146 BSX-W144 Calibration of Wall Thermometer 0 17.04.2013 147 BSX-W145 Filter Bags Usage Procedure 0 17.04.2013 148 BSX-W146 Business Continuity Management 1 19/3/2020 149 BSX-W147 Checkweigher Verification-BSX2, Filling Line 1 0 24.10.2013 150 BSX-W148 Product Recall/Withdrawal of Coles Product 0 14.02.2014 151 BSX-W149 Change Control Management 1 31/3/2021 152 BSX-W150 Test Method – Refractive Index 0 16/10/2015 153 BSX-W151 Sampling Bulk More Than 7 Days 0 6/12/2016 154 BSX-W152 Dispensing Procedure for Perfume 0 16/3/2016 155 BSX-W153 Handling of Maione Semi-Finished Bulk 0 1/12/2015 156 BSX-W154 Warehouse Checklist For Loading (for Container & Lorries) 0 15/6/2016 157 BSX-W155 Handling of Customer Returned Goods 0 20/3/2017 158 BSX-W156 Internal Audit/Self Inspection 1 10/5/2021 159 BSX-W157 Internal Calibration of Weighing Scale 1 11/2/2020 160 BSX-W158 Operation, Cleaning & Monitoring of Laminar Flow Hood 0 6/9/2017 161 BSX-W159 General Premise Check 0 1/11/2017 162 BSX-W160 Preventive Maintenance – Dust Collector 0 1/11/2017 163 BSX-W161 Preparation/Calibration & Verification of Dipstick 0 1/11/2017 164 BSX-W162 Verification of Stainless Steel Ruler 0 1/11/2017 165 BSX-W163 Hot Water Usage For Operation 0 9/10/2017 166 BSX-W164 Updating Company Website KIV 0 2/5/2018 167 BSX-W165 Recall/Withdrawal of Finished Product Made For Pental 0 20/7/2018
168 BSX-W166 Transfer Raw Mats into Prod White Area 0 22/10/2018 169 BSX-W167 Control of Reference Samples 0 2/1/2019 170 BSX-W168 Verification of Halal Uncertainty for RM, Products & others 1 15/7/2019 171 BSX-W169 Manual Sealing Machine – SOP 0 15/4/2019 172 BSX-W170 New Material Selection 0 15/7/2019 173 BSX-W171 Test Method-Surface Monitoring Using Dry Swab 0 15/7/2019 174 BSX-W172 Stability Study 1 13/11/2019 175 BSX-W173 Test Method-Colilert Test for Detection of E.Coli & Coliform in Water 0 14/1/2020 176 BSX-W174 Test Method-Simplate Method for Detection of HPC Count in Water 0 14/1/2020 177 BSX-W175 Halal Sertu Cleansing 0 22/1/2020 178 BSX-W176 Artwork Control 0 3/3/2020 179 BSX-W177 Cleaning Protocol of Sachet Machine at Bsx3 0 21/12/2020 180 BSX-W178 Handling of Internal NCR (Non-conformance Report) 0 15/4/2021 181 BSX-W179 Halal Master List Entry & Validity Screening 0 28/1/2022 182 BSX-W180 Test Method - Iodine Test 0 17/10/2022 183 BSX-W181 Test Method – Total Plate Count & Total Yeast & Mould Count for Personal Care Products Using TAT Neutralizing Enrichment Broth 0 1/10/2022 184 BSX-W182 Hazard Identification, Risk Assessment & Risk Control (HIRARC) 0 25/10/2022
APPENDIX 8
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 1 SUPPLIER AUDIT CHECKLIST Date of Audit Supplier Supplier’s Material / Service Scope Material/ Service supplied to BSX Supplier’s certification (if any) A. FACILITIES (YES) SAT. NCR OFI N/A 1. Overall maintenance of the premises 1.1 Is the general housekeeping & environment acceptable, clean and free from dust? 1.2 Are the sanitary installations for personnel adequate and sufficiently clean? 1.3. Is the infrastructure and building well maintained? 2. Are there an acceptable separate or defined areas for storage, production, quality control, ancillary, washing, toilets and employee changing area? 3. Is there a designated area for drinking, eating, and smoking? 4. Is there sufficient space provided to cater for operations such as receipt, storage and Production? 5. Is the material and personnel flow acceptable to prevent mix-ups 6. Is the lighting adequate in all areas? 7. Is ventilation sufficient for intended operation? 8. Is pipework, drains and ducts kept clean and suitably designed? 9. Is pest control program in place? 10. Housekeeping & Cleaning & Sanitization of Premise: 10.1 Is housekeeping / cleaning & sanitization program for premise in place? 10.2 Cleaning chemical/ lubricant residue must not be in contact with the product. TOTAL: Comments & Findings:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 2 B. PURCHASING/ INCOMING INSPECTIONS (RAW MATERIALS/ PACKAGING MATERIALS/ OTHER PRODUCTS SUPPLIED) (YES) SAT. NCR OFI N/A 1. Does incoming inspection check incoming shipments to the requirements of the purchase order, specifications, and applicable drawings? 2. Are incoming goods properly labeled, stored, and traceable? 3. Do incoming inspection records indicate acceptance or rejection of incoming material? 3.1 Are inspection sampling plan sizes adequate? 3.2 Are adequate written inspection instructions available as guidance to inspectors? 3.3 If testing equipment is needed during inspection calibrated and in good condition? 3.4 Are accepted, quarantined and rejected status properly identified and physically segregated? 4. Are incoming raw materials of different types sufficiently separated to avoid cross contamination? 5. Are other materials (packaging, labels, supplied products) inspected upon reception? 6. Are materials properly stored protected from exposure to weather? 7. Is purchasing of material according to procedure 8. Is the vendor’s qualified supplier list available? 9. Is there a defined procedure for supplier qualification? 10. Is there a defined procedure for continuous monitoring of supplier’s performance? 11. Based on records of quality performance, is the supplier able to address issues when necessary? (e.g. failed inspection) TOTALS: Comments & Findings: C. PRODUCTION & PACKAGING (YES) SAT. NCR OFI N/A 1. Is the production & packaging area tidy, free of dust, and other contamination? 2. Is the approved production & packaging procedure / instruction available at the workstation? 3. Is there any proper line clearance and start up check? 4. Is unique batch number assigned to each batch of manufactured product? 5. Is there adequate control to prevent any defective or rejected products from being packed into cartons? 6. Are semi-finished products well segregated from final finished products in the packing area?
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 3 7. Are approved finished products packed immediately in order to avoid dust and contamination? a. If not, are they properly stored and protected? a. 8. Do workers wear gloves, hats / caps when necessary? 7. Is the method of product count into master carton/ bag accurate? a. If not, is the current procedure acceptable to avoid the possibility of shortage of products? a. 9. Are packed master cartons/ bags well stored in a covered area or a good shelter from weather conditions? 10. Are cartons/ bags properly labeled? TOTALS: Comments & Findings: D. IN-PROCESS CONTROL (IPC) (YES) SAT. NCR OFI N/A 1. Is in-house QC laboratory available and is any testing being done as part of in-process control? 2. Are written test methods available and results of laboratory testing properly reviewed and recorded? 3. Are reagents, solutions, reference standards etc properly labeled and identified and still fit for use? 4. Are all samples sent to laboratory properly identified and is sampling plan adequate? 5. Is the approval for line start-up given based upon Q.C. review, comparison with BSX approved Quality reference samples? 6. Are there line patrols by quality inspectors or other means to monitor the compliance of the product to meet quality and safety requirements? 7. Is there in-process Q.C. by quality inspectors to monitor the compliance of the product with the product specification? 8. Do records show rejected lots being well identified and segregated from accepted lots? a. Are rejected lots immediately reworked or destroyed? 9. Are the inspection defects charted, analyzed, and monitored to improve the problems encountered? 10. Are there adequate, clearly written criteria / instructions available for inspectors to follow?
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 4 11. Are the written instructions being followed? 12. Are the inspection and test equipment sufficiently reliable (including calibration) to verify conformance of the semi-finished or final products? 13. Are customer product drawings / specifications / inspection plans readily available from the Q.C. or engineering department? 14. Are adequate inspection and testing records maintained? TOTALS: Comments & Findings: E. FINAL INSPECTION (YES) SAT. NCR OFI N/A 1. Do the factory’s quality inspectors perform any internal final inspection on goods prior to warehousing or shipping? 1.1 Is there a final inspection performed by quality control on a batch by batch basis? 2. Are records of inspection and test data maintained? 3. In cases of finished product rejections that result in reprocessing, is another complete final inspection performed? 4. In cases where product does not meet performance specifications, is there a formal investigation with conclusions and appropriate follow-up? 5. Are finished goods properly identified, stored in defined areas under appropriate conditions for appropriate length of time? 6. Are released, quarantined or rejected material stored in their respective physical locations or properly controlled to prevent mix ups? 7. Are customer drawings / specifications readily available from quality control or engineering department on request? 8. Is the sampling size of the products for final inspection adequate enough to show the confidence of product’s compliance to quality and safety? 9. Are retain samples of finished product being kept in appropriate manner according to duration specified as per company, customer or regulatory requirements? 10. Are there procedures that require “acceptable” inspection reports to authorize packing and shipment of the products? 11. Does the factory perform 100% check on functionality? a. If not, is the current procedure sufficient? TOTALS:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 5 F. EQUIPMENT MAINTENANCE AND CALIBRATION (YES) SAT. NCR OFI N/A 1. Does the factory have the properly designed production and testing equipment available to perform all required production & testing operations? 2. Is the equipment in good operating condition? 3. Is all relevant equipment properly and timely calibrated when required? 3.1 Are equipment calibration procedures and instructions in place? 3.2 Are records being kept for the calibration of the equipment? 4. Is there any preventive maintenance schedule/ program? 4.1 Is the equipment being well maintained? 5. Is there any cleaning and sanitization schedule/ program for critical equipment? 5.1 Is the machinery & tools cleaned regularly? 5.2 Cleaning chemical/ lubricant residue must not be in contact with the product. TOTALS: Comments & Findings: G. NON-CONFORMING MATERIALS / PRODUCTS (YES) SAT. NCR OFI N/A 1. Is there a procedure in place to handle non-conforming material and product? 2. Is non-conforming material properly segregated at all stages? 3. Is non-conforming material sufficiently identified? 4. Are adequate records maintained to show the status of such non-conforming materials? 5. Do records show that re-worked parts / materials have been re-inspected to comply with standards? 6. Is disposal of scrap material handled satisfactorily? 7. If non-conforming materials are used, is there proper documentation of deviation and,is there adequate identification and checking to specification? 8. Is the corrective action of non-conforming materials efficient? 9. Can the factory demonstrate how they handle the non-conforming materials such as products that fail the mechanical tests? Comments & Findings:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 6 10. A defined area must be identified and marked out and only used for the storage of quarantined/ Rejected item. TOTALS: Comments & Findings: H. SAFETY / SECURITY (YES) SAT. NCR OFI N/A 1. Is personal safety protective gear provided for workers near machines to prevent accidents? 2. Are there warning signs provided in the facilities to make people aware that there is danger in the area (i.e. hot surface, don’t tough, wear ear plug, etc)? 3. Are there regular safety trainings conducted by the factory for the workers and records of training available and kept in personnel files? 4. Any hazardous chemical transferred from its original container should be labeled with the appropriate hazard warning label. 5. Are there proper fire safety equipment in the facility? 6. Is there adequate staff supervision to minimize risk of intentional product/process contamination? 7. Is there 24 hours security guard on duty? 8. Do all visitors have to sign in before entering? 9. Is access controlled to each area & adequate fencing in place? TOTALS: Comments & Findings:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 7 J. WASTE MANAGEMENT (YES) SAT. NCR OFI N/A 1. Facilities should be in place for segregation and collection of recyclable material. 2. Waste and effluent management must comply with local enforcement requirements. 3. External waste containers must be managed to ensure a tidy pest free environment. 4. Dedicated, clearly identified containers must be used for the collection of waste. TOTALS: Comments & Findings: K. PRODUCT IDENTIFICATION AND TRACEABILITY (YES) SAT. NCR OFI N/A 1. Is the batch number/ lot number being used to trace for the product? 2. Is the product traceable from FG until RM & / or RM until FG? TOTALS: Comments & Findings: I. PERSONAL HYGIENE (YES) SAT. NCR OFI N/A 1. Effective personal hygiene standard must be in placed at the site. 2. Hand washing must be completed prior entering product handling areas and after eating or visiting the toilet. 3. Personnel must not cough or sneeze over materials or products. Spitting must be prohibited in all areas. 4. Food/ drink must not be consumed in production and storage areas (except water when provided by site) TOTALS: Comments & Findings:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 8 L. PRODUCT DESIGN AND DEVELOPMENT (YES) SAT. NCR OFI N/A 1. Is there any correspondence/record to show on the product design and development stage between BSX / customer with material supplier? 2. Is the product specification agreed with customer? 3. Are proper documentations in place? TOTALS: Comments & Findings: M. TRANSPORTATION AND DELIVERY (YES) SAT. NCR OFI N/A 1. Is there vehicle inspection before loading? 2. Is the delivery of goods on time as per agreed with customer? TOTALS: Comments & Findings: N. INTERNAL AUDIT (YES) SAT. NCR OFI N/A 1. Is the internal audit being conducted regularly? 2. Is the internal auditor being trained and competent to conduct the audit? TOTALS: Comments & Findings:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 9 O. INTERNAL COMMUNICATION (YES) SAT. NCR OFI N/A 1. How is information communicated to staff or worker? TOTALS: Comments & Findings: P. TRAINING (YES) SAT. NCR OFI N/A 1. Did the worker train before start to work? 2. Is the worker competent at their job? 3. There should be a defined time period during which the new starter has a ‘training buddy’ or extra supervision. 4. Are workers trained on GMP requirements? TOTALS: Comments & Findings: Q. SALES & ORDER PROCESSING/ CUSTOMER FOCUS / CUSTOMER HANDLING (YES) SAT. NCR OFI N/A 1. Is sales and order processing according to procedure? 2. Is customer requirement properly captured and fulfilled? 3. Is the customer complaint being captured on a logging system? 4. Trained personnel must investigate all complaints in detail. The investigation must determine whether the complaint is product specific or is an issue that may affect more than one product. 5. Complaint trends must be monitored and communicated to the site management and production teams 6. Are complaints from BSX appropriately handled and Corrective action has been verified to be adequately carried out? TOTALS:
Lot 5011, Jalan Teratai Batu 5 ½ Off Jalan Meru 41050 Klang Selangor Darul Ehsan. (Co. No. 254805-D) Tel No.:- 03-33926529 Fax No.:- 03-33928766 Email : [email protected] Rev: 5 (February 2023) Page 10 Comments & Findings: R. ETHICAL (YES) SAT. NCR OFI N/A 1. Worker : 1.1 Local or foreign worker? Outsourced? 1.2 Working hour – how long per day? 1.3 Accommodation – clean? 1.4 Safety shoes available? 1.5 Passport – who hold the worker’s passport? TOTALS: Comments & Findings: S. HALAL (YES) SAT. NCR OFI N/A 1. General 1.1 Ingredients/packaging and processing aids source are halal compliance? 1.2 Non- Halal Ingredients /Packaging is not allowed to be stored in the same premise? 1.3 Preparation, handling, processing, packaging, storage or transfer of products shall be in compliance with Halal requirements. 1.4 Use of appliance/ brushed from animal is not allowed? TOTALS: Comments & Findings:
APPENDIX 9
▪INTEGRATED CHECKLIST & REPORT WITH HALAL REQUIREMENTS YEAR 2022▪ Audit Site: Bodibasixs Manufacturing Sdn Bhd: BSX 3 Manufacturing Sdn Bhd: Lot 5011 ✔ Lot 5034 ✔ No.3, Lrg Sungai Puloh 1A/KU6 Audit date: ___________________________ Audited department : ___________________________ Done by : ___________________________ Auditee Acknowledgement: ___________________________ Report of: ISO 22716: 2007 Criteria: Guidelines on Cosmetic Good Manufacturing Practice, ISO 22716:2007 International Standard Scope: As per 17 clauses in copyrighted material licensed to SGS SA. MHMS Criteria: Malaysian Halal Management System. Scope: As per clauses in the Guideline. COSMETIC GOOD MANUFACTURING PRACTICE Criteria: Guideline for Cosmetic Good Manufacturing Practice, Annex1 Part10: Guidelines for Control of Cosmetic Products in Malaysia, 1st Revision, 2017. Scope: As per above Criteria’s Guideline clauses HAS 23000 – 1 Criteria: Halal Certification Requirements for Processing Industry. MUI, Indonesia. Scope: As per clauses in the Guideline.
Scope: As per above Criterias Guideline clauses. ISO 9001: 2015 Criteria: Malaysian Standard MS ISO 9001:2015, Quality management systems – Requirements (Second revision) Scope: As per clauses in Standard. MPPHM Criteria:” Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020” Scope: As per clauses in the Guideline. ISO 22716:2007 Cosmetic GMP ISO 9001:2015 HAS 23000‐1 / MHMS/ MPPHM Audit Report 3 Personnel 2. PERSONNEL 7. Support HAS criteria/ General requirements 3.1 Principle (explanation) 3.2.1 Organization chart 3.2.2 Number of people 3.3.1 Management responsibilities 3.3.2 Responsibilities of personnel 3.4.1 Training & skills 3.4.2 Training & GMP 3.5 Personnel hygiene & health 3.6 Visitors & untrained personnel 2.1 Organization, Qualification and Responsibilities 2.2 Training 4. Context of organization 4.1 Understanding organization & Context (review/monitor internal & external issues: Issues Log) 4.2 Understanding needs & expectations of interested parties (Issues Log) 5. Leadership 5.1 Leadership & commitment 5.1.2 Customer focus 5.2 Policy 5.3 Organizational roles, IV A‐2.0 / 5‐2.0 Halal Policy /_ a) Halal Policy that states company’s commitment to produce halal product is available. b) Halal policy has been disseminated to all stakeholders (Management, halal management team, workers, suppliers). c) Evidence of halal policy dissemination is maintained
responsibilities, authorities 6. Planning 6.1 Actions to address risks & opportunities (Dept Risk Assessment) 6.2 Quality objectives & planning to achieve them 7.0 Support 7.1.2 People 7.2 Competence 7.3 Awareness 7.4 Communication 9. Performance evaluation 9.1 Monitoring, measurement, analysis & evaluation (Monitoring & Evaluation using BSX‐F33) 9.1.2 Customer satisfaction (annual customer survey by Marketing) 9.1.3 Analysis & evaluation 9.3 Management review IV A‐4.0 /5‐4. Internal Halal Committee (IHC)/_ a) IHC / Halal Management team has been appointed and there is a proof of the assignment. Chairperson and members are permanent staff. b) Team includes all parties involved in critical activities. Minimum 4. c) Responsibilities of each team member is clearly defined. d) Team has necessary competency and authority. e) Meeting to be conducted at least twice a year and with records. f) Team is supported with sufficient resources which are needed for preparation, implementation and continual improvement of HAS. g) Halal Executive (HE) fulfill requirement mentioned in MHMS clause 4 (3). IV A‐3.0/ 5‐ 8. Training/_ a) Procedure on training for all personnel involved in critical
pesoe oed cca activities are available. b) Internal training has been conducted at least once a year. c) Internal training has been done to all employees related with critical activities, including new employee (Within 3 months from the date of employment). d) Internal training material has already covered MPHM, HAS 23000 and awareness. e) Internal trainer is a certified Trainer under Halal Professional Board (HPB). f) Internal training results has been evaluated to ensure the competency of trainees. g) IHC attended competency training at least once in 3 years and must be trained by external training provider that has been certified by HPB. h) Evidence of training (external/internal) is maintained.
_ /_ / IV‐ 17(9) Workers / Staff a) Number of Muslim workers are Sufficient. ( Min 2 in production every shift) b) Muslim workers given an enough time to perform Prayer. c) Staff shall practice code of ethics and Good Manufacturing Practices (GMP) and other related regulations. d) Workers shall wear proper and suitable attire. IV A‐11.0 / 5‐10 Management Review/_ a) Management review procedure has conformed to MPHM and HAS 23000. b) The management review has been performed at least once in a year and attended by top management/the representative. c) Result of management review has been informed to parties who are responsible for each activity. d) There is evidence of management
d) There is evidence of management review implementation 4. Premises 3. PREMISES 7. Support HAS criteria/ General requirements 4.1 Principle (explanation) 4.2/ Types 4.3/ Space 4.4/ Flow 4.5 Floors, walls, ceilings, windows 4.6 Washing & toilet facilities 4.7/ Lighting 4.8/ Ventilation 4.9/ Pipework, drains & ducts 4.10/ Cleaning & sanitization 5.5 (premises/equipment’s) 4.11/ Maintenance 5.6 (premises/equipment’s) 4.12/ Consumables 5.7 (premises/equipment’s) 4.13 Pest control 3.1 Effective measures should be taken to avoid any contamination from the surrounding environment and from pests. 3.2 Household products containing non‐hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that due care should be exercised to prevent cross contamination and risk of mix‐ up. 3.3 Painted line, plastic curtain and flexible barrier in the form of rope or tape may be employed to prevent mix‐up. 3.4 Appropriate changing rooms and facilities should be provided. Toilets should be separated from the production areas to prevent product 7.1.3 Infrastructure a) buildings & associated utilities IV A‐5.0 Production Facilities /_ / IV‐ 17(8) Premise, 17(10) Sanitation. a) There is no production equipment that made from Haram/najs material (such as brush from hair). b) Technique of material and product sampling ensures that there is no cross contamination with haram/najs materials/products (if there is non‐certified products). c) The factory compound shall be fenced or having a control mechanism to prevent pets or wild animals from entering from entering or remain in the factory area. d) Effective control system from contamination of animal rearing centers, sewerage plant and premises that process non‐Halal materials. e) Facilities to manufacture Halal
contamination/cross contamination. 3.5 Defined areas should be provided for, wherever possible and applicable. 3.6 Wall and ceiling, where applicable should be smooth and easy to maintain. The floor in processing areas should have a surface that is easy to clean and sanitize. 3.7 Drains should be of adequate size and should have trapped gullies and proper flow. Open channels should be avoided where possible, but if required they should be able to facilitate cleaning and disinfection. 3.8 Air intakes and exhausts and associated pipework and ducting, when applicable, should be installed in such a way as to avoid product contamination. 3.9 Buildings should be adequately lit and properly ventilated appropriate to the operations. compliant products only. f) Worker’s hostel is not in the premise. g) There is evidence of premise cleaning.
3.10 Pipework, light fittings, ventilation points & other services in manufacturing areas should preferably be installed in such a way as to avoid uncleanable recesses & run outside the processing areas. 3.11 Laboratories should preferably be physically separated from the production areas. 3.12 Storage areas should be of adequate space provided with suitable lighting, arranged and equipped to allow dry, clean and orderly placement of stored materials and products. 3.12.1 Such areas should be suitable for effective separation of quarantined materials and products. Special and segregated areas should be available for storage of flammable and explosive substances, highly toxic substances, rejected and recalled materials or returned goods.
3.12.2 Where special storage conditions e.g., temperature, humidity and security are required, these should be provided. 3.12.3 Storage arrangements should permit separation of different labels and other printed materials to avoid mix‐up. 5. SANITATION AND HYGIENE 5.1 Personnel 5.2 Premises 5.3 Equipment and Apparatus 5. Equipment 4. EQUIPMENT 7. Support 5.1 Principle (explanation) 5.2 Equipment design 5.3 Installation 5.4 Calibration 5.8 Authorizations 5.9 Back‐up systems 4.1 Design and Construction 4.2 Installation and Location 4.3 Maintenance 7.1.3 Infrastructure b) equipment, including hardware & software. Clause related to no.5 6. Raw materials & packaging materials Clause not available Clause not available HAS criteria/ General requirements 6.1 Principle (explanation) 6.2 Purchasing 10. STORAGE 10.1 Storage Areas IV A‐4.0 / 5‐ 7.0 / IV‐ 17(1) Raw Material.
6.3 Receipt 6.4 Identification & status 6.5 Release 6.6 Storage 6.7 Re‐evaluation 6.8 Quality of water used in production 10.2 Stock Handling and Control a) Procedure of new material selection ensures that new materials that will be used for certified products has been screening internally by HE and should have sufficient supporting and valid documents. b) New materials that will be used for certified products have been screening internally by HE and should have sufficient supporting and valid documents. c) Master Checklist of material will be updated accordingly once screening done. d) All materials are completed with sufficient and valid supporting documents. e) There is procedure which ensures that all of materials supporting documents used are always valid. f) Material origin from animal sources should have valid Halal certificate. g) For MUI, new materials that will be used for certified products must be approved by Authority
(either by new material approval letter, positive list material, or material which have MUI Halal Certificate listed on authority website. h) There is evidence of new material selection implementation. i) DI water System. j) Procedure of New Product Development. Procedure of new product development ensures that new products must be halal compliance. k) There is evidence of new product development implementation l) Procedure of Purchasing Procedure of material purchasing ensures that all materials purchased for certified products must be available. m) All material purchased for certified products must follow the master checklist. For MUI, must be
approved by Authority. n) There is evidence of material purchasing implementation. o) Procedure of Incoming Material Checking. Procedure of incoming material checking is to ensure the suitability of information written in the supporting document (or information in the list of Halal materials) to information that appears on the label. p) Incoming material checking already covered checking of material label (including material name, code, producer name, producer origin, Halal logo (if applicable), etc.). q) Incoming material checking results show that the information on materials’ document is in accordance with materials’ label. r) There is evidence of incoming material checking implementation. s) Procedure of Material/Product Storage and Handling
Procedure of material/product storage and handling ensures that there is no contamination of material/product by haram/najs materials. t) There is evidence of material/product storage. 7. Production 6. PRODUCTION 8. Operation HAS criteria/ General requirements 7.1 Principle (explanation) 7.2. Manufacturing operations: 7.2.1 Availability of relevant documents 7.2.2 Start‐up checks 7.2.3 Assignment of a batch number 7.2.4 Identification of in‐process operations 7.2.5 In‐process control 7.2.6 Bulk product storage 7.2.7 Re‐stocking raw materials 7.3. Packing operations: 7.3.1 Availability of relevant documents 7.3.2 Start‐up checks 7.3.3 Assignment of batch number 7.3.4 Packaging line identification 6.1 Starting Materials 6.2 Batch Numbering System 6.3 Weighing and Measurement 6.4 Procedure and Processing 6.5 Dry Products 6.6 Wet Products 6.7 Labelling and Packaging 6.8 Finished Product: Quarantine and Delivery to Finished Stock 8.1 Operational planning & control IV A‐5.0 Production Facilities/_ / IV‐ 17(3) Processing. a) All production facilities have been registered. b) Production for certified product made from materials approved by Halal authority and produced in production facilities that fulfilled the criteria. c) The formula in production is same with standard formula (if product has formula). d) Production facility that used to produce certified products is free from najs and completed with sanitation facility (hand‐washing facilities toilet etc)
7.3.4 Packaging line identification 7.3.5 Checks of on‐line control equipment 7.3.6 In‐process control 7.3.7 Re‐stocking of packaging materials 7.3.8 Identification & handling of work‐in‐process facilities, toilet, etc.) e) There is evidence of production implementation. f) Procedure of Production Facilities Cleaning. Procedure of production facilities cleaning ensures cleaning of production facility that contact with material/product can remove najs/impure and the method to measure the elimination of najs. g) Cleaning agent for production facility cleaning does not come from haram/najs material. h) There is evidence of production facility cleaning.
8. Finished products 6. PRODUCTION 8. Operation HAS criteria/ General requirements 8.1 Principle (explanation) 8.2 Release 8.3 Storage 8.4 Shipment 8.5 Returns 6.8 Finished Product: Quarantine and Delivery to Finished Stock 7. QUALITY CONTROL 7.3 Returned Products 8.5.1 Control of production & service provision 8.5.2 Identification & traceability 8.6 Release of products & services IV A‐6.0 Product /_ / IV‐ 17(2) Product, 17(6) Labelling a) Name / Shape of certified product doesn’t associate with haram products or worship that not in accordance with Islamic Sharia. b) Sensory profile of certified product doesn’t tend to be similar with haram product. c) Labeling/ Packaging of the certified product fulfills the criteria of the above‐mentioned clause. d) Illustrations of the certified product fulfill the Islamic Syariah Law. e) For repacked/relabeled product, the origin products/ bulk should have JAKIM/ MUI Halal certificate or else to produce in different facility (BSX 3) f) Procedure of Transportation Procedure of transportation ensures that there is no
ensures that there is no contamination of material/product by haram/najs materials during transportation. g) There is evidence of material/product transportation. 9. Quality control laboratory Clause not available Clause not available HAS criteria/ General requirements 9.1 Principle (explanation) 9.2 Test methods 9.3 Acceptance criteria 9.4 Results 9.5 Out‐of‐specification results 9.6 Reagents, solutions, reference standards, culture media 9.7 Sampling 9.8 Retain sample IV B‐7.0 / 5‐11.0 Laboratory Analysis /_ a) Procedure of sending samples for analysis for critical ingredients (if related). b) Samples sent to the recognized lab. c) There is evidence of report of the analysis. 10. Treatment of product that is out of specification. 7. QUALITY CONTROL 8. Operation HAS criteria/ General requirements 10.1 Rejected finished products, bulk products, RM & PM 10.2 Reprocessed finished products & bulk products 7.2 Reprocessing 8.7 Control of nonconforming outputs IV A‐9.0 Handling non‐ conformance product /_ /_ a) Handling of non‐conformance product procedure has conformed to HAS 23000. b) If there is non‐conforming product, procedure ensures that the
product will not be reworked, down grade, reformulation or not sold to consumer who requires halal products. 11. Wastes Clause not available Clause not available Clause not available 11.1 Principle (explanation) 11.2 Types of waste 11.3/ Flow / Containers / Disposal 11.4/11.5 12. Subcontracting 11. CONTRACT MANUFACTURING AND ANALYSIS. 8. Operation Clause not available 12.1 Principle (explanation) 12.2 Types of subcontracting 12.3 Contract giver 12.4 Contract acceptor 12.5 Contract 8.4 Control of externally provided processes, products & services 13. Deviations Clause not available 8. Operation Clause related to no.10 8.7 Control of nonconforming Outputs. 10. Improvement 10.2 Nonconformity & corrective action. /
14. Complaints & recalls 12. COMPLAINTS 13. PRODUCT RECALLS Clause not available Clause not available HAS criteria/ General requirements 14.1 Principle (explanation) 14.2 Product complaints 14.3 Product recalls IV A‐8.0 / 5‐9.0 Traceability /_ a) Procedure of traceability ensures that the certified products are made from approved material (including coding of material/product if any) and produced in the production facilities that fulfilled the criteria. b) Product Mock recall should be conducted once a year and recorded. 15. Change control Clause not available Clause not available Clause not available 16. Internal audit 9. INTERNAL AUDITS 9.2 Internal audit HAS criteria/ General requirements 16.1 Principle (explanation) 16.2 Approach 16.3 Follow‐up 9.2 Internal audit IV A‐10.0 / 5‐5.0 Internal Halal Audit /_ a) Procedure of internal audit has conformed to MPHM and HAS 23000. b) Internal audit has been performed once in a year.
c) Scope of internal audit has covered the implementation of MPHM and HAS criteria. d) Internal auditor has followed external/ internal training with MPHM and HAS 23000 scopes. e) Internal auditor is independent to audited area. f) Result of internal audit has been delivered to the parties who are responsible for audited activities. g) Corrective action (if any) and its time limit has been determined. h) Corrective action (if any) is able to solve the weaknesses and prevent recurrence in the future. i) The results of internal audit have been recorded. For MUI, must be uploaded on the Cerol system annually. j) There is evidence of internal audit implementation. 17. Documentation 8. DOCUMENTATION 7.5 Documented information HAS criteria/ General requirements 17.1 Principle (explanation) 17.2 Type of document 8.1 Introduction 8.2 Specifications 7.5.2 Creating & updating 7.5.3 Control of documented 5. _ / 5‐13.0 /IV‐ 17(14) Documentation
17.2 Type of document 17.3 Writing, approval & distribution 17.4 Revision 17.5 Archiving 8.2 Specifications 8.3 Documents for Production 7.5.3 Control of documented information Documentation a) Halal File b) HAS (Manual Halal Assurance System). c) DI water System (Specification & Halal certificates) Rev: 0 Updated 2/8/2022
APPENDIX 10
Management Review Meeting (MRM) Year – Minutes Date : Time : Present : Absent with apology : 1.0 OPENING REMARKS BY MANAGING DIRECTOR 2.0 REVIEW OF QUALITY POLICY/STRATEGIC DIRECTION & STRATEGIC PLAN 3.0 REVIEW OF MINUTES OF MRM Year _ _ _ _ 4.0 REVIEW OF RISK ASSESSMENT Year _ _ _ _ 5.0 REVIEW OF ISSUES LOG Year _ _ _ _ 6.0 REVIEW OF SUMMARY OF NCRs &OFIs OF INTERNAL AUDIT Year _ _ _ _ 7.0 REPORT ON ANNUAL INTERNAL AUDIT PLAN Year _ _ _ _ 8.0 REPORT ON HALAL MATTERS Year _ _ _ _ 9.0 REVIEW OF CUSTOMER COMPLAINTS Jan-Dec Year _ _ _ _ 10.0 REVIEW DEPARTMENT OBJECTIVES Year _ _ _ _ 11.0 ANY OTHER MATTERS
Minutes prepared by: Approved by: ____________________ ____________________ Ho Yew Pun Managing Director Date: Attached the signed attendance list.
Meeting Attendance List Date : Time : Subject : MRM (virtual, Teams) No. Name Designation Signature 1. Ho Yew Pun Managing Director 2. Lee Pang Executive Director 3. Andrew Chong Senior GM - Corporate 4. Hii Lee Choo Asst GM - QA/R&D 5. Vacant Asst GM – Business Development 6. Ng Ing Ai Senior Mgr. - Production 7. Vacant Warehouse Personnel 8. Esther Yee Senior Mgr. - Business Development 9. Vonnie Phang Senior Mgr. - Business Development 10. Eileen Tan Senior Mgr. - Product Development 11. Vanessa Khoo Senior Mgr. - P&P 12. Jamie Lai Senior Mgr. - QA 13. Caryn Chong Manager - Business Development 14. Annette Lee Manager - Business Development 15. Ben Ho Manager - Business Development 16. Ang Gaik Lim Manager - Production 17. TP Tan Manager - Production 18. Ahmad Shah Manager - Engineering 19. Mazilawati Manager - Admin 20. Nicholas Chan Manager - Finance 21. Liyana Ithnin Manager - Regulatory Affairs √ = Present X = Absent M/L = Medical Leave