SOP:14:QA:110:01:NIBT PAGE 1 of 8

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1 SOP:14:QA:110:01:NIBT PAGE 1 of 8 Northern Ireland Blood Transfusion Service STANDARD OPERATING PROCEDURE (Operational Copy) Document Details Document Number: SOP:14:QA:110:01:NIBT Supersedes Number: Not Applicable No. of Appendices: NONE Document Title: TECHNIQUES TO BE EMPLOYED DURING QUALITY INVESTIGATION Prepared By: S Jamison Job Title: RA&C Lead Department: RA&C Document Authorisation/ Issue & Implementation Prepared By: S Jamison RA&C Lead Approved By: A Macauley Regulatory Affairs and Compliance Manager Date: Date: ISSUE DATE: 3 RD MARCH 2014 EFFECTIVE DATE: 12 TH APRIL 2014 CROSS REFERENCES This SOP refers to the following documents: Doc. Doc. Title Type No. SOP QA:070 Procedure for Reporting and Management of Quality Incidents FORM DD:951 Investigation and CAPA SOP QS:018 Raising An Incident Using The Q Pulse Quality Incident Wizard

2 SOP:14:QA:110:01:NIBT PAGE 2 of 8 Key Change from Previous Revision: New SOP 1 RESPONSIBILITY 1.1 All staff are responsible for reporting of incidents and participation in investigations and root cause analysis as required. 1.2 Incident investigators are responsible for ensuring investigation is carried out in a professional and objective manner and techniques such as those described in this SOP are applied as appropriate to determine the root cause/s of the incident and identification of effective corrective and preventative actions. 1.3 Heads of Department are responsible for overseeing completion of incident investigations within their area. 1.4 RA&C Department are responsible for reviewing and approving investigation and providing guidance during investigation. 1.5 Root cause analysis experts are responsible for providing advice and guidance to investigators during investigation phase. 2 INTRODUCTION 2.1 GENERAL NIBTS procedures are in place to ensure product and service quality is maintained, minimising any risk to donors, patients and staff. When there is a deviation from routine practice/ procedure or where product or service quality is compromised, a quality incident investigation must be raised to resolve the issue. Timely and thorough investigation of quality incidents/ deviations will: Prevent defective product/ components from being issued. Ensure faults in clinical test methods are identified and corrected Determine the root cause of the problem, to implement remedial/ corrective/preventative actions that limit risk of the problem recurring. Give assurance of the quality of product/ service Comply with regulatory requirements This SOP sets out methods of data gathering and interview to be used during incident investigation, and examples of techniques that may be applied during formal root cause analysis.

3 SOP:14:QA:110:01:NIBT PAGE 3 of CLINICAL RELEVANCE/ PURPOSE OF EXAMINATION Not Applicable. 2.2 PRINCIPLE OF EXAMINATION Not Applicable. 3 HEALTH AND SAFETY 3.1 There are no direct health and safety implications associated with following this SOP however it is recommended that individuals using display screen equipment e.g. computer screens do not remain in the same position for prolonged periods of time, ensure that they sit in a comfortable position and have adequate work space. 4 MATERIALS 4.1 Q Pulse 5 access required 5 CALIBRATION Not Applicable 6 PROCEDURE 6.1 See SOP:QA:070 Procedure for Reporting and Management of Quality Incidents for an overview of the quality incident procedure. This SOP sets out specifically the processes at hand to carry out the investigation stage of quality incident investigation. The investigator will use their best judgment to decide how deep to investigate the problem. This subjective decision will be reached, based on the magnitude and severity of the incident. The investigator will be notified they have been assigned an incident to investigate via from RA&C Department. Investigation details should be recorded and submitted using FORM:DD:951 Investigation and CAPA Gathering of Data Data gathered as the incident is raised (see SOP:QA:070 and SOP:QS:018 Raising An Incident Using The Q Pulse Quality Incident Wizard) should provide an indication of where to begin the investigation. Date and location of the incident, SOPs applicable, donor (donor number) or patients (H&C number)

4 SOP:14:QA:110:01:NIBT PAGE 4 of 8 involved, equipment, donation components/ batches involved, should be traceable from the initial Q Pulse entry. All remedial actions taken will also be recorded, including fate of any components/ batches. Any missing data should be gathered during investigation Incident investigations should be reported using FORM:DD:951 in a well organised way, using correct spelling, grammar and punctuation. Where possible a chronological order of events should be used, including dates and times of events when known, to simplify any review of the investigation Factual and objective statements should be used wherever possible. Staff/ donors/ patients should not be mentioned by name, rather report staff title/ location, donor number, H&C number. Do not seek to assign blame to an individual Avoid drawing conclusions on cause of incident until all data is gathered, and root cause analysis is performed The investigation document i.e. FORM:DD:951 should detail all aspects of the investigation such as what was ruled in or ruled out as root causes, how each conclusion was reached and what tools e.g. 5 whys were used. 6.2 Interviewing of staff Gathering information by interview should be carried out as soon as possible once an incident has been detected. Events will be fresher in the interviewees mind, resulting in a more productive interview. Formal interviews should only be carried out for major/ critical incidents; however use of the techniques listed may be beneficial for any incident investigation. Interview must be carried out as soon as possible after incident detected Interviewee should be briefed in advance the purpose of the interview. Only one person should be interviewed at a time (Interviewee may request a colleague to accompany them) For protracted interviews, the interviewee s line manager should be informed, to release the interviewee from routine work Interviews are best carried out in a quiet, private area It must be made clear to the interviewee that this is a data gathering exercise, not a disciplinary procedure. Interviewer should explain the interview and investigation process During the interview: Interviewee must be allowed to describe the circumstances of the incident uninterrupted, and encouraged to visualise events

5 SOP:14:QA:110:01:NIBT PAGE 5 of 8 Interviewer should then go through facts gathered from this description. This may correct misunderstandings or allow recollection of further information. Interviewer must avoid suggesting information to interviewee Ask questions in the order that events have been described. This will allow better recollection, and ensure no stage has been missed. Use questions that encourage further discussion of events. Closed questions prompting limited response should only be used to clarify specific issues. At close of interview, allow interviewee to read any minutes taken, and resolve any issues that present themselves Minutes taken should be signed and dated by both parties, scanned and attached to the incident in Q Pulse 6.3 Tools for Identification of Root Cause The root cause of a quality incident may be determined using one or a number of the techniques listed: Brainstorming A brainstorming meeting may allow a group representing different departments involved with an incident to explore causal aspects of a quality incident that may otherwise have been missed The group will familiarise themselves with the incident, then will put forward ideas of possible influencing factors. All factors are recorded Once ideas of any possible influencing factors have been exhausted, the group will collectively go through the list of ideas gathered, to assess likelihood that each is a causative factor, and prioritise response required for each.

6 SOP:14:QA:110:01:NIBT PAGE 6 of Whys: This technique uses progressive questions to drill down to the cause or causes of an incident. Incidents scored as yellow or green may be best investigated using The 5 Whys and/or Ishikawa fishbone root cause analysis. For example: Why did the FFP thaw out? Why did the fridge temperature spike? The fridge temperature spiked The door was left ajar Why was the door left ajar? The BMS was issuing product and forgot to close the door Why did the BMS forget to close the door? Only one BMS in department; was very busy; disabled alarm but distracted by receipt of an emergency order Why was there only one BMS in the Department? The department is short staffed Why is the department short staffed? Two staff members ill and one on leave (Root Cause) This technique therefore has identified the initial problem to be the failure of the BMS to close the fridge door, but also revealed that the alarm had been disabled without appropriate corrective action been taken and ultimately indicated that the root cause of the incident was inadequate staffing levels within the department. NB. The number of questions asked will be dependent on the situation and may be more or less than five.

7 SOP:14:QA:110:01:NIBT PAGE 7 of Ishikawa fishbone: Where an incident has many potential influencing factors or causes, listing all these factors for individual analysis may allow more thorough analysis of each factor. It may be useful to have a brainstorming session represented by all departments affected, to ensure all factors have been identified. Each factor can then be analysed by the 5 Whys, to determine its influence on the incident. Individual Team Process/ Procedures/ Products Records/Policies Incident Root Cause Education/ Equipment/ Working Organisational/ Training Records Environment Strategic Each heading should be considered in context of the problem identified and any appropriate causal factors identified. Once all causal factors have been identified agreement should be reached as to which factors are the root causes of the problem More complex investigations (Red/Amber incidents) may require Failure Mode and Effects Analysis (FMEA) or a combination of several of the techniques described. FMEA is best used to find fault in a multistep process, where the process is analysed step by step, and any potential sources of failure at each stage noted. Examine both SOP and actual practice, to confirm they accurately reflect one another, and to decide which steps are suitable for analysis. The process may also be used for analysing product, where each product component is individually inspected. Create a diagram/ flowchart to assist in tracking the investigation (submit as evidence). On analysis of each step during an investigation, consider: What has deviated from normal procedure in the step? What are the potential sources of error within the step?

8 SOP:14:QA:110:01:NIBT PAGE 8 of 8 What control measures are in place to mitigate these errors? Once all deviations and potential sources of error are identified in each step, it must be assessed which of these may have a causative impact on the incident. Where control measures have failed or been absent, the reason for the failure should be investigated, and new control measures introduced Root Cause analysis is to be carried out by the individual investigating an incident, with input from trained NIBTS Root Cause Analysis Experts where required. The best method for use in each incident may be subjective, and several techniques may be employed at once. Evidence of the analysis implemented must be recorded on Q Pulse with the submitted investigation A formal meeting must be convened for all category red incidents, during which root cause will be reviewed. Identifying any additional corrective and preventive actions (including modifying or creating new procedures and work practices). Plan, agree and implement the corrective and preventive actions. From the investigation, the following shall be established (If applicable): The Root Cause of the problem, including all possible causes and potential effects/risks to quality, safety and efficacy of the blood components/products, if known. The overall Final Conclusion shall be recorded. Note If the root cause has been determined to be Human Error the report must detail the reasons why the root cause has been deemed as Human Error and demonstrate that all other potential causes have been eliminated. 6.4 LIMITATIONS OF EXAMINATION Not Applicable 7 RESULTS Not Applicable