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Showing posts from April, 2013

FOOD INDUSTRY: ISO 22000 & HACCP (Part II)

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Food Safety Requirements Because much of HACCP was included in ISO 22000, it’s important to understand a little bit of what HACCP is. HACCP could be defined as the system used to formally identify, evaluate, and control hazards that are significant to food safety.

FOOD INDUSTRY: ISO 22000 & HACCP (Part I)

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The last few years have provided ample evidence that control of food safety is critical. Recent media reports have clearly documented supply chain shortcomings that have threatened consumers’ health and safety. These ongoing problems and the need for consumer safety cry out for additional tools to dramatically reduce or eliminate risks.

PHARMACEUTICAL QUALITY SYSTEMS (PQS) ICH Q10

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The European Medicines Agency divides the ICH harmonised tripartite guideline in five main paragraphs:  Pharmaceutical Quality System Management Responsibility Continual improvement of process performance and product quality Continual improvement of the pharmaceutical quality system Glossary

QUALITY ASSURANCE IN ELECTRONICS

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Customer satisfaction is the number one priority for every electronics company. The Quality Management Systems (QMS) are focused on understanding customer requirements and striving for excellence in Quality, Delivery, Service and environmental responsibility. Company and employees have to be committed to providing quality products and services that meet or exceed our customer’s requirements through ongoing continuous improvement to services, processes, product functionality, reliability and cost. Furthermore, through total employee involvement and teamwork, the company should be dedicated to its own growth, which enhances customer satisfaction, creates jobs, provides opportunities for advancement, and improves employee self-esteem.

RISK MANAGEMENT: NEW APPROACHES

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Risk management is the ability to identify risk, assess it, and mitigate it. Although there are many definitions of risk management, the following share common attributes: "Risk management is the culture, processes, and structures that are directed toward the effective management of potential opportunities and adverse effects. (AS/NZS 4360:1999--"Risk Management")" "Risk management is the identification, assessment, and response to risk to a specific objective. (Enterprise Risk Management--Integrated Framework, COSO, 2004)"

ISO 14001 & OHSAS 18001

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The essential difference between ISO 14001 and OHSAS 18001 is that ISO 14001 focuses on managing your organization's impact on the external environment, while OHSAS 18001 focuses on managing your organization's internal environment to ensure a safe and healthy workplace. Structurally, the two standards are essentially identical. The requirements are essentially identical. Consequently, the processes and documentation needed to implement and certify to ISO 14001 and OHSAS 18001 are essentially the same. Only the intent and focus are different.

PHARMACEUTICAL QUALITY: ISO 15378 & ICH Q10

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Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made. Today we are analysing two representative quality management directives in Pharmaceutical Industry.

ROOT CAUSE ANALYSIS

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Root Cause Analysis (RCA) is a popular tool in the engineer’s problem-solving tool kit. Virtually, it implies that there is only one root cause, when in reality most problems are usually caused by a complex combination of several factors, some of which are more significant than others.

LEAN INNOVATION

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Lean means creating more value for customers with fewer resources. A lean organization understands customer value and focuses its key processes to continuously increase it. The ultimate goal is to provide perfect value to the customer through a perfect value creation process that has zero waste.

PHARMACEUTICAL QUALITY: VALIDATION

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Manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. In spite of the fact that it is mandatory from the government and regulatory bodies, it is also a fact that quality of a pharmaceutical product can not be adequately controlled solely by pharmacopoeial analysis of the final product. Today quality has to be built in to the product right from its inception and rigorous international environmental, safety and regulatory standards need to be followed.

GEOENGINEERING

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"Geoengineering is large-scale intervention in the Earth system to counteract human-induced climate change. There are two main types of geoengineering approaches: Carbon dioxide removal (CDR) and Solar radiation management (SRM)." — University Of Exeter: Climate Change & Sustainable Futures. In 2009, a Royal Society report warned that geoengineering was not an alternative to cutting greenhouse gas emissions, but conceded the technology might be needed in the event of a climate emergency.

ISO 9001

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ISO 9001 is much more than a standard. It should be part of a company’s strategic plan rather than something to get certified to because customers require it. The guidelines and quality principles in ISO 9001 are just good business practices. Several management teams think of the standard as something the quality department should focus on; in many cases it’s an afterthought rather than a strategic part of their business plans. Sometimes it’s only thought about when a customer asks if a company is ISO 9001-certified, or when it appears on a bid questionnaire for a project.

SMALL BUSINESSES

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Data from the U.S. Bureau of Labor Statistics has revealed that “49 percent of establishments survive 5 years or more; 34 percent survive 10 years or more; and 26 percent survive 15 years or more”. In other words, the probability of your business surviving the next 5 year is less than its probability of failing and this is no different online. If you’re not careful, your business will most probably not last 2 years. How could you change this fact? From an individual level to the business level, there are a lot of things you can do to ensure your business not only survives the test of time but that it is also very profitable; here are 5 little changes that can take your small business to the next level.