What are examples of the elements of Quality Control System and the activities of analytical testing?

Our company will be audited by European Medicines Agency this coming May. They asked, ';What are the elements of our quality control system? What are the activities of analytical testing, packaging and component testing?'; I have a hard time to understand the content of the questions. I was wondering they expect answers, such as calibration verification, and verification of method performance specifications for the first question, and evaluation of analytical methods for the second. If someone can give me some example, that would be a big help. Thanks.What are examples of the elements of Quality Control System and the activities of analytical testing?
Yes, you need help fast and this space does not contain enough room to answer everything that you need to get ready for 鈥?however, maybe I can get you started 鈥?





I am an IRCA QMS 2000 Lead Auditor and very much understand what is being ask!








First 鈥?reference materials that you should be aware of:





European Quality Award 鈥?http://www.efqm.org/


Malcolm Baldrige National Quality Award 鈥?http://www.quality.nist.gov/


ISO 鈥?Quality Management System (QMS) 9000 series 鈥?http://www.iso.org/iso/home.htm


American Society for Quality (ASQ) 鈥?http://www.asq.org








The EFQM and Baldrige are quality awards 鈥?these look at the best of the best organizations.





ISO (International Organization for Standardization) standards (which is similar to what you are going through) is set up on a base level that any company or organization should be able to meet.





Your goal should be to get somewhere between what the standards are asking for and the top-level quality awards. The probability is that your organization is already doing a lot of thing very good 鈥?also called customer satisfaction.





Now for the quality control system (also called a quality management system). The ISO 9000 series breaks this up into five categories: Quality Manual; Quality Management; Resource Management; Product Realization and the Measurement System. The auditors want to first see what type of a documented system you have to control the overall processes for the business that you are in.





So if you are making some kind of a widget, how has your organization planned to produce what is wanted by the customer, the steps that are gone through to actually make the widget including any product testing of supplier parts or actual components and how the widgets are packaged, shipped and delivered to the customer so that no damage is done to the widget. Once all that is done, how do you know that the customer likes what you sold to them?





Ideally, what you need is some form of documentation (keep is as simple as possible) using the outline of the ISO 9001:2008 below








4 Quality management system


4.1 General requirements


4.2 Documentation requirements


4.2.1 General


4.2.2 Quality manual


4.2.3 Control of documents


4.2.4 Control of records





5 Management responsibility


5.1 Management commitment


5.2 Customer focus


5.3 Quality policy


5.4 Planning


5.4.1 Quality objectives


5.4.2 Quality management system planning


5.5 Responsibility, authority and communication


5.5.1 Responsibility and authority


5.5.2 Management representative


5.5.3 Internal communication


5.6 Management review


5.6.1 General


5.6.2 Review input


5.6.3 Review output





6 Resource management


6.1 Provision of resources


6.2 Human resources


6.2.1 General


6.2.2 Competence, awareness and training


6.3 Infrastructure


6.4 Work environment





7 Product realization


7.1 Planning of product realization


7.2 Customer-related processes


7.2.1 Determination of requirements related to the product


7.2.2 Review of requirements related to the product


7.2.3 Customer communication


7.3 Design and development


7.3.1 Design and development planning


7.3.2 Design and development inputs


7.3.3 Design and development outputs


7.3.4 Design and development review


7.3.5 Design and development verification


7.3.6 Design and development validation


7.3.7 Control of design and development changes


7.4 Purchasing


7.4.1 Purchasing process


7.4.2 Purchasing information


7.4.3 Verification of purchased product


7.5 Production and service provision


7.5.1 Control of production and service provision


7.5.2 Validation of processes for production and service provision


7.5.3 Identification and traceability


7.5.4 Customer property


7.5.5 Preservation of product


7.6 Control of monitoring and measuring devices





8 Measurement, analysis and improvement


8.1 General


8.2 Monitoring and measurement


8.2.1 Customer satisfaction


8.2.2 Internal audit


8.2.3 Monitoring and measurement of processes


8.2.4 Monitoring and measurement of product


8.3 Control of nonconforming product


8.4 Analysis of data


8.5 Improvement


8.5.1 Continual improvement


8.5.2 Corrective action


8.5.3 Preventive action





Again, this is your starting point. The next thing will be to show the auditors how you are continually improving the companies system to do better!