Quality Systems, Part 1
FDA, Happy Customers, Medical Devices, QMS, QS, Quality System
One of the challenges companies face is developing, implementing and maintaining a Quality System, QS (or Quality management System, QMS). And I have found great satisfaction in helping companies, large and small, gain a better understanding of:
- What a Quality System is;
- How a Quality System can be implemented in a way that not only doesn’t bankrupt the company, and actually helps the company be a better company;
- How to maintain a Quality System that continues to provide value to the business.
This is the first in another series about some things I’ve learned about Quality Systems that can really help your company be a better company. To begin, in order to understand what a Quality System is, it’s best to understand what quality is.
FDA puts it this way:
“the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance”.
While ISO 13485 does not explicitly define quality, it refers to quality in the introduction to Quality Management Systems this way:
“(ISO 13485) can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements”.
I have combined these two perspectives with my own view of quality from my experiences with everything from quality medical devices to quality restaurants to quality cars:
“happy Customers”
I believe it’s that simple: if you have happy Customers, you have achieved quality.
For medical devices, this must consider the “Customer” to include the person or entity that buys the product, the Users who use the product to deliver healthcare, and most importantly the Patient whose healthcare outcome is most affected by the product.
With this definition of quality, it’s fairly easy to define Quality System:
“an organizational structure, responsibilities, procedures, processes, and resources that results in happy Customers”.
So here’s the tip:
Develop, implement and maintain a system of processes that work together to result in happy Customers.
For medical device companies, this consists of the following groups of processes:
- Processes that result in device designs that meet or exceed Customer needs and expectations
- Processes that result in consistently producing devices that meet or exceed Customer needs and expectations
- Processes that continue to ensure devices meet or exceed Customer needs and expectations after production
- Processes that support the previous three groups
Here’s a list and basic description of specific processes in each of the (4) groups of processes in a medical device Quality System
Design Processes
- Design Controls
Production Processes
- Production and process control
- Identification
- Traceability
- Process validation
- Receiving, in-process, and finished device acceptance
- Acceptance status
- Nonconforming product
- Device labeling
- Device packaging
- Handling
- Storage
- Device History Record (DHR)
Post-production Processes
- Distribution
- Installation
- Complaint files
- Servicing
Support Processes
- Management responsibility
- Quality audits
- Personnel
- Document Controls
- Purchasing Controls
- Inspection, measuring, and test equipment
- Corrective and preventive action
- Device Master Record (DMR)
- Quality system record
- Statistical techniques
Design Controls
This process covers the development of a product from after feasibility to transfer to manufacturing, and any changes after transfer to manufacturing.
Production and process control
This process covers the ongoing manufacturing of products.
Identification
This process covers the identification of products by unit, lot or batch using such methods as Serial Numbers, Lot Numbers or Batch Numbers.
Traceability
This process covers the tracing of critical components by unit, lot or batch into the associated finished unit, lot, or batch, as well as tracing finished units, lots, or batches to where they were distributed.
Process validation
This process covers the establishment and validation of process controls to ensure the manufacture of components or products which cannot be verified by subsequent inspection and test.
Receiving, in-process, and finished device acceptance
This process covers the inspection, test or other acceptance processes at incoming, in-process and final stages.
Acceptance status
This process covers the identification of all components, sub-assemblies and finished products as to whether they are “accepted”, “rejected” or “not yet determined” (on hold pending inspection and/or test).
Nonconforming product
This process covers the handling of components, sub-assemblies and finished products that do not meet specifications.
Device labeling
This process covers the labeling on products, provided with products (i.e. User Manual) or on the product packaging.
Device packaging
This process covers the selection and verification of product packaging, and the actual packaging process prior to shipment.
Handling
This process covers the handling of components, sub-assemblies and finished products from point of receipt through to shipment, including devices used for handling.
Storage
This process covers the facilities, environment, methods and devices used to store components, sub-assemblies and finished products from receipt through to shipment.
Device History Record (DHR)
This process covers the creation of records to demonstrate that each finished unit, lot, or batch was produced per the current DMR, including traceability of constituent elements.
Distribution
This process covers the records of when, to where, and the identification numbers of each finished unit, lot, or batch shipped.
Installation
This process covers the installation of and any associated verification activities for products that are installed by the Manufacturer’s personnel.
Complaint files
This process covers the handling of any reports that allege deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Servicing
This process covers the activities by the Manufacturer to maintain products in proper working order, or return products to proper working order, after they have been placed into use.
Management responsibility
This process covers the ongoing review and decision-making process by management to keep the Quality System operating effectively.
Quality audits
This process covers the ongoing checking of the processes of the Quality System to ensure documented procedures are being followed and are effective.
Personnel
This process covers the selection and training of a Manufacturer’s staff to ensure only safe and effective devices are design, produced and shipped to Customers.
Document Controls
This process covers review, approval and availability of documents that are used in and/or produced by the Quality System.
Purchasing Controls
This process covers the selection of Suppliers, and the procurement of components and sub-assemblies used to produced finished products, or services provided that are part of the Quality System.
Inspection, measuring, and test equipment
This process covers the design, assembly and validation of equipment and fixtures used for Acceptance activities.
Corrective and preventive action
This process covers the review of data regarding the performance of the Quality System, and activities undertaken to prevent or correct the occurrence of nonconforming productor other quality problems.
Device Master Record (DMR)
This process covers the establishment and maintenance of the “recipe” for each finished product including materials, manufacturing processes, acceptance activities, packaging, labeling, installation, maintenance, and servicing.
Quality system record
This process covers the storage and retention of Quality System procedures and records produced by those procedures.
Statistical techniques
This process covers the selection and use of appropriate statistical methods used in Quality System processes.
If these processes are implemented in a complete and consistent way that works together to continuously result in happy Customers, you will have a Quality System.