I do not have any work experience in this field. However, from what we learned so far. I would choose the second option you posted. Reason being is the work instructions step. This is vital in any Quality Management System as it can reduce many errors in the later steps. The advantages for the first would a similar version which enlists the required documents to complete a task. However, the disadvantage would be more likely leaving room for interpretation for the team. On the other hand, the second option you posted is more detailed and will reduce the time and cost of any project in the long run.

Fady,

I have worked in the past at a fairly large pharma, which had a very thorough QMS system. Advantage of this, is that everything is kind of well characterized, drawback, a lot of paperwork to shift through during training.

I have also worked at a small start-up, nutraceutical, and was there during the actual QMS setup phase. In order to start production as soon as possible, QMS was bare bones, in many instances almost non-existent. But they were making changes to it as the problems came about, even making changes to methods upon how to make changes. Now the advantage they had was it was quick implementation, and changes, due to the whole QA department consisting of 2 people. All they did was churn out SOPs all day long, and got paid very handsomely for it. But I feel if this company were to be audited by the FDA, I'm pretty sure the outcome wouldn't be great.

I wish i had experience on QMS for me it seems very important since quality management system can be defined as the implementation of dedicated activities in a project to obtain continuous improvement, and enhance the organization efficiency. The foremost effort of this system is to correctly and precisely define the procedure that will cause creation of quality products and quality services. The aim is to prevent the errors while within the project, and not after a product has been delivered to the user. There are many benefits to a quality management system, due to which the organizations are devoting more efforts to improve quality management.

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning the process and getting the team trained to understand the requirements for the quality manual, quality procedures and records.
Within the small biotech company, as a clinical manufacturing scientist, my team would constantly be working to formulate SOP’s and identify problems that came about during the manufacturing process and after production runs work closely with QA to provide feedback to the quality documents. Some of the items like work instructions were not created until the manufacturing facility had been established and sample production runs had been run.

Both types of QMS are beneficial for a company to ensure the best quality products and work environment. The first type of QMS takes into consideration the general quality measure by including a quality manual, quality procedures, and records. The second QMS seems to be the more effective approach. With the second method, the work instructions and quality policy are also included so there are more factors that are considered to ensure the quality. In addition, with the work instructions, there is a better chance for employers to create the product more efficiently and make fewer mistakes. As others have mentioned, as well, since the second method requires more factors, it is likely take more time and possibly use more money.

Dimensioning the QMS documentation based on organizational needs is essential for a functional QMS.The first set of QMS requires manuals,record ,procedure are required in simplest form.Small organization focus on documentation should be simple and ultimate customer’s satisfaction .They can have documented procedure included in QMS manuals.The second set of QMS is more effective in finding way balance to regulatory requirement,customer issues,correcting deficiencies.Quality policy sho commitment to continual improvement.work instructions are should be very detailed on how to complete a task .

The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency. Keeping that in mind I believe that the organization that utilizes the 5 different steps would be more beneficial. Assuming that this process is used by a larger organization, the extra steps actually lead to more efficiency due to a more clarity in instruction and step that more stages give. The first set of steps might work for a smaller company just because of the smaller size but might only be tailors to said the company. The policy is a directive of the top management with respect to quality and in addition to work, the instructions can help in reducing errors. In short term, it is a long process but it is more practical in long-term efficiency.

I haven't worked at company that directly deals with this, but I think you can call any document anything so the importance is the content of the documentation. I think the necessary documentation/titles would be what we encountered in this week's simulation. With at the top of the Quality Manual (QM) which is the document that explains how the Quality System will run, like how the materials will be inspected and how their acceptance/rejection need to be documented. The Quality System Procedures (QSPs) explain what will be done in order to fulfill the QM and is described at high level including how each material will have its own Work Instruction. Then the Work Instructions/SOPs which will set how to perform a task that details how the material will be inspected and what do with it after its accepted/rejected and then the SPEC document. Overall I think as long as the content is covered it doesn't really matter the exact title of the documents but I agree the general hierarchy and content is necessary, especially as @gp232 mentions the FDA were to audit.

I have never worked in the industry. With my very limited related experience, I think the best set up of QMS depends on the size and function of the company.If the company is very small, it's ineffective to have such a big quality management system. For example, as @gp232 have mentioned about the QA department consisting of 2 people, as long as it proves to be effective, it would be the right fit. As the company grows, I'm sure adjustment would be made and the QMS has to expand.

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