1. Deviations: Writing Quality Assurance Reports (QARs)
Global Quality Operations - Training and Program Development

2. Why is it difficult to write QARs?
Time and / or stress
Don’t like writing / find it difficult
Too many different groups / people involved
We understand our own operations and thus don’t fully explain everything
We don’t have all the information / facts
Politics / blame
And
Expectations are not clear
Not sure the right level of detail
Don’t have training

3. Learning Objectives
Identify the “5 Cs” to keep in mind when writing QARs
Identify at least 3 tips for staying objective in our writing
List the components of the WICS Model
Identify SMART requirements for writing corrective and preventative actions

4. Agenda Introduction Prepare for Writing Purpose, Audience
Organise Ideas
Technical Writing
Writing Styles
Five C’s
Language Use
WICS Model
WICS / DMAIC
WICS by section
Closing Points

5. Preparing for Writing You need to: Establish your purpose
Know your audience
Gather the facts
Organize your Ideas
Overview slide describing the next section
Point out that if something is not pertinent, then it probably should not be written down.
Examples of this are: stray comments, emotional comments (maybe about a personality conflict), Cover your assets reports (CYA)

6. Establish your Purpose
What is the purpose of QARs?
To accurately describe an event
To identify why it happened (the cause)
To facilitate actions to avoid it happening again
So we can fully understand what happened (when we read it in a few years time, maybe with an Auditor!)

7. Know your Audience Ask yourself these questions:
How knowledgeable is my audience?
What do they already know?
What do they need to know?
What is my audience’s purpose for reading?
To approve the content?
To make a decision?
To know what to do next?
Does my audience have special concerns about the subject? What are they?

8. Know your Audience Immediate, Future
Court of Law
Family / Friends
Consumers
For each audience, talk about what their concerns may be when they read the QAR.

9. Know your Audience Always define acronyms the first time you use them.
Reduce your use of jargon
Write for a knowledge level that would minimize questions if you presented the information to your “peer group”.
Lets define “peer group”
Definition of peer group: Those people that work with you on site, those people who are sitting in the room here with you today. They work at the same level as you but may have a different technical background to you. Your immediate audience for QARs is your peer group. You want to make sure that what you write is understood first and foremost by your peers.

10. Organize your Ideas What do you know? What else do you have?
Process and/or Structure Description
Facts on the event
Supporting information
Applicable scientific principles / concepts
What else do you have?
Unsubstantiated ideas / testimonials and remaining questions

11. Agenda Introduction Prepare for Writing Purpose, Audience
Organise Ideas
Technical Writing
Writing Styles
Five C’s
Language Use
WICS Model
WICS / DMAIC
WICS by section
Closing Points

12. Writing Styles
Literary writing conveys a mood, a story, and to paint a picture for the audience. The purpose is to entertain.
Technical writing conveys facts in an objective way. Feelings and picturesque speech are out of place - objectivity is the key. The purpose is to transmit information.

13. 5 C’s The 5 Cs Comply with the 5 C’s Rule CLEAR CONCISE COMPLETE
COHERENT
CONSISTENT
5 C’s

14. The 5 Cs - Clear The sentence should have one and only one meaning.
Precise and organized words
Gets to the point
Known language

15. The 5 Cs - Clear The operator was unsure of the speed of the mixer.
The speed of the mixer is defined in the SOP but during this batch, the operator did not record the speed. or
The speed of the mixer is not defined anywhere.

16. It is NOT a Literary contest!
The 5 Cs - Concise
Simple words, few syllables
Avoid duplication
Short sentences
Short paragraphs
It is NOT a Literary contest!

17. The 5 Cs - Complete Contains all needed information
WHO – Position Title, Name (If appropriate/ needed)
WHAT – Action, event description
WHERE – Place, Facility, specific operation section
WHEN – Time, day, stage, shift
HOW – Methods, technique, conditions, etc.
WITH WHAT – Materials, instruments, equipments, resources

18. The 5 Cs - Complete
Graphical and other visual tools may be extremely useful, eg. Charts, process flows, diagrams, photographs, etc.
“A picture speaks a
thousand words”
Defect A
Defect B
Important to stress that: You should attach all information required to support the decision that was made.
Attachments should be used where appropriate e.g. a digital picture sometimes helps a great deal, but the size of the attachment needs to be considered (IS may be able to suggest the best format). If a protocol / report needs to be attached then the SIGNED copy needs to be scanned into the document, NOT the WORD file with no signatures.
Reference all attachments. Are you sure you know why that attachment is there?
With QARs, it’s important to attach enough information
to support the decisions that were made.

19. The 5 Cs - Complete
Example of Process Control System (PCS) trend

20. The 5 Cs - Coherent
Information, facts, data, descriptions & conclusions should follow an orderly sequence which is easily understood by a reader not familiar with the site, products or processes.
To do this:
Limit the number of ideas in a sentence.
Use “white space” to separate ideas
Use logical patterns to present your information, eg. By time sequence, by topic/subject, cause and effect, etc.
This slide is all about getting the point across that all information and details need to be put down on the page in some sort of logical format.

21. The 5 Cs - Coherent Chunking information is easier on the reader
If using paragraphs, start the paragraph with a topic sentence (e.g. Impact on Water System)
Remember that white space helps the reader
Create using margins, tables, spacing, indentations

22. The 5 Cs - Consistent Be consistent or logical with your use of:
Tense (eg. past / present / future)
Sentence structure
Descriptors / identifiers (eg. Equipment name or equipment number)
Terminology (eg. Operator, technician, etc)
Format (eg. Bullets, numbers, paragraphs indented, etc)

23. Language Use - Subjective vs. Objective
Objective – Based on observable phenomena, presented factually.
The contamination weighs 14.9g, is 5cm long and 2cm wide.
It is black and rectangular in shape.
Subjective – Information is altered by the observers' opinions / thoughts / experiences.
The contamination is a small object that feels quite heavy.
It has often appeared before, but I had thought we had fixed it.
Describe the difference between objective and subjective.

24. Language Use – Tips for staying objective
Always consider unintended consequences:
E.g. Due to a lack of knowledge of the technician…
E.g. Due to the excessive heat in the laboratory…
E.g. Due to the SOPs being out of date…
E.g. Due to our inability to deliver the results on time….
Avoid unnecessary adverbs and adjectives:
Writing furiously, working strangely, drastic drift
Avoid unsupported superlatives:
This is the biggest particle size we’ve ever seen…
Things to help you stay objective
…more…

25. Language Use – Tips for staying objective
Avoid imprecise words that you can’t quantify/justify:
…less than usual…
Use universal statements carefully:
E.g. All, never, always, every, etc.
Base speculation on sound logic, or justifiable science.
Don’t use double negatives
‘Resources will not be unlimited’
‘There is no reason why the piece of equipment
should not be replaced’

26. Language Use - Legal
Avoid statements that reflect on Compliance or Legal Status:
A “Violation” of Law
“Defective” product
Legal judgments and interpretations should be avoided.
Do not use inflammatory words such as:
Careless, terrible, dangerous, intentional, severe, reckless, incompetent, etc.
Use of words like ‘defective’ or ‘safe’ ‘unsafe’ may be ok to use if the product is still on site, if released onto the market then of course this is a much more serious issue.

27. Language Use - Grammar & punctuation
How much does punctuation really matter?
Woman without her man is nothing.
Woman, without her man, is nothing.
Woman, without her, man is nothing.
Ask a male in the room to punctuate this statement with 2 commas and then ask a female in the class to do the same.
Point here is that punctuation can dramatically change the meaning of a sentence.

28. Language Use - Purpose of punctuation
Separates thoughts
Shows changes in ideas within a sentence
Can indicate emotion or urgency!
Handout available on English punctuation use (Request from Vicci)
Be careful using Microsoft Word (using the spill check function)

29. Agenda Introduction Prepare for Writing Purpose, Audience
Organize Ideas
Technical Writing
Writing Styles
Five C’s
Language Use
WICS Model
WICS / DMAIC
WICS by section
Closing Points

30. What is the WICS Model?
Model to help you structure writing/reviewing QARs
Uses a review/assessment sheet
Gives you guidance and a way to cross check
Broken into:
What Happened (W)
Impact/Investigation ( I )
Cause (C)
Stop and Support (S)

32. W D I M C A S I C Solutions What’s the problem: Deviation description
Initial scope
Immediate actions
Define the problem:
Problem definition (What, where, when, Who)
Significance
Desired State W D VA
NVA
Impact and Investigation:
Involved batches
Previous and Future batches
Other areas / processes / systems
Measure the problem
Time series
Pareto’s
Others (ID., ...) I M
1000
-1000 10 20 30
UCL X
LCL D B F A C E
Other
What’s the Root Cause:
Use M1 tools
If not identified, due diligence
Analyse : What’s the Root Cause ?:
Process analyses
Fishbone
Flow charts … C A VA
NVA
Stop and Support:
Corrective actions
Remedial Actions
Batch Release
Improve ID
Select
Pilot
Implement S I
Need to further explain this slide
Solutions
Control : Verify & Maintain solution
Standardisation
Training
Control Charts
Verify results C
UCL
LCL

33. W – What Happened? Includes these sections: Deviation description
Immediate actions (reaction)
Scope of the incident
The ‘W’ section of WICS usually centers around the first 24 hours of a deviation occurring.

34. W – What Happened? Deviation description
Focus on being objective and factual
Do not include irrelevant items (information that belongs in another section)
Speculation is not appropriate in this section
Provide detail: such as dates, times,
Provide context; such as where in the process the observations were made.
Provide comparison; such as what is normal or expected or required
Use your process knowledge and experience
Check for clarity with a “peer”
This is the what, when, where, how portion. Timelines, observations, anything that was abnormal- all could have contributed to the event.
Time: minutes may be important if it is a temperature excursion for example, hours may be important if it’s exposure to the air etc
Context: provide the ‘relevant’ details here not everything

35. W – What Happened? Immediate actions taken Examples:
Depending upon the type of incident, actions may be necessary to prevent further product/production loss and/or prevent further expansion of the problem.
DO NOT include remedial or corrective actions (unless they really were immediate and did not need approval)
Examples:
Stop further production
Adjust processing parameters (e.g. adding reactant to drive a process to completion, increase mix times, etc.)
Turn off tap, remove obstruction, etc.
Notify Supervisor / Process Engineer
Pointers:
These generally differ from lot specific corrective actions, in that these are the immediate processing adjustments essential to process the material to a safe, stable, and secure point in the process where it can be evaluated. There are cases where an immediate corrective action can also serve as a batch corrective action, such as the addition of a filter in the process to remove particulates.
Of course you will not have any immediate actions if the deviation is discovered upon batch review.
‘I called the supervisor’ or ‘I raised a deviation’ do not count as immediate actions, you must do more than this.

36. W – What Happened? Scope of incident - initially
Define the batches that were in process at the time.
If no batches involved, define the area / process / equipment that are involved.
Scope is perhaps the most important of all elements, as this ensures patient safety in the event of market action investigations. An improperly determined scope can leave adulterated material in the market (which can endanger patient safety), or cause the unnecessary destruction of acceptable goods (at unnecessary cost). Scope is an element that has to be determined both quickly and accurately.
This is something that is not carried out very well in our industry as it requires a lot of effort to find the scope of the problem.
The image of the shopping basket is to demonstrate ‘What is my scope?’ ‘What is in the basket?’
Is it 1 batch, 3 packaging lines or 5 SOPs?
Think about how big is my problem?

37. I – Impact / Investigation
Includes these sections:
What is the full scope of this incident?
How does the incident impact on the batch(s) we produce?
What other concerns does the incident raise?
Note: This information can be included in an Impact Assessment Document (MSWord)
1) Verify the scope
2) Consider impact on the product
3) Consider impact on other things in our world

38. I – Impact / Investigation
Scope of incident
Verify the initial scope by:
Identify the last time/date the process and equipment were working properly
Direct observation or records (logbooks, schedules, etc)
If scope changes during the investigation, document the rationale
Scope is perhaps the most important of all elements, as this ensures patient safety in the event of market action investigations. An improperly determined scope can leave adulterated material in the market (which can endanger patient safety), or cause the unnecessary destruction of acceptable goods (at unnecessary cost). Scope is an element that has to be determined both quickly and accurately.
This is something that is not carried out very well in our industry as it requires a lot of effort to find the scope of the problem.
The image of the shopping basket is to demonstrate ‘What is my scope?’ ‘What is in the basket?’
Is it 1 batch, 3 packaging lines or 5 SOPs?
Think about how big is my problem?

39. I – Impact / Investigation
Impact on the batch during manufacture must be understood
Batch was subsequently processed, put on hold, etc
Impact on the compliance of the batch must be clear. E.g. what is the affect to:
Validation status
Regulatory filings / dossiers
cGMP standards
Don’t assume – check and document.
Needs more ‘impact assessment’ on the underlying systems/processes.

40. I – Impact / Investigation
Remember to consider impact on:
Previous batches
Future batches
Impact on areas / processes / systems may also need to be reviewed
Define what resolved each concern and the proof (records) maintained to support this.
Some examples of other concerns:
Broken seal on a drum – may not ultimately affect the product, but may have an impact on future purchasing or inventory control, cross contamination, etc.

41. C - Cause
Root Cause: These are the conditions or actions which caused the deviation, that if corrected, would prevent recurrence.
Methods of root cause analysis are many and varied.
There is specific training to cover Root Cause as part of RFT site initiative
Discuss the difference between root cause and assignable cause as applicable to the site.
Doesn’t really matter what you call it, as long as you get to the cause.
Use the example of ‘My car stopped’
Why?
Because it ran out of petrol
I didn’t fuel up this morning
I slept in
Because my alarm clock didn’t go off
Because there was a power cut
Always consider how far back you need to go, it’s doesn’t make sense to go back to the very beginning and there is no rule for this, it depends on the situation.

42. C - Cause
Simple or minor incidents may have a quick investigation with an easily identifiable root cause.
Complex incidents may need a complete root cause investigation to establish:
The most probable cause(s) and the basis on which the final root cause(s) was reached.
What factors were specifically eliminated as a root cause, and the rationale for that judgment.
You may need to do a complex problem analysis. There are tools to help you do this e.g. RFT method 1
Use your RFT Tools!

43. C - Cause Root Cause – None found?
It is equally important to document what factors were evaluated and eliminated, and on what basis they were eliminated as a root cause.
This is the key to due diligence
Demonstrates to compliance officials a good faith effort to seek out and find the root cause.
Need to document the investigation and outcome – may be useful next time (to you!)
Need to set detection/monitoring points to spot recurrence early
Is it ok that you didn’t find a root cause – yes but you can’t give up trying to find it either (due diligence – ‘I tried’). You still must do something and document that.
E.g. monitoring/checking points – prepare for reoccurrence of the issue
What you do depends on the criticality of the problem, the product, the process.
If my computer crashes I’m not going to go ring up Microsoft and ask why.
If the hard drive has died buy a new one and back up and save files to prevent loss of information in the future.

44. S – Stop and Support Includes these sections:
Remedial and Corrective Actions
Lot Disposition

45. S – Stop and Support What is the difference…
…between
Immediate Reactions
Investigative Actions
Remedial Actions
Corrective Actions

46. S – Stop and Support Immediate Reaction
Actions taken in response to the problem to immediately minimize or rectify the scope or impact of the problem.
Must be recorded.
Examples:
Repairing the pipe, turning off the tap, etc.
Example of an immediate action is e.g. a temperature excursion – adjust the temperature control and bring it back to within range

47. S – Stop and Support Investigative Actions
Actions taken to determine or clarify the scope, impact or root cause of the deviation on the product or process.
Must be recorded.
Additional processing / testing needs to be defined and agreed in conjunction with QA.
Example of an investigative action: Check the trends to determine how long the temperature was out of range for

48. S – Stop and Support Remedial Actions
Actions taken until you can figure out how to really fix the problem.
If it’s a simple and isolated incident, remedial action may be all that’s appropriate.
No need to look further into the root cause or develop an action plan
Must be implemented, communicated and recorded.
Examples:
Substituting a component temporarily
Retraining an individual
Implementing an interim process or procedure
Analogy – remedial actions are the tourniquet applied to staunch the flow of red ink from an organizations process
Corrective actions are the surgical procedure the permanently repairs the cause of the seepage.

49. S – Stop and Support Corrective Actions
Actions taken to deal with an existing non-conformity
To fix the process
To fix the batch(s)
Need to determine what is the real root cause and develop a corrective action plan.
These actions must be implemented, communicated and recorded.
Example, for the batch:
Reprocessing / rework
Inspection/sorting
Example, for the process:
Adding a new supplier to the approved vendor list
Retraining operator(s)
Calibrating a micrometer
E.g. Mislabeling issue – the incorrect labels were removed and the correct labels were issued and applied to the drums.

50. S – Stop and Support Preventive Actions
Corrective and Preventive actions (CA and PA) are closely related
CAPA are often misinterpreted / used, as they are based on different inputs:
CA is a reactive process designed to address existing non-conformities (something has gone wrong)
PA is a proactive process used to address potential problems (nothing has gone wrong, yet!)
Thus, PA is not relevant for Deviations / QARs….
Preventive Actions may be initiated based upon trends and other data.
Reference: Robitaille, D “The Corrective Action Handbook”. Paton Press.

51. S – Stop and Support SMART Corrective Actions
Actions/commitments must be SMART
Specific
Measurable
Accountable
Realistic
Timely
Must stand alone
So that you don’t have to go back and read the QAR again to understand what is needed.
Must be verified
Training – reference copy of training records.
Update SOP – reference when SOP version was approved

52. S – Stop and Support SMART Corrective Actions
Specific
With enough detail so that when you read it, you know what needs to be done; includes the old and new (to pinpoint what needs to be changed and allow easier approval)
Measurable
Includes some sort of acceptance criteria (pass/fail; update; increase by %; install; reduce by distance; review of 5 Batch Records.)

53. S – Stop and Support SMART Corrective Actions
Accountable
Allocated to someone by personal name; agreed commitments are tracked.
Realistic
Linked to the conclusion and if implemented will reduce the likelihood of the problem recurring; is not just a “sticking plaster” or “stop-gap” to write something in the QAR
Timely – Needs to be based on:
Criticality of the problem (effect on production process, product, people, etc.)
Frequency or likelihood of event occurring again
Amount of resources needed (low hanging fruit)

54. S – Stop and Support Are these good Corrective Actions?
“Management will discuss this issue with all personnel at the next team meeting and all personnel will be reminded of the importance of the checkers role.”
“Update recipe to change the temperatures.”
“We will communicate this issue to all affected colleagues.”
“Add to preventative maintenance schedule.”

55. S – Stop and Support Lot Disposition
Determined by QA based on the following criteria:
Have we fully addressed all of the concerns with this product / lot?
Have all corrective actions (for the batch/lot) been completed?
Have we got to the real root cause?
Does it all make sense (logical / scientific)?
Can we prove all of this for the future (records)?
Have we followed Quality Risk Management principles in making our batch disposition decision?

57. Closing Points QARs reflect on you and the company
Use WICS to help you write a good QAR
Poorly written QARs not only confuse issues but may detract from the substance of the report and lead to regulatory observations
Take advantage of a chance to prepare / approve a document you can be proud of
Grammar, punctuation and writing do make a difference
QARs must stand on their own and not be subject to misinterpretation
QARs should still be clearly understood if reading them a few years later

58. Finally… Questions? Complete the training record
Complete the learning evaluation

59. References and Reading
Robitaille, Denise “The Corrective Action Handbook”. Paton Press.
Robitaille, Denise “The Preventive Action Handbook”. Paton Press.