Deviation - 6 Steps RCA_CAPA_final draft

Initial Problem Statement, Impact and Remedial Action→Initial Problem Statement:Several deficiencies were identified by CAG audit concerning the in use of deviation management process regarding:-No look back in some deviations at potential cross contamination in all other batches manufactured and resultant impact on any batches within GSK control or in the market.- In appropriate classification of number of deviations as For Information Only- Number of deviations were with same root cause and not considered repeated on Trackwise system.→Impact:Potential impact on product and process compliance→Remedial Action:- Assessment was done for the impact of cross contamination on the previous batches concerning the deviation observed by the auditors.- Decision was taken to stop classifying deviations as For Information Only unless approved by Head of quality

App. I To GP532/05

Step 1 – Initial problem statement

1

Lead Sahar El Menyawi

Team Wael Philoppos, Mohamed Tohamy, Wael Abdel Salam, Yasser Mahdy, Mahmoud El Khouly, Saad Okasha, Samy Emam, Gina Shawky, Ahmed Fakher, Ahmed Abdallah, Mennatallah Mahmoud, Mohamed Esmail, Ahmed Fathy.

5W and 1H5W & 1H IS IS NOT Data required

WhoWho discovered it? Which team? Skills? CAG auditors

Process ownerL2L1

Previous occurrencesChange events

What What product? What input materials? What reagents? Extent of the problem? Details of other batches

Several gaps in the in use of deviation system, some deviations without assessment for potential

cross contamination of previous batches, classification of deviations as For Information

Only and repeated deviations

Other deviations and investigation

e.g. complaints and OOS

WhenWhen did it happen? Day/time? When did the issue begin? When has it happened before? Frequency? Pattern between occurrence and time? Seasonal trend?

During CG audit on Cairo site from 15 to 19 May 2016

Before 15 May 2016

WherePhysical location (building, line, equipment, etc) Process Step? Has it happened elsewhere onsite?

Cairo site value streams (production, engineering, lab.) ---

WhichWhich characteristics changed over time? Is there a turning point? Is there a step change in occurrence?

When deviations are not attended by all involved key members of investigation team

Deviations attended by whole team and reviewed by manangers and

VSL

HowHow was it detected? What was going on at the time? What changes occurred? Time pressures? Competing priorities? Full team available?

Upon selection of deviations by CAG auditors to verify the in use compliance to deviation

management process

L1L2

Investigation teamReviewers

App. II To GP532/05

Should Happen Did Happen Gap AnalysisAs per SOP GP512/22‘Handling of GMP Deviations’:- GMP deviations to be classified as per definition into:Critical incidentCritical deviationMajorMinorFor Information Only (FIO)-Deviation should be initiated on Trackwise within 24 hours of discovery of the incident-Initiating a deviation:•By observer• Use App. II as guidance for deviation determination• Record deviation:OccurrenceAssigned to Short descriptionEvent descriptionRemedial action

Classification is done into the five categories but FIO deviations did not comply with the stated definition but fit with Minor one.

- Deviation is usually opened upon 24 hours of incident discovery Done in accordance to SOP except:-Not all deviations are opened by the observer- Remedial actions are not stated every time at that early stage but documented during investigation

Classification of FIO is not based on standard definition and criteria stated in the SOP but on impact on the event on product quality.

-Opening of deviations are not always opened by the observer but by OQ.- Remedial actions are not documented upon opening of deviation but during investigation process.

Gemba date: 30 and 31 May-2016

App. III To GP532/05Gap Analysis

2 3

Should Happen Did Happen Gap Analysis-Area owner assesses the deviation with OQ -The initial deviation assessment must cover potential impact on product quality and regulatory compliance as follows:•Impact on batches immediately affected• Impact on other batches•Microbiological risk• Current location and status of impacted product• Remedial actions• If the deviation was reported before and reason for recurrence

- Non mandatory fields are listed and to be completed if necessary

No initial assessment was done in accordance to SOP details, mandatory fields on Trackwise are only recorded.

- Non mandatory fields are not usually field during deviation initiation

Initial assessment as per the procedure details is not implemented, the deviation is recorded as per mandatory fields only present on Trackwise in short sentences.

- During deviation initiation, fields on Trackwise are usually filled when they are manadatory



2 3

Should Happen Did Happen Gap Analysis- Assign QA for approver

-Add child action item or CAPA if required.

- App. I is used when observer has no access or when system is broken-down

-Creation and closure of action item

-Initial QA approval

-All deviation records are approved by OQ upon initiation.

- No action item or CAPA are assigned at this stage, remedial actions are recorded later on during investigation.

- App. I is not usually used , since deviation is not usually opened by operator.

- No action items were created

- Deviation records are approved by OQ

- No gap

-Remedial actions are documented during investigation not upon initial recording of deviation.

- Deviation is either opened by area owner or OQ that have access on Trackwise, so App. I is not usually used by the observer who has no system access

- Not mandatory, however, no action items were created.

- No gap



2 3

Should Happen Did Happen Gap Analysis- Investigation and RCA:Complete the required fields for•Initial investigation• Investigation team member

• Gather information• Gap analysis• What should happen

• What happened

• Potential causes• RCA

• CAPA overview•RCA failure category• Re-occurrence• Investigation summary• Attachments

- Fields are completed with required data for the following fields:• Initial investigation (but not start immediately upon opening of deviation record)• Investigation team member (usually few team members attended)• Gather information • Gap analysis• What should happen (included in gap analysis field)• What happened (included in gap analysis field)• Potential causes• RCA (usually 5 whys, in case 6 step RCA, App. III of SOP GP532 is used and attached to deviation record in attachment section)• CAPA overview•RCA failure category• Re-occurrence (but not based on SOP definition for FIO)• Investigation summary• Attachments

- Delay in start of the investigation after opening of the deviation.-Not all key team members attend the investigation meetings- Re- occurrence is documented but not based on standard data.



2 3

Should Happen Did Happen Gap Analysis- Critical or major deviations must be led by an individual with expert knowledge in the process under investigation and experience in leading investigations

-Document GEMBA conducted

- Document RCA using RCA template

- Independent RCA facilitator separate from the investigation team should be considered

-RCA should include gap analysis for the process as designed and as operated.

-Assessment of each gap must be done using the expertise in investigation team

- Critical and major deviations are led by area owner or OQ .

- Outcomes of GEMBA are documented in investigation or gather information sections.

- 6 step RCA is done using SOP GP532 template, however, some investigations are documented using GPS template

- RCA is facilitated through OQ

-RCA covers process as designed and as operated

-Assessment of gaps is not usually done by the required expertise

Critical or major deviations are not led required expert in the process.

-No gap

-Not all 6 step investigation are documented using the approved template in SOP GP532.- RCA is not facilitated through independent separate individual but through OQ.

-No gap

-Assessment of gaps is not usually done by required experts .



2 3

Should Happen Did Happen Gap Analysis- If incident impacts other sites, contact center of excellence or representative in the cluster

- For complex investigation that exceed 25 calendar days of investigation, interim report must be issued for extension with justification approved by Head of Quality

- Scalability of RCA should depend on classification

- 6 step RCA must be done for Class 1,2, 3 and recurrent deviations while other class through one of the problem solving methodologies

- Incidents of high impact or might impact other sites are communicated through MEA weekly escalations and through contact with regional quality expert.

- In case of investigation exceeding 25 calendar days, no interim report is usually issued.

- Scalability of RCA should depend on classification

- 6 step RCA is done for class 1,2,3 and repeated deviations, other classes through 5 Why methodology

No gap.

No approved interim report issued for extended investigation as per SOP template.

No gap

No gap



2 3

Should Happen Did Happen Gap Analysis- Investigation completion and closure:•QA review the parent deviation record and associated CAPAs• If more information is required, he sends asking for more information, otherwise, if information is complete the OQ chooses ‘close deviation’• Risk assessment including impact, level of risk and justification• Conclusion• Reported event• Justification for repeated deviation• Overdue justification• Impacted batches with batch number• Closure of deviation• Re-opening when required by authorised person

- OQ review the deviation and associated CAPAs

-If more information is required, the record is sent back to request more information.-If information is complete, OQ chooses to close deviation

- Some deviation not include risk assessment, others with inappropriate risk assessment covering backward view.- Conclusion is documented- Not documented (non-mandatory field)- Not documented (non-mandatory field)

-Not documented (non-mandatory field)-Impacted batches with associated batch number are documented- Deviation is closed after review by OQ- Re-opening is done by authorised OQ with IT ticket

No gap

No gap

Inappropriate risk assessment

No gapNot documentedNot documented

Not documentedNo gap

No gapNo gap



2 3

Should Happen Did Happen Gap Analysis- Cancelling deviation requires justification and electronic signatures

-Class 1 and 2 deviations must be escalated to Head of Quality and if impact other sites they must be alerted

- Deviations that impacts product in market, head of quality must be informed and referred to PIRC process

- Deviation related to contamination must follow QD422

- Time interval for repeated deviations for Class 1,2 and 3 is 3 years and for class 4 and 5 is 1 year. Categorisation of repeated deviations by root cause by running query on Trackwise for keywords

- Cancelled investigation are associated with appropriate justification and electronic signatures

-All deviations are escalated to head of Quality and if impact other sites, they are escalated through MEA weekly TC and MEA Quality council

- Deviations impacting product in market are escalated to HEAD OF Quality and follow LIC and PIRC process

- All deviations follow GP512

- Repeated deviations are categorised by root after running query on Trackwise for keywords, but there is no standard common pool to review all deviations collectively for previous years.

No gap

No gap

No gap

QD422 not followed

No standard common data pool to review all deviations for previous years



2 3

Should Happen Did Happen Gap Analysis- Investigation lead should invite compliance officer responsible for CAPA during CAPA agreement phase

- CAPA plan of critical incident, deviation or recall must be communicated to other potentially affected sites via quality alert.

- For repeated deviations, trending of root cause should be done and after action review of proposed CAPA and associated escalations to quality council

- QA must confirm classification of deviation considering any new information after initial assessment

- Compliance officer responsible for CAPA is invited during CAPA agreement in 6 step RCA

- Investigation, RCA and CAPA for critical deviation incident or recall is communicated to any other impacted site through MEA weekly TC, MEA Quality council and regional head of quality decides whether an alert is required to be raised or not.- Repeated deviations are trended by root cause and escalated monthly to quality council and TAP2 Quality.

- OQ confirm classification after initial assessment of deviation

Not all CAPAs are shared with compliance officer for all deviations except 6 step RCA.No gap

No gap

No gap



2 3

Should Happen Did Happen Gap Analysis- For CAPAs or action items that were done during investigation, objective evidence has to be attached to deviation report.

- Periodic review:•Area manager should ensure that all deviations and effectiveness of associated CAPAs are periodically reviewed as per SOP QD5150.• Frequency of review must be based on risk• Quality Council must review any significant issues arising from the review• Electronic GMP deviation list is maintained on team site for trending purpose

- Most CAPAs are not done at time of closure of deviation and those corrective actions done, are stated done without attaching objective evidence.

- Periodic review is not in use and currently is done through monthly monitoring of deviation trend and breakdown on TAP 2 production and Quality council

No objective evidence attached for done actions or CAPAs during investigation.

Deviation periodic trending is not in use.



2 3

Should Happen Did Happen Gap AnalysisWhen a deviation is requested to be published with multiple versioning in case of third party communication, an interim report associated with deviation must be issued detailing reason of versioning and deviation progress.

-The person on assigned to field and QA approver are sent electronic email from the system for notification before deviation due date by 7 days and on due date

- If root cause is obvious in Minor and FIO deviations, a rationale is documented process proceed to CAPA.

- No request has been asked by third party for versioning of deviations.

- The person on assigned to field and QA approver are sent electronic email from the system for notification before deviation due date by 7 days and on due date

- In case of minor and FIO, the record is initiated on Trackwise and follow investigation process and 5 Whys and CAPAs are assigned.

No gap.

-No gap

-No gap



2 3

Should Happen Did Happen Gap Analysis- Where there is uncertainty of root cause, risk must be assessed, controls are put to increase detection and consideration given to escalation of significant risks to RMS.

- Critical deviations or incidents to be escalated to MEA Head of Quality to assess the need for raising quality alert.

-Responsibility:•Observer: Notify area managerTake remedial actionsOpen deviation

- In case of uncertainty of root cause, probable causes are assessed, controls are put in place but no escalation to RMS.- Referring is usually done to RMS actions for deviations related to opened risks.

- Escalation is done through weekly MEA TC and monthly MEA quality council to regional head of quality to assess the need of raising quality alert.

-Observer:•Notify area manager• Sometimes take necessary remedial actions• Not usually open deviation

-No escalation between outcome of deviation and RMS.- Referring is usually done to RMS actions for deviations related to opened risks.

- No gap

-Opening of deviation and necessary remedial actions are not all the times done by observer.



2 3

Should Happen Did Happen Gap Analysis- Area manager:•Seek OQ guidance to assess deviations• Ensure deviation is recorded and initially assessed• Remedial actions are taken• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Accountable for periodic review of deviation , investigation and CAPA effectiveness

- OQ officer:• Assess deviation with area owner• Review remedial actions• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Confirm proper initial assessment of deviation

- Area manager:•Assess with OQ deviations• Not usually follow to ensure deviation is initially assessed• Remedial actions are done with communication between area owner and OQ but not documented on time or at initial phase.•Share in investigation with the team but not usually with full attendance• Not accountable for periodic review

-OQ officer:•Assess deviation with area owner• Review remedial actions• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Confirm proper initial assessment of deviation

- Partial gaps in accountability for:•initial assessment •Recording of remedial actions on time• Full attendance of deviation meetings• Periodic review not in use

- No gap



2 3

Should Happen Did Happen Gap Analysis- Area manager:•Seek OQ guidance to assess deviations• Ensure deviation is recorded and initially assessed• Remedial actions are taken• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Accountable for periodic review of deviation , investigation and CAPA effectiveness

- OQ officer:• Assess deviation with area owner• Review remedial actions• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Confirm proper initial assessment of deviation and severity

- Area manager:•Assess with OQ deviations• Not usually follow to ensure deviation is initially assessed• Remedial actions are done with communication between area owner and OQ but not documented on time or at initial phase.•Share in investigation with the team but not usually with full attendance• Not accountable for periodic review

-OQ officer:•Assess deviation with area owner• Review remedial actions• Participate in investigation team to identify root cause and ensure required CAPA are assigned for implementation• Confirm proper initial assessment of deviation but not usually risk assessment properly cover all aspects of impact

- Partial gaps in accountability for:•initial assessment •Recording of remedial actions on time• Full attendance of deviation meetings• Periodic review not in use

Gap in proper risk assessment to cover all aspects of impact on batches



2 3

Should Happen Did Happen Gap Analysis- OQ Section Head:•Review and approve deviation record and confirm severity • Ensure investigation is done with appropriate RCA tool• Review CAPA

-OQ manager:•Review and approve RCA and CAPA• Monitor periodic trend review

- Head of Quality:• Ensure deviations that have potential to impact product in market are handled through PIRC/recall process

-OQ Section Head:•Review and approve deviation record, but some gaps in proper assessment of deviation risk impact and severity• Ensure investigation is done with appropriate RCA tool• Review CAPA

-OQ manager:•Review and approve RCA tool and CAPA.• Monitor periodic trend review

- Head of Quality:• Ensure deviations that have potential to impact product in market are handled through PIRC/recall process

-Gap in review of risk assessment to cover all aspect of impact

-Periodic deviation review is not in use

-No gap



2 3

Refined Problem StatementThe problem statement to be refined based on the identified gaps prior start of Step 4

Deviations were not being investigated appropriately to ensure full impact of deviation was assessed & appropriate actions implemented due to some gaps in timeline, key member investigation team attendance and responsibility, classification and initial impact assessment with relevant appropriate remedial actions, also, level of challenges in relation to investigation details including backward, forward and current impact assessment on product batches, line of sight and tackling of root cause with relevant CAPAs. Moreover, improper link between deviation system and other systems as RMS.

App. IV To GP532/05

Refined Problem Statement

Measurement Man Method

MaterialsMachineMother Nature

App. V To GP532/05

Step 4 - Potential Causes

Fishbone4

- Trending Review

-Team attendance - interim report for overdue investigation - level of challenging- Timeline adherence -In correct link between deviation , RMS & other quality systems - RCA/CAPA/problem statement line of sight - standard way of classification not in-use

-Classification not standardized- approval / review level -Recurrence assessment- impact assessment

- Timeline adherence - work load

Deviations were not being investigated appropriately to ensure full impact of deviation was assessed & appropriate actions implemented due to some gaps in timeline, key member investigation team attendance and responsibility, classification and initial impact assessment with relevant appropriate remedial actions, also, level of challenges in relation to investigation details including backward, forward and current impact assessment on product batches, line of sight and tackling of root cause with relevant CAPAs. Moreover, improper link between deviation system and other systems as RMS.

Step 5 - Five WhysApp. VI To GP532/05

Five Whys – Root Cause AnalysisProblem

description Rank Why 1 Why 2 Why 3 Why 4 Why 5

1. standard way of classification not in-use (Especially for FIO )

2- Improper assessment of Recurrence.

1.1 It was assessed based only on the impact of product quality & considered as documentation administrative work only.

2.1-No standard pool for all deviations to be tracked before assessing the recurrence .

2.2-Inadequate capability regarding dealing with TrackWise.

2.3 Inadequate determination of the final root cause from 5 Whys.

1.1.1 Wrong understanding for definition of FIO

2.1.1-Some deviations are on old excel sheet format while others are on TrackWise.2.1.2description of deviations not standardized .

2.2.1-No standardized way to run system for specific queries.2.2.2 Site SME for track wise is not consulted.

2.3.1-No proper cross-functional team attendance.2.3.2-Cross-function team do not want to find the root cause as a part of a system.

1.1.1.1definition in SOP is subjective & need to be clarified with some examples.1.1.1.2People capabilities regarding classification need development.

2.3.2.1 Cross-function team not able to put CAPA regarding systemic root causes.

1.1.1.1.1 Copied from the GQMP without further clarification.

2.3.2.1.1 Cross-function team not having proper capability on finding proper solutions.

5



descriptionRank Why 1 Why 2 Why 3 Why 4 Why 5

3-Inappropriate impact assessment

4-Periodic review Trending for deviations weren’t done by area .

3.1-Inability of assessor for wider view of event

3.2-Not all of the details of the investigation and assessments are documented.

4.1- No standard way to enable area owner to perform trending

3.1.1-Insufficient experience of OQ

3.1.2-insufficient experience of SMEs(area owner)

3.1.3-Absence of Independent deviation expert to challenge and review deviations.

3.2.1-No standard way for assessment3.2.2- poor attendance of SME and investigation team

4.1.1-No sufficient details in the SOP to describe which trends to be performed.

3.1.1.1-High staff Turnover 3.1.1.2-Insufficient practical training .

3.2.2.1-No specific steps to follow during assessment.

4.1.2-Recently identified during Gap analysis 4.1.3-SOP for periodic review of trending is not in use.

5



description Rank Why 1 Why 2 Why 3 Why 4 Why 5

5- No adherence to the investigation time lines.

6-Incorrect link between the deviation system and RMS.

7-Interim report for overdue investigation not done.

5.1- Delay in the start of investigation by the team.

5.2-Not all users have trackwise accounts.

6.1-Referring to the risk action as tool of investigation.

7.1-Investigation leader does not know that he should complete such report.7.2-No proper follow up from investigation system owners.

5.1.1- Lack of commitment from investigation leader.5.1.2- Investigation is not lead by the process expert (SME).5.1.3- No consistent attendance by all members of the investigation team through all investigation sessions.

6.1.1- Misunderstanding for utilizing risk as a tool for assigning CAPAs.

7.1.1-No enforcement for issue the form upon expected overdue investigations.

7.1.1.1- The responsible person is having other priorities (which is closing other investigations)

7.1.1.1.1-Workload from other deviations in the same area.7.1.1.1.2-High priority for supply impact deviations

5




8- Poor attendance of the investigation team all over the investigation sessions

8.1-Lack of commitment from investigation leader.

8.2-Facing lots of debates during the investigation

8.3-Relying on OQ on deviation handling

8.4-No sponsorship from upper management

8.5-Insufficient challenges from the deviation SME.

8.1.1-Workload from other deviations in the same area.8.1.2-High priority for supply impact deviations8.1.3-Mindset of Investigation leader that he should be the investigation leader.

8.2.1-Not convinced that the incident is a deviation8.2.2-Some attendees coming with a preconception and jump to conclusions.

8.3.1-Lack of ownership.

8.5.1- No mandatory actions on Trackwise to close investigation before challenging by several SME8.5.2 insufficient time to review and challenge at tend of investigation

8.1.1.1-One area owner (investigation leader)

8.1.3.1-No standard list for SME for investigation leader.

8.2.1.1-Appendix II in SOP GP 512 is not followed.8.2.2.1-Conflict of interest between being an investigation team member and doing the CAPAs as well.

8.5.2.1- Delay in root cause identification

8.5.2.1.1- Delay in starting the investigation

5




9-Delay in starting investigation

11-Improper RCA/CAPA Line of sight

9.1-No Standardized detailed KPI to visualize different milestones and timelines of the investigation9.2-Detailed KPI not escalated to quality council.9.3-Poor attendance of the investigation team all over the investigation sessions

11.1-Insufficient challenge of investigation.11.2Delay in start of investigation.11.3-Insufficient experience.

5

Step 6 - CAPAApp. IX To GP532/05

Key CAPA – Solution Specification and SMART-A/RCAPA Objective : (State the root cause, RC, and the desired end result, ISS (Ideal Solution Specification) of the CAPA plan)

ActionIn Place

Verification Package

In Use Verification Package

CAPA Leader /CAPA Team By When Status

1)Update SOP GP 512 to Clarify FIO category with examples. SOP update

CAPA effectiveness through in use

verification GEMBA and L1

Mostafa Radwan

August 2016

L3Corrective

2)Refreshment training on QMS gap analysis process for GQP/GQMP process owners (to be on annual frequency).

Scripted training to be

scheduled

Evidence for conduction of

training

Mennatallah Mahmoud

August 2016

LocalPreventive

3)Workshop for Deviation /RCA/CAPA to be twice per year.(add on track wise biannually )

Scripted workshop to be

scheduled

Evidence for conduction of

workshop

Sahar El Menyawi

August 2016

L3Preventive

4)Update SOP GP512 to include that the investigation leader is to lead an investigation only after attending Deviation /RCA /CAPA workshop and passing relevant assessment. SOP update



Mostafa Radwan

August 2016

L3Preventive

5) Update SOP GP512 to include a decision tree for how to perform deviation classification as simple tool with examples. SOP update



Mostafa Radwan

August 2016

L3Corrective

6



ActionIn Place




6) Update SOP GP512 to add that FIO must be approved by Quality Head.

SOP update



Mostafa Radwan

August 2016

L3Corrective

7) Update SOP GP512 to document the rationale of classification on TrackWise deviation record.

SOP update



Mostafa Radwan

August 2016

L3Corrective

8)Dedicated deviation system owner for handling all investigation aspects .

Assign dedicated

investigation system owner

Improved KPIs Sahar El Menyawi

July 2016

LocalPreventive

9) Update SOP GP512 to provide standard steps for the description based on 5W+1H with examples.

SOP update



Moustafa Radwan Done

DoneL3

Corrective

6



Action In Place Verification Package


CAPA Leader /CAPA

Team By When Status

10) Update SOP GP512 to mention running query by description TrackWise. For better identification of repeated deviations SOP update



Moustafa Radwan

Done DoneL3 Correcti

ve

11)Update SOP GP512 ,SOP GP 532,GP 502 and TO 530 to add details of queries to be run and seeking support from QWF expert in case of not being able to perform a specific query.

SOP update



GP 512 Mostafa Radwan

August 2016

LocalPreventi

ve

SOP updateCAPA effectiveness

through in use verification GEMBA

GP 532 Saad Okasha

August 2016

LocalPreventi

ve



GP 502 Rasha Elbohi

LocalPreventi

ve



TO 530 Ahmed Fathy

LocalPreventi

ve

6




In Use Verification

Package


12)Update induction training SOPs for all departments to include practical qualification packages with assessment for Investigation leader ,SMEs and OQ SOP update

CAPA effectiveness

through in use verification

GEMBA

Quality Induction training SOP Moustafa Abdo

August 2016

LocalPreven

tive

SOP update

CAPA effectiveness


GEMBA

NLVSEngineeringTechnicalLogistics

LocalPreven

tive

13) Review SOP QD5150 to include any details how to perform the deviations trending on monthly basis with detailed responsibility for area owner & OQ. And ensure in use verification

Evidence of SOP review and update

CAPA effectiveness through in use verification GEMBA

Saad Okasha Sep2016

LocalPreven

tive

14) Update SOP GP512 to include details how to perform the risk assessment through questions and document on TrackWise. SOP update

CAPA effectiveness


GEMBA and L1

Mostafa Radwan

August 2016

L3Correcti

ve

6



ActionIn Place




15) Increase the capability of assessors through EDM and level of challenge.

Scripted EDM training

Evidence for passing assessment for assessors

Sahar El Menyawi

December 2016

L3Preventive

16) Update L1 Schedule to perform monthly L1 on the deviations system to verify the in use of Deviation description, classification, root cause analysis, line of sight with CAPA and the risk assessment.

Appendix update


verification GEMBA and L1 verifying the mentioned points

Saad Okasha July2016

L3Preventive

17)Create a list for Key persons who need Trackwise account

List created List createdMohamed

TohamyJuly

2016

LocalPreventive

18) Add CAPA on Trackwise on each person requiring access on Trackwise to create accounts for the ones who do not have accounts.

CAPAs assigned Accounts created Mohamed Tohamy

August 2016

LocalPreventive

19)Update SOP GP 512 to include that one of the criteria of assessment is to review any related risk actions and revisit risk score if required, and add any appropriate actions in the deviations.

SOP update



Mostafa Radwan

August 2016

L3Corrective

6



ActionIn Place




20) Create a standard list for SME for investigation leader.

List created List createdMostafa Radwan

July 2016

LocalPreven

tive

21)Create KPI to monitor milestones for all deviations to be visualized on TAP 2 according to 6 steps RCA timelines

KPI developed KPI improved

Saad Okasha July 2016

LocalPreven

tive

22)Visualize KPI #21 per department monthly in Quality council.

KPI developed KPI improved

Wael Philoppos August 2016

LocalPreven

tive

23) Assessment for the impact of cross contamination on the previous batches concerning the deviation #363174 observed by the auditors.

Assessment Created

Assessment Created

Gina Shawky Done

DoneL3

Remedial

24)Create procedure to control user access management within QC.

Procedure created

In use verification GEMBA to provide evidence of control of access management

Ahmed Abdallah Done

DoneL3

Preventive

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25)Regarding deviation number 436191 perform assessment of the audit trails to verify if any admin actions were performed.

Impact assessment performed

Impact assessment performed

Ahmed Abdallah

August 2016

L3Remedial

26)Perform 6 steps RCA for deviation # 413510 for the repeated overdue maintenance

6 step RCA performed


Mohamed El Serafy

July 2016

L3Remedial

27)Perform 6 steps RCA for deviation #363174 for the cross contamination.



Ahmed Abdel Ghaffar and Gina Shawky

August 2016

LocalCorrecti

ve

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Deviation - 6 Steps RCA_CAPA_final draft

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