify, avoid,

eliminate or minimise the risk of foreign body contamination.

Y Generally good controls in place across site and operations, no significant risks observed. Good foreign body controls operated.

5.8.1 Foreign body control

5.8.1.1 Y 5.8.1.2 Y Glass and brittle plastics policy (WR026, v2) in place and a register maintained (WR027, v12). No unnecessary glass present, light fittings protected with polycarbonate housings / covers throughout. Monthly check of glass and hard plastic items against register carried out (example audit reports seen from 25/09/15 and 08/08/15). Further daily sign off on the start-up check sheet asks regarding glass or hard plastic breakage at machines (integrity sheet WR064). However, some clear plastic faces on pressure gauges on. Glass breakage controlled within Incident Procedure (OP18 V7) in place and detailed to define actions in event of breakage incident. Breakages required to be reported via WR016 record form.

5.8.1.3 Y 5.8.1.4 Y

5.8.1.5 Y

5.8.2 Sharps control

5.8.2.1 Y 5.8.2.2 Y Knife and scissor controls formalised. Blades issued by Hygiene & Quality Coordinator on new for old basis according to Blade Replacement procedure OP023, v4. Record of issue made. Knives kept in toolboxes.

5.8.2.3 Y 5.8.2.4 Y

5.8.2.5 Y

5.8.3 Chemical control

SOI Controls shall be in place to prevent contamination from chemical or biological hazards.

Y

Minimal chemicals used (floor cleaning only - food safe chemical, Novacote – used for adhesive removal on laminator, Ambersil and Rocol Food Grade maintenance lubricant range, food grade compressor oil; food grade hand soap).

5.8.3.1 N 5.8.3.2 Y Non-conformance 5.8.3.1 - Blue dye water bottle for absorbance testing on line not labelled with content.

6. PERSONNEL

6.1 Training and competence FUNDAMENTAL

SOI The company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity and are competent to undertake their job role.

Y Staff adequately trained according to a formal induction training process (and an agency induction training programme). Refresher training provided. Employees supervised during production operations as required.







6.1.1

All personnel, including temporary personnel, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period. Induction training shall include the company hygiene rules.

Y Training programme in place for all staff, including company induction and hygiene rules. Hygiene rules compiled in line with requirements of BRC Packaging standard.

6.1.2

The company shall routinely review the competencies of staff and provide relevant training as appropriate. This shall cover all packaging quality assurance, potential contamination and safety hazards, including those specific to established critical process steps.

Y

Refresher training programme followed for all employees and repeated every 2 years. Training carried out by Hygiene and Quality Coordinator.

6.1.3

Records of training shall be kept for all current and recent key employees.

Y

Training records maintained. Examples reviewed during audit with regard to employee responsible for monitoring CCP (KK).

6.1.4

A programme of refresher training shall be in place.

Y Refresher training given every 2 years and records present to indicate that training was carried out on an ongoing basis with re-training schedule for 2016 and 2017, for example, KK refresher 24/03/15.

6.1.5

The company shall document training procedures and records to demonstrate that training is effective and regularly reviewed.

Y Documented systems in place, including induction, agency induction and refresher training procedure and training records.

6.2 Access and movement of personnel SOI The company shall ensure that access and

movement of personnel, visitors and contractors shall not compromise product safety and quality. Y

Detailed factory plan in place showing exits / entrances, personnel facilities etc. Internal walkways clearly designated.

6.2.1 Y 6.2.2 Y

6.2.3 Y

6.3 Personal hygiene SOI The company’s personal hygiene standards shall be

documented and adopted by all personnel, including visitors to the production facility. These standards shall be developed with due regard for risk of product contamination.

Y

Company hygiene rules suitably documented (Personal Hygiene Rules WR024 v13). Rules covered jewellery, eating, drinking, smoking, protective clothing, hand-washing etc. Generally good compliance noted with hygiene rules. Personal medicine controls specified within WR070; use permitted on shop floor without dispensation.

6.3.1 Y 6.3.2 Y

6.3.3 Y 6.3.4 Y

6.3.5 Y 6.3.6 Y

6.3.7 Y 6.3.8 Y

6.3.9 Y

6.4 Medical Screening







SOI Health conditions likely to adversely affect product safety shall be monitored and controlled.

Y

Medical conditions that could affect product safety defined in hygiene rules and medical questionnaire system (separate questionnaires for employees, night-shift workers and visitors). Illness reporting requirement stated within hygiene rules and included instruction not to enter factory if suffering from various specified gastro-intestinal conditions. Medical screening questionnaire (WR060 for non-permanent employees, WR183 for permanent, WR266 night shift workers) completed as appropriate by all personnel prior to starting work. Health questionnaire required to be completed by visitors prior to factory entry. Blue, metal detectable plasters provided to staff as required and issue recorded on WR030 log sheet.

6.4.1 Y 6.4.2 Y

6.4.3 Y

6.5 Protective clothing

SOI Appropriate protective clothing shall be worn in production and storage areas to minimise the risk of product contamination.

Y

Suitable and sufficient protective clothing provided to staff. Employees were provided with disposable white coats and coloured mob caps that were typically changed on a daily basis. All operatives observed to wear protective clothing appropriately during the audit. Protective clothing required to be removed to go to canteen, toilet, smoking etc. Beard snoods available and worn as appropriate.

6.5.1 Y 6.5.2 Y

6.5.9 Disposable garments and mobcaps used. Non-conformance 6.5.11 - Blue disposable gloves not subject to formal control; no reference to blue glove controls in hygiene rules document WR024.

6.5.3 Y 6.5.4 Y

6.5.5 Y 6.5.6 Y

6.5.7 Y 6.5.8 Y

6.5.9 N/A 6.5.10 Y

6.5.11 N

report b06381 final 2015 · audit report global standard for packaging and packaging materials...

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