Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.
Yep. That’s the word that comes to mind whenever anyone mentions FDA inspections.
But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think. There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome. Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.
Tuesday, August 2, 2016
Tuesday, June 14, 2016
More Than a Warehouse to Me
Impossible to write a love song about FDA warehousing regulations, you say?
Challenge accepted.
(Sung to the tune of Billy Joel's "She's Always A Woman.")
Challenge accepted.
(Sung to the tune of Billy Joel's "She's Always A Woman.")
Tuesday, April 26, 2016
Movie Quotes for QA Professionals
What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.
In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes. Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues. Such a great idea was just asking to be stolen. And who are we to resist the siren call of piracy? So here’s our best attempt at making #QAmovieQuotes go viral.*
…And because the rhymes were just too good, we couldn’t resist…
If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time. Please share your humor! (Fair warning – we took all the good ones.)
By Laurie Meehan
________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.
Photo credits
Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain
In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes. Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues. Such a great idea was just asking to be stolen. And who are we to resist the siren call of piracy? So here’s our best attempt at making #QAmovieQuotes go viral.*
“I’m gonna schedule an audit… he can’t refuse.”
- Vendor Oversight Manager at Corleone Clinical
“Batches? We don’t need to see no stinking batches!”
- Said no GMP auditor ever.
Auditee: “You want candor?”
Auditor:” I want the proof.”
Auditee: “You can’t access the proof!”
(Not even A Few Good Men can view electronic source documents at some sites.)
Auditor:” I want the proof.”
Auditee: “You can’t access the proof!”
(Not even A Few Good Men can view electronic source documents at some sites.)
"Contemporaneous. You keep using that word.
I do not think it means what you think it means."
- Inigo Montoya, CCRP
“I’ve always depended on the kindness of trainers.”
Oh no. Who let Blanche talk to the Inspectors?
“I love the smell of Wite-Out in the morning.”
- Compliance Auditor, Fraud Division
“Get busy complyin’ or get busy tryin’.”
(Motivational poster at Shawshank Consulting)
“Fecal transplants happen.”
“Audits are like a box of chocolates…”
[Sorry.]
“That’s all right. He can call me ‘Sour’ if he wants to. I don’t mind.”
Not every audit is like a trip to Magic Kingdom.
Jr. Auditor: “How do you know it’s a glitch?”
Sr. Auditor: “It looks like one.”
It’s not witchcraft; it’s experience – the holy grail of the QA industry.
“Of all the org charts in all the sites in all the world, you had to look into mine.”
Qualification records are amiss at Casablanca Research Institute.
And amiss is still amiss.
[Again, sorry.]
“What we’ve got here is a failure to refrigerate”
Dr. Luke’s Hand might be Cool, but his Investigational Product isn’t.
(Is the study drug supposed to be the Color of Money?)
…And because the rhymes were just too good, we couldn’t resist…
“What we’ve got here is a failure to investigate.”
“What we’ve got here is a failure to remediate.”
CAPA fail, Newman Style
If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time. Please share your humor! (Fair warning – we took all the good ones.)
By Laurie Meehan
________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.
Photo credits
Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain
Tuesday, March 22, 2016
SOP Revision, SWAT-Style
By Laurie Meehan
SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.
The SWAT Technique
Last month, we worked with a company to revise a set of SOPs using a technique we call SWAT. (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.” It’s the best we could do. Don’t judge.)
The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color. The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time. Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.
It’s Not For Everyone
Up front, we need to say that SWAT won’t work for every organization. While the size of the company may not be important, the size of the working team needs to be fairly small. Also SWAT won’t work for every set of SOPs. The documents need to be part of a natural grouping – a set of similar procedures – and not a random collection.
But in the right situations, SWAT works very well. Last month, we conducted a 2-day SWAT session with a client’s QA department to revise a set of 10 auditing SOPs. We’ve also successfully used the technique with ClinOps teams, for example, to revise sets of monitoring SOPs.
SWAT Planning and Preparation
The SWAT process begins with central planning. A coordination team selects a logical grouping of SOPs to revise, and assembles a list of specific revisions to be made. Where it’s not possible to provide specific revisions, instructions and guidelines are developed, such as “remove audit report distribution details” or “update to reflect new file safeguarding practices.”
Each SWAT participant is assigned an SOP from the revision set. The participant doesn’t need to be the author of record, but must be knowledgeable enough to “represent” the SOP – to learn the document well and understand how it’s similar to the other SOPs in the revision set and in what ways it’s unique. Based on this understanding, prior to the SWAT session, participants make applicable revisions to their individual documents using the information received from the coordination team. Participants should also note questions and any open issues appropriate for SWAT discussion using inline comments.
SWAT Session
The result of the SWAT session is a set of approval-ready SOPs. The precise structure of the SWAT session to get you there depends on a variety of factors, such as how similar or dissimilar the SOPs are, the extent and complexity of the revisions, and whether subject matter expertise is concentrated or distributed among the group. But all successful SWAT sessions we’ve conducted share these attributes:
If you’ve ever worked on SOPs, you know there’s a big difference between done and almost done. To help ensure you emerge from the SWAT session with the former, time must be allotted for participants to format, polish, and conduct a quality review. If it’s possible to scare up some on-site administrative support, that could help expedite the process.
SWAT Benefits
When you look on your team’s Outlook calendar and see 3 entire days blocked out, it can seem like an awful lot of time devoted to SOP revision. But SWAT really doesn’t take any longer than the usual process, it’s just more obvious. Does SWAT take significantly *less* time? Mmmm, not sure, but SWAT brings with it other benefits.
SWAT produces a more consistent set of SOPs. Since every document is compared to every other, it’s easy to notice and correct incidental differences.
SWAT is a cross-training opportunity. Participants enter SWAT knowing their own SOP very well. They leave knowing the whole SOP revision set very well.
SWAT gets it done. Auditors, how many times have you cited facilities for failure to revise their SOPs within the specified window? It’s not because there’s a willful disregard for SOP procedures. It’s because, in the real world of work, revising SOPs is seldom prioritized highly enough to get on anyone’s schedule until the end of the revision window encroaches or – oops – has passed. But schedule a SWAT and they will come. (And because the effort is so visible and so obviously resource-intensive, no one wants to be the one to drop the ball. Participants come prepared and the resulting documents are the better for it.)
SWAT is a lot more fun. Revising SOPs on your own is really boring. Revising them in immersive sessions with colleagues is significantly more enjoyable. Gallows humor reigns supreme. Copious amounts of chocolate are consumed. Air horns are blown in celebration. Friendships, sobriety, and hair color remain intact. Participants live to write another day.
_______________________________________________________________________
Photo Credit: Tenaciousme CoffeeArt, under Creative Commons License
SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.
Last month, we worked with a company to revise a set of SOPs using a technique we call SWAT. (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.” It’s the best we could do. Don’t judge.)
The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color. The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time. Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.
It’s Not For Everyone
Up front, we need to say that SWAT won’t work for every organization. While the size of the company may not be important, the size of the working team needs to be fairly small. Also SWAT won’t work for every set of SOPs. The documents need to be part of a natural grouping – a set of similar procedures – and not a random collection.
But in the right situations, SWAT works very well. Last month, we conducted a 2-day SWAT session with a client’s QA department to revise a set of 10 auditing SOPs. We’ve also successfully used the technique with ClinOps teams, for example, to revise sets of monitoring SOPs.
SWAT Planning and Preparation
The SWAT process begins with central planning. A coordination team selects a logical grouping of SOPs to revise, and assembles a list of specific revisions to be made. Where it’s not possible to provide specific revisions, instructions and guidelines are developed, such as “remove audit report distribution details” or “update to reflect new file safeguarding practices.”
Each SWAT participant is assigned an SOP from the revision set. The participant doesn’t need to be the author of record, but must be knowledgeable enough to “represent” the SOP – to learn the document well and understand how it’s similar to the other SOPs in the revision set and in what ways it’s unique. Based on this understanding, prior to the SWAT session, participants make applicable revisions to their individual documents using the information received from the coordination team. Participants should also note questions and any open issues appropriate for SWAT discussion using inline comments.
SWAT Session
The result of the SWAT session is a set of approval-ready SOPs. The precise structure of the SWAT session to get you there depends on a variety of factors, such as how similar or dissimilar the SOPs are, the extent and complexity of the revisions, and whether subject matter expertise is concentrated or distributed among the group. But all successful SWAT sessions we’ve conducted share these attributes:
- Duration of 2 to 3 days. Just long enough to accomplish the aggressive goal, just short enough to keep everyone from diving out the window.
- Real-time revision. The “SOP of the hour” is projected on a screen while participants sit in front of PCs and update their assigned SOPs accordingly.
- Rigorous facilitation. It’s natural for discussions about company procedures to morph into other topics, such as business strategy or staffing requirements. Discussion *will* get off topic. When it does, the facilitator must act quickly to table it. You can maintain a list of tangent topics on a flip chart, schedule a meeting to discuss the most pressing items, ring a cowbell, blow an air horn, or drop a quarter in the “Diversion Jar” and move on, but keep those conversations out of your SWAT session. Save the war stories for dinner.
- Commitment to the process. Scheduling the session is one thing, but remaining dedicated to the session is an act of will. It’s so ridiculously easy for outside work to creep in. Management and participants must be committed to carving out the time and keeping the barbarians at the gate.
- Of course: Plenty of caffeine and yummy treats.
If you’ve ever worked on SOPs, you know there’s a big difference between done and almost done. To help ensure you emerge from the SWAT session with the former, time must be allotted for participants to format, polish, and conduct a quality review. If it’s possible to scare up some on-site administrative support, that could help expedite the process.
SWAT Benefits
When you look on your team’s Outlook calendar and see 3 entire days blocked out, it can seem like an awful lot of time devoted to SOP revision. But SWAT really doesn’t take any longer than the usual process, it’s just more obvious. Does SWAT take significantly *less* time? Mmmm, not sure, but SWAT brings with it other benefits.
SWAT produces a more consistent set of SOPs. Since every document is compared to every other, it’s easy to notice and correct incidental differences.
SWAT is a cross-training opportunity. Participants enter SWAT knowing their own SOP very well. They leave knowing the whole SOP revision set very well.
SWAT gets it done. Auditors, how many times have you cited facilities for failure to revise their SOPs within the specified window? It’s not because there’s a willful disregard for SOP procedures. It’s because, in the real world of work, revising SOPs is seldom prioritized highly enough to get on anyone’s schedule until the end of the revision window encroaches or – oops – has passed. But schedule a SWAT and they will come. (And because the effort is so visible and so obviously resource-intensive, no one wants to be the one to drop the ball. Participants come prepared and the resulting documents are the better for it.)
SWAT is a lot more fun. Revising SOPs on your own is really boring. Revising them in immersive sessions with colleagues is significantly more enjoyable. Gallows humor reigns supreme. Copious amounts of chocolate are consumed. Air horns are blown in celebration. Friendships, sobriety, and hair color remain intact. Participants live to write another day.
_______________________________________________________________________
Photo Credit: Tenaciousme CoffeeArt, under Creative Commons License
Tuesday, February 2, 2016
Study Sites: Too Many Vendors, Too Little Time
By Laurie Meehan
“I can’t get the IWRS to assign a kit number.”
“My ECG reports take forever to come back from the Core Lab.”
“The eCRF won’t let me create a new subject.”
“This stupid machine is blinking an error code again.”
Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.
“I can’t get the IWRS to assign a kit number.”
“My ECG reports take forever to come back from the Core Lab.”
“The eCRF won’t let me create a new subject.”
“This stupid machine is blinking an error code again.”
Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.
Wednesday, December 9, 2015
The Sound of Compliance
Is data integrity music to your ears? Ours, too!
ALCOA, GAMP, Part 11, GIGO, we cover it all.
(Sung to the tune of Simon and Garfunkel's "The Sound of Silence.")
ALCOA, GAMP, Part 11, GIGO, we cover it all.
(Sung to the tune of Simon and Garfunkel's "The Sound of Silence.")
Tuesday, October 20, 2015
One Q & a Lotta A’s about SOPs for Research Sites
By Laurie Meehan
You know how it is with those LinkedIn discussion groups. You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved. So naturally, when I encountered the post above -- which had managed to attract 32 responses -- I was curious to see what had garnered such attention. (And yes, that was 3 months ago and I’m just getting around to writing about this now. Don’t judge me.)
Posted on LinkedIn in July:
“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”
You know how it is with those LinkedIn discussion groups. You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved. So naturally, when I encountered the post above -- which had managed to attract 32 responses -- I was curious to see what had garnered such attention. (And yes, that was 3 months ago and I’m just getting around to writing about this now. Don’t judge me.)
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