Friday, September 5, 2008
System testing approach: Black Box Testing
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Tuesday, August 19, 2008
Use QA As Your First Step To Outsourcing
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Steve Mezak is a successful Silicon Valley technical entrepreneur and international outsourcing expert. Get your copy of his free report on "Outsourced Development - A Secret Weapon for Quickly Creating Software Products" now at http://www.accelerance.com/
Sunday, August 17, 2008
Quality System Automation in the GLP Environment
How Automation Assists Sponsors, Facility Management Personnel, Study Directors and QAUs Comply with Good Laboratory Practices
Maintaining a quality system that complies with the FDA's GLP regulations requires the cooperation of four groups and/or individuals. The GLP regulations specify these groups as follows:
• Study Sponsors • Facility Management Personnel• Study Directors (usually only one per study)• QAU (Quality Assurance Unit)
Extensive ResponsibilityEach of these groups or individuals should be 1) an integral part to the conduct of every non-clinical safety study and 2) should adhere to the respective responsibilities assigned by the FDA. Since these responsibilities are extensive, the automation of GLP management is highly recommended for life science industries that are already fighting against breakneck product-to-market time warps.
Study SponsorsSponsors often carry the weight of ultimate responsibility for every non-clinical study. After all, it is the sponsor who will reap success when a study is fruitful or take the traumatic brunt (i.e. usually financial loss) when it fails.
It is easy to understand therefore why the sponsors of many non-clinical studies are eager to ensure the greatest possible speeds and accuracy levels during testing procedures, especially when one considers that GLP related "organizational and documentation requirements increase operational costs of up to 30% compared to [a] non-GLP operation."1
Study Sponsors Have a Responsibility for Action According to GLP regulations, a sponsor is responsible for records management processes (even if he or she manages copies of records that are technically already officiated) and the archival of materials that support non-clinical studies. These processes could (of course) be streamlined with solutions slated for GLP management, but first, two questions:
• Are records management and document archival processes really worth automating with a quality system?
• Isn't records management a fairly simple endeavor?
The answer to these questions are YES and absolutely NOT! When a careful sponsor considers the following he or she is likely to see the overwhelming benefits of investment in records management/document control solutions.
Consider ThisWhen you consider that paper-based submissions have been delivered by the truck load (that is a LOT of paper) to the FDA and that all U.S. material for FDA submissions needs to be saved and archived for 2 years following FDA approval and for 5 years following FDA submission, it is easy to see that the entire archival time period may span across 10 years and involved millions of documents. Who wants to handle those responsibilities manually or even with email, PCs and filing cabinets?
A GLP quality system that incorporates records management and document control capabilities is essential for the more effective fulfillment of study sponsor responsibilities.
Facility Management PersonnelFacility management personnel also have responsibilities entailed by GLP regulations. These responsibilities include the following:
• The designation of the study director;• Study monitoring;• The hiring of a new study director if the current director is not performing well;• Make sure that a QAU is accessible;• Characterize test articles/control articles;• Ensure that there are enough qualified employees to conduct the study.
Quality System CharacteristicsThe facility management personnel would benefit from 1) a quality system that provided the same centralized document control access that a sponsor could access and 2) audit trend capabilities, work forms capabilities (automated), analytics, training capabilities, etc.
Study DirectorThe study director can be compared to the CEO of a successful company. He or she is the helm of the non-clinical study's ship and has perhaps more responsibilities than any other person associated with non-clinical study work. These responsibilities, according to the FDA's website2 assume that a study director will ensure that:
• "The protocol, including any change, is approved as provided by 58.120 and is followed."
• "All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified."
• "Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented." • "Test systems are as specified in the protocol."
• "All applicable good laboratory practice regulations are followed."
• "All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study."
Quality System RequirementsFor a study director a quality system that will encompass document control for SOPs and protocols would be valuable as well as change control capabilities, automated routing/approval features, deviations/nonconformance identification capabilities, CAPA capabilities, etc.
Quality Assurance Unit (QAU)The quality assurance unit assigned to a non-clinical study holds (as a group entity) the main responsibility for GLP compliance assurance. The QAU's responsibilities include the following:
• Manage the laboratory's master schedule• Maintain study protocol copies• Conduct inspections of the various studies at appropriate intervals• Make sure that the inspection records display the appropriate data (i.e. study identity, inspection date, problems, etc.)• Update management and the study director in regards to any problems discovered during an inspection• Submit reports of status to the same (on a periodic basis)• Become the determiner of deviations that are made from essential documentation.
A Quality System for the Quality Assurance UnitA quality system for the quality assurance unit would also be of great value if the quality system provided the following:
• Document control for the laboratory's master schedule, protocol documentation, status reports, etc.• Audit management capabilities for inspections• Analytics and reporting tools for more effective presentations made easier• Deviations and nonconformance capabilities• Automated routing and collaboration for documents that need to be approved and collaborated on by a variety of groups or individuals.
ConclusionGLP management relies on people, and people in return rely on technologies that will streamline routine processes. Many of the GLP processes have not only become routine but have also become gargantuan in proportion. Those groups or individuals with GLP non-clinical study responsibilities and GLP accountability requirements would do well to consider those technology solutions that provide the features mentioned within the content of this article.
1) labcompliance.com/tutorial/glp/default.aspx?sm=d_a#introduction2) accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1&subpartNode=21:1.0.1.1.22.2
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality system automation in the GLP regulated environment, please feel free to contact a MasterControl representative.
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Six Sigma Quality Control Certification
The new emphasis on quality is why businesses have now become more concerned about maintaining the quality of products and services than ever before. This in turn has created a huge demand for quality-assurance professionals who have the necessary domain knowledge and expertise to ensure the desired level of quality.
It is then not surprising to know that quality-assurance has now become a viable career option and that many corporate employees who already have successful careers are planning to make a shift and make their career in the world of quality assurance.
Available Options
There are many ways to make a career as a quality assurance professional, but if you want to get the best possible results, then you should certainly consider a Six Sigma quality control certification course. The reason for this is that Six Sigma has become the most commonly utilized quality-improvement initiative, the world over. This implies that if you get a Six Sigma certification, you will never have to worry about getting the right job.
The pay package that you will get as a Six Sigma professional will depend on your overall experience and domain, but rest assured that you will get decent pay because even a beginner commands anywhere between $40,000-$60,000 a year. What is even more comforting is the fact that in two to three years, the same person can easily think about earning as much as over a hundred thousand dollars per year.
Basic Requirements
The basic qualification and requirement for a Six Sigma certification course may vary depending on the type of institute you enroll in. Usually a bachelor's degree is enough to enroll in a Six Sigma certification course, but since the course covers plenty of topics related to scientific theories and concepts, it will be a lot easier for you if you have some form of specialization in subjects such as mathematics and physics. But you need not worry even if you do not have such specializations, because the tutorials that will be provided to you by the institute will have everything you need to know. You just have to make sure that you thoroughly read and understand the concepts and methodologies that are explained in the tutorials.
The best thing about Six Sigma quality control certification courses is that they are now available online, which means that if you do not want to take unwanted risks, you can continue with your existing career until you pass the certification exam and get formal recognition of a certified Six Sigma professional. You can prepare for the certification exam in your free time and in the comfort of your home. What else can you ask for?
Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions - Six Sigma Online ( http://www.sixsigmaonline.org ) offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts.
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Quality Assurance Management
"Quality is never an accident; it is always the result of intelligent effort." John Ruskin.
Efforts produce results and that is what quality assurance is all about. This isn't a geeky management concept. It's for real, and the better you implement it, the more you benefit. Quality assurance covers all the activities in a series of planned actions necessary to provide customers with the product they expect. It plays a role throughout - be it in designing, developing, manufacturing, installing or servicing. Quality is sometimes defined as doing things right the first time and this is the ultimate objective of quality assurance. Naturally, that also means savings in cost and time.
Many businesses have well developed quality assurance systems that have emerged over a period of time, and are regularly reviewed. Hence, it is important that new businesses also incorporate a quality assurance policy in order to stay competitive.
Grab a pen and paper to take down some tips on total quality control:
Devise quality policies: This is the first and foremost document to be framed. Ensure that you have a quality policy that lists the procedures to maintain quality control. Remember to circulate the document across the organization so that everyone knows what is expected. This will help your staff streamline work flows to achieve maximum qualitative output. It is difficult to implement quality if there isn't a common understanding across your staff.
Upgrade infrastructure: Make sure you have the required infrastructure capable of implementing the policies. You will need to invest in relevant resources ranging from technical expertise and investment in software, hardware and training to staff development. At the same time, you will need to protect your systems infrastructure adequately. Systems Continuity Plan Pro software from protects your Information Technology (IT) assets: facilities, power, network, systems, storage, operating systems, applications and documents.
Employ periodic checks & audits: It is essential that you employ periodic checks to ensure that quality policies are implemented well. Without such checking procedures you might fail to keep a tight focus on implementing total quality control. Also, provide a system of audit trails to track results of periodic checks. This will help you look into potential failures which might pose a threat to the overall quality system.
Learn from others: If starting from scratch seems difficult, seek help from professionals. You may also find helpful case studies on quality assurance. Again, if there are people with prior experience within your organization, ask them to share their valuable knowledge. Books like 'The Handbook of Software Quality Assurance' and 'Customer Oriented Software Quality Assurance '' on and can give you a head start when trying to develop a quality assurance plan.
Set realistic goals: Do not aim for perfection! Be realistic and aim for "fitness for purpose". This is based on available resources, such as funds and expertise. Often, while seeking the best you may drive out the good. Hence, keep goals within reach.
Last of all, remember that quality assurance is for you to implement. It is for you to ensure that the deliverables are up to the mark. Seek to deploy quality assurance procedures throughout the length and breadth of your company. For more information, read about the ISO 9000 quality assurance standards.
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Web Design and Quality Assurance
Web design and Web hosting
Present day's software programming techniques have reached to a new height to cope with the ever-changing scenario of web design and web hosting principles. With the growing security concerns and increasing need of quality assurance, the task of web development has become increasingly challenging for today's IT community. To ensure highest data security, new tools like PHP programming, .Net programming, etc. have evolved over the years. With rapid development in the e-commerce activity, web hosting has become the new way of existence for the business community. Mere knowledge on software programming is no more enough for achieving success in web development. In a single word, web design and web hosting calls for all the efficiency of software programming coupled with administrative skills, business awareness and a quality expertise on the multimedia art.
Phases of Web design
Basic understanding of HTML and Microsoft's FrontPage, in addition to expertise on .Net programming and PHP programming, are essential in order to establish greater quality assurance in web development and web hosting fields. Following are the different phases of web design, if followed meticulously success can be achieved without much difficulty.
(a) Phase I: Defining Scope. Every web development project should have a defined scope outlining the need of gathering related information, risk and budget analysis, defining constraints, etc. The scope should be defined keeping in mind the business needs and existing technology of software programming.
(b) Phase II: Project Planning. Information gathered is now required to be re-evaluated with complete quality assurance guidelines. Formalities regarding web hosting also require to be conceptualized now.
(c) Phase III: Design and Testing. Now the actual designing should start. Testing also needs to be accomplished along every stages of web development in order to provide a consistent degree of quality assurance. There is a wide spread belief within the IT community that testing can be tasked at a later stage; but that is not fruitful and goes against the ethos of software programming technology.
(d) Phase IV: Production and Implementation. In this phase, content and layout are merged to give a final shape to the web development. Uses of PHP programming and .Net programming techniques are very important in this phase as they are the state-of-the-art tools for such purposes.
(e) Phase V: Maintenance and Updating. Once the web hosting is completed, maintenance and updating at regular intervals are mandatory to keep the website purpose-worthy.
Issues of Quality Assurance
Quality of design and quality of conformance are the two types of quality issues that we generally come across with the web development. Quality of design calls for a sound knowledge on the software programming techniques, especially knowledge of PHP programming and .Net programming are very much essential in order to ensure quality assured web development. Quality of conformance is the degree to which the design specifications are met during the development and implementation stages. Web site quality assurance plan should include the ways and means of design specification evaluation, procedures of audits and reviews, prescribed ways of monitoring defined standards, mechanism for error reporting and error tracking, etc.
Mansi Aggarwal Recommends that you visit http://www.discussweb.com for more information on Web design and Web hosting.
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ISO 9000 Quality Assurance
ISO 9000 is a set of standards developed by the ISO (international organization for standardization) for quality assurance systems. It was first published in 1987 and the standards were modified in 1994. ISO 9000 serves as a true base for organizations to improve their quality assurance systems.
A quality assurance system involves the organizational structure, duties, procedures, processes, and materials for applying quality management. It is designed to help businesses assure their services and products, and please customer hopes by meeting their specifications. Quality assurance covers all activities of a product?s life cycle, including planning, controlling, measuring, testing and reporting, and improving quality levels.
ISO 9000 quality assurance models view an enterprise as a network of interconnected processes. For a quality system to be ISO-compliant, the processes should address areas known in the standard and should be documented and practiced as described. Documenting a process gives an organization the opportunity to understand, control, and improve its process network.
ISO quality assurance is a management activity that contains auditing and reporting actions. These two functions assist the manager to verify the efficiency of the quality system. ISO 9000 expresses quality assurance resources in general terms that can be used by any organization irrespective of the products or services provided. However, ISO 9000 does not explain how a business should apply these quality system elements.
Most companies first attempt to get certified to one of the quality assurance system models in the ISO 9000 series. For this, the company?s quality system and actions are audited by third party auditors for conformity to the standard and for effective operation. Upon successful certification, the company obtains a certificate from a certification body represented by the auditors.
ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.
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Automate Your Quality Assurance
Quality assurance is a wide range of methods which provide businesses with expected results. It's know that working with quality is one of the possible way to improve the product and as a result number of products sold. It's a good idea to improve quality assurance with information technologies, getting tests results as an electronic document will enable improve the total efficiency of quality service.
The key idea about improving quality assurance with IT technologies is automation. You need to have attention of your employee only in some certain cases, where it's actually needed to do a human check. The task is to automate other processes, which can be performed by computer.
Your tactic and strategy depends on your goals, size of your company, tests scale, but the most common approach for building testing system will include three steps. Researching the object of the test, suggesting and automating test affords, actual test performing and reverse analysis of performed tests. Let's pay attention to every aspect of the test.
First, it's important to research carefully the object of the tests. It can be some computer-related product, for instance software. Then it's important to identify the functions which should be tested in order to evaluate the product performance. There are a different approaches to tests, some should just answer the question "If it works?", others should answer the questions "How good does it work?".
If you deal with some real-world object, then it's obvious that you will need someone help to check the object. But it doesn't mean that you will not be able to automate testing. First, it is easier to test if your tester will have a list of items that should be tested together with description, how to test information. Then some computer software installed on PocketPC can guide the man trough the testing process and suggest a way to put down his opinion of the certain item.
It is important that results of quality assurance tests should be represented as a report, as a single file which is easy to share with others. The most common format for this kind of files is the number of test case together with test description and the values which was obtained. If quality assurance manage have this file, then it would be easy for him to compare actual test results with some key report file.
Actually, here some easy to implement automation is possible. If you have two versions of the test document, one the key document and another the tests results document, then you will be able to pass these documents to some third-party compare utility to perform the comparison. The most popular compare tools suggest a way to automate this task with command line interface.
What to do after the actual tests were designed and performed? It is task to do a reverse analysis. Try to think about tests as a possible opportunity. Try to find some opportunity which will make your products more reliable. Quality tests should not just answer the question if it works or not, they should help you to create a better product.
If you are interested in how to compare html, check Sam Miller web-site.
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Quality Control Versus Quality Assurance - Is There A Difference?
Quality Control Versus Quality Assurance - Is There A Difference?By Marci L. Crane
It's not uncommon to hear the similar phrases quality control and quality assurance1 used interchangeably. This tendency, though a seemingly benign blunder, is actually a revealing reflection of an unhealthy quality management system.
What is quality control?First of all, quality control is the "check" or the "end-of-the-immediate-task-at-hand" record or analysis that determines the acceptability or unacceptability of a product, a product plan, a product part, etc. Tasks related to quality control may include documented reviews, calibration, or additional types of measurable testing (sampling, etc.). Tasks related to quality control will reoccur more often than activities associated with quality assurance.
The Final DeterminationEssentially, quality control is determined by the comparison of a product against the original specifications that were created before the product existed.
Who is involved with quality control?Tasks related to quality control will usually require the involvement of those directly associated with the research, design or production of a product. An employee in charge of quality control related tasks is likely to report to his "local" department head and no further.
Quality Control Software: What functions should it perform?Quality control software should be able to automate electronic "checks" and "tests" (best if done via a web-based system).
These checks may include the following quality control tasks:
• Customer complaints documentation.• The record keeping of electronic forms or documents associated with step-by-step quality control processes.• Forms routing.• Automatic distribution and grading of training exams.• Collaborative tasks.
What is quality assurance?Quality assurance is more or less the determination of the processes that will determine the template and pattern of quality control tasks. Quality assurance assignments do not have to be measurable, although quality assurance evaluators will often use past experience or regulation as a guide for process determination.
The Final DeterminationEssentially, quality assurance is determined by top-level policies, procedures, work instructions and governmental regulations.
Who is involved with quality assurance?As opposed to quality control checks, quality assurance reports are more likely to be performed by managers, by corporate level administrators or 3rd party auditors.
Quality Assurance Software: What functions should it perform?A quality assurance software solution should provide tracking and analytics (i.e. plus reporting features). A complete CAPA digital management solution is also a plus.
The most important function a quality assurance software solution however is flexibility and capability to be customized. After all, every quality assurance process determination will vary from company to company and a software solution should ideally be molded to the various needs of those companies.
The Importance of Distinguishing Quality Control from Quality Assurance ActivitiesIt is important to treat the quality control tasks as separate from the quality assurance activities for the following reasons:
1) A product with continuous quality control checks may be entirely successful but the processes that govern those checks may still prove faulty (take too much time, too much revenue, etc.)
2) One person should not be performing both quality control and quality assurance assignments. Since quality assurance essentially controls the ebb and flow of quality control, having one person over both types of tasks is inherently a conflict of interest.
3) The two types of tasks are different. Why think about quality control and quality assurance as the same sort of process when quality control tasks are measured by specific details (i.e. numbers, specifications, etc.) and quality assurance activities are measured more by written policies, higher level work instructions or even by the opinions of management?
4) Some companies devote too much energy to quality control and some to quality assurance. Both processes must receive evaluation and management.
ConclusionFor life science and high-tech professionals an understanding of why quality control and quality assurance are important and how quality control and quality assurance tasks can best be accomplished are foundational building blocks for a strong regulated company.
1. www.builderau.com.au/strategy/projectmanagement/soa/Quality-control-vs-quality-assurance/0,339028292,339191784,00.htm
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information regarding quality control and quality assurance solutions, please feel free to contact a MasterControl representative.
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Applying Quality Assurance to Our Lives
Applying Quality Assurance to Our LivesBy Kamyar Shah
Quality assurance has been defined as a process that allows a person to take meaningful and deliberate steps to attain a specific target or ambition. Many companies use quality assurance employees or companies in order that they know at all times that their company has the highest standards for products and employees.
A big question that a lot of people might have is, if quality assurance helps so many companies and is so effective in creating successful businesses, why do individuals not take these same tactics and apply them in their everyday lives? It is a great question, and one that should be asked by anyone seriously wanting to improve their life and relationships. If people were as careful with the choices they make in their own lives, whether big or small, as they were picky about the people who work under them or the type of image they put across at work, they would see huge improvements in their lives.
Take the above mentioned definition of quality assurance , for instance. It is a process. So many people think they have to do things right the first time, and if they do not, they give up. While trying your hardest and trying to get it right the first time is a good idea and shows strength and focus, you have to realize also that you are human, and mistakes happen constantly. If you do not succeed the first time, or even the second, all you can do is try again. If it is important enough to you, you will try until you get it right, it is that simple.
Not only is it a process, but it is a process of meaningful and deliberate steps. These steps are very small many times, so small that you might not even see them. If you have problems in your life, or a theoretical mountain you have to climb, it may seem initially impossible, and you might feel like giving up before you begin. But every step, even if it is tiny, gets you a little closer to where you want and need to be. The steps are meaningful because they are personal to you. Only you can decide what each step you take will be, and therefore mean to you. The steps are deliberate because you decide to take them, you choose to take them. It is a choice, not something you fall into by accident, or let happen to you. When you realize that you truly have this control, and that you can make big things happen by controlling smaller seemingly unimportant things, you will gain load of self confidence and a great feeling of empowerment that is priceless in getting you to your goal.
And this is the last part of the definition of quality assurance , your goal, or target. It is also somehow the first part of the process as well, in that you have to know what your target is before you can even think about beginning to aim for it. Possibly you have decided on a target already, or maybe you do not even know what you want. Whatever the case, you have to know what it is you want, what is your ambition, before you can begin the long path to excellence in both your life and your personal relationships. And once you know, remember to always keep it in your sights.
Source : http://www.secretshoppingblog.com/
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Quality Assurance is Final Judge
Have you checked out the carton of milk in the supermarket? Read the print on it and there are bound to be some lines of text that specify about the class of the packed product. You are not only informed about the manufacturing and expiry date along with the batch number, but there is mention of the grade of the product which compares with a certain set national and international standards. When you are spending your hard earned money to purchase a product you need to be assured that you are getting exactly what you had paid for and what is specified on the label and nothing less. Quality assurance goes a long way to guarantee the customer that they are getting their moneys worth.
Most of the leading manufacturers use specialized quality assurance software. These programs have analytics and tracking along with reporting features. Data is fed into these programs which contain the parameters of the product being inspected and it is the job of the software to see that the products adhere to strict performance parameters. While most of these programs are tweaked by the software specialists to adhere to a particular product, there is some software which can be fine tuned by the end user so that it can check different products manufactured by them. Since the same company may have different products and they might have different criteria to determine their class, it makes sense to go in for flexible software.
Distance education is another sphere where quality assurance plays a big part. The general criterion is that the educational institutes should dedicate a minimum number of hours each semester for their courses. Apart from that there are other guidelines which specify that the students learning via these online courses should have ready access to online as and when they require.
Decent online education programs should have complete details about the courses they provide along with the fees they are charging for the same. They should also state whether they are accredited or not. Education plays a major part in determining the future of a person and an improper education might make or break their career. Hence these guarantees play a major part when one is opting for an online education course. Quality assurance is getting much importance in this sector and strict measures are being adopted to meet the standards.
You have just seen an advertisement about the latest mini MP3 player and have been bowled over by its capabilities. If the model can do a somersault while wearing the same and enjoy the music at the same time, there is no doubt that it will not let you down while you are jogging. Apart from that, the ad also states about the number of playing hours that you can expect from a fully charged battery. You must have also come across ads of mobile phones dropping from a height of 10 feet and yet functioning properly. Do not be taken in by these ads for they do not always portray the truth. Look for the quality assurance details in the packet that accompanies these products because that is your sole guide about the excellence of the product. To keep it short and sweet never judge a product just by viewing its advertisements. Ads have to be flashy to promote a product.
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