Common Quality System Challenges: Document Change Control

Posted on: June 6, 2018

One of the challenges for medical device companies, especially startups, is reviewing, approving, and implementing changes effectively as part of the Quality Management System.  Startup companies have varying degrees of knowledge and experience with Quality Management Systems.  The following are some of the common hurdles to overcome when meeting Document Change Control requirements whether it is FDA or ISO 13485:

  • Will the change justification meet Quality and Regulatory requirements?

To write an understandable and supportive justification takes time and thought.  When changes are urgent and the team driving the change is overloaded and being pressured, then the language for the change ends up incomplete.  It is important to remember that the quality of your product is dependent on the quality of the documentation.  Therefore, it is better to spend the time and get the documentation as good as it needs to be to meet the risks of the product.

  • Was there a proper “where used” done to make sure all affected parts and documents are being addressed?

A common mistake is to use memory or an internal “expert” on which parts and documents are affected.  A system is needed to ensure consistency.  The system can be electronic or paper, but it should ensure that everyone can search the same way and get the same results.

  • Have training requirements been properly captured and completed prior to closing the change order?

Everyone understands the importance of training, especially for new employees.  It becomes a bit difficult to assess and execute training for changes. The extent and significance of the changes will determine the training requirements, and the training matrix can help determine who needs to be trained.  Rewarding and recognizing employees who are regularly meeting new training requests is a great way to encourage others to follow suit.

  • How do you make sure the change is assessed properly? Do you rely on the memory of the reviewers, or have detailed procedures and checklists?

Sometimes what appears to be a minor change to a component or process can have significant repercussions to the design of other components or subassemblies, production processes, or the suppliers who produce the part.  It is very helpful to have a checklist of questions as part of your change order process to confirm the change is assessed and properly qualified / implemented.

  • Are materials properly dispositioned and suppliers notified of changes?

When part numbers are changed, it is easy to lose track of inventory related to that part.  Typically, the materials department gets involved to help decide how to handle the materials in the pipeline from raw materials to finished goods.  This will be determined by the significance of the change.  If the part is made by a supplier, the purchasing department or document control can send the updated specifications and provide direction on what to do with inventory in progress or already produced.

  • Does the completed form meet Good Documentation Practices (GDP), especially if done on paper?

Blank spaces or incomplete fields on the change order form are common, as well as changes made without traceability of who made the change.  Thorough review helps reduce these errors, but creating a user friendly form that allows users to add rows as needed, or use “N/A” boxes can make it more intuitive to prevent these type of documentation errors.

Clearly, a lot of things can go wrong with what would seem to be a relatively simple process.  Monitoring Change Control performance through auditing by your Document Control specialists and tracking the quality of each change order is a great tool to help improve the Change Control process.  In addition, the results can be shared during Management Review to show the effectiveness of this process.

Contributed by Vee Arya, a Quality Director at Cannon Quality Group with over 25 years in medical device experience in all aspects of quality leadership and support (Quality Strategy and Objectives, Design Control, Production Support, Process Validation, Complaints, CAPA, NCRs, Supplier Management, Management Review, etc.)

Cannon Quality Group provides outsourced Quality Management System solutions to startup medical device companies that are engineer focused and compliant. Cannon’s number one priority is delivering QMS solutions that make sense for the stage and goals of its clients’ business. Cannon Quality Group’s mission is to be the Change in Qualitywww.cannonqualitygroup.com.

Testimonials

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

-Scott Russell/President and CEO at Emboline, Inc.

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

-Caroline Jewett/Consultant for PvP Biotech

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

-Tom Mason/Director QA, Vactronix Scientific

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

-Don Bogue/President/CEO, Compact Imaging

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

-Kathleen Perry/Twist Biosciences

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

-Gideon Wald/CTO Welkin Health

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

-Peter Wulff/CFO JenaValve

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

-David Hesting/QA Director, Profusa, Inc.

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

-CQG client/

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

-CQG Client/

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"

-Delane Dale/Quality Director – BioInspire Technologies
Need a Controlled Environment?
/* */