Still remember the old adage concerning quality management? “If there are written, then it will never happen."
All businesses that are running require a quality management system or Quality Management System (QMS). But unfortunately not all companies implementing such systems. If Yes, many were not organize and well plan.
What is the QMS and why is it so important? A QMS that success consists of procedures and systems which are write out and control. These procedures is the basis of event that can be audit by the internal auditor or external. An effective QMS will identify steps process which becomes the key to success and prevents most of the failures before they occur. This system will protect the supply chain company, brand and the most important thing is to protect and ensure customers remain satisfy.
The first step is to create a flow chart or mapping process. A flow chart or map process is a tool commonly use statistics to find out details of the trip production and manufacturing processes. A map of this process is easy to understand and it is very useful to help discuss big-picture visualization production process in the form of step-by-step.
The map process will identify problems that may occur, allowing us to do a check point quality and provide the necessary documents to support the process. When all the steps have been written down and the entire process flow chart agree upon by all departments involve, then this process will be the control of formal plan. The project leader and leader of the quality assurance and then sign and approve the control plan and the final step of the process from the product.
The FMEA helps the process of identifying potential errors occur and also the bad effects of those mistakes. FMEA provides an overview of the possibility of error and our ability to detect the error. This process is carried out by a team of minimal FMEA consists of one person and a maximum of ten people. Their job is to do the estimation of the likelihood of disabilities and the effects.
FMEA team will identify high risk priority numbers (RPN) as the basis for the development of procedures and quality control. Measurements will be made base upon the results of the NDP in the entire manufacturing process. For example, NASA use FMEA to identify potential errors that can occur in a program of the U.S. astronauts to the moon landing, and then back to Earth.
To ensure that Your measurement system does not cause an error in the process, tools and electronic manual calculations need to be calibrate. These measurements are part of the gauge repeatability and reproducibility (R & R). Gauge R & R is express as the percentage of error in measurement.
Error reading from most measurements errors are generally less than 10 percent. But for a job that is critical, such as the production of pharmaceuticals, error reading only reach 3 percent. The determine factors of risk involving customers as well. This measure is also useful in reducing costs, prevent the loss of confidence in the company.
Some systems quality management leads to Six Sigma. The ultimate goal is to eliminate the causes of defects and errors, and to minimize variations in the manufacturing process. This will reduce costs and increase profit. These initiatives include forming a team that has been train on a specific skill.
A Six Sigma process is measured based on the number of products free of defects are produced, which will hopefully reach 99.99966 percent, or less than 3.4 defects per million opportunities (DPMO defects per million opportunities/). To achieve this, the process is run must first validated. This process refers to the Protocol validation system or SVP (systems validation protocol), as part of a validation master plan of the company.
A SVP validation consists of the IQ-OQ-PQ. This validation will test conformity of QMS and fulfillment. Installation Qualification (IQ) is document on verification of eligibility and oversight equipment. Indicates that the cancellation, the subsystem and the system has been install correctly and in accordance with the applicable code and design made. IQ also validate that the recommendations from reliable taken accordingly.
Operational Qualification (OQ) is a document verification stating that cancellation, the subsystem systems and have better performance in accordance with the specifications in the whole operating range representative or anticipate. In some facilities, OQ can overlap with IQ.
Performance Qualification (PQ) is document evidence that defines a process and a system function that is expect, and producing the expect results in the normal operational conditions. This documentation can also be a reference for process capability (number of anticipate from defects per million).
QMS system the best ever will fail if not done with the preparation. The audit trace is very vital to be done after the system was form.
For example, to trace audit: Let's say you're making 30 products to customers. Then the customers come to audit. The audit team is of the customers you want to see the system documentation for the product #1 and #2 products. Customer audit team you then browse the documentation describing every step is complete. That is (training, APQP, FMEA, process design, gauge control, inspection and approval of first article inspection, in the process. And the final inspection, finishing retention period for records of quality, and so on).
Because you do not know from the beginning which products will be audit record of all customers, then the quality should be prepare in full.
Many businesses, particularly pharmaceutical and biotechnology, must ensure that the products they create meet the requests and needs of the identity, durability, quality and purity.
Companies undergoing operational with the above regulation will expect the same from their supplier. To do this, it takes a dedicate management team, employees are train properly. Even fully commit, regular audit activity, and most importantly, a solid quality management system and clearly written.
Source: Manufacturing.net; Gina Butler & Donald Dobert, ATL
All businesses that are running require a quality management system or Quality Management System (QMS). But unfortunately not all companies implementing such systems. If Yes, many were not organize and well plan.
What is the QMS and why is it so important? A QMS that success consists of procedures and systems which are write out and control. These procedures is the basis of event that can be audit by the internal auditor or external. An effective QMS will identify steps process which becomes the key to success and prevents most of the failures before they occur. This system will protect the supply chain company, brand and the most important thing is to protect and ensure customers remain satisfy.
There are several steps involve in creating an effective QMS and solid. These steps are:
- Statistical tool and control plans.
- Failure Models and Effects Analysis FMEA or (as part of advanced product quality planning or APQP).
- Protocol validation system.
- Current Good Manufacturing Practices (cGMP).
The first step is to create a flow chart or mapping process. A flow chart or map process is a tool commonly use statistics to find out details of the trip production and manufacturing processes. A map of this process is easy to understand and it is very useful to help discuss big-picture visualization production process in the form of step-by-step.
The map process will identify problems that may occur, allowing us to do a check point quality and provide the necessary documents to support the process. When all the steps have been written down and the entire process flow chart agree upon by all departments involve, then this process will be the control of formal plan. The project leader and leader of the quality assurance and then sign and approve the control plan and the final step of the process from the product.
The next critical step i.e. FMEA.
The FMEA helps the process of identifying potential errors occur and also the bad effects of those mistakes. FMEA provides an overview of the possibility of error and our ability to detect the error. This process is carried out by a team of minimal FMEA consists of one person and a maximum of ten people. Their job is to do the estimation of the likelihood of disabilities and the effects.
FMEA team will identify high risk priority numbers (RPN) as the basis for the development of procedures and quality control. Measurements will be made base upon the results of the NDP in the entire manufacturing process. For example, NASA use FMEA to identify potential errors that can occur in a program of the U.S. astronauts to the moon landing, and then back to Earth.
QMS & Measurement system
To ensure that Your measurement system does not cause an error in the process, tools and electronic manual calculations need to be calibrate. These measurements are part of the gauge repeatability and reproducibility (R & R). Gauge R & R is express as the percentage of error in measurement.
Error reading from most measurements errors are generally less than 10 percent. But for a job that is critical, such as the production of pharmaceuticals, error reading only reach 3 percent. The determine factors of risk involving customers as well. This measure is also useful in reducing costs, prevent the loss of confidence in the company.
Some systems quality management leads to Six Sigma. The ultimate goal is to eliminate the causes of defects and errors, and to minimize variations in the manufacturing process. This will reduce costs and increase profit. These initiatives include forming a team that has been train on a specific skill.
Integration of six sigma system
A Six Sigma process is measured based on the number of products free of defects are produced, which will hopefully reach 99.99966 percent, or less than 3.4 defects per million opportunities (DPMO defects per million opportunities/). To achieve this, the process is run must first validated. This process refers to the Protocol validation system or SVP (systems validation protocol), as part of a validation master plan of the company.
A SVP validation consists of the IQ-OQ-PQ. This validation will test conformity of QMS and fulfillment. Installation Qualification (IQ) is document on verification of eligibility and oversight equipment. Indicates that the cancellation, the subsystem and the system has been install correctly and in accordance with the applicable code and design made. IQ also validate that the recommendations from reliable taken accordingly.
Operational Qualification (OQ) is a document verification stating that cancellation, the subsystem systems and have better performance in accordance with the specifications in the whole operating range representative or anticipate. In some facilities, OQ can overlap with IQ.
Performance Qualification (PQ) is document evidence that defines a process and a system function that is expect, and producing the expect results in the normal operational conditions. This documentation can also be a reference for process capability (number of anticipate from defects per million).
Quality management system
QMS system the best ever will fail if not done with the preparation. The audit trace is very vital to be done after the system was form.
Trace the audit ensure something like:
- Operations carry out in accordance with the QMC written and approve.
- The quality system adequate form and preserve.
- The entire personnel have been train.
- Training records update and well maintain accurately.
For example, to trace audit: Let's say you're making 30 products to customers. Then the customers come to audit. The audit team is of the customers you want to see the system documentation for the product #1 and #2 products. Customer audit team you then browse the documentation describing every step is complete. That is (training, APQP, FMEA, process design, gauge control, inspection and approval of first article inspection, in the process. And the final inspection, finishing retention period for records of quality, and so on).
Because you do not know from the beginning which products will be audit record of all customers, then the quality should be prepare in full.
Many businesses, particularly pharmaceutical and biotechnology, must ensure that the products they create meet the requests and needs of the identity, durability, quality and purity.
Companies undergoing operational with the above regulation will expect the same from their supplier. To do this, it takes a dedicate management team, employees are train properly. Even fully commit, regular audit activity, and most importantly, a solid quality management system and clearly written.
Source: Manufacturing.net; Gina Butler & Donald Dobert, ATL
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