Medical device re-registration, the need to submit the product quality tracking report how to write, the best model, thank you!

Product

Product

Quality

Quantity

Tracking

Report

Report

Medical bed product quality tracking report

Medical beds since the approval of the registration of the production of March 31, 2003 to March 31, 2008, **** production of 4,298 sheets, a delivery of qualified 4,123 sheets, 95.93% higher than the planned target of 2.00%. Delivery and inspection qualified 4123, a delivery and inspection qualified rate of 95.93%, 2.00% higher than the planned target.

I. Enterprise quality control measures for products and internal audit of product quality review:

1. In order to ensure the realization of the enterprise quality policy and quality objectives, product quality has taken the following control measures:

(1) Clearly define the enterprise internal functional institutions, the responsibilities of personnel at all levels, the authority and the corresponding remuneration.

(2) Reasonable allocation of resources necessary for the normal operation of the quality system.

(3) the development of feasible quality management system and quality reward and punishment system.

(4) Starting from the source, the procurement of raw materials, the strict implementation of the supplier evaluation and screening system, so that the procurement work is always in a state of control, so that unqualified raw materials shall not be put into production and use.

(5) clear production schedule and product quality conflict, should give priority to ensure product quality.

(6) strengthen the control of the whole production process, especially the key process, strict process discipline assessment, strengthen self-inspection, mutual inspection, sampling, so that product quality is always under control.

(7) Strengthen the maintenance of production equipment, inspection instruments, so that they are in a good accuracy level and controlled state.

(8) regularly or irregularly carry out quality analysis activities, develop product quality improvement plan, timely treatment of products in the production process of technical quality problems.

(9) To analyze, deal with, and formulate improvement measures for non-conforming products in accordance with the principle of three no spares.

(10) Strengthen the production site and warehouse management, raw materials, semi-finished products, finished products are stacked in an orderly manner, the warehouse is ventilated, bright, clean, and in strict accordance with the three-color five-zone stacking management.

2, the inspection of product quality

The company was certified from March 31, 2008 after three years of product quality inspection is:

The year of last year's unqualified items have been rectified and corrected, and fully verified by the inspector, mainly in the company's staff quality awareness has improved greatly, product quality is stable and has increased, product sales market Further expansion, service quality has been strengthened and guaranteed, customer satisfaction reached 99%, basically no customer complaints. Production environment has been improved, the allocation of resources is more reasonable, the quality of the target is practicable, three years of quality objectives have been completed and slightly improved, the enterprise's overall quality management is more standardized and rationalized.

According to the audit, the following three aspects need to be strengthened:

(1) Further strengthen the training of employees, especially the training of laws, regulations and skills.

(2) Each department should do a good job in collecting various information and analyzing the data, and make records.

(3) Formulate practical sales policies, increase the construction of the sales team and sales efforts, and strive to produce more, sell more, collect more and make more profit.

Two, the product in the use of the process of user feedback on product quality:

Enterprises have to send product quality questionnaires to customers at the beginning of each year, to understand the quality of the company's products in the process of using the quality of the company's products, based on the quality of the feedback questionnaire statistics concluded that: the company's product quality is stable and reliable.

In 2009, for example: the company sent 158 quality questionnaires, feedback 98, of which there is no quality problems, the user is satisfied with 94, accounting for 96%, there are quality problems, the customer is not satisfied with 4, accounting for 4%, the 4 information sheets of the 4 products in 1 due to packaging is not firm, in the long-distance transportation of the product screws loosened, affecting the quality of the delivery, the user is not satisfied; the other 3 products itself no quality problems, due to transportation delays in the delivery period, the explanation of coordination work is not timely, the user is not satisfied.

Although the above problems have been sent to install, debugging, apologize to the user, but the problem is objective, in the user's influence is difficult to eliminate.

In response to the above problems, this year we have reinforced all the factory products in the packaging, the equipment in the box without the possibility of movement, and strengthen the contact with the freight company, communication, to ensure that the product is safe, quality and on time to the hands of customers.

Third, the product cycle inspection, daily factory inspection of product quality, drug supervision and management department product quality supervision and sampling:

1, the product cycle inspection, daily factory inspection of product quality.

Over the past few years, the product quality of the company has been relatively stable and gradually improved. In 2009, for example, the company produced 1150 sheets of this type of equipment, a qualified 1115 sheets, the qualification rate of 97%, after the return to repair all qualified, the final qualification rate of 100.00%.

Several main inspection indexes are as follows:

Sequence

No.

Standard requirements

1

Heavy loads in the middle of the position of the amount of concave <50mm

2

Residual l amount of 24h<3mm

3

Heavy weights in the bed frame on either side of the amount of concavity <20mm

This is a good example. The amount of concave <20mm

4

The amount of residual l after 24h <5mm

5

The bed and the bed surface should be fixed securely and not loose after assembly.

6

The length of the bed surface 1900-2000mm

7

The height of the bed surface from the ground 480-630mm

8

The back frame of the maximum folding angle of ≥ 65 degrees

9

Foot Frame Maximum folding angle ≥ 50 degrees

10

The headboard curved round the two diameters should be <90mm

11

The appearance of neat, the surface shall not have a front, burrs, scars and other defects.

12

Welds should be uniform, there shall be no burns, cold type, leakage welding and other defects.

13

Rocker operating resistance <2000g

14

Clockwise rotation of the back frame, the foot frame rises, and vice versa falls.

15

Swing handle should be dismantled when not in use, not allowed to be exposed outside the bed frame.

16

The footlocker should be accurate and reliable when it falls into the slot.

Four, the enterprise implementation of adverse event monitoring system and monitoring of adverse events:

Enterprises have established an adverse event monitoring system by the sales company at the beginning of each month by telephone or visit and other forms of users or agents to understand the use of the product in the user.

Under normal circumstances, the sales company once a month to fill in the user to use the product information in the adverse event report form, and explain that the situation is normal, no adverse events, the end of the month to report to the Quality Department, the implementation of the zero adverse event reporting system.

When an adverse event occurs, the sales company timely fill out the adverse event report form reported to the quality department, the quality department timely reported to the general manager. The Quality Department is responsible for reporting adverse events to the external authorities in a timely manner.

In recent years, the company has no adverse events, and there is no record of adverse events.

Fifth, the enterprise collected information about product quality, statistical analysis and measures taken and verification:

Enterprise 2011 *** sales of medical beds 1120, received quality information feedback form 12, that is, there are 12 products have occurred in varying degrees of quality problems, accounting for the number of sales of 0.015% of the 12 products *** repair or replacement of parts 18 Problems, but are not the main key pieces of the problem, there are 12 sheets of pieces, accounting for 66.66% of the 16 problems, indicating that the quality of outsourced pipe fittings problems, in response to the problem, the Ministry of Technology and Production and Supply Department *** with a variety of domestic supply pieces of the supply quality of the collection of the analysis, that the current domestic rubber seals the level of quality can not be achieved for life, only to take the replacement of wearing parts to solve this problem, the So in the product packaging with wearing parts.

From the user feedback quality information, experience proved to be basically true, the feedback of the problem after repair or replacement of the user is very satisfied with the user's favorable opinion.

The overall situation of enterprise product quality is good, over the past few years, both in the production process, or sold products have not appeared in the major quality accidents, small problems are also very few. Product quality and user satisfaction are improving, we will continue to work hard to further strengthen the quality management and after-sales service, so that users of the company's products more assured and satisfied.

Attached: 1 copy of product quality questionnaire

Legal representative's signature: Wang Guanfu Shandong Ming Gansu Medical Equipment Co.

March 31, 2012 March 31, 2012

Product quality questionnaire

Product name

Specifications

Sequence

No.

Standard Requirements

Real Data

Remarks

1

Heavy load in the middle of the position under the amount of <50mm

2

Residual amount of 24h <3mm

3

Heavy weight in the frame of either side of the amount of under the amount of <20mm

4

The amount of residual l after 24h <5mm

5

The bed and bed assembly should be fixed firmly and not loose.

6

The length of the bed surface 1900-2000mm

7

The height of the bed surface from the ground 480-630mm

8

The back frame of the maximum folding angle of ≥ 65 degrees

9

Foot Frame Maximum folding angle ≥ 50 degrees

10

The headboard curved round the two diameters should be <90mm

11

The appearance of neat, the surface shall not have a front, burrs, scars and other defects.

12

Welds should be uniform, there shall be no burns, cold type, leakage welding and other defects.

13

Rocker operating resistance <2000g

14

Clockwise rotation of the back frame, the foot frame rises, and vice versa falls.

15

Swing handle should be dismantled when not in use, not allowed to be exposed outside the bed frame.

16

The footlocker should be accurate and reliable when it falls into the slot.