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Normative references (ISO14971: 2007) 3. Terms and definitions 4. Ethical considerations 5. Clinical investigation planning 6. Clinical investigation conduct 7. Suspension, termination and close-out of the clinical investigation 8. Responsibilities of the sponsor 9. Responsibilities of the principal investigator.
- Life-cycle assessment or life cycle assessment (LCA, also known as life-cycle analysis) is a methodology for assessing environmental impacts associated with all the stages of the life-cycle of a commercial product, process, or service. For instance, in the case of a manufactured product, environmental impacts are assessed from raw material extraction and processing (cradle), through the.
- ISO 9000 history and revisions: ISO 9000:2000, 2008, and 2015. ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of more than 160 countries. The standards underwent major revisions in 2000 and 2008.
Today, manufacturing companies gather massive amounts of information through measurement and inspection. When this measurement data is being used to make decisions regarding the process and the business in general, it is vital that the data is accurate. If there are errors in your measurement system, you will be making decisions based on incorrect data or producing non-conforming parts. A properly planned and executed Measurement System Analysis (MSA) can help build a strong foundation for any data-based decision-making process. That is the entire purpose of clause 7.1.5.1.1 Measurement system analysis in IATF 16949.
What is a Measurement System?
Before we dive further into MSA, we should review the definition of a measurement system and some of the common sources of variation. A measurement system has been described as a system of related measures that enables the quantification of particular characteristics. It can also include a collection of gauges, fixtures, software and personnel required to validate a particular unit of measure, or make an assessment of the feature or characteristic being measured. The sources of variation in a measurement process can include the following:
- Process – test method, specification
- Personnel – the operators, their skill level, training, etc.
- Tools/Equipment – gauges, fixtures, test equipment used, and their associated calibration systems
- Items to be measured – the part or material samples measured, the sampling plan, etc.
- Environmental factors – temperature, humidity, etc.
All of these possible sources of variation should be considered during MSA. Evaluation of a measurement system should include the use of specific quality tools to identify the most likely source of variation. Most MSA activities examine two primary sources of variation: the parts and the measurement of those parts. The sum of these two values represents the total variation in a measurement system.
An effective MSA process can help assure that the data being collected is accurate and the system of collecting the data is appropriate to the process. Good reliable data can prevent wasted time, labor and scrap in a manufacturing process. A good example of this was a major manufacturing company which began receiving calls from several of their customers. The customers reported non-compliant materials received at their facilities sites. The parts were not properly snapping together to form an even surface or would not lock in place. The process was audited and found that the parts were being produced out of spec. The operator was following the inspection plan and using the assigned gauges for the inspection. The problem was that the gauge did not have adequate resolution to detect the non-conforming parts. An ineffective measurement system can allow bad parts to be accepted and good parts to be rejected. These errors result in dissatisfied customers and excessive scrap. MSA could have prevented the problem and ensured that accurate useful data was being collected.
How to Perform MSA
MSA is a collection of experiments and analyses performed to evaluate a measurement system’s capability, performance and amount of uncertainty regarding the values measured. We should review the measurement data being collected and the methods and tools used to collect and record the data. Our goal is to quantify the effectiveness of the measurement system, analyze the variation in the data and determine its likely source. We need to evaluate the quality of the data being collected in regards to location and width variation. Collected data should be evaluated for bias, stability and linearity.
During an MSA activity, the amount of measurement uncertainty must be evaluated for each type of gauge or measurement tool defined within the process Control Plans. Learn more about Control Plans in the article How to Develop a Control Plan According to IATF 16949. Each tool should have the correct level of discrimination and resolution to obtain useful data. The process, the tools being used (gauges, fixtures, instruments, etc.) and the operators are evaluated for proper definition, accuracy, precision, repeatability and reproducibility.
Overall Objective of MSA
A measurement system is a process by which we assign a number to a characteristic of a product or service. The first step in assessing a system is to understand this process, and determine whether it will satisfy our requirements.
The data collected using a measurement system is used:
- To control processes
- In estimating the existence of the relationship between variables that can affect the outcome of a process
- To conduct analytical studies to increase the knowledge about the system of causes and its effect on processes
- To focus on measurement systems where readings can be repeated on each part, and reproduced by different operators.
A measurement is not always exact. Measurement system variation affects individual measurements and decisions based on data. Measurement system errors are classified into five categories: bias, repeatability, reproducibility, stability, and linearity. You need to know the extent of variation before deciding on the following applications.
Use this freeIATF 16949:2016 Implementation Diagramto learn in which phase you will implement measurement requirements.
ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK)
OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. Many organizations now identify, capture, internalize and leverage relevant OK as an important business strategy. The many ways OK can be used to add value to an organization include:
· Improving products, services and QMS processes.
· Improving employee training and performance.
· Reducing business and QMS risks.
· Making more informed decisions about courses of action.
· Anticipating, understanding and adapting to trends and changes in its business environment.
· Exploiting existing and acquired knowledge assets.
· Developing new opportunities.
· Leveraging OK to gain competitive advantage. Teleport for mac.
· Promoting a learning environment to further stimulate creation of new knowledge.
Your organization must determine and manage the OK necessary for the operation of QMS processes and to achieve conformity of product and services.
Requirements regarding OK were introduced for the purpose of:
· Safeguarding the organizational knowledge from loss of knowledge, e.g.
· Through staff turnover;
· Failure to capture and share information;
· Loss or theft by personnel or outsiders.
· Encouraging the organization to acquire knowledge, e.g.
· Learning from experience;
· Mentoring;
· Benchmarking;
· Building relationships with relevant interested parties.
OK is generally of two types;
· Explicit knowledge – that which can be written down, transferred, and shared. It is definable and can be protected by the legal system;
· Tacit knowledge – is know-how that is usually hard to describe. It can be demonstrated but difficult to document as it resides in the minds of employees. It become evident through performance and on-the-job training.
What is organizational knowledge (OK)?
It can be defined as information combined with experience, context, interpretation, and insight that is useful in making decisions and taking action specific to your organization and QMS. Such information includes:
· Specific technical and procedural information required to produce conforming products and services and for controlling QMS processes needed to produce them. These may include product and service specifications, drawings, process flow diagrams, product and process steps, criteria, work instructions, or verbal instructions, etc.
· Novel, unique, highly creative and innovative ways of doing things that are formally encoded in business processes, practices, methods, etc.
· Lessons learned from past failures, near miss situations and successes,
· Capturing undocumented knowledge (explicit and tacit) and experience that resides within the minds of employees and employee groups,
· Developed or acquired knowledge – patents, practices, technologies, research & development,
· The results of research and improvement projects for products, services, processes and business practices,
· Knowledge of markets, competitors, customers, suppliersand interested parties, e tc,
· Knowledge acquired through consultants, conferences, universities, research institutes, etc, on best practices or to resolve specific business and QMS problems,
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the discussion on organizational knowledge in my eBook focuses on the specific actions that your organization must take to address this requirement
An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot.
Cleanrooms By United produces fully functional ISO 7 cleanrooms that meet all required specifications and requirements. We provide the layout, square footage, and features that your project specifications require. The custom, flexible, modular construction of our ISO 7 clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs evolve.
Contact us for more information regarding our ISO 7 clean room options or call us at 800-959-0878 and we will gladly answer any questions that you may have. Cleanrooms By United is your trusted source for premium grade, high-efficiency ISO 7 clean rooms.
ISO 7 Cleanroom Standards
Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. ISO class 7 clean rooms were previously defined under US Federal Standard 209E but are now defined under ISO 14644-1, however, both are still regularly used as reference points.
- US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air.
- ISO 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 7 Cleanrooms
(FED STD 209E Equivalent: Class 10,000)
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5µm | ≥1µm | ≥5 µm |
| — | — | 1,020,000 | 352,000 | 83,200 | 2,930 |
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 10,000 Cleanrooms
Astropad 1 0. (ISO 14644-1 Equivalent ISO 7)
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5µm | ≥5 µm |
| 350,000 | 75,000 | 30,000 | 10,000 | 70 |
ISO 7 Cleanroom Protective Requirements
Class 10,000 cleanrooms require workers to wear fewer protective garments than cleanrooms with a lower classification but still require the use of cleanroom clothing such as face masks, hair and beard covers, and lab coats or other frocks to cover street clothing. In some ISO7 cleanrooms, coveralls and gloves may also be required. Cleanroom clothing is made from nonwoven fabrics to prevent contamination from shedding material fibers. Gloves are sterile and made from latex, nitrile or other synthetic materials.
Depending on industry and application requirements, other precautionary measures may be taken to control particle count in an ISO 7 cleanroom environment. Sticky mats are often placed outside of cleanroom entrances to remove dirt and other contaminants from shoes. Pass-thru cabinets fitted with filtration systems may also be used to safely transfer products while limiting the number of people entering and exiting the room.
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Cleanroom requirements vary widely based on industry standards and the type of processes being performed. Always consult with a cleanroom professional for assistance in selecting the design and classification that are best suited for your application. Common ISO 7 clean room requirements include:
- Product pass thru’s
- HEPA fan filters
- Heat welded vinyl or epoxy floors
- Gowning atrium
- Air locks
- Air conditioners
- Entrance and exit sticky mats
- Sealed lighting
- Bunny suit, booties, and hood requirements
- Stainless steel bench and hands free sink
How to Determine the Correct Cleanroom Classification Based on Your Needs?
A typical cleanroom is designed to keep outside contaminants and particles at a minimum based on the ISO clean room standards. Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, the two things that can introduce particles and contamination into your cleanroom are people and processes.
Photo to sketch pro 4 serial number. Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. The lower the ISO class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class.
As an example, Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot. The chart below provides an explanation of the differences between our clean room classes.
ISO 7 Cleanroom Applications
ISO 7 clean rooms provide air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot and a minimum of 60 air changes per hour. Industries that utilize ISO 7 cleanrooms include:
- Laboratories
- Aerospace product development
Contact Cleanrooms By United for ISO 7 Cleanrooms Today
Contact us for more information regarding our ISO 7 clean room options or call us at 800-959-0878 and we will gladly discuss your specific cleanroom requirements. Cleanrooms By United is your trusted source for premium grade, high-efficiency ISO 7 cleanrooms.
