Wear Safe Assessment Report RAV 2016

Assessment Report.
Wear Safe (Malaysia) Sdn. Bhd.
Report Author Swee Lan San

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Visit Start Date 23/05/2016
Assessment Report.
Introduction.
This report has been compiled by Swee Lan San and relates to the assessment activity detailed below:
Visit ref/Type/Date/Duration Certificate/Standard Site address
8168468 FM 598969 Wear Safe (Malaysia) Sdn. Bhd.

Re-certification Audit (RA Opt 2) ISO 13485:2003 Lot 5068 & 5069,
Batu 4, Jalan Meru,
23/05/2016 CE 598967
41050 Klang,
6 day(s) Healthcare Selangor Darul Ehsan,
Effective no. of employees : 350 93/42/EEC Annex V, Section 3.2 Malaysia
Total no. of employees : 350 (2007/47)
Satish Champaneri
FM 598970
ISO 9001:2008
MD 598968
ISO 13485:2003 & EN ISO 13485
8442713 PAL 598971 Wear Safe (Malaysia) Sdn. Bhd.

Re-certification Audit (RA Opt 2) PAL Lot 5068 & 5069,
Batu 4, Jalan Meru,
25/05/2016
41050 Klang,
0.5 day(s) Selangor Darul Ehsan,
Effective no. of employees : 350 Malaysia
Total no. of employees : 350
Assessment Scope
The management system processes at the Lot 5068 & 5069, Batu 4, Jalan Meru, 41050 Klang, Selangor Darul Ehsan, Malaysia
Assessment Objectives
To conduct a recertification assessment to determine the effectiveness of implementation of the QMS applicable within the proposed
scope of registration, in accordance with the company objectives, policies and procedures, applicable requirements of the
management standard(s) & BSI Conditions of Contract and to determine whether a re-certification recommendation can be made.
To verify all requirements of ISO 9001:2008 have been effectively implemented.
To verify all requirements of ISO 13485:2003 and EN ISO 13485:2012 have been effectively implemented.
To verify Wear Safe (Malaysia) Sdn. Bhd. has implemented all requirements of ISO 13485:2003 and the most current version of Part
1 of the Canadian Medical Device Regulations. GD210 will be used.
To determine if the management system meets the requirements of:

MDD 93/42/EEC Annex V 3.2

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Assessment Report.
To verify effective implementation of the requirements of Ministerial Ordinance No. 169, 2004 published by Ministry of Health Labour
and Welfare of Japan.
Management Summary.
Overall Conclusion
The objectives of the assessment were met.
There were no obstacles encountered during the course of the audit. No factors were encountered during the audit that would affect
the reliability of this assessment.
All areas were covered per the assessment plan.
Audit report authors are as per the assessment team listed. The recommendation included in this assessment is based on
assessment of Lot 5068 & 5069, Batu 4, Jalan Meru, 41050 Klang, Selangor Darul Ehsan, Malaysia & dates of audit 23-26 May 2016
The report was finalised and issued on 30 May 2016.
The management system has been effectively implemented, addresses the proposed scope of registration and is in accordance with
the company objectives, applicable requirements of the management standard & BSI Conditions of Contract. The result of this
assessment enable a recommendation for recertification dependent on submission of a satisfactory action plan.
A corrective action plan is required to define the action to address the non-conformities identified during this assessment and detailed
in this report. The corrective action plan must include the correction (containment), root cause, corrective action, timescales & person
responsible for implementation.
All Requirements of ISO 9001:2008 have been effectively implemented.
All Requirements of ISO 13485:2003 and EN ISO 13485:2012 have been effectively implemented.
The capacity to systematically meet agreed requirements for products and services supplied within the scope of the certificates is
confirmed and the requirements of ISO 13485:2003 and Part 1 of the Canadian Medical Device Regulations are met.
The management system meets generally meets the requirements of MDD 93/42/EEC Annex V 3.2
Ministerial Ordinance No. 169, 2004 published by Ministry of Health Labour and Welfare of Japan is effectively implemented within
the management system.
Corrective actions with respect to nonconformities raised at the last assessment have been reviewed and found to be effectively
implemented.
2 nonconformities requiring attention were identified. These, along with other findings, are contained within subsequent sections of
the report.
A nonconformity relates to a single identified lapse, which in itself would not indicate a breakdown in the management system's
ability to effectively control the processes for which it was intended. It is necessary to investigate the underlying cause of any issue to
determine corrective action. The proposed action will be reviewed for effective implementation at the next assessment.

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Assessment Report.
Please submit a plan to BSI detailing the nonconformity, the cause, correction and your proposed corrective action, with
responsibilities and timescales allocated. The plan is to be submitted no later than 10/06/2016 by e-mail or fax to the correspondence
address below, referencing the report number.
Mandatory Requirements Re-Certification.

Review of assessment finding regarding conformity, effectiveness and relevance of the management system:
The standards were fully assessed. There were no trends to suggest a breakdown in their QMS. This review includes the physical
location and records associated with the company QMS certification.
A total of 1 Major non-conformity (UAV) and 8 minor non-conformities raised for the last audit cycle and actions have been taken
accordingly to close the NC. Organization has also improved awareness, monitoring and audit system resulting to the discovery of
more findings in the internal audit system for subsequent audit periods. The organization has managed to effectively implement the
designed management system in compliance to the specific requirements of the quality management system. Overall performance in
the previous cycle of certification yielded improving trend on the aspect of achieving the desired objectives and targets and
improvement on the management system.
Management system strategy and objectives:
Over the next 3 years the business expects growth gently and planned to expand more sale volume by focus for more increase
capacity in future. Consideration of the management strategy has been used in developing of people by provide training, addition
resources, maintain safety of product and effectiveness of QMS.
Review of progress in relation to the organisation's objectives:
The company objective is in line with their quality policy. The organization has demonstrated the establishment and tracking of
appropriate key performance objectives and targets and monitored progress towards their achievement which is generally being met
with continual improvement made. The management review process demonstrated capability to ensure the continuing suitability,
adequacy and effectiveness of the management system. Overall, the organization has demonstrated effective implementation,
maintenance and improvement of its management system.
Review of assessment progress and the re-certification plan:

A total of 6.5 man-days been completed, based on 544 FTE proposed in Jan 2016. This was in line with scheme requirements and the
recertification plan. However, reduction of employee to 350 people (as to date), based on MDP200 (15% reduction based on 3 shifts,
low complexity activities, identical activities performed on all shifts and low risk class of products), recertification requires 6. A total of
6.5 mandays is still within 6days (15%reduction) and 7days (no reduction) Therefore propose in next cycle year for 350 people,
based on MDP200 CAV= 3 mandays plus M-visit every 2 year due to there are sterile product in scope. Conclusion in next cycle Year
2017: CAV 1 = 4.0 manday ( 3.0 manday CAV plus 1.0 manday micro visit), Year 2018: CAV 2 = 3.0 manday, Year 2019: RA = 6.0
manday (would be re-confirm the number of employee before visit )
BSI Client Management Impartiality and Surveillance Strategy:

No issue with impartiality. All P/T codes were involved in every visit.

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Assessment Report.
Do you want the current Total assessment days / Cycle to continue ?

Yes
Justified Exclusions
Justified exclusions have been confirmed
details:
7.5.1.2.2 Installation Activities, justification: gloves do not require installation in order to be used
7.5.1.2.3 Service provision product servicing, justification product servicing is not applicable to gloves
7.5.3.2.2 & 8.2.4.2 particular requirements for active implantable medical devices and implantable medical devices, justification
gloves are not implantable medical devices
Areas Assessed & Findings.

Review of change and Top management interview : 5.1-5.6
Interviewed: Mr. Ong Tong Lee (General Manager), Mr TK Loh (Assistant QA Manager and Management Representative)
Organization QOC-001 rev 3 (date 18/4/16) has update as a new General manger and assistance factory manager.
Plant maintenance, production report to Assistance factory manager and others departments direct report to GM
Top management interview has commitment to fulfill the standard requirement and customer requirement. Focus on meeting internal
and external requirement.
Top management has review objective target and proposed some target can be more challenge such as absenteeism. To increase the
capacity of production therefore the production and packing staffs planned to be increased. Currently product quality is meet
customer requirements. There are no any critical complaints.
Organization has planned to produce Powder free NR Latex Examination Gloves OLPYT ST5 Sterile at Dipping line no 2. Therefore
the qualification run to validate process, sterilization dose setting, technical file has been updated.
Top management has provided evidence of its commitment to the development and implementation of the quality management
system and continually improving its effectiveness.
Top management has ensured that responsibilities and authorities are defined, documented and communicated within the
organization. Top management has established the interrelation of all personnel who manage, perform and verify work affecting
quality, and has ensure the independence and authority necessary to perform these tasks.
Quality manual, QMS Policy and Objectives, analysis of data : 5.3, 5.4, 5.5.1, 5.5.2, 5.5.3, 4.1, 4.2.1, 4.2.2, 5.4.1
Interviewed: Mr. Ong Tong Lee (General Manager), Mr Loh (Assistant QA Manager and Management Representative)
Quality policy was seen established in align with the organization and was well communicated through organizational several method
of internal communication (e.g. induction, briefing, framed at strategic areas, etc.)
Company quality policy is committed to satisfy customer requirement by supplying gloves with an assured level of quality. To
establish and continuously improve the effectiveness of the quality system including requirements of International Standards,
Regulations and National regulatory requirements. Continuous improving employee efficiency by providing proper training.

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Assessment Report.
Quality objectives established for relevant departments. Proper action plans/procedures have been established to implement and
monitor the progress and achievement of these objectives. Quality level targets at factory for online QC surveillance@post stripping,
post dipping, QA final release, as well as performance targets at various sections. Data has monitored and continually review monthly
in the annual management review meeting.
System documentation comprise of Quality manual, system procedures and interaction with related quality plans and forms/checklist.
The management system documentation demonstrated conformity with the requirements of the assessment standard and provided
sufficient structure to support implementation and maintenance of the management system.
Quality Management System (QMS) Manual QM-W5-001, Revision 06, effective date: 18 Apr 2016, reviewed by Mr Ong Tong Lee,
General Manager and approved by Mr Charles Lim Ooi Chow, Executive Director.
Change has been made to the Quality Manual on Appendix 1 restructure WSMs Organization Chart and added the microbiology
laboratory department.
Management Review : 5.6, 8.4, 8.5

Auditee: Mr Loh (QA Assistant Manager)
Quality Management Review Meeting is planned to be conducted at least once per year.
Verified the last Quality System Management Review conducted on 19/5/16, attended by General Manager, Assistant Factory
Manager, HOD, MR and key personnel in the organization. Agenda discussed were action items from previous Management Review,
quality policy, quality objectives, process performance and product conformity, nonconformance, CAPA closure, effectiveness and
trend data, result of audits and status of commitments, customer complaint, key internal & external (e.g. regulatory or market)
changes that could affect the QMS, adequacy of the QMS in terms of the business unit structure, staffing and resources,
recommendation for improvement and conclusion about the quality systems for continuing effectiveness.
Based on the sampled objective evidence, the area assessed is generally found to be effective in meeting the standard requirements.
Internal Audit : 8.2.2, 8.5.1, 8.5.2, 8.5.3

Auditee: : Ms Sazalinda (QA Executive)
Document reviewed: Internal Quality Audit Procedure, Doc No. QS-0029, Rev 1
Internal audit is scheduled to be conducted once per year.

Verified the following in the procedure: Internal Audit Schedule, Internal Auditor qualification, planning an internal audit, conducting
an Internal Audit, Internal Audit Report, filing of records.
Findings category is classified under: Major, Minor (observation) and opportunity for improvement. CAPA must be initiated for major
and minor.
Verified Internal Audit Schedule Year 2016 which covers all areas / elements to be audited, e.g. production (manufacturing &
maintenance, inspection & testing-online QC, former management), validation (online, offline, packing), QA (Document control
system), purchasing, waste water treatment, compounding and resource training. Internal Audit Report was generated for each area
audited.
Packing, treatment process, lab, QA, Micro, warehouse, marketing, maintenance are planned to be conducted from 7 June to 29
June. The internal audit was done over the period of 19 Apr to 29 June 2016. So far no non-conformity raised from the audit, other
than OFI
Verified that selection of auditors and conduct of audits maintained objectivity and impartiality of the audit process, whereby auditors
did not audit their own work

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Assessment Report.
The results of the internal audit done appear to represent an acceptable tool that the QMS has been implemented and properly
maintained by internal resources.
Customer feedback, Complaint, advisory notice, recall : 8.2.1,8.5.1,8.5.2,8.5.3

Interview: Mr. TK Loh: Assistance QA Manager
Complaint procedure QS-028 rev 2 is established as procedure for handling of complaint

The receiving of complaints to be log, and investigation for further corrective/preventive action including improvement.
Seen Monitoring log since year 2016 total 9 cases all is closed.
Customer complaint registration form and investigation report as below is completed.
Complain no.: V-009/16 product N8833 Nitrile Exam glove problem Dirt/stain
Complain no. V-008/16 product N8830 OCPFNF-BE Problem Palm size smaller
Complain no. V-005/16 Product Sensi touch exam NP problem tear outer pouch
Complain no. V-002/16 Product Powder surgical Problem Insect/back stain
There was none of adverse events to be incident report, advisory notice issuance, vigilance report, and mandatory report.
QA manager or assistant QA manager shall review and determine whether required to report or not
Advisory notice, Recall will be performed follow procedure QS-0052 rev0, whenever discover of serious defect or suspected cases.
For adverse event that need to be report, will follow procedure QS-0051rev 1 for Europe, QS-0017 rev0 for Canada and QS-0019 rev0
for Japan. The procedure as refer to MEDDEV 2.12-1 rev 8 the report timeline is clearly mention in procedure and meet the
requirement.
Post market surveillance is performed follow procedure QS-0050 via the MDAs accessible to MHRA website.
Conclusion: The feedback system is well established as per set of procedures.
Observations.
Type Area/Process Clause
Observations Customer feedback, Complaint, advisory notice, recall Contract
Scope CE 598967
Details: There was not defined the procedure to notify BSI via BSI e Vigilance Portal in documented procedure.
Regulatory requirement : CMDR, MDD, JPAL

Interview: Mr. TK Loh: Assistance QA Manager
For product selling to Canada under own brand name of WSM as a manufacturer, license has already been approved and issue to
WSM 5 according to ISO 13485 Certificate provided to Health Canada.
1. Device license no. 92951: Sterile Latex Surgical Gloves
2. Device license no. 92952: Sterile latex Examination glove
3. Device licence no. 92953: Sterile Nitrile Examination glove
Manufacture ID no. 138296 License issue in 0 2014/03/05

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Assessment Report.
Procedures have been established to support and fulfil the CMDR, MDD and JPAL and relevant requirement. There are list of
procedure:
1. QS-0013 rev0 Medical Device license handling: Health Canada, the procedure outline the application, obligation, handling and
maintaining of License also include amendment to medical device license and annual renewal process.
2. QS-0014 rev 0 Application & Classification Rules for medical device, Health Canada
Under rules of schedule 1 of CMDR the surgical gloves are classified as class II (rule 1) and examination gloves are classified as class
II (rule 2)
3. QS-0015 rev0: Health Canada Labelling review. To establish the procedure for review the contents of label and comply with CMDR
as per section 21(1), the language must label in either English or French as per section 23(1).
4. QS-0016 rev0: Canadian Distribution/Importer Problem or customer complaint procedure has defined procedure on
importer/distributor maintain records of proble. QS-0009 rev 1 Notification to certify body on the change of QMS, QA manager shall
inform BSI service Malaysia bhd m and complaint.
5. QS-0017 rev 0: Mandatory problem reporting: None of the case occurs. The timeframe to report has comply with requirement
6. QS-0009 rev 1 Notification to certify body on the change of QMS, QA manager shall inform BSI service Malaysia bhd of any
indented modification to Management system product or manufacturing process with may affect compliance with the following
ISO13485, ISO9001, CMDR, MHLW MO 169
7. QS-0004 rev 1 defined the control of quality record as per MDD, CMDR, J-PAL requirement
8. QS-0027 rev 0 Technical documentation Generating procedure
9. Quality and process record retain 5 year, For Notify body record / CA record forever retain, technical file, DMR retains life of
device plus 5year, training record retain life of employment/minimum 5 year.
10. QS-0050 rev 0 Post market surveillance procedure: A review of post marketing experience was review on month basis Seen Post
marketing surveillance review record on March and April 2016
Intouch brand product deliver to Canada, however WSM5 has OEM product e.g.Medline, as seen DHR and packaging.
JPAL
-Accreditation certificate for foreign Medical device Manufacture issued 2013 valid 2018
-The quality manual and related procedure has updated to reflect with Japanese Pharmaceutical Affairs Law (J-PAL), Ministry of
Health, Labour, and Welfare (MHLW) Ministerial Ordinance 169, 2004.
-QMR is appointed to QA manager has responsibility and authority under OJD-001 to ensure that QMS system is established
maintained and implemented according MO 169.
-Medline international Japan KK as the Marketing authorization holder
Conclusion: Generally comply with requirement. One minor NC was issued
Observations.
Type Area/Process Clause
Observations Regulatory requirement Annex II 3.4
Scope CE 598967
Details: Organization has planned to produce Powder free NR Latex Examination Gloves OLPYT ST5 Sterile at
Dipping line no 2 . (Existing is subcontract to sister company, WSM2) . However it is unclear that
organization has considered whether this change is significant change and need to notify to BSI. It is a
potential to not comply with requirement.

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Assessment Report.
Design and development control, risk assessment : 7.3

Interview: Ms. Rolisna: QA Executive, Mr. TK Loh :Assistance QA Manager
The Design and development procedure DC-0001 rev 0 was established to maintain plans the described the design and development
activity and define the responsibility. Design procedure DC-002 until DC-008 has fully established. Since WSM5 has been set up there
were no changes on design file. The design files were kept at WSM 5. The latest design history file is W04/10 (request date
6/10/2010) Powder Free Polymer Coated Polyisoprene Surgical Gloves which review and satisfied since BSI visit in year 2012.
The last Design transfer project Nitrile Exam gloves , this review since BSI visit in year 2014
Design request form MKT transfer of dipping location form PGA to WSM5 for Nitrile exam glove 09/07/2013
All dipping process control was remain the same. To immolate the OCPENT-BE-300 (On line chlorination Powder fee Nitrite finger
texture blue colour)
Seen record DC-0001 Initial assessment, Form A summary of powder free nitrile examination gloves description as a design inputs
Design output as per material specification, test report, process specification etc. was transfer and documented.
Design verification in as per compared product inspection against with product requirement was done.
Design review was done accordingly.
Process validation , Seen report W-FROQ-D08/2013, W-FRPQ-D08/2013, OQ qualification was done 2 days continuously at dipping
line 8 is to determine the acceptable operating window worst case 1 and worst case 2. PQ qualification was done in 3 days
continuously for nominal values setting for key process parameter. The critical parameters was defined such as machine speed,
Coagulant temperature, Latex dip temperature, Vulcanizing oven temperature, Final rinsing, Chlorine concentration
Visual inspection, water tight, physical property, powder, bioburden as according QC post striping, OA pre-packing was inspected and
pass criteria as defined in protocol W-VPOQ-D08/2013 , W-VPPQ-D08/2013
Risk management for class I product sterile powder free nitrile rubber examination gloves (RM/RA-W5/3-1 rev00) was evaluated and
approved on 11 Nov 2013. All possible hazardous situations have been identified since Design, preproduction, production, post-
delivery, post sterile, by report conclusion the Product is safe to be user as per intended use.
Conclusion: The design control was well established and maintain.
Technical file / Product labelling : 4.2,8.2.3,8.2.4

Interview: Ms. Rolisna: QA Executive, Mr. TK Loh :Assistance QA Manager
Technical Documentation Generating Procedure QS-0027 rev 0 was established a procedure for generate and preparing technical
documents in accordance to MDD 93/42EEC amendment M5, Annex V, Annex VII consist with information for product description,
Location and responsibility , Manufacturing process, sterilization, labelling, risk management, EC Declaration , ER check list. QA
manager has a responsible in generating technical documentation and updated technical information when it is necessary. Technical
file will be retained in Document Control Center for the life of device + 5 year. Technical file were generate as per product family
below
1) Technical file no. TF/W201/MDD, Sterile Powder Free NR latex surgical gloves
2) Technical file no. TF/W202/MDD, Sterile Powder NR latex surgical gloves
3) Technical file no. TF/W101/MDD, Sterile Powder Free NR latex examination gloves
4) Technical file no. TF/W301/MDD, Sterile Powder Free Nitrile rubber examination gloves
5) Technical file no. TF/W501/MDD Sterile Powder Free Non-latex surgical gloves
Sampling technical file: Technical file no. TF/W201/MDD, review the heading and contain is completed as per below, the technical file
was updated date 12/1/2015 by section 16 is restructured to be independently update without affecting future technical file revision.
- Name and address Legal manufacture and sterilization site
- Synergy Sterilization Rawang (M) Sdn Bhd, Synergy sterilization (M) Sdn Bhd (Kuala Ketil)
- European Authorized representative: Obelis S.A. Belguim Release of liability Addendum to the European Authorized representative
services agreement was provided.
-The product was classified under class II a according rule 6, 7 Product shelf life was defined 3 Year from manufacturing date.
Natural rubber latex, natural color and blue color

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Assessment Report.
-Intended use to be worn on hand by surgeons and /or operating room personnel to protect a surgical wound from contamination
and to be worn once and then discarded.
-Device description and family devices are defined the gloves type under family, Design and features, List of material used, labeling
requirement, Manufacturing and QA process, Design input specification
-The device does not incorporate any accessories as defined in article 1
-The device has no incorporate any substance that consider as medicinal product and are not derived from any animal issues or other
biological substances.
- Conformity path is I,V, VII
- List of raw material used, sterilization overview, design input specification, Quality assurance, List of harmonized standard , product
speciation
- Product labeling &IFU was prepared according requirement, seen Check list of label requirement. The symbols used in the labelling
are refer to BS EN ISO 15223-1
- Clinical assessment report was performed by literature review routes.
-The product test results shown comply with reference standard. The biocompatibility test was available. Primary Skin Irritation test,
Cytotoxicity, Extraction protein, Chemical residue, Physical property, Endotoxin.
-Risk assessment was performed by using FMEA technique which analysis base on severity, occurrence level
-EC declaration was prepared to declare compliance with directive 93/42EEC amendment 2007/47/EC.
-Completed the ER checklist, Annex V and Annex VII according directive 93/42EEC amendment 2007/47/EC.
Technical file are established according MDD93/42EEC of 14 June 1993 as amended by Council Directive 2007/42/EEC and will be
review and update one a year. As seen checklist of technical document review on date 12/1/2015.Technical file was defined the
manufacture will inform the notified body, BSI for any plan of substantial change
This assessment also covers for sampling technical file: Technical files no. TF/W101/MDD, Sterile powder free NR Latex Examination
gloves review the heading and contain is completed as per below, the technical file was updated date 01/4/2016 by section 1-12 due
added the manufacturing site 2, update the product code, update CE certificate.
The manufacture has plan to produce Power free NR latex examination at WSM 5, this product produce at WSM 2 before
-The product test results shown comply with reference standard. The biocompatibility test was available. Primary Skin Irritation test,
Cytotoxicity, Extraction protein, Chemical residue, Physical property, Endotoxin
Biocompatibility was compete testing Skin irritation test , Dermal sensitization , cytotoxicity, protein content, chemical residue, power
residue, physical property, endotoxin,
-Risk assessment was performed by using FMEA technique which analysis base on severity, occurrence level refer to RM/RA-W5/104
A, rev 0 date 22/9/2015 comply to Risk management procedure QS-0044 rev 1
-The risk evaluation is cover allergic, powder level, gloves tear, loss of barrier, tear, short gloves etc.
Risk base on process cover for incoming, compounding, dipping, packing, warehouse, delivery, sterilization
By conclusion the risk assessment and risk control has been conducted taking into account all know and foreseeable risk. Consider is
safe to be used according to its intended purpose.
The organization has evaluated all individual residue risk as well as overall residue risk against with benefit. The identified medical
benefits outweigh the identified overall risk residue.
Process validation : 7.5.2

Interview: Anazura: QA supervisor , Ms. Rolisna: QA Executive,
Process validation, Seen report W-FROQ-D02/2015 date 17 Nov 2015, Protocol W-VPOQ-D02/2015 date 26 Oct 2015
Scope of qualification run is limited to validate Dipping machine no. 2 for product type Powder free NR Latex Examination Gloves
OLPYT ST5 Sterile for WSM5.
OQ qualification was done 2 consecutive production run was 24 hr at dipping line 2 is to determine the acceptable operating window
worst case 1 and worst case 2.

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Assessment Report.
Protocol no. W-VPPQ-D02/2015 date 27 Oct 2015, Report W-FRPQ-D02/2015 date 25 Nov 2015
PQ qualification was done in 3 days continuously for nominal values setting for key process parameter. The critical parameters was
defined such as machine speed, Coagulant temperature, Latex dip temperature, Pre Leaching tank temperature ,polymer TSC, Main
oven temperature, Post reaching temperature
And completed the verification of process validation Pre-requisites of SOP, training and calibration
All QQ and PQ run performed in accordance with protocol. Visual inspection, water tight, physical property, powder residue,
bioburden, protein content, moisture and gloves bioburden as according QC post striping, OA pre-packing was inspected and pass
criteria as defined in protocol
Sterilization validation report Powder free NR Latex Examination Gloves (OLPYT ST5 240) Short thermoform unit package (poly to
poly) W-FRSV-15-1004 date 29 Feb 2016
Product biobuden 3 lot of finished goods was send to internal lab for bioburden testing.
Verification dose was obtained from standard ISO11137-2 and actual dose are with in limit
Sterility test was conduct on irraditation product at 9.1+/-10% kGy , 25 kGy and 45+/-10 kGy all pass
All outer pouches test for Seal leak test, Seal strength test , product visual inspection, water tight test, physical property test,
packaging visual inspection as condition Pre-sterile , Min 25 and 45 kGy
By conclusion the sterilization process effectiveness and meet SAL
Control of sterile product QS-0056 rev 1 control dose at 25-40 kGy.
Dose mapping will be carried out when has commercial run product.
Conclusion: Validation has carried out as per protocol and meet requirement.
Production and Quality control - Sterile /Non sterile and non-latex surgical gloves, non conforming product control :
7.5.1,8.2.3,8.2.4
Interview: Mr. TK Loh: Assistance QA Manager, Ms. MazniHashim: Technical and compounding manager, Mr. Nizam: Production
executive, Ms Lim Wai Kwan : Packing manager, Ms. Lim Chee Wang: Executive , Ms. Norhayat : QA supervisor
Visit production at ground floor, well separate for Latex and non-latex production since compounding, dipping process, inspection by
segregate tank, machine.
Review preparation and inspection record for compounding latex batch SPP 2138
The record can traceable to chemical and latex used in process. The approved for use record shown inspection results are meet
criteria.
Review the preparation of Coagulant batch no. CD 0048 and CD2032 and lab test result found completed record and meet
formulation.
Site visit at machine no. 3 (DD-SPBPPS 0.15) review process control check list date 24/5/16 which monitored every 2hr. and in
process lab control sheet found meet acceptable according process control parameter DPC-2007 rev 4
Review tumbling process record, machine T4 for batch no. MA-240516-03-L-65-015 was completed record.
Review record on line QC post striping and QA post tumbling (QA1) are completed visual inspection and dimension inspection.
QA 2 after 100%Air inspection was checking water Leak test, Visual inspection , example batch as per QWI-2002
Inner wrap process, observe at GPM3 P/O 4508432213 SPBPPS-0.15, seen line clearance checklist and in-process real time
inspection every 2 hr.
Pouching at Triomat number 2, P/O no 71590 (TR6AB) seen line clearance record and Tiromat power pack pouch which monitored
sealing temp, time, pressure, speed every 2 hr.
In-process real time inspection every 2 hr. such as seal integrity, dye leak test was carried out.
QA in RTI , sampling per PO and size was recorded in Visual inspection for surgical glove, QA packing and labelling inspection. The

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Assessment Report.
inspection covers pack seal, shipper, inner box, seal integrity, dye leak test, seal strength test, seen PO 71590 (SPBPPS-0.15).
Seen QA3 Final release inspection was under controlled condition which approved by QA manager. The final inspection was meet
criteria and AQL since visual inspection, leak test, dimension, physical property test, powder residual, protein, and packaging test.
Conclusion: In generally is comply with standard requirement.
Infrastructure and work environment control : 6.3,6.4

Interview: Ms. Lee Siew Chan (Microbiology), Mr. TK Loh (Assistance QA Manager)
Site visit at packing room has been well controlled and clearly entry instruction such as Gowning procedure, Rule and regulation in
control area and Effective hand washing procedure. Environment monitoring was defined on procedure QS-0061 rev 2. The
monitoring frequency will be once a month. The types of test are Microbial in process water, viable air count, Non-viable air count,
Viable Compressed air count, Surface microbial air count.
As per review record packing room 1-5 and production found within controlled limit.
Conclusion: All comply with standard requirement.
Laboratory : 8.2.4,8.2.3,6.3
Interview: Erna Suzieani
Site visit at laboratory, review in process control as seen Laboratory test report of monitoring in process chemical solution latex
compound, coagulant and polymer.
Finished product was test follow the laboratory test request form such as physical properties, powder content/ powder residual
following
Physical properties testing were carried out as per instruction, reviewed of LWI-0014, LWI-0018, LWI-0007.
Control at tensile testing room at temperature 23+/- 2 degree C, humidity 50+/5 %, monitoring and record two times a day.
All test equipment found verification/calibration valid.
Conclusion: Appropriate operating at Laboratory according to relevant procedures.
Final inspection, traceability, product release : 8.2.3,8..2.4,7.3

Interview: Ms. Rolisna: QA Executive
Packing report PO 4508055726 Order OWS-0235/2015 , PI-SPBPYS -0.16 brand Sensicare customer Medline-industries-Inc refer
to Production batch MA-190815-09-L-70-004 , chlorination batch no. C1411152101 packing lot no
Packing lot 602805572670 packing date 12/2/2016
Final release inspection record pass inspection visual inspection, Water tight test, physical property, dimension, protein, powder
residue, seal integrity, dye/seal leak lest.
COI no. MY01S11591410-1-1
Container/ Loading inspection repot date 15/3/16
Process control checklist PI date 19/8/15 machine 9 very 2 hr.
Conclusion: Well traceability control
Purchasing, Supplier and subcontractor Control : 7.4.1

Auditee: Shaffe Ramli (Purchasing Officer, Glove Division)
Document reviewed: Vendor Evaluation and Approval for Packaging Material, QS-0022, Rev 3, effective date: 7/8/2015; Vendor
Evaluation and Approval for Chemical & Latex, QS-0069, Rev 3, effective date: 7/8/15

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Assessment Report.
For packaging materials, vendor/supplier evaluated in accordance to New Vendor Assessment Questionaire. After the evaluation,
qualified vendor registered to Approved Vendor List (AVL). Sighted New Vendor Assessment Questionaire and assessment audit
report (dated 9/1/14) to Percetakan Tenaga Sdn Bhd, which qualified as packaging material vendor effective from 25/2/14
Vendors were monitored monthly through the following indicators: Delivered product quality and delivery schedule performance.
Results recorded on the Monthly Vendor Performance Report. Sighted Vendor Performance Report for month Jan 2016, Feb 2016 and
March 2016. Overall good/excellence rating.
All monthly Vendor Performance Report was summarized into a report and compiled for management review.
Sighted data analysis of supplier performance and management review dated 19/5/16.
Vendor audit was carried out to new or potential vendor, reassessment audit (AVL vendor) and problematic supplier. Sighted vendor
audit report to Harta Packaging Industries (Selangor) Sdn Bhd on 25/8/15, Tiong Tat Printing Industry Sdn Bhd on 21/10/15, F.A
Graphic Sdn Bhd on 8/9/15, South Island Plastic Sdn Bhd on 1/10/15 and Tiong Tat Printing Industry Sdn Bhd (problematic supplier)
on 20/4/15, Synthomer Sdn Bhd (synthomer EL746SXL Nitrile latex vendor) on 13/11/15, H&R Wax Malaysia Sdn Bhd on 28/10/15
and Innerys Mineral Malaysia Sdn Bhd on 21/10/15
Based on quantity purchased within 2 year the top two and three onwards vendors, re-assessment VAQ was conducted to them.
Sighted vendor re-assessment questionnaire for Harta Packaging Industries (Selangor) Sdn Bhd, Chuan Thong Industries Sdn Bhd,
Sonoco Products (M) Sdn Bhd
All the above vendors verified listed in the Approved Vendor List (packaging material) which last updated on 18/1/16 and AVL
(chemical) which last updated on 1/6/15
Sighted yearly sub-contractor assessment audit report (2015-01) for Synergy Sterilization (M) Sdn Bhd at Plot 203, Kuala Ketil
Industrial Estate, 09300 Kuala Ketil, Kedah, Malaysia. SHKK mainly sterilizes powder free & powdered NR Latex Surgical gloves,
powder free non-latex surgical gloves, powder free NR latex exam gloves and powder free nitrile exam gloves, by gamma irradiation.
Sighted yearly sub-contractor assessment audit report dated 21/4/16 for Synergy Sterilization Rawang (M) Sdn Bhd at Lot 42,
Rawang Integrated Industrial Park, 48000 Rawang, Selangor.
Available of service agreement between Synergy Sterilization (M) Sdn Bhd with Wear Safe Malaysia Sdn Bhd dated 6/6/2012 and
Synergy Sterilization Rawang (M) Sdn Bhd with Wear Safe dated 3/12/15
Customer related process/ Order receiving and planning process : 7.2.1-7.2.3

Interview: Mr. Tan Boon Chong, Planning Assistant Manager
Document reviewed: Order Processing Procedure, QS-0041, Rev 0
Customer process was performed according Order processing procedure QS-0041 rev 0. Processing the order received from
Marketing. Production planner responsible to schedule the delivery based on the order received. Factory manager or his designee
responsible to verify and approve the Order form, Order Form Packing Material, Purchase requisition and delivery schedule.
Production planner responsible to issue Purchase Requisition (PR) for the packaging material and gloves, and plan for production run.
Once of approved Order Form, planner sends a copy to QA and packing. Packing to generate Purchase Order Notification (PON)
together with relevant information. Planner reviews and check PON, QA Executive to check and reconfirm PON against OF.
Production run dipping lines scheduled accordingly to meet order requirement. Seen planning schedule for month May 2016.

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Assessment Report.
The details of product requirements were defined in order form such as product code, AQL, quantity, packaging material, printing
code, shipment date etc that will be communicated to production and QA person.
Seen Order form OKB-0539/2016 dated 28/4/16 upon Customer Order 4543197396 from Customer Hartmann Rico A.S. for product
Digital PF-Bulk ER46001BA-NA-OCPYF-240 and Digital PF-Wallet ER46001BA-NA-OCPYF-240, detailed with AQL, item code, size,
quantity, packing condition, final inspection location, bioburden test frequency, lot number format, customer request to put
cardboards at the bottom, on top and both side of the container to avoid wet damage during the transit.
Seen Order Form OW5-0186/2016 dated 20/4/16 against Customer Order USPO#2016135 MYPO#801384 (4524936650) from
customer Cardinal Health Malaysia Sdn Bhd for product Flexam N8831NS EB56701JC-BE-OCPFNF-300-BE, detailed with packing
condition, final inspection location, size, quantity.
Seen Order Form OW5-0053/2016 dated 17/2/16 against Customer Order 71590 from Medline International B.V. for SR11502UD-NA-
ME-SPBPPS-290-0.15mm detailed with customer special request on packing method, supplier pre-print info, sticker and inner wrapper
barcode. PON detailed with the Artwork, type of packing, scheduled shipment date.
Latex and Nitrile Examination gloves: Production and Quality control, traceability, nonconforming product control,
Finish goods warehouse and delivery : 7.5.1, 7.5.3, 7.5.5, 8.3, 8.2.3, 8.2.4,
Auditee: Mr. TK Loh (Assistance QA Manager), Mr An Boon Seong (Assistant Production Manager), Ikhram (Compounding Executive),
Ms Lim (Assistant Manager of Warehouse), Aliff (Lab Executive); Ms Chew (Packing Executive)
Documents reviewed: QA1 Pre-packing Inspection Procedure for Examination Gloves, QWI-1005, Rev 2, and procedure/WI stated
below.
Product realization procedures were checked and verified through sampling of activities and records. Each stage of the processes was
supported by operation procedure/WI/drawings displayed at each station/site/area.
Process(s) were sighted, observed and trailed as follows:
Latex and nitrile examination gloves manufacturing process and activity were checked involving raw material incoming inspection,
storage tank, chemical preparation tank, compounding, feeding tank to dipping line which involve acid and alkaline cleaning, rinsing
tank, washing brush, coagulant dip tank, coagulant oven, latex dip tank, latex oven, pre leaching, polymer tank, polymer oven,
beading station, oven, post leaching, slurry oven, pre-stripping, stripping, tumbling, WIP, packing and delivery, together with their
inspection (QA/QC) activities.
Verified records (process flow, quality plan, process control checklist, in process lab control checklist, inspection report, travel card
etc.) and trailed samples (latex exam) Batch No SC-240516-02-2, SC-220516-02-2 and SC-220616-02-1 for Machine No 02 and
samples (nitrile exam) Batch No. SC-150516-07-1 and SC-150516-07-2
Each tanks was monitored 2 hourly for temperature and 8 hourly for pH, concentration and/or %TSC according to the Process
Parameter Document DPC-1005, Rev 1 (latex exam) and NBR Exam Gloves OCPFNF-WH-LD 300, DPC-3002, Rev 0 (nitrile exam).
Pre-packing inspection by visual inspection, water leak test and physical dimension test. Results recorded into travel card. Checked
travel card for Batch No. SC-220516-02-1 and SC-220516-02-2 from M/C No. 02, Product Name PYS-5.4G, verified the sample size,
AQL and frequency followed according to procedure QWI-1005.
Latex exam - The compounded latex with Batch No. EG22934, EG2295 and EG2296 verified tested for %Total Solid Content (TSC)
and pH and recorded in the FL-60, Rev 1 NR Latex Compound Exam Preparation Approved for Use Latex (Exam). Noted on the
In-Process Lab Passed stamped on the form. Verified the compounding prepared did follow formulation stated in the CFL-1001, Rev 2
Formulation Latex Compound for OLPY(T), (F), (S) 5.4G and Natural Rubber (NR) Examination Glove Compounding, CWI-1001, Rev
1.

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Assessment Report.
Compounding mixture contains HA Latex, Texapon, 20% KOH solution, N700, TM Chemical, Aquamax 48 and Webrix Freesil. Checked
incoming inspection test for
a)HA latex LX(W5)0051 Supplier E Hup Huat, inspection checked on 12/5/16; HA latex LX(W5)005 Supplier E Hup Huat,
inspection checked on 16/5/16. Lab tested on pH, %TSC, %alkalinity, MST; CoA inspection for maturation, DRC%, KOH Number and
VFA, as well as visual inspection. Verified lab test results meeting specification stated in Specification for In-coming Natural Rubber
Latex LWI-0081 (In-coming NR Latex Inspection and analysis Rev 2)
b) TM Chemical T27-05/16-003(W5) Supplier Hai Poh Marketing, checked for CoA, as per according to RMS-0018, Rev 3 In house
Chemical, Material Inspection and Analysis Specification.
c) N-700 C1-05/16-001 (W5) Supplier Imerys Mineral, inspected on 5/5/16 as according to RMS-0018
c) Aquamax A7-04/16-001(W5) Supplioer Luxchem, inspection as according to RMS-001 Rev 1
Sighted packing for Product PFNFBE 200mm, BN: PB-210316-16-2 and PB-200316-17-1; OCPFNF-300-BE (Cardinal Health) and
SPBPPS-290-0.15mm (Medline International). Seen visual inspection for bi-fold inner wallet and pouch, for regulatory defect (AQL
0.25), critical (AQL 0.25), major (AQL 1) and minor (AQL 2.5) and recorded in FQ-12 QA Visual Inspection for Examination Glove
(Cardinal). Seen shipping and delivery arrangement for Packing List, order no. OWS-0116/2016, consignment 220/16/2, customer
MOPAK Medical, checked for carton number, glove size, lot number and quantity before delivery.
Incoming warehouse, packaging material warehouse, finished good warehouse:

Seen chemical, gloves, packaging material and compounded latex stored in designated, secured and sheltered area. Incoming goods
recorded onto stock cards and finished goods stacked on a pallet and segregated based on different brand and shipment.
Storekeeper inspects every incoming containers received based on quantity and item description, QA inspector sampling and testing
on goods, PASSED green sticker applies to each material upon acceptance of use. The ICM number indicated on the PASSED sticker
for traceability purpose. Documents seen are Handling and Controlling of Incoming Material, QS-0032, Rev 0; Handling, Storage and
Preserving of Incoming Material, QS-0033, Rev 0, Handling and Controlling Incoming Packaging Materials, QS-0036, Rev 0
Warehouse is being monitored for the temperature and humidity two times daily (7-10am, 12-3pm). Seen record for May 2016,
temperature all below 38C and humidity below 85%, following requirement stated in SWI-0020, Monitoring of Temperature and
Humidity in Warehouse Working Instruction. Seen designated area for quarantine products.
Conclusion: In generally is comply with standard requirement and one minor NC was raised to production dipping process control.
Maintenance and Calibration : 6.3, 7.6

Auditee: Ariff (Lab Executive), Production Executive
Document reviewed: Control of Inspection, Measuring and Test Equipment, QS-0030, Rev 3
Seen monthly inspection checklist for dipping machine, Machine No 2 and 3 for Apr, May and June 2016, machines checked for the
thermos oil piping, coil and tank. Sighted monthly preventive maintenance done to Dipping Line for Machine No. 1-8 as per PM
checklist.
Calibration Schedule established for equipment. Sighted the Masterlist of internal calibration/verification schedule and Masterlist of
External Equipment Calibration Schedule, detailed with the equipment internal ID number, equipment name, model, serial number,
location, frequency of calibration, calibration range, tolerance limit, calibration date and due date.
Verified calibration status by the calibration label, tag and calibration report for
1) Weighing balance, lab, ID No. LATB-022/1, verification done 14/4/16, valid till 14/8/16.
2) Standard Weight Set, lab, S/N ZSTW-003/1, calibration done on 19/11/15, valid till 19/11/16
3) pH meter, lab, ID No. LPHM-001/1 and LPHM-002/1, verification done on 21/3/16, valid till 21/6/16
4) MST Machine, ID No. LMST-001/1, calibration done on 10/5/16 valid till 10/6/16

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Assessment Report.
5) Tachometer, S/N ZTCM-001/1, calibration done on 16/5/16 valid till 16/5/17

6) Universal Testing Machine, S/N 3345S2507, calibration done on 15/12/15, valid till 14/12/16
7) Weighing Machine, Compounding, ID No. GWMC-001/1, calibration done on 6/3/16, valid till 6/7/16
8) Digital thickness gauze, ID No. CDTG-009/1, calibration done on 10/4/16, valid till 10/7/16
Pest control done monthly by Rentonkil. Seen Rodent Control Station Summary Report #52842 done on 30/3/16, #66249 done on
28/4/16 and #56198 done on 20/5/16.
Awareness, Training, Competence, responsibility, authority and communication : 5.5.1, 5.5.2, 5.5.3, 6.2.1, 6.2.2,
Auditee: Mr Norman Lim (HR Manager); Ms Gunasuntharri (HR Executive)
Document reviewed: Competence, Awareness & Training, QS-0058, Rev 0
Organization chart established. Job description was developed, communicated during hiring and induction program.
Training plan is established yearly. Seen training calendar for year 2016. Sighted training record for
1) Gigetrak Calibration Management dated 23/2/16 attended by Mohd Aliff Bin Razali
2) E-TDMS & E-TNA dated 24/3/16 attended by Pang Mok Shyan, Jessca Wong, Lee Swee Gee, etc
3) E-recruitment, E-manpower & E-Succession Planning dated 5/4/16 attended by Norman Lim, Gunasunthari
Seen Job Description, employee job qualification records and training evaluation for
1) Production Supervisor, Babu A/L Muniandy. Training provided were Machine start up procedure, chemical filling, offline cleaning
procedure, gloves tumbling procedure (training date 8/4/16)
2) QA Inspector, Md Luthfor Rahman. Training provided included WSM Quality Policy and objective, pre-packing sampling and
inspection procedure at post tumbling for surgical gloves, physical dimension test procedure, rework procedure for glove failed
inspection (dated 24/2-1/3/16)
3) Packing Operator, Satendra. Trainings provided includes defect awareness at packing department, gowning procedure for clean
room, rules and regulation for clean room, manual pouching, sealing and final packing procedure dated 27-29/8/15
Seen appointment letter from Executive Director dated 15/3/16, appointed Mr Loh Tuck Kuan, Assistant QA Manager as Quality
Management Representative (QMR). Job description clearly described in the QS-0010, Rev 1 Management Representative Procedure.
Document and record control : 4.2.3, 4.2.4

Auditee: Sazalinda (Document Controller)
Documents reviewed: Document Control System, QS-0001, Rev 0; Control of Records Procedure, QS-0004, Rev 1
A four level documentation is used to clearly communicate quality requirements: Level 1 Quality Manual, Level 2: Standard Operating
Procedure, Level 3: Work Instructions, Level 4: Quality Records, Reference Documents.
Master copy identified with Document Centre Master Copy stamped in green colour, QA Controlled document stamped in red colour,
Obsolete stamped with Obsoleted in red colour.
Available of Approved Distribution List last updated on 2/1/16 for Standard Operating Procedures QS-001 to QS-0075
Available of the updated Masterlist of SOP
Sampled Obsoleted copy of RMS-0018, Rev 3, In-House Chemical/Material Inspection & Analysis Specification, verified stamped with
identification OBSOLETED

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Assessment Report.
Records are properly kept, easily retrieved and identifiable and the contents are legible. Retention period for records clearly stated in
the Appendix 1 of Control of Records Procedure, for example QA inspection record, CAPA, customer complaint record for 5 years,
device master records for life of device+5 years
During the course of the visit logos were found to be used correctly.
Major Nonconformities Raised at Last Assessment.

Ref Area/Process Clause
1272509M1 Assessment Summary Annex IIV
Scope CE 598967
Statement of non Krutex Latex Surgical gloves have been inappropriately labelled with Regulatory approvals
conformance:
Requirements: The EC declaration of conformity is the procedure whereby the manufactureror his authorised
representative who fulfils the obligations ..
declares that the products concernedmeet the provisions of this Directive which apply to them.
Objective Krutex Latex Surgical gloves carries CE 0086. These gloves are not covered by the Declaration of
Evidence: Conformity by WearSafe and has not been approved by BSi.
Actions: Sighted the CAPA for 1272509M1

Action taken to update Declaration of Conformity (DoC) to incorporate affected product in technical file.
Verified the DoC dated 3/12/15 which has been included the Krutex Latex Surgical Gloves, Catalogue
Number 260973. Verified inner wrapper unit package has been updated with WSM5 name and address with
manufacturer symbol, EC Rep name and address, distributed by Jorgen name and address.
Closed?: Yes
Nonconformities Raised at Last Assessment.

1203527N1 Production 7.2.3
Scope MD 598968
Statement of non Customer requirement has not implemented

conformance:
Requirements:
Customer communication
The organization shall determine and implement effective arrangements for communicating with customers

Page 17 of 30
Assessment Report.
in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments,
c) customer feedback, including customer complaints (see 8.2.1), and
d) advisory notices (see 8.5.1).
Objective Customer order no. OW2-0113/2015 has indicated that "All Paul Hartman shipment are require to do a 3
Evidence: stage of bioburden-on line QC, Pre-packing, Pre-shipment" while acutual only do quarterly
Actions: Correction: All current Order Form reviewed and revised to state that the requirement for bioburden test is
conducted at quarterly interval.
Root cause: Due to internal miscommunication, requirement was misinterpreted
Corrective Action: All Order Form indicate the requirement for pre-shipment product bioburden test upon
due quarterly.
Closed?: Yes
1203527N2 Calibration 7.6
Scope MD 598968
Statement of non Tolerance limit of external calibration equipment has not determine and documented.
conformance:
Requirements:
Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring devices needed to provide evidence of conformity of product to determined requirements
(see 7.2.1).
The organization shall establish documented procedures to ensure that monitoring and measurement can
be carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable
to international or national measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements. The organization shall take appropriate action on the
equipment and any product affected. Records of the results of calibration and verification shall be
maintained (see 4.2.4).

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Assessment Report.
When used in the monitoring and measurement of specified requirements, the ability of computer software
to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and
reconfirmed as necessary.
NOTE See ISO 10012 for guidance related to measurement management systems.
Objective Calibration procedure, no. 5.4.3 has indicated that Acceptance criteria for Standard reference equipment
Evidence: using for calibration of MTE (measuring and test equipment) shall be set up as raito 1:3. However this ratio
has not taken to be set up as a criteria.
Actions: Correction: Tolerance value is hand-written in the relevant column as a temporary measure until replaced
with official revision of masterlist.
Root cause: Tolerance limit of external calibration equipment has been overlooked during documentation
Corrective action: Tolerance limit being calculated and determined according to MTE (Measuring and Test
Equipment) set up ratio 1:3 and documented in the revised Masterlist of External Equipment Calibration
Schedule.
Closed?: Yes
1203527N3 Sterilization validation /sealing validation /routine control: 7.5.2.2
Scope MD 598968
Statement of non There was partial failure control of Quarterly dose audit according ISO 11137-2 Established the sterilization
conformance: dose.
Requirements:
Particular requirements for sterile medical devices
The organization shall establish documented procedures for the validation of sterilization processes.
Sterilization processes shall be validated prior to initial use.
Records of validation of each sterilization process shall be maintained (see 4.2.4).
Objective Determine the bioburden of each of at least 10 each product and calculate the average bioburden was not
Evidence: implemented for Quarterly dose audit Q1 (2015) product Lot 2015-044 W5.
Actions: Reinstate the requirement in procedure and implement product bioburden test
Seen Quarterly dose audit for Powder free NR latex surgical (DD SPBPYF 0.17) Q1 year 2016
Product lot 2016-002W5 AVG result =98
Dose audit irradiation 8.01-9.79 kGy , sterility test pass test
Closed?: Yes

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Assessment Report.
1203527N4 Work environment control: 6.4
Scope MD 598968
Statement of non Inconsistency monitoring of microbiological as per Environment monitoring program W-QII-LMT-001 rev
conformance: 008 and
Environmental monitoring procedure QS-0061-rev 0.
Requirements: Work environment
The organization shall determine and manage the work environment needed to achieve conformity to
product requirements.
The following requirements shall apply.
a) The organization shall establish documented requirements for health, cleanliness and clothing of
personnel if contact between such personnel and the product or work environment could adversely affect
the quality of the product (see 7.5.1.2.1).
b) If work environment conditions can have an adverse effect on product quality, the organization shall
establish documented requirements for the work environment conditions and documented procedures or
work instructions to monitor and control these work environment conditions (see 7.5.1.2.1).
c) The organization shall ensure that all personnel who are required to work temporarily under special
environmental conditions within the work environment are appropriately trained or supervised by a trained
person [see 6.2.2 b)].
d) If appropriate, special arrangements shall be established and documented for the control of
contaminated or potentially contaminated product in order to prevent contamination of other product, the
work environment or personnel (see 7.5.3.1).
Objective Seen monitored microbiological record of May 2015

Evidence: 1) W-QII-LMT-001 is mentioned to check compressed air of pneumac machine at packing department every
3 month while actual practice was not monitored.
2) W-QII-LMT-001 is mentioned to check surface microbial count of tumbling machine while QS-0061-rev0
is mentioned to check machine/table/wall/floor once per month. But the actual practice was monitored on
Former and Plastic bin at production.
3) There was monitored soft water by monthly as per W-QII-LMT-001 but this requirement are not included
in QS-0061, sampling point of Fluid bioburden.
Actions: 1) QS-0061 rev 2 was include Viable air count by Compressed air count at ex-strip and ex-machine
Seen record for Viable air count data sheet date 22/03/2016 and 19/4/2016 , result shown with in alert
limit.
2) QS-0061 rev 2 was update the sampling point for former, plastic bag, machine at production , and table
, floor at packing room
3) QS-0061 rev 2 add up the monitoring of soft water. Seen monitoring record on March and April 2016
Closed?: Yes
1203527N5 Surgical: Production and Quality control, traceability, nonconforming product 7.5.1.1
control, Finish goods warehouse and delivery:

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Assessment Report.
Scope MD 598968
Statement of non There was partial failure control at QA2 which not comply to Quality plan DD-SPBPYS 0.17 rev 2 and QWI-
conformance: 2002 rev 3 QA-Pre-packing sampling inspection procedure.
Requirements:
General requirements
The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,

b) the availability of documented procedures, documented requirements, work instructions, and reference
materials and reference measurement procedures as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery and post-delivery activities, and
g) the implementation of defined operations for labelling and packaging.
The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that
provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount
approved for distribution. The batch record shall be verified and approved.
NOTE A batch can be a single medical device.
Objective QA-Pre-packing for visual inspection record (QA 2) of batch MA-110515-05 was defined the criteria of visual
Evidence: defect (Minor) at GI AQL 4.0 Sample 80, Accept =7, Reject =8 which not comply to Quality plan and
procedure at AQL 2.5 Accept = 5 reject =6.
(Quality plan DD-SPBPYS 0.17 rev 2 and QWI-2002 rev 3,QA-Pre-packing sampling inspection procedure)
Actions: Revise QWI-2002 rev 4 to describe inspection criteria AQL by product/gloves type
And brief all inspectors on the entry error and retain date 30/6/2015
Closed?: Yes
1272509N1 Assessment Summary Annex I
Scope CE 598967
Statement of non Storage temperatures for the Intouch PF have been inappropriately labelled
conformance:
Requirements: The label must bear the following particulars:

.any special storage and/or handling conditions
Objective Shipper for the Intouch PF size 7 ref INTW 0570 Lot 2015 322 W5 expiry 2018-10 had storage temperature
Evidence: symbol of storing inbetween 10 and 40C. There is no documented evidence for this in the Technical file.

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Assessment Report.
Actions: Sighted the CAPA for 1272509N1. Verified action taken to revise artwork to remove the temperature
symbol on dispenser box unit packages.
Closed?: Yes
Minor Nonconformities Arising from this Assessment.

1336568N1 Regulatory requirement Annex II 3.4
Scope CE 598967
Statement of non Procedure are not adequate to address the requirement to inform the notified body for signification change.
conformance:
Requirements: The manufacturer must inform the notified body which approved the quality system of any plan for
substantial changes to the quality system or the product-range covered. The notified body must assess the
changes proposed and verify whether after these changes the quality system still meets the requirements
referred to in Section 3.2. It must notify the manufacture of its decision. This decision must contain the
conclusions of the inspection and a reasoned assessment.
Objective The documented procedure are not defined the requirement to inform the notified body for signification
Evidence: change which approved the quality system of any plan for substantial changes to the quality system or the
product-range covered.
Existing procedure QS-0009 rev 1 was limit only Notification to certify body (BSI service Malaysia bhd) on
the change of QMS,
1336568N2 Latex and Nitrile Examination gloves: Production and Quality control, 8.2.4.1
traceability, nonconforming product control, Finish goods warehouse and
delivery
Scope MD 598968
Statement of non Production process control parameter is not entirely follow procedure
conformance:
Requirements:
General requirements
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product realization
process in accordance with the planned arrangements (see 7.1) and documented procedures (see 7.5.1.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the
person(s) authorizing release of product (see 4.2.4).
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been

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Assessment Report.
satisfactorily completed.
Objective Latex Exam Glove - Checked record in the Process Control Checklist dated 22/5/16 for M/C 02 Shift 1 and
Evidence: 2, found discrepancy for the control limit stated in process control checklist and procedure DPC-1005 Rev 1
Process Parameter For NR Exam Gloves OLPYS 5.4G. In process Lab Control Checklist, Exam, FD-41(e), Rev
1 showed Nitric acid concentration cleaning tank #1 (2.5+/-0.5%), FC4 concentration cleaning tank #2
(4.0+/-1.0%), water flow rate cleaning tank #2 (2+/-0.5 LPM), however Document DPC-1005 showed NA
1.5-2.5%, FC4 3.5-4.5% and water flow 1-3 LPM). If following the specification stated in DPC-1005, MC#2
dated 22/5/16, Glove type: OLPYS 5.4, the FC4 concentration monitoring at 0000-0030 time showed 3.3%
will out of specification.
Nitrile Exam Glove - Pre-leaching tank#4 temperature (65+/-3 stated at process control checklist), whereas
process flow chart for NBR Exam Gloves OCPFNF-WH-LD 300, DPC-3002, Rev 0 stated 60-70degC
Assessment Participants.
On behalf of the organisation:
Name Position
Ong Tong Lee General Manager
Mah Jun Jie Assistant Factory Manager
Loh Tuck Kuan Assistant QA Manager
Tan Boon Chong Assistant Manager Planner
An Boon Seong Assistant Manager Production
Lim Wai Kwan Packing Manager
As in Attendace List .
The assessment was conducted on behalf of BSI by:
Name Position
Sumalee Kasempongtongdee Team Member
Swee Lan San Team Leader
Continuing Assessment.
The programme of continuing assessment is detailed below.

Page 23 of 30
Assessment Report.
Site Address Certificate Reference/Visit Cycle
Wear Safe (Malaysia) Sdn. Bhd. Contract 200621408

Lot 5068 & 5069,
Visit interval: 12 months
Batu 4, Jalan Meru,
41050 Klang, Visit duration: 3.0 Days
Selangor Darul Ehsan,
Next re-certification: 01/05/2019
Malaysia
Re-certification will be conducted on completion of the cycle, or sooner as required. An entire system re-assessment visit will be
required.
Re-certification Plan.
WEAR S-0047471854-000|CE 598967
Visit1 Visit2 Visit3 Visit4
Business area/Location Date (mm/yy): 05/16 05/17 05/18 05/19
Duration (days): 6.5 4.0 3.0 6.0
Latex and Nitrile Examination & Surgical gloves: Production and X X X X

process control, packing, traceability, nonconforming product control
Finish goods warehouse and delivery X X X X
Raw material warehouse and incoming inspection X X X X
Customer related process, order receiving and planning X X X
Process validation X X X
Design & development X X X
Risk management X X X
Management Review X X X X
Internal Audit X X X X
Corrective Action inc. Complaints, PMS, and vigilance system. X X X X
Purchasing and supplier control X X X
Document and record control X X X
Competency, training and awareness X X X
Maintenance and calibration X X X X
Microbiologist visit X X

Page 24 of 30
Assessment Report.
Recertification X X
Next Visit Plan.

Visit objectives:
The management system processes at the Lot 5068 & 5069, Batu 4, Jalan Meru, 41050 Klang, Selangor Darul Ehsan, Malaysia
To conduct a recertification assessment to determine the effectiveness of implementation of the QMS applicable within the proposed
scope of registration, in accordance with the company objectives, policies and procedures, applicable requirements of the
management standard(s) & BSI Conditions of Contract and to determine whether a certification / re-certification recommendation can
/ could be made.
To verify all requirements of ISO 9001:2008 have been effectively implemented
To verify all requirements of ISO 13485:2003 and EN ISO 13485:2012 have been effectively implemented.
To verify Wear Safe (Malaysia) Sdn. Bhd. has implemented all requirements of ISO 13485:2003 and the most current version of Part
1 of the Canadian Medical Device Regulations. GD210 will be used.
To determine if the management system continues to meet the requirements of MDD 93/42/EEC Annex V 3.2
To verify effective implementation of the requirements of Ministerial Ordinance No. 169, 2004 published by Ministry of Health Labour
and Welfare of Japan.
Visit Criteria
93/42/EEC Annex V, Section 3.2 (2007/47), ISO 9001:2008, ISO 13485:2003 & EN ISO 13485, PAL,manual, policies, procedures,
work instructions, legal and statutory and customer requirements, other related certification requirements
Visit Scope
This visit will cover the location activities for the management system processes at the Wear Safe (Malaysia) Sdn. Bhd. at Lot 5068 &
5069, Batu 4, Jalan Meru, 41050 Klang, Selangor Darul Ehsan, Malaysia
Date Assessor Time Area/Process Clause
Date Assessor Time Area/Process Clause
Assessor 1 &
1 Dec 2016 9:00 Opening meeting and review of changes
2
9.30-
Day 1 Assessor 2 Microbiologist visit 7.5.2, 6.4
16.30
Management review meeting, data analysis and
Assessor 1 9:30 improvement, including quality policy & 5.1-5.6, 8.1, 8.2, 8.4, 8.5
objectives

Page 25 of 30
Assessment Report.
11:00 Internal Audit 8.2.2, 8.5.2, 8.5.3
12:00 Lunch
Corrective and Preventive Actions, including
13:00 8.2.1, 8.3, 8.5.1-8.5.3
customer complaints
15:00 Technical file and related regulatory MDD, CMDR, JPAL
16:30 Day Brief
17:00 End of day 1 audit
Production and process control Latex/nitrile

Day 2 Assessor 1 9:00 7.5.1, 7.5.3, 8.2.4, 8.3
surgical
12:00 Lunch
13:00 Material & FG warehouse, delivery 7.5.5, 8.2.3
15:00 Machine maintenance, infrastructure 6.3
16:30 Day Brief
Production and process control Latex/nitrile

Day 3 Assessor 1 9:00 7.5.1, 7.5.3, 8.2.4, 8.3
exam
12:00 Lunch
13:00 Incoming inspection, laboratory 7.5.5, 7.4.3, 8.2.4
14:30 Calibration 7.6
15:30 Purchasing 7.4
16:30 Day Brief
Day 4 Assessor 1 09:00 Design / validation 7.1, 7.3
11:00 Document and record control 4.2
12:00 Closing meeting
12:30 End of assessment (CAV1)
Please note that BSI reserves the right to apply a charge equivalent to the full daily rate for cancellation of the visit by the
organisation within 30 days of an agreed visit date.

Page 26 of 30
Assessment Report.
Scope of Certificate CE 598967 (Healthcare).

Main Scope
The manufacture of sterile surgeons natural rubber gloves and sterile surgeons polyisoprene gloves. Those aspects of Annex V
relating to securing and maintaining sterility in the manufacture of natural rubber latex and nitrile examination gloves
The scope has been confirmed as correct.
Location Scope
Wear Safe (Malaysia) Sdn. Bhd. Main Certificate Scope applies.

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia
WEAR S-0047471854-000
Scope of Certificate MD 598968 (ISO 13485:2003 & EN ISO

13485).
Main Scope
Design and manufacture of Sterile and non sterile latex and nitrile rubber examination gloves and sterile latex and non-latex surgical
gloves. Design and manufacture of non-sterile latex procedure gloves
Location Scope

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia
WEAR S-0047471854-000
Scope of Certificate FM 598969 (ISO 13485:2003).

Main Scope
Design and manufacture of sterile and non-sterile latex and nitrile rubber examination gloves and sterile latex and non-latex surgical
gloves. Design and manufacture of non-sterile latex procedure gloves.

Page 27 of 30
Assessment Report.
Location Scope

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia
WEAR S-0047471854-000
Scope of Certificate FM 598970 (ISO 9001:2008).

Main Scope
Design and manufacture of sterile and non sterile latex and nitrile rubber examination gloves and sterile latex and non-latex surgical
gloves. Design and manufacture of non-sterile latex procedure gloves.
Location Scope

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia
WEAR S-0047471854-000
Scope of Certificate PAL 598971 (PAL).

Main Scope
Design and manufacture of non-sterile/sterile latex and nitrile rubber examination gloves and sterile latex and non-latex surgical
gloves.
Location Scope

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia

Page 28 of 30
Assessment Report.
WEAR S-0047471854-000
Scope of Certificate Contract 200621408 ().

Main Scope
Location Scope

Lot 5068 & 5069,
Batu 4, Jalan Meru,
41050 Klang,
Malaysia
WEAR S-0047471854-000
Notes.
The assessment was based on sampling and therefore nonconformities may exist which have not been identified.
If you wish to distribute copies of this report external to your organisation, then all pages must be included.
BSI, its staff and agents shall keep confidential all information relating to your organisation and shall not disclose any such
information to any third party, except that in the public domain or required by law or relevant accreditation bodies. BSI staff, agents
and accreditation bodies have signed individual confidentiality undertakings and will only receive confidential information on a 'need
to know' basis.
This report and related documents is prepared for and only for BSIs client and for no other purpose. As such, BSI does not accept or
assume any responsibility (legal or otherwise) or accept any liability for or in connection with any other purpose for which the Report
may be used, or to any other person to whom the Report is shown or in to whose hands it may come, and no other persons shall be
entitled to rely on the Report.
Should you wish to speak with BSI in relation to your registration, please contact your customer service officer.
BSI Services Malaysia Sdn Bhd

B-08-01(East) Level 8,
Block B, PJ8, No. 23,
46050 Petaling Jaya,
Selangor, Malaysia.
Tel: +603 79607801 Fax: +603 79605801
E-mail (for corrective action plans): capmy@bsigroup.com
Regulatory Compliance.
BSI requires to be informed of all relevant regulatory non-compliance or incidents that require notification to any regulatory authority.
Acceptance of this report by the client signifies that all such issues have been disclosed as part of the assessment process and
agreement that any such non-compliance or incidents occurring after this visit will be notified to BSI as soon as practical after the
event.
Expected Outcomes for Accredited Certification.

Page 29 of 30
Assessment Report.
What accredited certification means:

The accredited certification process provides confidence that the organization has a management system that conforms to the
applicable requirements of the certified standards covered within this assessment and scope of certification.
What accredited certification does not mean:
It is important to recognize that certification defines the requirements for an organization's management system, not for its products
or services. It does not imply that the organization is providing a superior product or service, or that the product, service or
performance itself is certified as meeting the requirements of an ISO standard or specification or that the organisation can
guarantee 100% product, service or performance conformity, though this should of course be a permanent goal.

Page 30 of 30

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Assessment Report.

Wear Safe (Malaysia) Sdn. Bhd.

Report Author Swee Lan San

Visit ref/Type/Date/Duration Certificate/Standard Site address

8168468 FM 598969 Wear Safe (Malaysia) Sdn. Bhd.

8442713 PAL 598971 Wear Safe (Malaysia) Sdn. Bhd.

To verify all requirements of ISO 9001:2008 have been effectively implemented.

To determine if the management system meets the requirements of:

Report Author Swee Lan San

All areas were covered per the assessment plan.

The report was finalised and issued on 30 May 2016.

All Requirements of ISO 9001:2008 have been effectively implemented.

Report Author Swee Lan San

Mandatory Requirements Re-Certification.

Management system strategy and objectives:

Review of progress in relation to the organisation's objectives:

Review of assessment progress and the re-certification plan:

BSI Client Management Impartiality and Surveillance Strategy:

Report Author Swee Lan San

Do you want the current Total assessment days / Cycle to continue ?

Areas Assessed & Findings.

Report Author Swee Lan San

Management Review : 5.6, 8.4, 8.5

Internal Audit : 8.2.2, 8.5.1, 8.5.2, 8.5.3

Internal audit is scheduled to be conducted once per year.

Report Author Swee Lan San

Customer feedback, Complaint, advisory notice, recall : 8.2.1,8.5.1,8.5.2,8.5.3

Complaint procedure QS-028 rev 2 is established as procedure for handling of complaint

Conclusion: The feedback system is well established as per set of procedures.

Observations Customer feedback, Complaint, advisory notice, recall Contract

Regulatory requirement : CMDR, MDD, JPAL

Report Author Swee Lan San

Conclusion: Generally comply with requirement. One minor NC was issued

Observations Regulatory requirement Annex II 3.4

Report Author Swee Lan San

Design and development control, risk assessment : 7.3

Technical file / Product labelling : 4.2,8.2.3,8.2.4

Report Author Swee Lan San

Process validation : 7.5.2

Report Author Swee Lan San

Report Author Swee Lan San

Conclusion: In generally is comply with standard requirement.

Infrastructure and work environment control : 6.3,6.4

Conclusion: Appropriate operating at Laboratory according to relevant procedures.

Final inspection, traceability, product release : 8.2.3,8..2.4,7.3

Purchasing, Supplier and subcontractor Control : 7.4.1

Report Author Swee Lan San

Customer related process/ Order receiving and planning process : 7.2.1-7.2.3

Report Author Swee Lan San

Report Author Swee Lan San

Incoming warehouse, packaging material warehouse, finished good warehouse:

Maintenance and Calibration : 6.3, 7.6

Report Author Swee Lan San

5) Tachometer, S/N ZTCM-001/1, calibration done on 16/5/16 valid till 16/5/17

Document and record control : 4.2.3, 4.2.4

Report Author Swee Lan San

Major Nonconformities Raised at Last Assessment.

1272509M1 Assessment Summary Annex IIV

Actions: Sighted the CAPA for 1272509M1

Nonconformities Raised at Last Assessment.

1203527N1 Production 7.2.3

Statement of non Customer requirement has not implemented

Report Author Swee Lan San

Ref Area/Process Clause