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Sec. 820.20b Management Responsibility. |
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(b) Organization.
Each manufacturer shall establish and maintain an adequate organizational
structure to ensure that devices are designed and produced in accordance with
the requirements of this part. Interpretation:
It is the organizations responsibility to put in place an
infrastructure to adequately develop and produce the medical device. It is not adequate to explain to the
FDA that resources were limited to effectively produce a medical device. Though this may seem obvious you
would be surprised how many organization explain to the FDA that they had to
do without certain provisions simply because there “wasn’t enough money in
the budget” (see FDA warning letters). (1) Responsibility
and authority. Each manufacturer shall establish the appropriate
responsibility, authority, and interrelation of all personnel who manage,
perform, and assess work affecting quality, and provide the independence and
authority necessary to perform these tasks. Interpretation:
You
should have a company organization chart to demonstrate to the FDA how all
people in your company are organized.
This is especially important to show who the top executives are since
they will be held accountable for major decisions. You will also need to have in place descriptions of each
of the jobs your personnel are responsible for. (2) Resources.
Each manufacturer shall provide adequate resources, including the assignment
of trained personnel, for management, performance of work, and assessment
activities, including internal quality audits, to meet the requirements of
this part. Interpretation:
As
indicated your company is required to have resources. You also need to show that personnel
have been trained to perform their particular job function. It is also important to demonstrate
that the training was effective. Internal
quality audits are critical to show that an organization is following it’s
quality system as designed. The
FDA will ask to show evidence of this in an audit. They wouldn’t necessarily ask to see what the observations
were or how the corrective actions were implemented. (3) Management
representative. Management with executive responsibility shall appoint,
and document such appointment of, a member of management who, irrespective of
other responsibilities, shall have established authority over and
responsibility for: (i) Ensuring
that quality system requirements are effectively established and effectively
maintained in accordance with this part; and (ii) Reporting
on the performance of the quality system to management with executive
responsibility for review. Interpretation:
In
both 3(i) and 3(ii) many organizations have found having a Quality manager
with equal authority (such as a vice president). One of the tasks of this person is to report findings of
the Internal Quality Audit to management with executive responsibility. (c) Management
review. Management with executive responsibility shall review the
suitability and effectiveness of the quality system at defined intervals and
with sufficient frequency according to established procedures to ensure that
the quality system satisfies the requirements of this part and the
manufacturer`s established quality policy and objectives. The dates and
results of quality system reviews shall be documented. Interpretation:
ISO
9001 calls this ‘Management Review Meeting’. This is done at least once a year and occurs as frequently
as quarterly. Among the items
discussed at this meeting are the number of nonconformances, customer
complaints, and any other deviations that quantify the effectiveness of the
quality system to reduce problems and improve product quality. An effective quality system should
see a reduction in the percentage of problems over time. (d) Quality
planning. Each manufacturer shall establish a quality plan which defines
the quality practices, resources, and activities relevant to devices that are
designed and manufactured. The manufacturer shall establish how the
requirements for quality will be met. Interpretation:
This
is literally a plan that states the goals of the organization to improve the
quality of it’s products. An
organization should be ready to show this plan to the FDA during an audit. (e) Quality
system procedures. Each manufacturer shall establish quality system
procedures and instructions. An outline of the structure of the documentation
used in the quality system shall be established where appropriate. Interpretation:
In
essence the quality system must be documented. A one page summary should be efficient to show how all
elements of the system come together to formulate the entire system used in
the quality of the product.
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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