Nur Syazana Binti Saiful 1211132 020501070292 3- 9- 7 Ara Green, 11900 Bayan Lepas, Pulau Pinang. 0194603231 [email protected] Semester 1 23/24 Dr Aminatul Saadiah Binti Abdul Jamil I am currently completing a one-year industrial attachment at Granulab Sdn Bhd based on a structured internship concept. This semester, I was assigned to the Quality Control (QC) department under the supervision of my industry supervisor, Nurul Ain Binti Jumri and Nurzahirah Binti Hasran. Additionally, I had the opportunity to work in many different departments and areas.
Medical device manufacturer of synthetic bone grafts. A leading bone graft manufacturer in Malaysia. Granulab manufacturing facility is certified with ISO 13485:2016 by BSI, Netherland. Granulab manufacturing facility is certified HALAL by JAKIM The facility can produce multiple types, forms, shapes, and sizes of synthetic bone grafts to cater to the needs of clients' hospitals, and patients. Prosteomax™ GranuMas® VeOsso • Composed of Hydroxyapatite (HA) • Innovative alternative material for surgeries requiring bone grafting procedures for non-load bearing applications in Orthopedics, ENT, Dental, and Maxillofacial. • Calcium Phosphate-based bone cement designed to treat bone losses and defects due to trauma injuries, non-union cases, or even diseases of bones. • Highly bio-resorbable. • Innovative alternative bone graft material in surgical applications for non-load bearing in veterinary medicine.
First and foremost, I feel grateful because I have been allowed by Allah to complete this Portfolio. Most grateful to Allah and his messenger prophet Muhammad S.A.W. I would like to thank my university supervisor, Dr Aminatul Saadiah Binti Abdul Jamil Without her assistance, this portfolio cannot be done completely. I would like to thank you for your support and understanding of being there from the beginning until this portfolio was accomplished. I would also like to show gratitude to my industry supervisor, Nurul Ain Binti Jumri and Nurzahirah Binti Hasran, Dr Fazilah Binti Fazan and staffs at Granulab (M) Sdn Bhd because without enthusiastic help and support from them, this report will be utterly lost. I am gratefully indebted to them for the good ideas and valuable comments on this portfolio. I would like to extend my gratitude to my internship mates, Rabiatul Adawiah Binti Raduan, Sharifah Aleya Ayunie Binti Syed Abd Rahman Al Zawawi, Khadijah Sahirah Binti Shaparrin, Nur Aina Sabrina Binti Nor Faizal and other friends who always helping me when I am not clear in this task. The greatest help I have ever experienced has come from their unwavering encouragement and unceasing support during this semester as they guide me with clear instructions for this portfolio and provide me with notes to understand it clearly.
• Production in Granulab • Packaging Process • XRD Operation • Learning and Note- Taking • Research and Information Gathering • Marketing Visit • Business Strategy • Research and Development • Documentation • Sales and Marketing Management • Testing and Monitoring • Packaging QC test • Incoming Raw material check • Testing and Monitoring • PPM
❖ Compile and learn about XRD manual operation. ❖ Read and learn about survey meters and dosimeters badge. The operation of XRD is a technique to investigate the atomic structure of materials, providing valuable insights into their composition and properties. In Granulab, X- Ray Diffractometer (XRD) is a tool that we used to study and identify the structure of material in products and samples by Granulab. Last semester, I only had the chance to see and learn how to analyze the structure of materials in products with my supervisor, but now in this semester, to be able to understand how the operation of XRD goes, I was given the task of compiling the manual operation and reading it in order to have a better understanding and provide a summary to my supervisor to further my understanding of the processes. XRD Machine XRD Machine after loading sample.
Technological application: X- Ray Diffractometer (XRD) and grinding machine and sieve machine X- Ray Diffractometer (XRD) provide analysis for materials identification including X- Ray Crystallographic structure of material such as chemical composition of materials, purity of products and samples, contamination of samples, crystallographic structure and crystalline phase material of product and samples. Based on my understanding, there are multiple processes involved in the operation of XRD machine, starting from startup and ending with shutdown. ▪ Crystallographic structure and crystalline phase ▪ Chemical composition of materials ▪ Figure of Merit (FOM) ▪ Phase Identification ▪ Quantitative analysis ▪ Ionizing radiation ▪ Radioactive Materials (RAM)
Graphic above shows a sequential workflow of XRD operation. Sample Preparation Warm Up XRD Machine Instrument Setup: Loading Sample Turn On Computer to Control Operation Start Analysis Shut Down of XRD Machine Create Report During the preparation of the product sample, the sample needs to be finely ground to a micro-unit level by a grinding machine and sieve shaker machine. This is to ensure homogeneity and to maximize the number of crystallites available for diffraction. Sieve shaker machine.
Technological application: PDXL software Material Identification Analysis aim to identify the crystalline phases present in the sample. The observed diffraction pattern is compared to a database containing known patterns for various materials. The database is PDXL software used to match the experimental pattern with known patterns for various crystal structures to help in phase identification present in the sample. The figure shows a picture of the computer are on during the XRD analysis of the sample. ✓ The width of peaks is inversely proportional to the crystal size. ✓ A thinner peaks corresponds to a bigger crystalline structure or crystallinity. If it shows stronger and sharper peaks, it reveals the higher crystallization. Loading a sample into XRD machine is a crucial step because it needs precise considerations and steps to ensure a successful sample loading on a sample holder. The sample needs to undergo sample mounting because the sample is powder, so the sample holder needs to be cleaned first using isopropyl alcohol solution (IPA), and then the sample flattened to create a smooth surface and ensure a uniform distribution onto the sample holder, which is a powder mount. During this step, the sample is mounted on a sample holder, and the X-ray source is set up to generate X-rays.
Figures above show notes about the operation of XRD machine and operation analysis of XRD. Crystallinity Phase Identification Technological application: Survey meter. A survey meter is a tool that I used during radiation monitoring, which aimed to track radiation levels in and around laboratories that contain radioactive materials or other sources of radiation.
Technological application: Dosimeter badge. A dosimeter badge is used to assess personal exposure to radiation, demonstrate that exposures do not exceed regulatory limits, and promote efforts to maintain exposures as low as reasonably achievable (ALARA). Basically, the dosimeter will be sent by month to Nuclear Malaysia Agency for assessment of the exposure dose of radiation workers as well as monitoring of the workplace safety with particular concern on the ionizing radiation hazard.
❖ Attend lecture session with Dr Fazilah Fazan. ❖ Study and learn about Radiation. Leaning and note-taking are the activities that help me to explore and gain knowledge as much as I can to develop myself. The encouragement to never miss the opportunity to learn and get exposure to knowledge, as said by Dr. Fazilah Fazan, really inspired me to learn and explore more. She constantly reminds us, the interns, to take advantage of our youth in learning, as there is always time, energy, and imagination to explore. ▪ Type of ionizing radiation ▪ Radioactive decay ▪ Half- life ▪ Biological effect ▪ Principle of radiation protection ▪ Bio- resorbable and bio- active ▪ System of Dose limitation
In bio- resorbable, the body can eventually absorb or decompose these substances. It is not necessary to remove them surgically because they are made to break down and resorb by normal physiological processes. Bio-active materials are made to interact with living things in order to trigger particular reactions. The goal of the interaction may be to increase biocompatibility, encourage tissue growth, or have a particular therapeutic impact. The session where Dr. Fazilah Fazan gave a lecture about bone and Granulab product, which is GranuMas and ProsteoMax. There is also related knowledge to learn, such as bio-resorbable and bio-active. "Learning is the only thing the mind never exhausts, never fears, and never regrets." - Leonardo da Vinci
In my free time when the work is done, my supervisor advises me to utilize leisure by reading and learning about radiation. There are some radiation-related notes that my supervisor has prepared for me. All the notes were very concise, made by the Nuclear Malaysia Agency, with detailed and comprehensive knowledge for me to understand the context. The topic of radiation is basically the same as below:- ➢ Ionizing Radiation ➢ System Dose Limitation ➢ Radiological Monitoring ➢ Radiation Safety and Protection ➢ Radioactive waste The figures above explain the topic Radiation Protection Organization and Programme. This topic refers to the procedures and safeguards put in place to reduce exposure to ionizing radiation In order to guarantee that the use of ionizing radiation is safe for people, the environment, and the general public.
The figures above explain the topic Management of Radioactive Waste, As it aims to deal with radioactive waste in a manner that preserves the environment safe both now and, in the future, without placing an excessive burden on the next generation.
Packaging QC test ❖ Perform a procedure to check the packaging of products and samples is protected and free from contamination in a safe and proper packaging. ❖ Perform leak test in packaging QC test ❖ Perform seal strength test in packaging QC test Incoming Raw Material ❖ Perform a procedure to check of an incoming raw material for production. ❖ Verify the incoming raw material to confirm that it meets requirement and performance specification. Planned Preventive Maintenance (PPM) ❖ Perform a routine check on X- Ray Diffractometer (XRD) weekly. ❖ Perform a physical visual check to verify the equipment in production site exceeds the calibration period or not. ❖ Perform a routine check of humidity and temperature in packaging, quality control and raw material room using hygrometer.
Testing and monitoring are two main things in the Quality Control (QC) Department. The department is in charge of the process where it needs to ensure the product is well maintained and improved. Testing and monitoring are usually to be done weekly, monthly, or annually according to Standard Operating Procedure (SOP) and Work Instruction (WI) of preventive maintenance. Meanwhile, the specification range and requirement which is set for testing and monitoring need to follow as stated in the Quality Control Plan (QCP) and Standard Operating Procedure (SOP). As I was assigned to be part of the Quality Department (QC) department, I did some important job that was given to me by my supervisor to get exposure and experience working in the department. The works are included below:- ➢ Packaging QC test ➢ Incoming raw material check ➢ Planned Preventive maintenance (PPM) The figure shows a picture of radiation monitoring, which is the test included in PPM. ▪ Leak test ▪ Seal strength test ▪ Planned Preventive Maintenance (PPM) ▪ Preventive maintenance ▪ Calibration
Technological application: Blister sealing machine. A packaging QC test is a procedure that aims to ensure the products and samples is protected and free from contamination with no leakage or foreign matter. This test comprises a leak test and a seal strength test. The rejected products that failed to meet the specifications of the tests will be required to be called for further action. This test also needs to be done in a controlled environment, such as a cleanroom, that creates the purest possible atmosphere by filtering out contaminants including dust, airborne microorganisms, and aerosol particles. Leak test is a process that inspectors employ to determine whether a product or object functions within a given leak limit. A quality control procedure used to evaluate a sealed package's integrity by looking for any breaches or leaks that could jeopardize the contents or products. this is due to the possibility that a packaging leak could cause contamination, spoiling, or product degradation. Stickers of QC pass.
Seal strength test is a process to measure and assess if the package sealing procedure complies with regulatory requirements. A quality control procedures to maintain seal strength during the packaging process and ensure that the seals on packaging materials are strong enough to withstand the rigors of transportation, handling, and storage. Aim: To assesses the integrity and strength of seals in packaging materials for maintaining the quality, safety, and shelf life of the packaged product. Testing method: Peel Testing • This method that are used to evaluate the force required to peel apart the layers of a sealed material. This is because, it helps assess the adhesion strength of the seal. Aim: To identify and eliminate any leaks or weak points in the packaging that could compromise the product's quality, safety, or shelf life. Testing method: Visual Inspection • A basic method used in Granulab Sdn. Bhd. where inspectors visually examine the packaging for any visible signs of leaks, such as cracks, holes, or defective seals. While it may be suitable for some applications, it may not be as reliable as more advanced testing methods.
Incoming raw material is a physical visual check that is conducted to detect if there is any visible and significant fault in the material when it is received. Quality control procedures are used on incoming raw materials to make sure they adhere to the necessary requirements. Also, it is compulsory to verify the incoming raw material to see whether it meets requirements and performance specifications or not, plus to ensure the received item is well and properly received with no physical damage. This procedure will involve inspections, testing, and verification of compliance with regulatory standards. In Granulab, Planned Preventive Maintenance (PPM) is planned and carried out on a regular basis, even while the asset is still operating as planned. It is an action to avoid failure of equipment and machine in Granulab. I was assigned to do several maintenances that needed to be done continuously. Radiation Monitoring Check expired calibration date and raw materials Hygrometer check In- House Calibration The physical visual check for incoming raw material includes the checking of: • Material description. • Any visible damage to the packaging materials. • Any damage to the package of material that was not visible prior to opening. • The quantity matches the packing list.
Radiation Monitoring aims to track exposed radiation levels at XRD machine area using a survey meter. This activity is required to be done on a weekly basis by checking and monitoring the exposed radiation levels of the X-ray diffractometer (XRD) machine to be within its dose limit. In addition, I needed to read from the readings of the survey meter and record it. Technological application: Survey meter Radiation Monitoring Check for Calibration sticker on survey meter and insert battery. Check battery. Select appropriate scale or range. Survey the area by checking the background radiation. Monitor the readings. Record the readings. Survey Meter Figures show pictures of Radiation monitoring.
Check expired calibration and raw materials. The aim is to observe and verify the equipment and raw materials that have expired or exceeded the calibration period at the production site. The equipment and machines that expired need to have red stickers indicating they are out of calibration and should not be used. The expired raw material and expired calibration period for the equipment at the production site will then be updated in the database listing. This is continuous monitoring of humidity and temperature on monthly basis to ensure the humidity and temperature are maintained at a specific temperature and humidity in the final packaging room, quality control room, and raw material room in Granulab Sdn. Bhd. Technological application: Hygrometer Check expired calibration date and raw materials Hygrometer check- control and monitor Figures above show pictures of tasks for checking expired calibration and raw materials and hygrometer. Hygrometer In- House Calibration This refers to performing calibration activities within a facility using its own equipment, personnel, and resources. In Granulab, the Ph Meter is one of the measuring instruments that needs to be calibrated internally. A sticker 'inhouse calibration’ in white is applied to indicate that purpose.
❖ Do a research and information gathering according the task given by Dr Fazilah Fazan. ❖ Attend a meeting to discuss about the task given and the online research. Research and information gathering are crucial processes of the works involving investigation and collection of data which are to solve problems and gain new insights about the bone graft product of Granulab Company and other company which is the competitor. Usually, Dr. Fazilah will give tasks that relates to online research to get her input and information about target audiences, competitors, industry trend and potential opportunity. The example of tasks for research and information gathering: ➢ Granulab Competitor Product ➢ Turkey Market Research
Technological application: Digital software- Microsoft word. This task was given to all the interns to search and collect data about industry trends and potential opportunity to locate distributors for bone graft company in Turkey. We were requested to :- ➢ Identify opportunities and position Granulab company and competitor products effectively. ➢ Identify orthopaedic and dental products, as well as implant and non-implant products in Turkey. ➢ Identify the manufacturer and distributor of the bone graft product in Turkey. ➢ Gather information regarding the contact details of target company in Turkey. ➢ Visualize and interpret the results based on our findings. ➢ Present our findings in a report. ▪ Market trends ▪ Reliability and validity ▪ Competitive analysis ▪ SWOT analysis ▪ Value proposition
Total Manufacturer Dental Implant Product Non- Implant Product Orthopaedic Implant Product Non- Implant Product Total Distributor Dental Implant Product Non- Implant Product Orthopaedic Implant Product Non- Implant Product The graphics above show how the information gathered from Turkish market research will be interpreted into two scopes, which are manufacturer and distributor.
❖ Plan business strategy. ❖ Execute business strategy. Technological application: Digital software- Canva, Microsoft PowerPoint and Excel. Business strategy involves in choosing what products or services to offer, identifying target market and determining ways to use resources for business plan. In Granulab, the objective of business strategy is to make use of the company's equipment as a tool to generate revenue for marketing. This strategy goes through several phases until it is successfully implemented and presented to the target market. Generate Ideas and Plan Initiate Action Organize for impact The graphic above shows a sequential flow of the business strategy.
Phase 1: Generate Ideas and Plan 1. Start with a briefing by Dr. Fazilah Fazan. 2. Plan business strategy. 3. Generate the ideas of the business strategy according to the assigned department. 4. Calculate price and profit margin of services appointed. ▪ Business Model Canvas (BMC) ▪ SWOT analysis ▪ Core competencies
1. Blasting the flyers to the target clients. 2. Contact the clients. 3. Follow up with clients. Phase 3: Organize for impact Phase 2: Initiate Action 1. Design flyer as promotional strategy to the target market. Several processes must be completed before the flyers are officially approved. 2. List out competitor price and target client contacts. • The target clients include the industry sector, universities and research institutions who might interest with the services offered for research project or testing services.
❖ Visit to the appointed hospital according to marketing visit scheduled. ❖ Meet potential customer and promote company product. ❖ Create a report. ❖ Present the report. Marketing visit often involves company representatives such as marketing executives or sales executives visiting to meet with potential clients in order to market the products or services that company offer, build a connection, and look for business prospects. In Granulab, we also use the similar concept as marketing visits to promote and strengthen partnerships with clients by approaching target and potential clients at hospitals. The figures above show my marketing visit at appointed Hospital.
Technological application: Digital software- Microsoft PowerPoint. The presentation of the report from the marketing visit was usually held at the end of the week. The details of the report are included:- ➢ A list of potential customers. ➢ A brief summary of a product that piques client interests and the reason. ➢ Information on the client relationship and contact details. ➢ Potential for further follow-up. ▪ Relationship marketing ▪ Personal selling ▪ Value- based selling ▪ Customer satisfaction evaluation
➢ I gained expertise in dealing with and interacting with clients since physicians and surgeons are typically the ones who use Granulab products on patients. ➢ I got to learn from the experience on how to promote products. ➢ I understood the medical term used in dealing with clients because Granulab supplies and manufactures medical products for bones. ➢ I managed to assess the advantages and disadvantages of Granulab product based on customer satisfaction evaluations. ➢ I managed to become familiar with the competitors in the bone graft field that supply similar product as Granulab.
❖ Learn and do marketing tender to help business grow. ❖ Perform an order handling processes in marketing department. Sales and marketing management typically involves in activities of planning, arranging, promoting, carrying out sales of company product to achieve revenue goals. I usually involved in managing some activities in sales and marketing department such as managing marketing tender and assisting the order handling procedure. Submission of bid ▪ Relationship marketing ▪ Order accuracy and quality control ▪ Customer Relationship Management (CRM) ▪ Order processing cycle ▪ Order tracking and visibility ▪ Strategic bidding
Technological application: Digital software- Microsoft Word and Excel The purpose of the marketing tender is to fulfill the business goals of the marketing department at Granulab. The marketing tender seeks to extend an invitation to suppliers, vendors, or service providers to fulfill the demands or tasks of an organization. It is primarily to promote competition among potential vendors that is set according to the scope and main field of the industry. Also, marketing tenders have steps to follow, including documentation and record-keeping. Under the direction of my supervisor, I was able to participate in the marketing tender process as a vendor representing Granulab. These are steps involved in a marketing tender for a vendor:- 1. Determine the scope and specific requirements of the marketing vendor. 2. Identify the marketing needs of an organization. 3. Prepare the tender or bid document as requested by the organization. 4. Submit the bid proposal before the set deadline. ➢ Do a quotation by providing content and the detailed outlining of the proposed items based on the requirements. ➢ Calculate the cost estimation. ➢ Include information such as terms and conditions.
Technological application: Shrink wrap tunnel and digital softwareMicrosoft Excel. Order handling is a critical process for businesses. Based on my experience in this department, I managed to perform order handling by helping other department throughout the entire process, from order placement to order fulfillment. The graphic below shows a sequential workflow of order handling that I experienced in Granulab Sdn. Bhd. Order placement Order verification: request the accuracy of the product Order entry to management system and database Shipping and delivery Order packing and preparation Create invoice and order confirmation by customer By following these steps, it is important to know that order handling can vary depending on the type of business. This process is only based on what I have experienced in the order handling process. Payment processing and customer feedback for order completion are the final steps, and I do get updates about the order status from time to time. Wrapped product using shrink wrap tunnel in final packaging process.
Supply Chain Management (SCM) ➢ Perform a record- keeping of Supply Chain Management (SCM) for Granulab (M) Sdn Bhd on Excel. ➢ Perform a payment voucher listing. Monitoring calibration ➢ Do a procurement of monitoring calibration. ➢ Analyze the results of monitoring calibration. Audit Preparation ➢ Do a labeling of Quality Control Department file. ➢ Do a partition for Quality Control Department file. ➢ Change Standard Operating Procedure (SOP) and Work Instruction (WI) into new review date. ➢ Prepare the document for audit.
The documentation process in a company is compulsory and essential for all departments in which it refers to organizing, creating, record- keeping and collecting data of documents as evidence for a report or material of a procedure that have been carried out. One thing I realized from the recent external audit is that the documentation needs to comply with regulations and standards because the processes and procedures that are well documented serve as evidence in regulatory audits, and good documentation methods support organizational effectiveness, credibility, and integrity. ▪ Document management ▪ Document workflow ▪ Document accessibility ▪ Document audit trails ▪ Internal and external audit
For me, this task is a tough one because I need to refer to all documents related to it and track every piece of data to insert into a table in Excel. Also, I need to complete the listing for the payment voucher. The document related in Supply Chain Management (SCM) included:- Technological application: Digital softwareMicrosoft word and Excel. Supply Chain Management (SCM) is a complete procurement management and interrelated process that includes organizing, carrying out, overseeing, and optimizing every activity associated with the movement of products, services, money, and data from the point of origin to the end user. This procurement management included in tracking the document of purchase request to purchase order to payment request. Purchase Request (PR) Invoice Purchase Order (PO) Payment Request Delivery Order (DO) Payment Voucher (PV) The figure above shows a picture of Payment Voucher files.