Still remember the old 'saying' about quality management? "If it's not written, then it will never happen."
All running businesses require a quality management system (QMS). But unfortunately not all companies implement the system. If so, many of them are not well organize and plan.
What is QMS and why is QMS so important? A successful QMS consists of written and control procedures and systems. These procedures are the basis of events that can be audit either by internal or external auditors. An effective QMS will identify the process steps that are key to success and prevent most failures before they occur. This system will protect the company's supply chain, brand and most importantly is to protect and ensure customers remain satisfy.
There are several steps involved in creating an effective and solid QMS. These steps are:
The first step is to create a flow chart or mapping process. A flow chart or process map is a commonly use statistical tool to know the details of a production trip and a manufacturing process. This process map is easy to understand and useful for helping to visualize the big picture of the production process in step-by-step format.
This process map will identify possible problems, allow us to check quality check points and provide necessary documents to support the process. When all the process steps have been written down and the entire flow chart is approve by all departments involve, this process will be a formal control plan. Project leaders and quality assurance leaders then sign and agree on the control plan and final step of the product.
FMEA helps to identify potential errors and also the adverse effects of those errors. FMEA gives an idea of the possibility of error and our ability to detect the error. This process is done by a FMEA team consisting of at least one person and a maximum of ten people. Their task is to estimate the possibility of defects and their effects.
The FMEA team will identify high risk priority numbers (RPN) as the basis for the development of quality and control procedures. Measurements will be made base on RPN results throughout the manufacturing process. For example, NASA uses FMEA to identify potential errors that could occur in the US astronaut landing program to the moon, and then back to earth.
To ensure that your measurement system does not cause errors in the process, the manual and electronic calculation tools must be calibrate. The measurement is part of the repeatability and reproducibility (R & R) gauge. The R & R gauge is express as a percentage of errors in measurement.
Reading errors from most error measurements are generally less than 10 percent. However, for critical work, such as pharmaceutical production, error reading only reach 3 percent. These factors determine the risks involve in the customer as well. This step is also useful in reducing costs, preventing loss of confidence in the company.
Some quality management systems lead to Six Sigma. The main purpose is to eliminate the causes of defects and errors, and minimize the variation in the manufacturing process. This will reduce costs and increase profits. These initiatives include forming a team that has been train on a particular skill.
A Six Sigma process is measure by the number of defect-free products produce, which are expect to reach 99.99966 percent, or less than 3.4 defects per million opportunities (DPMO / defects per million opportunities). To achieve this, the process must first be validate. This process refers to the system validation protocol or SVP (systems validation protocol), as part of the company's validation master plan.
An SVP consists of IQ-OQ-PQ validation. This validation will test the QMS in terms of conformity and compliance. Installation Qualification (IQ) is a document verification of equipment feasibility and uniformity. Indicates that its system, system and subsystems are correctly install and in compliance with applicable codes and designs. The IQ also validates that the recommendations from the suppliers are respond appropriately.
Operational Qualification (OQ is a document verification stating that the system's performances, systems and subsystems have performance that matches the specifications across the range of representative or anticipated operations. In some facilities, OQ can overlap with IQ.
A Performance Qualification (PQ) is document evidence that defines expect system processes and functions, and produces expect results under normal operational conditions. This documentation can also be a reference to process capability (the anticipate amount of defects per million).
The best QMS system will fail if not done with preparation. Trace audit is vital to do once the system is establish. Trace audits ensure certain things like:
For example for trace audit: let's say you create 30 products for customers. Then the customer comes to do the audit. The audit team of your customers wants to see the system documentation for product # 1 and product # 2. Your customer audit team then searches for documentation depicting every step taken (training, APQP, FMEA, process design, gauge control, first article inspection and approval, in-process inspection, finish, final inspection, retention period for quality records, etc.) .
Since you do not know from the start which products will be audit by customers, all quality recordings should be fully prepared.
Many businesses, especially pharmaceuticals and biotechnology, must ensure that the products they make meet demand and needs in terms of identity, resilience, quality and purity.
Companies that are undergoing operations with the above regulations will expect the same from their suppliers. To do this requires a dedicate management team, well-trained and commit employees, regular audit activities, and most importantly, a solid and clear quality management system.
All running businesses require a quality management system (QMS). But unfortunately not all companies implement the system. If so, many of them are not well organize and plan.
What is QMS and why is QMS so important? A successful QMS consists of written and control procedures and systems. These procedures are the basis of events that can be audit either by internal or external auditors. An effective QMS will identify the process steps that are key to success and prevent most failures before they occur. This system will protect the company's supply chain, brand and most importantly is to protect and ensure customers remain satisfy.
There are several steps involved in creating an effective and solid QMS. These steps are:
- Statistical tools and control plans.
- Failure Models and Effects Analysis or FMEA (as part of advance product quality planning or APQP).
- System validation protocol.
- Current Good Manufacturing Practices (cGMP).
Mapping Process
The first step is to create a flow chart or mapping process. A flow chart or process map is a commonly use statistical tool to know the details of a production trip and a manufacturing process. This process map is easy to understand and useful for helping to visualize the big picture of the production process in step-by-step format.
This process map will identify possible problems, allow us to check quality check points and provide necessary documents to support the process. When all the process steps have been written down and the entire flow chart is approve by all departments involve, this process will be a formal control plan. Project leaders and quality assurance leaders then sign and agree on the control plan and final step of the product.
The next critical step is FMEA
FMEA helps to identify potential errors and also the adverse effects of those errors. FMEA gives an idea of the possibility of error and our ability to detect the error. This process is done by a FMEA team consisting of at least one person and a maximum of ten people. Their task is to estimate the possibility of defects and their effects.
The FMEA team will identify high risk priority numbers (RPN) as the basis for the development of quality and control procedures. Measurements will be made base on RPN results throughout the manufacturing process. For example, NASA uses FMEA to identify potential errors that could occur in the US astronaut landing program to the moon, and then back to earth.
Measurement System
To ensure that your measurement system does not cause errors in the process, the manual and electronic calculation tools must be calibrate. The measurement is part of the repeatability and reproducibility (R & R) gauge. The R & R gauge is express as a percentage of errors in measurement.
Reading errors from most error measurements are generally less than 10 percent. However, for critical work, such as pharmaceutical production, error reading only reach 3 percent. These factors determine the risks involve in the customer as well. This step is also useful in reducing costs, preventing loss of confidence in the company.
Lead Management
Some quality management systems lead to Six Sigma. The main purpose is to eliminate the causes of defects and errors, and minimize the variation in the manufacturing process. This will reduce costs and increase profits. These initiatives include forming a team that has been train on a particular skill.
A Six Sigma process is measure by the number of defect-free products produce, which are expect to reach 99.99966 percent, or less than 3.4 defects per million opportunities (DPMO / defects per million opportunities). To achieve this, the process must first be validate. This process refers to the system validation protocol or SVP (systems validation protocol), as part of the company's validation master plan.
An SVP consists of IQ-OQ-PQ validation. This validation will test the QMS in terms of conformity and compliance. Installation Qualification (IQ) is a document verification of equipment feasibility and uniformity. Indicates that its system, system and subsystems are correctly install and in compliance with applicable codes and designs. The IQ also validates that the recommendations from the suppliers are respond appropriately.
Operational Qualification (OQ)
Operational Qualification (OQ is a document verification stating that the system's performances, systems and subsystems have performance that matches the specifications across the range of representative or anticipated operations. In some facilities, OQ can overlap with IQ.
Performance Qualification (PQ)
A Performance Qualification (PQ) is document evidence that defines expect system processes and functions, and produces expect results under normal operational conditions. This documentation can also be a reference to process capability (the anticipate amount of defects per million).
The best QMS system will fail if not done with preparation. Trace audit is vital to do once the system is establish. Trace audits ensure certain things like:
- The operation is perform in accordance with QMC written and approve.
- Adequate quality system is form and maintain.
- All personnel have been properly train.
- Record training is update and maintain accurately.
For example for trace audit: let's say you create 30 products for customers. Then the customer comes to do the audit. The audit team of your customers wants to see the system documentation for product # 1 and product # 2. Your customer audit team then searches for documentation depicting every step taken (training, APQP, FMEA, process design, gauge control, first article inspection and approval, in-process inspection, finish, final inspection, retention period for quality records, etc.) .
Since you do not know from the start which products will be audit by customers, all quality recordings should be fully prepared.
Conclusion
Many businesses, especially pharmaceuticals and biotechnology, must ensure that the products they make meet demand and needs in terms of identity, resilience, quality and purity.
Companies that are undergoing operations with the above regulations will expect the same from their suppliers. To do this requires a dedicate management team, well-trained and commit employees, regular audit activities, and most importantly, a solid and clear quality management system.
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