Planning for the Unpredictability of Change

...and it Begins


Change, defined: The act, process, or result of altering or modifying

Change is inevitable and sometimes even predictable but, then again, that depends. If you’re an orthopaedic device company obligated to follow the edicts of 21 CFR, Part 820 and ISO 13485:2003, the frequency of change is directly aligned with the complexity of your Quality Management System (QMS). Also, the classification of the medical device being designed, manufactured or serviced, the maturity of your systems and the robustness of process control can also have a huge impact on change. What makes it complicated is that these examples of the parameters of change commonly happen in concert rather than in solo. Companies that are not ready for that dynamic can struggle day-in and day-out with a brand of motivation that can be unpredictable and sometimes damaging to compliance initiatives. Change can actually put a company on its heels, especially if these changes are not planned for.


This article cannot do justice to all of the possible changes that can occur in a typical QMS because of company variability and systems’ latitudes. Also, the number and types of changes could be the subject for a substantive volume of work. This article is just an overview that will focus on the changes associated with document control, design and development and purchasing controls. All are hot buttons in the regulated orthopaedic industry that we live in every day.


Document Control Changes

The most common changes that your QMS could experience lie in the areas of document controls. These changes should be reviewed and approved by an individual with the established responsibility and authority to obviate the chance of issuing inaccurate policies, procedures or work-instructions. Single-handedly, the Good Manufacturing Practice Regulations for medical devices require at least 90 to 100 different types of records (objective evidence) to be generated depending upon the scope and process/product risks involved. Records are generated because of procedural demands. If these procedures are frequently changing, for whatever reasons, the outputs will change accordingly. Conversely, if the outputs (process or product) must be revised to enable system compliance, that could place a lot more emphasis on the ramifications of changing for the wrong reasons. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date and when the change becomes effective.


For a more mature QMS, a change control procedure is one of a series of standard operating procedures (SOPs) used to produce and control documents or activities that result in record keeping. This procedure should contain an appropriate degree of flexibility. That is, all changes do not need the same degree of evaluation and approval. Changes that do not receive the necessary evaluation and review could result in hazardous or ineffective devices, as exemplified further into the process. It is never direct root cause. Change dynamics are sometimes masked by process innuendo. Making uncontrolled changes is considered a violation. 21 CFR, Part 820 is a flexible Regulation which allows manufacturers to develop and use procedures that meet specified needs. These are usually established during the design control process, or when a QMS is being constructed.


Design Changes

Changes to a design element are controlled by having each manufacturer establish and maintain procedures for identification, documentation, validation or, where appropriate, verification. The review and approval of design changes before their implementation into the manufacturing phase is a cross-functional phenomenon involving the players that will be affected by the change.


That makes sense. Most of the details of the change control system are left to the manufacturer to develop, document and implement.


After design activities are put into motion and the physical design evolves into an accepted entity, subsequent changes to the device specifications are commonly proposed, evaluated, reviewed, summarily approved and documented as such. The addition and revision of these design inputs in relationship to defined and anticipated outputs will affect the current design requirements in accordance with the procedures for design control, design change control and document control. These changes could affect ongoing choices that have to be made concerning the proper essential requirements and, ultimately, the validated confirmation of intended use supported by a safe and efficacious product.


The impact of making changes becomes a critical path destined to amble into manufacturing where, again, changes can be realized during and after production and distribution. The puzzle starts coming together—until you can’t find the reason why a puzzle piece is missing. Something could have changed.


As the design activity progresses toward the final stage, it is expected that the degree of change control will increase. A design change control procedure should at least address under what conditions change control is required, documenting the reason for the change, any differences in the change control process when outside parties are involved, analysis of the design to identify other elements that are impacted by the change, and, for significant changes (including any change requiring verification and/or validation), placing the reason for the change in the design history file along with the required design verification, validation and review documentation.


Post-production changes to the design can emanate from complaints, corrective actions, preventive actions, medical device reporting, non-conforming product trends, customer feedback, service reports, adverse event trends, etc. Failure can be one instigator of change, especially if you are determined to succeed. These changes are serendipitous in nature, should be based upon trends rather than aberrant results and, for the most part, are fairly unpredictable. Clues to possible design changes can be initially realized during the early stages of hazard determination and risk analysis.


There is a fine line drawn between robustly-presented design outputs and outputs that have their origins cradled between mitigated intent and failure. All of these types of changes should be presented to and filtered through a cross-functional group of people such as a Quality Review Board to make decisions as to scope, risk and ultimately, disposition. The ramifications of design changes, post-production, in comparison to design changes made during the actual design process are far different in scope and in documented intensity. Re-initializing a product into the design process can mean a regulatory resubmission (e.g., a 510(k)), the revalidation of both product (for example, a clinical study) and process, etc.



Purchasing Controls/Acceptance Activities

The dynamic of this relationship between the buying of products, services and raw materials and the activities around disposition and usage is one of the most impactful areas for change and the ramifications of making the correct decisions based upon these changes.


The purchasing process affects design from the early stages of realizing that parts and services must be bought under controlled conditions and summarily monitored as to the success or failure of the design output. There are risks involved during these process steps of evaluating and monitoring the suppliers that can “make or break” the outcome of parts, materials, assemblies, services and ultimately, the device. For example, changing or losing a key supplier mid-way through the design process can have catastrophic results both financially and from a quality/logistics standpoint.


At this juncture in the design process, there has been an investment of time and resources to the extent of “locking” in to device materials and components. This process of “locking in” is primarily based upon successful verification of outputs to desired inputs, and possibly conducting early-on qualification runs or clinical protocol development. The other possibilities evidenced as the design progresses into manufacturing controls could necessitate the re-testing, re-validation and re-design. Commonly, the loss of monies and resources should force the medical device manufacturer to, hopefully, strategize early and with confidence. This grass roots strategic initiative could minimize the chances of changing without control.


After design and during the manufacturing/acceptance activities processes, changes to raw materials, components, assemblies and processes can force a company to revert into the design arena and use the “re” prefixes yet once again. Costly and time consuming is understating the obvious when it comes to those “re” words. “Re” can be an outcome of changes that are out of synch with strategic direction. The cGMP-QSRs and ISO 13485:2003 try to enable manufacturing establishments to preclude those situations from happening by forcing to at least attempt to have suppliers inform their medical device customers of such changes before implementation.


This is important, because the appropriate quality, manufacturing and regulatory decisions can then be discussed before the fact rather than after the “fire has started.” In the ideal world this agreement is comfortable to talk about over lunch, but in the real world, the impact of the size of your company in relationship to the size of the supplier and the necessity to trim costs commonly dictates (and sometimes overwhelms) the notion that that this “heads-up” information will be conveyed.


So, the manufacturer, whether in the design or the commercialization phases, is forced to heighten the scope and intensity of incoming inspection/sampling plans. This is usually not a planned change and, in fact, lacks any measurable benefit at this juncture. By definition, inspection is basically not effective as a process for qualifying products. Control of changes should have a firm foundation based upon process validation, competent core initiatives and measured reliability. Changes of this nature can have far-reaching effects depending upon the design stage gate, i.e., how far along into the design process you are or whether this change is already part of production controls.


…..and in the End


Companies that are overwhelmed with changes on a daily basis are sometimes called “fire-fighters.” One could write a book about this type of company and the beleaguered people who tolerate, fold under and thrive upon their innate ability to make decisions “on the run” and basically on their heels, sometimes falling backward. Some people (and companies) even reward these process-savvy, fire-fighter types as being the knights on shiny white horses as they come to save the day, or have figured out a way to avoid following bulky procedures to enable the shipment of orthopaedic devices to customers on time.


This behavior, unfortunately, becomes part of the company culture, a “way of life,” if you will…and a tough habit to break. This unrelenting kind of company culture could be a signal that process control is not effective. Procedural implementation is, at least, suspect, product and process design is inundated with compliance and reliability gaps, management supports all aspects of “just getting by” and compliance, built upon solid objective evidence, could be in jeopardy.


Relying on the excitement of daily changes can turn the QMS into a carnival ride rather than a controlled and steady regimen of processes that deal with change in predictable manner. The end point of all of the gyrations we go through every day at a medical device manufacturing site is to produce safe and effective medical devices for humans. Carnival rides are not for faint of heart.


John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. Email John at This email address is being protected from spambots. You need JavaScript enabled to view it..

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