#auditing assurance Assignment sample

[ercsprivatelimited]

How can foreign manufacturers obtain BIS certification for products sold in India?

India's rapidly growing economy and consumers have made it a key market for producers across the globe. Yet, the Indian government demands some certifications to ensure uniformity, safety, and quality of products. The Bureau of Indian Standards (BIS) provides an essential certification known as the BIS Certification. International companies must obtain BIS certification before their products can legally enter and be sold in the Indian market.

The emphasis in this article is on how following Indian standards is important, as it describes steps and requirements necessary for foreign enterprises to obtain BIS certification.

What is BIS Certification?

The Bureau of Indian Standards, which is India's national standards body under the Ministry of Consumer Affairs, issues BIS Certification. It confirms a product to be under the relevant Indian Standard (IS). In certain products, the certification is mandatory to ensure consumer safety, quality assurance, and national standardization.

Electronics, household appliances, chemicals, cement, steel products, and others are some of the products that need BIS certification. Foreign manufacturers who wish to export certain products to India under the Foreign Manufacturers Certification Scheme (FMCS) need to obtain BIS certification.

Products Covered Under FMCS

FMCS covers a broad spectrum of consumer and industrial products, such as but not restricted to:

Products made of steel and aluminum

Cement

Home appliances, such as switches and electric irons

Pressure cookers

Toys

Gas Cylinders

Food-grade plastic containers

Note: The list of products that need BIS certification is revised from time to time. To check the status of their product, manufacturers can either check the official BIS website or consult a compliance expert.

Why is FMCS Certification Important?

Here are a few points that explain why BIS Certification for foreign manufacturers is important:

Required for Market Entry: Goods subject to BIS's mandatory certification cannot be sold in India in the absence of a valid FMCS license.

Clearance of Customs: Goods not bearing the FMCS clearance or ISI mark are not allowed in Indian ports.

Brand Credibility: Consumers and Indian retailers have greater trust in products bearing the BIS mark.

Adherence to the Law: Penalties, product rejection, or even an import ban may follow noncompliance.

Step-by-Step FMCS Certification Process for Foreign Manufacturers

Given below is the procedure involved in the BIS FMCS Certification:

1. Ensure that the BIS Standard applies

Find out if your product is on the list of mandatory BIS certification first. All regulated products are assigned an exclusive Indian Standard (IS) code that stipulates quality and safety standards.

2. Appoint an Indian Representative with Authorization (AIR)

There should be an Authorized Indian Representative (AIR) appointed by overseas manufacturers to act as the lawful link between them and BIS. This is a requirement under FMCS.

3. Prepare Documentation

The Foreign Manufacturer Certification Scheme application requires a range of documents, including:

Application Form VI and Form VII

Factory layout and manufacturing process details

Quality control plan and testing equipment list

Authorization letter for AIR

ISO 9001 certificate (if available)

Test reports from in-house labs or previous compliance certificates (optional)

4. Submit Application to BIS

Apply online via the Manakonline Portal and pay the applicable fees. This includes:

Application fee

License fee

Inspection charges

Marking fee (based on annual production volume)

5. Factory Audit by BIS Officials

This is a critical part of the BIS Certification for Foreign Manufacturers process. BIS sends its inspection team to the overseas factory to:

Verify the production and testing facilities

Ensure quality control measures align with Indian Standards

Draw product samples for independent testing in India

6. Product Sample Testing in India

Indian testing labs approved by the BIS test samples collected during the industrial audit. Testing ensures that products are up to the relevant Indian Standards prior to a license being granted.

7. FMCS License Grant

BIS issues the foreign manufacturer a license if the product is tested and the factory inspection is satisfactory. Each approved unit of the product must bear the ISI Mark, which is allowed under the license.

Validity and Renewal of FMCS License

The FMCS BIS Certification is initially valid for one year and can be renewed annually upon:

Submission of required fees

Continued compliance with standards

Factory re-inspection (if deemed necessary by BIS)

Challenges in the Long FMCS Certification Process:

The FMCS License Process takes four to six months or more from application through licensure.

Factory Inspection at the Site: Organizing the visit of the BIS officials can be expensive and practically difficult.

Indian Testing Requirements: Testing of products has to be conducted in India in BIS-approved laboratories, which is time-consuming and costly.

Complex Documentation: One requires professional training to present accurate technical information, processes, and test plans.

Conclusion

For foreign manufacturers looking to bring regulated products into the Indian market, BIS certification under FMCS is a requirement. The process ensures that products meet India's high standards of safety and quality, although it demands technical sophistication, factory inspection, and testing.

International producers can gain long-term exposure to India's large and vibrant consumer base through an understanding of the FMCS BIS Certification for Foreign Manufacturer arrangement, the appointment of a capable AIR, cautious preparation of documentation, and coordination with BIS inspections.

[autopartspecialist]

How to choose the right BMW spare parts trading company: A complete buyer’s guide

When it comes to choosing the right supplier for BMW spare parts, quality, authenticity, and service reliability are some of the factors that make it difficult to select the right supplier. This systematic approach allows buyers to assess providers effectively, receive real parts, and get dedicated support. This guide details important factors for consideration in purchasing parts for maintenance or aftermarket upgrades, including assessment of certifications and evaluation of logistical capabilities.

Verify supplier credentials

The first thing buyers should do is verify that a supplier has the legal and industry credentials to prove its legitimacy and reliability. The verification process includes checking for business registration documents alongside ISO certification and official component manufacturer authorizations. Established businesses demonstrate transparency by keeping detailed records of their membership in trade associations and their valid licenses. Third-party audits and customer testimonials provide additional evidence that the supplier upholds compliance standards.

The supplier's operational history including business duration and BMW replacement part management experience demonstrates stability. Additional due diligence requires warehouse location verification alongside digital batch tracking investigations and warranty term confirmation. The combination of official recognition and robust operational transparency in supplier credentials validates the genuine origin of parts from production lines.

Assess product quality standards

Quality assessment starts by verifying that components meet either OEM documentation or recognized aftermarket industry standards. Buyers must ask suppliers to provide detailed technical data sheets that show material compositions along with manufacturing tolerances and performance test results. Certified quality management systems—such as ISO/TS accreditation—indicate consistent adherence to production benchmarks. The assurance of component durability comes from implementing thorough testing methods that include stress analysis and endurance trials. Suppliers who maintain transparency will show documentation of their batch inspections alongside serial number tracking capabilities.

High-quality providers can be distinguished through warranty coverage examinations and evaluations of post-sales support policies. Visual inspection methods using high‑resolution images or sample shipments enable purchasers to verify product finish quality and fitment compatibility ahead of big orders. Buyers who strictly evaluate quality standards protect their investment in parts and vehicle reliability by avoiding premature failures which lead to costly downtime. A supplier partnership based on direct sourcing from established manufacturing lines eliminates the risk of quality degradation through intermediaries.

Evaluate customer service and support

A dependable customer support system enables smooth procurement processes and efficient issue resolution from part acquisition through the entire lifecycle. Buyers must review how quickly representatives respond to their inquiries while ensuring technical support covers multiple languages and provides expert installation guidance. A clear return and warranty structure demonstrates product quality assurance while streamlining the claims process. When providers deliver thorough installation manuals together with video tutorials and on-demand training they create practical value for users.

The response time performance of various support channels including phone calls and live chat reveals how dedicated a provider is to meeting customer satisfaction goals. Suppliers demonstrating superior service level agreements through guaranteed response times and resolution periods qualify as top-tier providers. Businesses should evaluate supplier programs that assign dedicated account managers to facilitate order coordination and deliver custom updates. The combination of proactive inventory alerts with forecasting tools helps prevent stockouts. A comprehensive support system delivers technical expertise alongside efficient communication to enable buyers maintain operational continuity.

Examine logistics and delivery capabilities

Timely part delivery and continuous maintenance operations depend on efficient logistics systems. Suppliers must provide multiple shipping options to buyers through express air freight and sea freight and local courier partnerships for evaluation. Understanding standard order lead times alongside urgent order lead times enables procurement to match its operations with project schedules. Warehousing facilities that are both domestic and international help maintain stock availability while minimizing transit times. Suppliers who provide consolidated shipping services and customs clearance assistance make international purchases more convenient.

The preservation of component integrity depends on packaging materials that deliver both high quality and efficient damage protection during product handling. Real-time tracking systems along with shipment notifications enable complete visibility across transit operations. Marine and air cargo insurance provides protection against loss or damage to shipments. The presence of regional distribution centers operated by suppliers allows buyers to achieve shorter delivery times and maintain just‑in‑time inventory management. Suppliers who offer drop-shipping services direct from their manufacturing plants help reduce overall handling expenses.

Consider regional expertise

Successful parts procurement requires businesses to understand regional market dynamics and regulatory compliance requirements. Local expertise helps businesses operate smoothly through customs regulations by ensuring duty compliance while meeting certification requirements and homologation standards in regions with strict import regulations and variable tax regimes. A BMW spare parts trading company in Dubai which demonstrates extensive experience with Middle Eastern fleets shows its capabilities for handling regional logistics and language barriers and legal framework compliance. Companies that specialize in specific regions provide key benefits including local storage of parts along with quick warranty handling and native knowledge of shipping routes.

Partnerships with authorized workshops and in-country service centers make it possible to provide technical support and manage returns. Knowledge of climatic and geographic factors helps identify components that resist corrosion and tolerate heat exposure. The use of local currency invoicing together with regional payment terms helps minimize exchange rate risks while streamlining procurement processes.

Explore digital ordering platforms

Digital platforms optimize order management through their single interface which unifies product catalogs with inventory control and delivery tracking functions. Buyers need to evaluate supplier websites and mobile applications by testing their usability alongside real-time inventory visibility and payment gateway security. The use of APIs allows integration with enterprise resource planning systems to automate purchase orders and streamline invoice reconciliation. Robust digital platforms offer predictive restocking alerts alongside bulk order templates and customizable expense monitoring dashboards.

The portal's built-in live chat function enables improved communication efficiency. The review of mobile device compatibility helps ensure field technicians and remote teams can access the platform. Advanced e-commerce functionality within selected providers streamlines online BMW parts procurement and minimizes manual data entry mistakes. Electronic parts catalogs that present high-resolution images and detailed specifications from suppliers enable precise part selection. Analysis of historical order data enables buyers to predict future demands and make optimized inventory decisions.

Risks from counterfeit components and delays are minimized by a methodical, risk controlled selection process of the BMW spare parts suppliers. Buyers verify credentials, assess product standards, evaluate support services, examine logistics, use regional expertise, and use digital platforms to secure reliable parts and maximize uptime. Following these guidelines gives purchasers the power to make decisions based on technical requirements and business goals.

[sudheervanguri]

Work from Home Opportunity at Parexel - Audit Coordinator | B Pharm, M Pharm, MSc

Work from Home Opportunity at Parexel - Audit Coordinator Are you looking for a work-from-home opportunity in the pharmaceutical industry? Parexel, a leading global clinical research organization, is hiring an Audit Coordinator for its Quality Management team. This is a remote role available across India, including Hyderabad and Mohali. If you have a background in pharmacy, life sciences, or related fields, this could be the perfect career opportunity for you! Job Overview Company Name: Parexel Job Title: Audit Coordinator Location: Remote (India), Hyderabad, Mohali Department: Quality Management Education Required: B.Pharm, M.Pharm, MSc (Life Sciences, Biological Sciences, or related fields) Experience Required: 1-2 years in Quality Assurance, Quality Management, or Clinical Trial Support Job ID: R0000031037 Key Responsibilities General Administrative Duties Organize meetings and business trips, draft minutes, and process travel expenses Download and distribute reports using appropriate systems Provide support in generating and analyzing reports and questionnaires Assist in client deliverables, including audit reports and metrics Maintain and update departmental organization charts Manage SharePoint folders and access permissions Oversee SOP reviews and stakeholder assignments Audit and Compliance Support Extract and compile awarded signed audit reports Assist in sponsor audits and regulatory inspections (SAI), including documentation support Gather essential documents such as CVs, job descriptions, and training packages Schedule and coordinate global QA meetings Assist in GxP audits, including sample selection and coordination Maintain compliance with Parexel’s international SOPs and GxP requirements Data Analysis and Reporting Collect, analyze, and interpret data for quality metrics Generate reports and visual presentations of key performance indicators (KPIs) Identify trends in quality metrics to improve processes Required Skills and Qualifications Education & Experience Bachelor's or Master’s degree in Pharmacy (B.Pharm, M.Pharm), Life Sciences (MSc), or related disciplines 1-2 years of experience in Quality Assurance, Quality Management, or Clinical Trial Support Knowledge of GxP guidelines and industry standards Technical & Soft Skills Strong Microsoft Office skills (Word, Excel, PowerPoint, Outlook) Expertise in Microsoft Excel (formulas, pivots, lookups, and chart generation preferred) Excellent written and verbal communication skills Ability to prioritize workload and meet deadlines Attention to detail and problem-solving skills Ability to work in a matrix environment with a global mindset How to Apply? Interested candidates can apply directly through the Parexel Careers Portal using the link below: Apply Here

[sgsystemsglobal]

Empowering Laboratories: Unraveling the Potential of LIMS Systems

In the realm of scientific research and laboratory management, efficiency, accuracy, and organization are paramount. Laboratory Information Management Systems, commonly known as LIMS, have emerged as indispensable tools, revolutionizing the way laboratories operate. From research institutions and pharmaceutical companies to environmental and clinical labs, LIMS systems have become the backbone of modern scientific endeavors, enhancing productivity and ensuring the integrity of data.

Understanding LIMS Systems:

LIMS systems are sophisticated software solutions designed to streamline and automate laboratory processes. They serve as comprehensive databases, meticulously managing sample tracking, data analysis, experiment scheduling, and quality assurance. By digitizing traditionally labor-intensive tasks, LIMS systems minimize human error, improve data accuracy, and accelerate the pace of scientific discovery.

Key Features and Benefits:

Sample Management: LIMS systems enable seamless sample tracking from collection to analysis. Each sample is assigned a unique identifier, allowing researchers to monitor its journey through various tests and experiments. This meticulous tracking ensures sample integrity and eliminates the risk of misidentification.

Data Management: LIMS systems organize vast amounts of data generated during experiments. Researchers can store, retrieve, and analyze data efficiently, facilitating collaboration and data-driven decision-making. Data security features safeguard sensitive information, ensuring compliance with industry regulations.

Workflow Automation: Laboratories often have complex workflows involving multiple steps and personnel. LIMS systems automate these workflows, scheduling tasks, sending notifications, and generating reports. This automation enhances efficiency, allowing researchers to focus on scientific analysis rather than administrative tasks.

Quality Control: Maintaining high-quality standards is paramount in scientific research. LIMS systems enforce standardized protocols, flagging deviations and ensuring adherence to predefined quality parameters. This proactive approach minimizes errors, enhances reliability, and accelerates the identification of anomalies.

Compliance and Audit Trails: Regulatory compliance is a significant concern for laboratories, especially in industries like healthcare and pharmaceuticals. LIMS systems maintain detailed audit trails, documenting every action and change made within the system. This transparency simplifies the auditing process and ensures compliance with industry regulations.

Integration Capabilities: LIMS systems seamlessly integrate with other laboratory instruments and software, creating a unified ecosystem. This integration allows for real-time data transfer, reducing manual data entry and minimizing the risk of transcription errors.

The Future of Scientific Innovation:

As technology continues to advance, LIMS systems are evolving to meet the ever-changing needs of laboratories. Artificial intelligence and machine learning algorithms are being integrated into LIMS, offering predictive analytics, anomaly detection, and data-driven insights. These advancements empower researchers to uncover patterns and correlations within vast datasets, accelerating the pace of scientific innovation.

In conclusion, LIMS systems have revolutionized laboratory management, enhancing efficiency, accuracy, and collaboration. By embracing these advanced solutions, laboratories can optimize their operations, adhere to stringent quality standards, and contribute significantly to scientific progress. The integration of LIMS systems not only transforms individual laboratories but also paves the way for groundbreaking discoveries and advancements that shape the future of various scientific disciplines.

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[jobuganda]

Agri Exim Uganda Jobs 2022 – 5 Fresher Quality ControlAssistants

Job Title: Quality Control Assistants – Agri Exim Uganda Jobs 2022 Organization: Agri Exim Uganda Job Location: Aboke, Arua, Dokolo, Gulu, Kasese     Agri Exim Uganda Profile: With sustainability as our cornerstone, we founded Agri Exim to bridge the gap between industrious farmers and customers seeking the very best in organic & natural produce. We’ve been able to do that and so much more – from meeting and exceeding our customers’ expectations to supporting our farmers at the grassroots level. At Agri Exim, every day is rewarding. From interacting with the farmers on the ground to shipping products all around the globe, our team works tirelessly to make sure that we deliver the very best. Our workforce is our strength and our biggest asset. We are passionate about what we do, and our values remain grounded while we grow together.   Job Summary: To assist in the smooth running of the quality control and quality assurance operations of the company and ensuring compliance to the food safety requirements as per the established Quality/safety monitoring plan and procedures.   Roles and Responsibilities: - To assist the Quality assurance manager in maintaining and continuous improvement of the Food Safety and Quality management system. - To carry out sampling and timely quality control analysis of incoming raw material as per the established quality monitoring plan and SOPs of the company. - Perform in-process quality control sampling and analysis from the process lines at regular intervals and record results accurately for production team to adjust machines where necessary. - To ensure proper hygiene of staff and cleanliness of the premises by implementing the cleaning schedule. - To accurately update of daily quality reports (raw material receiving and in the process). - To inspect raw material and Finished Goods trucks for cleanliness and conformity to food safety. - Assist the Quality manager in implementation of the pest control program. - To implement Pre-requisite programs and monitor the performance of Critical Control Points as per the established HACCP plan. - Ensure that the reference/retention samples and their records are well stored and maintained respectively for the prescribed product shelf life for future reference. - Carry out proper food safety documentation and record keeping by ensuring that all the necessary records are completed and filed as required. - Report any nonconformities observed in the operations to ensure the safety and quality of the product. - To participate in internal and external Quality Systems audit activities - Any other official duty as may be assigned from time to time by superiors.   Minimum Qualifications: - Minimum of a Diploma in Science Technology (Chemistry, Biology), or Food Science and Technology - Minimum 2 years experience in Agro-processing quality control in or Food and Beverage Industry.   How To Apply for Agri Exim Uganda Jobs 2022 All l suitably qualified and interested candidates should send their CV and application letter via the email below: HR@agrieximfze.com Deadline: 2nd July 2022 NB: Indicate the preferred location in the application.     For similar Jobs in Uganda today and great Uganda jobs, please remember to subscribe using the form below: NOTE: No employer should ask you for money in return for advancement in the recruitment process or for being offered a position. Please contact Fresher Jobs Uganda if it ever happens with any of the jobs that we advertise. Facebook WhatsApp Twitter LinkedIn Read the full article

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Benefits Of QA and QC Activities

Benefits Of QA Activities:

●     Maintaining accurate and comprehensive records of all project activities.

●     Project personnel are assigned roles and responsibilities.

●     Personnel training is required to ensure that sample collection techniques and equipment are used consistently.

●     Field and laboratory operations are audited.

●     Sample custody is tracked from the time it is collected in the field until it is analyzed.

●     Statistics are used to determine the number of samples and sampling sites required to obtain data of a required level of confidence.

Benefits Of QC Activities:

●     Analyses of unspiked and spiked samples

●     Analyze the sample again.

●     Analytical equipment should be inspected and calibrated regularly.

●     Reagents and water should be inspected for contamination regularly.

QA actions are taken to manufacture a safe and effective product through its design by following QC’s into the product life cycle. After a product has been manufactured, quality control (QC) procedures are used to ensure that it is safe and effective. Both QA and QC are required. You can't depend only on quality control to "test quality into" a product.

Creation (QA) vs. Verification (QC)

QA activities produce a roadmap for developing high-quality products. It entails establishing guidelines for product design, production, packaging, distribution, marketing, and sales. QA activities generate a road map for developing high-quality products. It entails developing policies for product design, manufacturing, packaging, distribution, marketing, and sales.

Process (QA) vs. Product (QC)

Quality control is a process-oriented discipline that focuses on preventing quality problems. The goal of quality control is to fix flaws in manufactured goods. This distinction can also be expressed as actions vs. outcomes. Quality control is a process-oriented discipline that focuses on preventing quality problems. Many examples are provided for each type of activity. QA processes include audits, documentation, change control, employee training, supplier management, and investigation procedures.

System (QA) vs. Parts (QC)

The methods and procedures used to protect quality standards are known as quality assurance control systems. Parts, as well as the system's outputs, are measured by quality control systems. Various activities, such as auditing suppliers and batch sampling raw materials, may be mandated by the QA system for quality management to ensure that inputs are consistently safe and effective.

Proactive (QA) vs. Reactive (QC)

The quality assurance goal is to prevent defects from occurring in the first place by using process design. Quality control (QC) is an after-the-fact process for detecting defects. Process design, such as documenting standard operating procedures, is part of QA (SOPs). When processes are followed, the end product should be safe and effective. The process of testing products to ensure that they meet safety and efficacy requirements is known as quality control. If quality issues are discovered during QC testing, immediate action should be taken to prevent an unsafe product from being shipped and distributed.

People in charge of quality assurance are more involved in the pre-project phase. Making a document for the project's quality standards, determining the manpower needed to manage the project, conducting initial product quality testing, establishing a project's quality standard, and so on. Along with the executive department, quality control personnel are responsible for the project's proper supervision. They examine whether the activities are carried out by the required quality standards. The control department's responsibilities include on-site rectification of a failed activity, site quality documentation, and supporting and correcting the execution department.

QA/QC courses in India include a variety of diagrammatic techniques that aid in the discovery of ideas, decision-making, and issue prioritization. An affinity diagram, a tree diagram, a network diagram, and so on are some examples. Quality assurance and quality control are interdependent; the quality control process receives input from the quality assurance process and feeds back to the quality assurance process so that the quality assurance personnel can validate the process.

While the value of a QC/QA course may be debatable while a project is in progress, the data and information gathered from the project will be sufficient to make the correct decision among alternative courses of action. If the project objectives were used as the design method, then an analysis plan and data collection aids in the implementation of all QA/QC procedures for all project activities, and complete records were kept throughout the project.

The QA and QC processes are dependent mutually; the quality control process receives input from the quality assurance process and feeds back to the quality assurance process, allowing quality assurance personnel to validate the process.

If anyone interested in his/her career in QA/QC should be familiar with the industry's standards and codes.

Enrolling in a QA/QCcourse may be a good idea because it will provide you with a thorough understanding of civil engineering standards and codes as well as a respectable career.

[free-lims]

Why Data Provenance is Crucial for Clinical Diagnostic Labs

What is Data Provenance?

Data provenance, also known as data lineage, refers to tracking the origin of data and continuous changes in data with time. Data provenance helps in tracking errors within data and finding sources of such errors. Furthermore, maintaining data provenance is essential for clinical laboratories if they are preparing for audits. Data provenance in a clinical diagnostic laboratory should commence from the time a sample enters the laboratory until the test results are reported.

Importance of Data Provenance

Clinical diagnostic laboratories generate and store massive amounts of data daily. Many laboratories still use traditional documentation methods to manage and record data. They still practice taking instrument readings manually and maintaining handwritten notes. These notes are then transcribed into excel sheets, thus leading to transcription errors. Moreover, manual procedures of data management reduce data interoperability, leading to data silos. Laboratory professionals also practice double data entry to catch and minimize errors but end up losing significant time and effort. Digital transformation is essential for laboratories to overcome these challenges and reinforce data provenance.

The digitization of processes and data management techniques is paramount for tracking provenance and eliminating data silos. Modern laboratories ensure that all steps of diagnostic processes are documented digitally so that they can track and manage all data using a single system. This helps them streamline workflows, meet compliance standards, and strengthen data provenance. Data provenance provides a cohesive understanding of the role of all staff members in a laboratory. When data is recorded electronically, it becomes easy to track its origin, share data and test results with colleagues, reducing the turnaround time. Furthermore, any changes in data can be easily updated and recorded for future use if maintained digitally.

Why Should Clinical Diagnostic Laboratories Prioritize Data Provenance?

Clinical diagnostic laboratories must securely manage sensitive patient data and laboratory records. This helps laboratories meet regulatory requirements, such as CLIA, HIPAA, ISO 15189. Data provenance also aids in interpreting data and tracing back the test results to samples and associated patients. Data provenance supports the reproducibility of laboratory findings by providing all the necessary data and associated metadata as and when required. The efficiency of laboratory processes and performance of laboratory staff can also be examined, providing an area for improvement in case of any deviations from set standards.

How Does a Clinical LIMS System Support Data Provenance?

A Laboratory Information Management System (LIMS) can help clinical diagnostic laboratories maintain data provenance in the following ways:

Assign role-based patient data access to authorized personnel only to safeguard Protected Health Information (PHI) of patients.

Track all laboratory activities along with a date and time stamp by maintaining a read-only audit trail.

Manage documents, such as procedure manuals, instrument maintenance manuals, and ensure document control.

Manage all patient data, including demographic details, patient consent, and patients’ medical history.

Store annotated sample data and track samples using barcodes and print labels.

Manage all aspects of sample genealogy. It also helps maintain a sample chain of custody (CoC) and access a complete history of each sample from accessioning to the final disposal.

Support instrument integration for the effective management of growing data volumes. Instrument integration also helps eliminate chances of transcription errors, data redundancy and also assures data integrity.

Ensure automated workflow management and track deviations from standard workflows.

Conclusion

Data provenance helps laboratories record the origin of data throughout the sample lifecycle. It helps laboratories understand the relevancy of data. Data provenance puts an end to functional laboratory silos and helps track and manage data in all steps of laboratory processes. Clinical diagnostic laboratories should create a foundation for strong provenance and ensure complete data traceability.

Data provenance helps modern laboratories streamline workflows and comply with regulations. Diagnostic laboratories must implement a secure and reliable data management system for collecting, storing, processing, analyzing, and reporting all data. A clinical LIMS system streamlines existing processes and facilitates data recovery even after years of diagnosis.

Originally published at https://freelims.org.

[iso27001inkochi]

ISO 17025 technical internal audit for organizations in Fiji

ISO 17025 Certification in Fiji laboratories are required in imitation of bear a software on inner audits according to determine whether or not their operations comply including ISO/IEC 17025 requirements about an ongoing basis. This includes auditing both administration or technical things to do to become aware of gaps, then in accordance with force improvements.

An advantageous balance subculture is imperative to insure that interior pragmatic audits are effective. Management ought to motivate an open, fair, collaborative endeavor between empirical auditors or auditees. The technical auditors ought to clearly talk together with auditees up to expectation gaps desire lie recognized collectively between system after power improvement, not in imitation of locate “fault” and solid blame.

In this article, I choice supply an overview of the quite a number empirical balance strategies and the pragmatic necessities blanketed within 3 sorts over empirical audits.

Are empiric audits comparable to administration audits?

The identical expert behavior, basic auditing skills, then good understanding concerning the ISO/IEC 17025:2017 norm is needed between each empirical or administration audits in accordance with assure he are unbiased then associate their purpose. ISO 17025 Registration in Sri Lanka technical auditors, simply as government administration auditors, necessity in imitation of lie independent, impartial, observant, perceptive, and targeted about assessing the willingness regarding processes, procedures, yet documented information towards particular balance criteria. The ISO 19011 standards over auditing pray to both: because example, reception a risk-based method then erection evidence-based decisions of findings.

What are the three kinds regarding audits?

There are 3 kinds concerning empiric audits ancient after investigate pragmatic competence: witnessing, vertical, and horizontal.

a) Witnessing

Witnessing involves staring at an auditee performing a particular activity, for example, a unique take a look at method, then assessing the degree concerning compliance. The auditor must remain supplied including the documented check technique against which agreement is assessed.

During the witnessing, ISO 17025 Services in Thailand the auditor would determine agreement together with relevant clauses, however solely as it tell according to the precise witnessing. This means, for example, only the witnessed auditee’s training data would remain assessed, because the unique activity.

 b) Vertical audits

A vertical empiric book involves choosing an alone report and reported end result and assessing consent with applicable clauses, but only for the unique laboratory things to do in accordance with get to the factor about reporting the specific result. The auditor would either assignment systematically backward, beside the file after the bond regarding the unique sample (or sampling, agreement included), yet leading beside the sample registration.

c) Horizontal audits

Horizontal audits involve assessing permission together with applicable clauses, but throughout every take a look at strategies yet things to do inside the scope over accreditation. Permanency for example, environmental controls (clause 7.7) then pragmatic sufficiency concerning army (clause 6.2). A horizontal audit ought to contain one and entire technical clauses. It would be done regarding a copy basis. This means, because example, because of army necessities (clause 6.2), though fundamental files certain as the procedure, coaching matrices, then structure templates are assessed, now not each and every army training file is included. Those so are selected, however, are assessed throughout every coaching activity.

How to get ISO 17025 Consulting Services in Fiji?

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[productionmanagement029638]

ProductionManagement

Providers on SupplierAudits to improve to match this Organization’s demands By auditing your providers, you strengthening your connection. Should you allow your providers"just get on with it" then you are missing out on opportunities for additional partnerships, better deals, and chances to discuss knowledge. It’s a humbling actuality which you can not do it on your own. This frequently has to do with resource allocation: Your company might allocate dollars to construct and sustain some actions in-house whilst opting to contract higher-cost surgeries to qualified providers who have the experience and equipment. Your outsourcing might arrive in the kind of production of a sterile inject able tablets, or even topical dose form or it might be product release and stability testing. After this manufacturing and analyzing are finish, the item might have to be kept under controlled humidity and temperature requirements and then SupplierAudits to places around the world. The providers you decide to execute these essential operations are of paramount importance to your institution’s achievement and to minimize stress-induced headaches through your business. However quality auditors measure in the lobby of the supplier without doing their assignments. Ask yourself these questions: Why is this provider being audited by me? Is this provider new to one which we’ve used or my organization? If utilized formerly, have I read within the former audit observations in addition to the provider’s answers and do I know them? Which audit observations do I guess are the most difficult for the provider to tackle and that are important to my business’s requirements for this item? Perhaps you have reviewed previously implemented SupplierAudits batch documents and analyzing data and are there any problems that need solved? Are there any deviations to follow-up on. Your comprehension of the provider’s work suggestion is of excellent significance in optimizing the scope of the audit. Which gear is very likely to be utilized? This listing of equipment is going to help you in requesting gear records. Stick to the audit deadline and Good audit preparation will help to maintain the audit. In advance of this audit.

Quality control is much like quality assurance. Among the qualities of all quality control is using well-defined controls. It attracts standardization to the procedure. Most organizations have an excellent control/assurance department that offers the set of criteria to be followed for every single item. Either an internal staff or a third party staff is hired to ascertain whether the products which are delivered to meet those criteria. Quality management depends on testing of merchandise, as product review gives a clearer image of the quality of the final product. There are various criteria offered for caliber control. The grade of a commodity is frequently influenced by deviations from target criteria and from the large variability around goal specifications. Successful excellent management needs to be in a position to tackle both those problems. Quality management can help companies in enhancing their goods on the marketplace together with brand recognition. Additionally, it aids in addressing liability issues, preparation and decision making, and fulfilling customer requirements. The hard work and fund involved in product delivery could be considerably improved with the assistance of superior control. There are many procedures of Quality control the performance of quality control. A quality management graph is a picture that depicts whether sampled goods or procedures are fulfilling their planned specifications–also, otherwise, the amount where they change from these specifications. When every graph analyzes a particular characteristic of this product it’s referred to as a uni variate graph. When a graph steps variances in many product characteristics, it’s referred to as a multivariate chart. Randomly chosen products are analyzed for the specified feature or attributes of the graph is monitoring. The x-axis monitors the samples examined. Assessing the routine of variance depicted by an excellent control chart will help determine if defects are happening randomly or systematically. Quality Assurance is popularly referred to as QA and concentrates on preventing flaw. Quality Assurance ensures that the procedures, Quality control , techniques and procedures are intended for the jobs are employed correctly.

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300+ TOP CLINICAL LAB TECHNICIAN Interview Questions and Answers

CLINICAL LAB TECHNICIAN Interview Questions :-

1. What are the responsibilities of clinical lab technician? Responsibilities of clinical lab technician varies with the department you are assigned to, but usually it involves Wide range of testing Running complex analysis Examine blood cells with mircoscope Scanning of specimen Using expensive chemicals wisely Maintaining and monitoring various equipment’s Checking contamination in chemicals at regular interval 2. What is GLP? GLP means Good Laboratory Practice. It is a framework or pattern under which research work are planned, performed, monitored, recorded, reported and archived. 3. Why GLP is followed in the lab? Following GLP standard, minimizes the chance of error occurs due to humans It supports for product registration, and also assures the suitability of data to the regulatory authorities It helps to reduce the cost of industry and governments by avoiding duplicative testing It helps to re-create a study from the recorded data and information 4. What are the common errors done by technician while handling pipette? Failure to pre-wet the pipette tip Disregarding temperature – temperature equilibrated Tip wiping over and again Choosing wrong pipetting mode Working too quickly Pipetting at a wrong angle Using wrong pipette tips 5. Why pipetting training is crucial for clinical technician? By having a proper pipette training, always helps to minimize the risk of volume variability caused by Operators, also a small fraction of the change in pipetting can give you the wrong result. LabTechncian 6. Define what is Aliquot? An aliquot is the known amount of homogeneous material, used to minimize the sampling error. It is usually used when fractional part is an exact divisor of the whole. 7. What are the different techniques for placing samples in micro-scope? Different techniques used for placing samples under micro-scope are Dry Mount: You simply put section of specimen with a cover slip over a sample Wet Mount: Samples are placed under various liquid medium like glycerine, water, brine and water Smear Slides: In this technique, sample is smear over the slide and on top it another slide is placed without forming bubbles Squash Slides: In this technique, lens tissue is used over the wet mount, and it will remove excess water Staining: Stains such as iodine, methylene blue and crystal violet is used to stain the specimen 8. What are different sterilization methods used in laboratory? The most common methods of sterilization practised in lab are Dry heat: Specimen containing bacteria is exposed to high temperature Wet heat: Pressurised steam is used to kill microbes, for example, autoclave that is like pressure cooker that produces steam. Filtration: Filtration is used where filters are as small as 0.2um is used Radiation: UV has limited penetration, so it is generally safe to use although it is less effective to X-rays and gamma rays. X-rays and gamma rays are used only for special purposes only Solvent: Solvent like ethanol and iso-propanol kills microbial cells but not the spores 9. What is the difference between sterilization and disinfection? Sterilization: The thorough sterilization of all microbes present on the surgical instrument is referred as Sterilization Disinfection: While reducing the total number of microbes below the risk level is referred as Disinfection 10. What is gas sterilization? In gas sterilization chemicals like ethylene oxide and mixture based on the substance are used for sterilizing substances. They are highly flammable and potentially explosive in nature; they are mixed with inert gases to neutralize their explosive nature.

CLINICAL LAB TECHNICIAN Interview Questions 11. What are the factors on which the gas sterilization depends on? Gas sterilization depends on factors like Concentration of the gas Humidity Time of exposure Temperature Nature of the load 12. What clinical lab audit is and what are the areas you can do clinical audit? A clinical lab audit is done in order to maintain and operate the lab at a standard level. The area that includes in clinical audit are Specimens: To check the patient register and see whether the specimen was received at the right time Turnaround time: To check whether the specimen was tested and returned at allocated time, and if delayed how to improve it GLP: To check whether the test methods carried out follows the standard procedures Purchasing equipment’s, reagents and other lab instruments Laboratory reports: To check whether they are precise and clear and look for any area for improvement Storage of reagents and specimens Safety policies and procedures: Use of dangerous substances should be audited, and every single accident in the lab should be recorded. 13. What is laboratory centrifuges? Laboratory Centrifuge is primarily used for testing liquids and substances for clinical trial samples. This device uses the centrifugal force to separate the liquids from the main sample or mixture. 14. What is supernatant? When sample is rotated into centrifuge, it will separate the mixture according to the density. Supernatant is the upper layer found in the sample after it is run into centrifuge. 15. What are the steps you can take to avoid imbalance in centrifuge? To avoid an imbalance in centrifuge it requires Balanced loading of the centrifuge rotor Even number of tubes should be loaded facing each other or in the opposite direction When odd number of tubes are loaded make sure, you make it even with adding one more tube with an equal amount of water of that of the sample tube 16. What is blank? Blank term is used to refer the sample tube which does not contain the analyte. 17. What is Calibration Curve? Calibration curve is the relationship between the various concentration of analyte in a suitable solvent or matrix and the signal response of the instrument. 18. What is co-chromatography? Co-chromatography is the procedure used to detect an unknown substance by comparing the chromatic comparison with a known substance. 19. What do you mean by a confirmatory test? For unambiguous identification of metabolites in the sample, alternative chemical method is used also known as a second test. 20. What is a positive control? Positive control is a specimen having the analyte at a concentration above a specific limit. 21. What is dynamic range? It is defined as a range over which a relationship exists between assay response and analyte concentration. CLINICAL LAB TECHNICIAN Questions and Answers pdf Download Read the full article

[free-lims]

The Importance of Internal Audits for Cannabis Testing Laboratories

An internal audit is a kind of self-assessment conducted to identify critical issues and helps determine the effectiveness of a laboratory’s risk management capabilities. Internal audits provide insights into a laboratory’s culture, operations, and compliance with applicable laws and regulations. The data is precisely analyzed in internal audits to provide recommendations for improvement.

It is essential to conduct an internal audit if your laboratory is preparing for a third-party audit. An internal audit is instrumental in identifying the operational gaps, minimizing the chances of failure. An internal audit provides you an opportunity to check audit preparations before an external assessor arrives at your facility. An internal auditor, or an auditing team, should conduct an audit impartially, keeping in mind the requirements of an external audit. Conducting an internal audit also makes laboratory managers more mindful of the loopholes that an external auditor may identify, enabling laboratories to work on the areas of improvement.

Few benefits of internal audits for cannabis testing laboratories are as follows:

Ensure compliance with industry standards, statutory and regulatory requirements, such as ISO 17025:2017, 21 CFR part 11, GLP, and state and local regulations.

Prevent expensive mistakes and improve operational efficiency.

Determine if the QA/QC processes implemented are effective in generating accurate and repeatable results.

Be better prepared to answer the questions of external auditors and face them with confidence.

Determine the effectiveness of the quality management system in place.

Determine if laboratory staff members follow pre-defined standard operating procedures (SOPs).

An internal audit is typically done under a CAPA (Corrective and Preventive Actions) program. CAPA is a part of the quality management system which controls and detects errors in laboratory processes so that corrective measures can be taken to prevent their recurrence. The CAPA program enables you to thoroughly investigate and determine the root cause of potential issues. It allows you to record customer complaints and aids in continuous improvement. An effective CAPA program enables laboratories to pinpoint the factors responsible for cross-contamination, such as improper environmental controls, poorly designed laboratory infrastructure. High-quality laboratory supplies are imperative for generating accurate test results. A CAPA program enables cannabis testing laboratories to monitor the performance of suppliers to determine if they are consistently meeting the specified requirements. Ideally, cannabis testing laboratories should procure supplies from vendors certified to specific standards.

Role of a Cannabis LIMS in Internal Audits

A laboratory information management system (LIMS) facilitates not only external audits but also internal audits. A LIMS maintains a read-only audit trail to track all laboratory activities along with a date and time stamp and other details, such as who made the change, the reason for making the change. A LIMS maintains ongoing training and competency records of analysts and helps assign analytical tasks only to the competent staff, assuring the accuracy of test results. A LIMS enables cannabis testing laboratories to record customers’ complaints and corrective and preventive actions taken for non-conforming activities. A LIMS automates enforcement of SOPs, maintains a decisive chain-of-custody to track sample custodians through the sample lifecycle, and manages suppliers and laboratory inventory. A LIMS manages all internal and external documents such as validated standard test methods, drawings, manuals and ensures version control. A Cannabis LIMS ensures timely calibration and maintenance of instruments, records calibration results, and flags instruments that are unsuitable for analysis. Furthermore, a LIMS automates laboratory processes to reduce human errors and flags samples that fail testing.

Conclusion

Cannabis testing laboratories should plan and conduct internal audits from time to time to identify potential drawbacks in their operational workflows. Internal audits are time-consuming and resource-intensive, however; they offer innumerable benefits. A successful internal audit ensures standardization of processes and increases the chances of surviving external audits. To prepare your cannabis testing laboratory for an external or third-party audit, you should prepare an audit checklist and conduct an internal audit to understand if there are any gaps between your current processes and the requirements of the standard, such as ISO/IEC 17025:2017. Cannabis testing laboratories should implement automated systems, such as a LIMS, to digitally manage samples, test results, SOPs, staff training records, certificates of analysis (CoAs) and increase operational transparency. A Cannabis LIMS saves significant time and minimizes transcription errors. A successful audit calls for effective preparation, a good quality management system, trained laboratory personnel, and foolproof processes.

Originally published at https://freelims.org.

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Supplier Audits

Providers on SupplierAudits to improve to match this Organization's demands By auditing your providers, you strengthening your connection. Should you allow your providers"just get on with it" then you are missing out on opportunities for additional partnerships, better deals, and chances to discuss knowledge. It's a humbling actuality which you can not do it on your own. This frequently has to do with resource allocation: Your company might allocate dollars to construct and sustain some actions in-house whilst opting to contract higher-cost surgeries to qualified providers who have the experience and equipment. Your outsourcing might arrive in the kind of production of a sterile inject able tablets, or even topical dose form or it might be product release and stability testing. After this manufacturing and analyzing are finish, the item might have to be kept under controlled humidity and temperature requirements and then SupplierAudits to places around the world. The providers you decide to execute these essential operations are of paramount importance to your institution's achievement and to minimize stress-induced headaches through your business. However quality auditors measure in the lobby of the supplier without doing their assignments. Ask yourself these questions: Why is this provider being audited by me? Is this provider new to one which we've used or my organization? If utilized formerly, have I read within the former audit observations in addition to the provider's answers and do I know them? Which audit observations do I guess are the most difficult for the provider to tackle and that are important to my business's requirements for this item? Perhaps you have reviewed previously implemented SupplierAudits batch documents and analyzing data and are there any problems that need solved? Are there any deviations to follow-up on. Your comprehension of the provider's work suggestion is of excellent significance in optimizing the scope of the audit. Which gear is very likely to be utilized? This listing of equipment is going to help you in requesting gear records. Stick to the audit deadline and Good audit preparation will help to maintain the audit. In advance of this audit.

Supply the audit server using a listing of the specialized, laboratory, and production staff you want to talk with and the documents you want to review. A host that is well-organized will probably have this available. SupplierAudits with your own audit schedule. This is crucial. The very best approach would be to devote time chasing down problems while glaring problems get none or care in any way. Continually refer back to the audit schedule and also remember to keep the information of your research report in mind whilst implementing the audit. Many auditors have contributed past lives in the lab or in production, while others began their careers in quality assurance and might have little technical background concerning equipment, manufacturing procedures, GMP utilities, and lab testing. Know your limits and, if needed, strengthen them by choosing a SupplierAudits adviser to help you through the audit.it's important that you ask to observe the client complaints about products you currently buy from the provider. Customer complaints are a significant source of information concerning high quality and the functionality of merchandise under real use. They are crucial in life science businesses and production, where complaints can indicate security problems. In ISO and FDA surroundings handling of complaints is regarded as a vital part of the quality system - and also a crucial element in ensuring compliance. Effective and quick complaint handling can reduce imports of nonconforming products. Capturing and exploring issues obtained through this station. Inside this region, the audit staff must search for repetitiveness to ascertain if other customers have experienced similar complaints regarding not merely the merchandise you currently buy, but in addition the provider's product lineup out your existing purchases SupplierAudits the audit, signs in client complaints indicates that the provider has a problem, that proof will be located through paperwork. By way of instance, paperwork may disclose recurrence or product failures of ship dates that are missed. A routine of boat dates that are missing indicates there is a production method that is failing currently affecting the provider's quality. 

As businesses add sellers, SupplierAudits and materials to their small business, keeping visibility across the supply chain gets more challenging. A provider having its suppliers adds yet another degree that blurs visibility at a provider's activities. Before and through provider audits, you need to review the chain of custody records. If a provider is outsourcing portions of its procedure, it is crucial that you make sure the provider has quality arrangements with associations from and that you're informed of the fact. You has to make confident the key builder has controls in place to take care of its vendors and have to be aware of if a subcontractor is in harmony with their controllers. Having controls in place reduces the odds of component or a product which shouldn't be taken discovering its way throughout the process. In overall, providers should be eager to show their subcontractors and those relationships could impact the company of a customer. If a provider allows it, then you ought to review the provider's audit findings of its suppliers; if the provider does not allow that, then you need to request to observe the provider's incoming review of subcontracted substances, in addition to any SupplierAudits documentation that will demonstrate the provider is holding its own sellers to quality criteria and getting quality items.A common issue area that's at best glossed over and at worst entirely ignored through an audit is the compliance with prerequisites because of its own utilities. Normally, these regions are also known by the employees and consequently, noncompliance abound. Some utilities could possibly be linked to the centre's construction management system, though some could be equipment. In any circumstance, the should have documentation of corrective actions, and documents of alerts that an acknowledgement of every alarm by staff members. The last thing is essential. This is the point where the implementation of quality systems will neglect. Create a point to ask documentation of corrective actions for every utility alarm. Additionally, water and SupplierAudits systems, for example compressed air and nitrogen, together with gases, need at every stage of use. Confirm the timelines for testing and sampling were conducted as guided by the procedures.

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production audit

Procedures create results and production audit to determine when the results are precise and being produced by a process. Monitor activity success. Celebrate the actions to find out whether the issue was eliminated by it. Auditing is a proactive attempt to guarantee a process is in check. Auditing indicates a willingness to commit to improvement and to go beyond the status quo. Any issues discovered and inform people affected. The idea is not to assign blame but to obtain a solution. 

The issues found become the basis for followup and corrective actions. You know better than to rush into placing an order with this new provider with just high hopes for assurance. You understand appropriate due diligence requires a production audit evaluation employing an effective excellent audit checklist to verify your expectations align with fact. And in this case, this kind of audit helps you avoid disaster. The supplier does not have a laboratory facility to confirm material makeup. Nor are there any documents showing the mill coordinates using a spouse laboratory for testing. You know this since these prerequisites were part of report and the audit framework. Everybody ought to be educated so that they can offer input and know. Furthermore, other processes will affect. Pick a group. The audit team should be educated regarding the procedure. 

They must be educated about audit methods like sampling and assessing results. They need to have the expertise to recognize issues and determine the activities. There's An audit a review of a process to determine whether it is performing. With verification your procedure audit checklist can help you in making enhancements that are significant. That caliber is the company as a priority for the two leaders. Establish for the shift and stick to the audit program which was established. The amount of observations will end up your sample of this job for this shift. The audit program should be determined as you can and ought to be as arbitrary. The production audit program ought to be followed to provide results based on a sample. Today's customers expect nothing less and it is incumbent on all producers to ensure this expectation is fulfilled. A way of assessing if or not a procedure is in control is an audit.