Business menu: QMS measures for update survey of medical device manufacturing and sales industry

Five years have passed since the law was revised in November 26, and an updated survey of the medical device manufacturing and sales industry is being conducted.

　

Our support administrative scrivener corporation supports such customers.

　

・Procedure manuals have been prepared, but they are not being implemented. The record is also mediocre.

・Last time, I asked a professional to make it for me, but now they just made it for me.

・I don't know what kind of records to start with.

1. Review of procedure manual

We worked together to create procedure manuals and product standards in order to comply with the legal revisions.

　

The original procedure manual was only a few pages long, and there were many things missing from the manual, so it was expected that it would be difficult to overcome the on-site investigation.

　

Therefore, we started by reorganizing the procedure manual.

　

As a first step, we provided a draft procedure manual from our support administrative scrivener corporation.

　

Since it was a company that we had been working with for many years, we asked them to listen and see the process in detail, so as not to change the actual work flow, and then presented them with a procedure manual that matched their work flow.

　

Additionally, although there was a change in the person in charge, the original procedure manual had not been updated and old information remained, so we took this opportunity to update the procedure manual to match the current situation.

　

At that time, it was discovered that there were changes that required notification, so we were unable to apply for renewal without first completing the change procedures. After checking the current status and past application status, we identified matters that required change procedures, successfully completed the change procedures, and applied for renewal.

　

Have there been any changes when applying for renewal? Please also check carefully. With the procedure manual in place, the second step was to prepare product standards and other documents.

　

Product standards were created for each product, but there was a lack of content.

　

This is a case seen in many companies, and it is a point that you need to be careful about.

　

Although the items in the product standard documents have changed due to legal revisions, the old laws are often still used. (Reference: Enforcement Notification (H26.8.27 Pharmaceutical Food and Drug Administration Bureau No. 0827 No. XNUMX))

　

First, we created a model for a product standard that met the requirements, understood the manufacturing flow, testing and inspection procedures, packaging labeling, etc. for each product, and compiled the product standards for all products into a file.

　

On the day of the investigation, government officials confirmed the contents of the procedure manual, and then checked the contents of the product standards by picking up the products that were shipped the most from the product standards file.

　

In a survey conducted five years ago, it was said that ``it was not seen to that extent,'' but even within the same prefecture, the areas checked and the severity of audits differ depending on the officer in charge.

　

"Same as last time" is often pointed out.

2. Operational support for procedure manuals

We gave a lecture to those who actually create records so that they could use the procedure manual.

　

First, use our tool (tree diagram) to get an overall picture.

　

It is a tool that allows you to understand the establishment status and relationships of all documents and records, so it seems that you were able to understand the overall picture of the procedure manual without feeling burdened.

　

Next, we gave a lecture on how to use the new procedure manual.

　

It is not realistic to have everyone understand all the procedure manuals and records at once, so we have explained the operation method by focusing on the important points and the records kept on a daily basis and important records.

　

Regarding manufacturing records, the person who actually keeps records on a daily basis was the person in charge of the manufacturing department, so I taught him how to keep records and how to use them.

　

We also checked the records that had been kept during implementation, provided some feedback, and confirmed that it was being operated without any problems.

3. Record creation support

I helped create something that I didn't keep as a record of what I was doing.

　

Although training and education were provided, no records were kept. This is also a case seen in many companies.

　

Therefore, after hearing about current educational methods, we proposed examples of records of appropriate education and training.

　

There are various types of training, including new employee training, OJT, and temporary training when a defective product comes out during regular training.

　

We proposed examples for each format and explained how to keep records in the future.

　

In addition to education and training, internal audits are a part of our internal audits, which we receive from customers who complain that it is difficult to keep good records.

　

Since we have not conducted internal audits or management reviews until now, we took this update as an opportunity to provide support for internal audits as well.

　

Internal audits and management reviews must be conducted regularly, and are points that the government often checks during investigations.

　We explained the basics, such as internal audit methods, audit points, and who is the best person to be an auditor. We also proposed examples of minutes for management reviews, and gave a lecture on how companies can conduct internal audits and management reviews in the future.

4. Support for on-site investigation methods

Immediately before the field survey, we will confirm the flow and important points of the field survey.

　

I visualized the situation when the officer in charge came and got a grasp of the actual flow.

　

The participants started with greetings, learned about the process of checking the manufacturing site, procedure manuals, and records, and asked mock questions.

　

The on-site inspection was completed without any issues and the update procedure was successfully completed.

This time, we explained the flow of support for update surveys for the medical device manufacturing and sales industry and manufacturing industry.

　

Although I have explained specific examples, I believe that the issues and objectives will vary depending on the customer.

　

・I want to overcome the renewal investigation without any burden.

・I want to understand the procedure manual thoroughly when updating it.

・I'm really worried about the field survey

　

Please contact us and we will provide you with advice and support based on your situation.

For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.

At the Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act for everyone, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors. .

Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.

We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.

Our support administrative scrivener corporation has a track record of applications in all prefectures across the country. Please contact us by all means.

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