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					 Are “Land Mines” Hiding
 in Your Supplier Records?
 by John Avellanet
Reprinted with permission from BioProcess International 8(4) (April 2010)




A
         growing trend in US Food                                                               It’s up to you define what the
         and Drug Administration                                                                appropriate balance is for your
         (FDA) warning letters has                                                              company based on risk to patient,
         been citations for “no justified                                                       product quality, efficacy, and other
rationale.” Since 2004, warning letters                                                         such factors. You have to use risk
taking companies to task for poorly                                                             management principles like those in
documented decision-making and                                                                  ICH Q9 (2). You have to assess your
risk-assessment practices has more                                                              risks, decide on controls, and
than doubled — from two in 2004 to                                                              document this.”
four in 2008 and five in 2009. These                                                                Outside the context of a
citations are always in relationship to                                                         conference, risks are not so neatly
risk-based decisions: sampling (what,                                                           assessed, and decisions are not so
how often, and how much),                                                                       nicely documented. This is where
nonconformances and corrective/                                                                 companies get into trouble.
preventative actions (when is “root
cause” actual root cause, when and                                                              Document LanD mines
why should an open nonconformance                                   www.istockphoto.com         Over the course of several days in
investigation be closed out), and                                                               August and September, I interviewed
clinical data decisions (what data to                   mines,’ written statements in the       Singer for my SmarterCompliance FDA
include or exclude, what patients to                    company’s paper or electronic files     regulatory intelligence newsletter
include or exclude).                                    that create havoc when uncovered in     concerning mistakes companies
   As the FDA continues to cajole                       an inspection” (1). Such land mines     continue to make that get them in
companies to adopt risk-based quality                   can be found in a company where         trouble with the FDA (1). During her
systems, such citations are becoming                    decisions about product safety and      time with the US Department of
more common. One area increasingly                      quality intersect with supplier         Justice, she prosecuted seven medical
coming under fire for poor decision-                    management.                             device and biopharmaceutical
making is supplier oversight. Of the                        Regulatory Expectations: When it    companies and their executives for
eleven warning letters noted above,                     comes to controlling risk and           violating FDA statutes and
30% are directly related to supplier                    documenting decisions related to        regulations.
selection, qualification, and control.                  supplier management, FDA officials         Singer is now president of the
Unfortunately, try as you might to nail                 expect you to balance safety and        Compliance Alliance consultancy
down your supplier quality                              quality with your available resources   (www.compliance-alliance.com) and
management standard operating                           and time. As CDRH quality systems       spends a significant portion of the
procedures and forms, poor                              expert Kim Trautman put it in August    year providing corporate workshops to
documentation and records will betray                   at the Supplier Quality Management      executive teams and companies on
you.                                                    Congress, 20 August 2009 in             document land mines that can get
   In an interview for my client                        Washington, DC, “You can’t put the      them into trouble. When it comes to
newsletter, former FDA prosecutor                       same level of scrutiny on all your      supplier oversight and risk-based
Nancy Singer noted, “Companies are                      suppliers as you do on your critical    control records, she noted three
full of what I call document ‘land                      suppliers. There has to be a balance.   common types of document land
10   BioProcess International              April 2010
                                                                                              •
mines: meeting minutes, memos                   justification memos stating their views
to files, and documents stamped                 about solving the issue and pointing
confidential or for internal                    fingers at who or what got in the way
use only.                                       — or noting that the inspectors had
    In meeting minutes, companies too           exceeded the scope of their inspection              Every SOP should
often capture what each individual at           in pointing out the lack of a holistic              have a section that
a meeting says. For instance, “Mary             compliance strategy. Such a memo to                 clearly spells out
said we should ask the distributor to           the file would be classified as a
recall the product. John said that he           document land mine that would give                  what RecoRdS
was concerned about the effect of a             future inspectors impetus to dig                    are produced as
recall on the bottom line. The                  deeper. If the company were ever sued,              part of it.
decision was not to recall the product.”        that file memo would give
When found in your product or                   ammunition to opposing counsel for
supplier files, all such meeting                painting a picture of executive
minutes do is give inspectors                   ineptitude and self-interest.             against the regs, but this investigation
ammunition to dig deeper and                       Stamping Confidential or For           is taking too much time; [the supplier]
question individuals about off-the-cuff         internal Use only on documents is a       is complaining that they’ll have to
remarks they make at meetings when              subtler land mine because it gives        start charging us more if we continue
they might not have all of the facts.           employees a false sense of security.      to delay any further. We should just
To eliminate this type of land mine, it         Here my experiences in defending          close it and wait for the government to
is better to state the overall conclusion       quality systems and internal corporate    take regulatory action.” Is this the
alone: “The team decided not to recall          documents to outside litigators back      type of opinion you actually want to
the product when a health hazard                up Singer’s explanation. Just because     retain in company records?
analysis revealed that there would be           something is stamped confidential             When I give presentations on
no harm to patients.”                           or for internal use only does not         building defensible documents and
    Memos to files can be tricky. FDA           keep it from being subject to review      putting in place FDA records-
inspectors tend to take a negative view         and public disclosure in the event of a   retention programs, I suggest that
of them. A positive use of a file note          lawsuit — nor does it mean FDA            every standard operating procedure
can be when executives realize their            inspectors will ignore the document.      (SOP) should have a section that
company has a gap in its compliance                                                       clearly spells out what records are
program and decide to take action to            suppLier-specific LanD mines              produced as part of it. In the case of a
resolve it. For instance, after an FDA          When it comes to unwittingly              supplier CAPA file, that might be a
inspection of supplier controls one of          endangering yourself in supplier          CAPA form, the root-cause summary
my clients realized that it did not have        management and controls, look no          found in an investigation, and the
any real integration among the quality          further than your supplier                verification report showing whether
management team, the regulatory                 qualification and management files        the preventative controls work(ed).
affairs group, and the supply chain             and your supplier corrective and          Assuming your company also conducts
management staff. As a result, the              preventative action (CAPA) files.         a periodic quality systems
company brought me in to conduct a              Singer suggests that biotech              management review, that might have a
full gap analysis and present a set of          companies be careful in how they          reference to the specific CAPA. But
recommendations and options. It then            phrase their supplier-related CAPAs. I    that’s it; more records could increase
used the memo-to-the-file format to             recommend further that before             the potential of document land mines.
document that process, including                implementing your CAPA program                The same holds true for your
decisions made on which                         — or constructing your CAPA files         supplier selection, qualification, and
recommendations to undertake and                — you carefully determine what            management files. I suggest that
the priorities and timelines for each           documents you actually need to retain     clients maintain a “communication
activity.                                       in your CAPA file and what to be          matrix” for all their critical suppliers.
    According to Singer, where                  cautious about. For instance, most        It would identify who at each
companies get into trouble with file            CAPA files that I’ve seen are not         company plays a role equivalent to
memos are when the memos are                    simply plain manila folders with a        quality manager, regulatory affairs
clearly written in an attempt to protect        single, filled-out CAPA form in each.     manager, computer department
the company or its employees from               Instead, they have printed-out copies     manager, and so on. Then the client
legal and administrative penalties,             of email threads, meeting agendas,        staff should query their counterparts
criticism, or other punitive measures.          investigation notes, and so on. Think     periodically through the year to check
In the situation above, after FDA               about what an inspector will surmise      in and learn what might have changed
inspectors uncovered the lack of                when he or she stumbles on a printed      or is planned that didn’t come through
integration among compliance teams,             email thread with one vice president’s    more formal communication channels.
the executives might have written self-         note reading, “I know this goes           In each supplier file, the company
12   BioProcess International      April 2010
                                                    •
would have its actual matrix — no                                                          management files, supplier CAPA
email strings or personal notes from                                                       files, and correspondence — the
individual conversations. Specifying                                                       company carries a significant amount
the documents to retain for proving                                                        of risk. To control that risk, take a
compliance helps to lower the risk of                     Information                      tiered approach to train personnel how
creating and retaining document land                      retention among                  to minimize document land mine
mines.                                                    attendees at tiered              creation, decide ahead of time what
  Supplier-Related Litigation and                                                          records to retain for every process, and
Land Mines: Inevitably, most                              training sessions                make sure you stay abreast of evolving
companies will be involved in a                           jumps tenfoLd                    FDA expectations when it comes to
lawsuit with at least one supplier. Files                 over the one-size-               documenting risk-based decision-
and documents related to that supplier                    fits-all approach.               making.
— CAPA files and supplier                                                                      As we proceed down the product
management files — will be subject to                                                      lifecycle path embodied in quality by
discovery and disclosure in such a                                                         design and ICH guidelines, our
lawsuit. And those records may also                                                        documented decisions travel with us.
be made public. For example, note the           mines), know what to do when they’re       As Nancy Singer frequently notes,
current release of correspondence and           uncovered, and learn how to work           “Our documents are like diamonds:
files between GlaxoSmithKline and               with staff and line workers to prevent     They are precious and last forever.” To
several of its suppliers in the Paxil           such problems in the future.               control risk throughout a product’s
litigation.                                     Employees need to understand what          development, manufacture,
    One of my biggest surprises over a          document land mines are, how easily        distribution, and postmarket
decade ago occurred when I became               they can slip into files, and how to       surveillance, a sponsor company needs
accountable for records at a                    minimize their chances of creating         to minimize the creation of document
biotechnology and medical device                such problems. To tackle this              land mines for inspectors to find and
company involved in litigation. The             segregation, Singer divided her own        cite. There is no better place to start
“open window” opposing counsel and              corporate workshop, “Dangerous             than in supplier selection,
plaintiffs had for reviewing our                Documents: Avoiding Land Mines in          qualification, and oversight. Are you
internal documents and                          Your Emails and FDA Documents,”            ready?
correspondence was staggering. And              into three different levels: one for
the penalties for not handing over              senior management, one for middle          references
requested documents and emails were             management, and one for general                1 Avellanet J, Singer N. Former FDA
                                                                                           Prosecutor on Document Mistakes.
millions of US dollars. In my                   employees.
                                                                                           SmarterCompliance 3(9) 2009: 8–9.
experience, document land mines                     Such a tiered approach to training
                                                                                               2 ICH Q9: Quality Risk Management.
become very expensive and very                  is the same method I noted as being        Fed. Reg. 71(106) 2006: 32105–32106; www.ich.
dangerous very fast.                            increasingly tied to effective training    org/LOB/media/MEDIA1957.pdf.
                                                in a recent teleconference for FOI             3 Finch J, Montambeau E. Retention Rates
training to controL risk                        Services (www.foiservices.com) called
                                                                                           Arlington, VA, 2000. •
                                                                                           from Different Ways of Learning. NTL Institute:
In addition to determining ahead of             “Making Required FDA Training
time what records will be retained in           Captivating.” Information retention
FDA files, a further measure to                 among attendees at tiered training         John Avellanet is an independent
control the risk of document land               sessions jumps tenfold over the one-       regulatory compliance expert and
mines is training employees and                 size-fits-all approach (3). Different      consultant for executives and business
management how to craft documents               types of documents and records are         owners. He is author of >100 articles and
and correspondence that, as Singer              created at different levels of an          author of the forthcoming book, Get to
points out, reflect your company’s              organizational hierarchy, so a tiered      Market Now! on turning FDA compliance
“commitment to making safe and                  and targeted approach provides a           into a competitive advantage. Avellanet
effective products that comply with             better means to get your environment       publishes the FDA compliance blog called
regulatory requirements” (1). This is           under control.                             Compliance Zen (www.ComplianceZen.
not something you can simply pick up                                                       com) and can be directly reached through
                                                                                           his independent advisory firm, Cerulean
along the way in your career.                   finaL thoughts
                                                                                           Associates LLC, PO Box 498, Williamsburg,
   From Singer’s experience, senior             A company’s records contain the proof      VA 23187-0498; 1-757-645-2864, fax 1-877-
managers need to understand how                 of its decisions, thought processes, and   322-5701; john@ceruleanllc.com, www.
often their employees write                     commitment to product safety,              ceruleanllc.com.
inappropriate statements in company             efficacy, quality, and regulatory
documents and correspondence.                   compliance. Document land mines
Middle management and line                      draw attention to noncompliance.
supervisors need to recognize such              When it comes to supplier records —
statements (e.g., document land                 especially supplier qualification and
14   BioProcess International      April 2010

				
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