This blog explores the legal implications of Document Control. While the title identifies ISO 9001, the same legal implications apply to ISO 13485, FDA’s Quality System Regulation and all other quality management systems, e.g. TS/ISO 16949, TL 9000, AS 9000, etc. This exploration will be done through a series of statements.
Quality Management Systems such as ISO 9001 must have documents and records to maintain the integrity and consistency of the QMS from product design to process control to post-production and to effective corrective and preventive action. Regulated systems such as the EU’s ISO 13485 and FDA’s QSR, use documents and records to assure that regulatory requirements are being satisfied.
Documents and records also provide critical information to attorneys and courts in litigation. While ISO 9001 provides an excellent platform to address legal issues and liability exposure, it requires a different skill set and professional expertise to conduct product liability and product safety audits vis-à-vis an ISO 9001 QMS or FDA QSR to reduce liability exposure.
Statement #1 “If you can’t prove it, it doesn’t exist!”
Central to a legal defense in product liability lawsuit is the ability of a company to prove that it makes a safe product. Proof of product safety begins with design. Consequently, design documents must be able to demonstrate that safety was a key issue when the product was designed. Since lawsuits generally occur years after the product was designed, the quality of the design files is critical.
In most cases the people who have created these files will have moved on to other positions, other companies or retired when the files are called upon in a lawsuit. It is a one reason that I walk people through a risk management/risk analysis such as ISO 14971 and draft the first copy for their editing. I explain that although I am a lawyer and not an engineer, all questions must be answered yes, no, n/a and written in clear English that will defend the company in case of questions by FDA, an EU government or product liability lawsuit.
A company may believe that it designs the best and safest products on the market, but, “If you can’t prove it, it doesn’t exist.” I once made this statement concluding a presentation to a group of medical device professionals, to be followed by an FDA representative who said, "What he just stated is true for FDA."
Everything you write can and will be used against you
While good documents are vital to manage an effective ISO 9001 QMS, bad documents can lead to grief in a courtroom. Poor and or careless communications include the following: QMS audit reports; Non-conformities; CAPA Reports & Minutes; Management Review Minutes; Safety Reports, i.e. risk analyses/hazards analyses, FMEA, HAZOP, Human Factors Studies, Essential Safety Requirements Checklists, EN Safety Standards, Technical Files; Validation Master Plans, Validation (IQ, OQ, PQ) Protocols & SOP’s; Memos; Field Notes; E-mail; Voicemail; electronic & paper records; meeting minutes, discussions, marginalia; correspondence; day planners; project documents; customer complaints, etc.
Each of the preceding type of communication has been brought into various lawsuits and each has contributed to adverse decisions against manufacturers. Words such as defective, negligent, unsafe, unreasonably dangerous, hazardous, reckless, callous, malicious, completely safe, shatterproof, harmless, indestructible and failsafe, etc., raise questions about the safety of a product.
An example helps to underline this point. A mid-level engineer writing a “ stream of conscious memo” to his boss recommended a small design change resulting in a California jury award compensation and punitive damages of $100 million dollars. The memo stated that the manufacturer could dramatically improve the safety of a product by incorporating a .30 cent design modification. The manufacturer decided to disregard the modification on a cost-benefit analysis. A decade later the Plaintiff’s attorneys located the memo during discovery and used it as a centerpiece of the Plaintiff’s personal injury in a catastrophic burn case. Similar memos have had similar impacts in other product liability cases.
Every type of communication is fair game in a lawsuit. Plaintiffs attorneys have turned to electronic communications such as e-mails believed to have been erased or trashed and have been retrieved them through electronic sleuthing and used them successfully in lawsuits. Only a small portion of these types of documents would fall under ISO 9001 document control, but the types of communications identified are also used in the operation of quality management systems.