Quality Audit can be defined as systematic, independent and documented examination by quality auditor which may be internal or external.
What is quality Audit?
Quality Audit can be defined as Systematic, independent and Documented Examination.
Why quality Audit is Required?
The reasons quality audit is required are as follows , so let us check it out one by one.
- To ensure that quality systems are maintained.
- To achieve the consistency between manufacturing and testing facilities.
- To ensure the customers requirements are understood and met.
- To improve processes going on in the industry.
- Also done to reduce the risk of failure.
- Regulatory requirements and for Business benefits.
- To check the cGMP compliance with the company's standard procedure.
Types of Audits
Generally the audits are divided into major two types, 1) Internal Audits and 2) External Audits. Let us check it out one by one and the importance of each audits and why is is performed.?
Internal Audits:
- Internal audits is carried out by the own organization on its own facilities, systems and the procedure going on in the company.
- To check whether they are following GMP as per ISO9000 and other guidelines or not.
- Reason for the audit should be the business benefits by building quality into the process and system.
Internal Audits Sub Category:
- The audit is performed by the staff of department by themselves i.e., individual from the same department will do the audit..This audit is for short duration which checks the documentation and housekeeping etc
- Second type of audit is performed by QA Department, comprising staff independent of the department being audited. The focus is more on system than housekeeping.
- Third types is carried out by corporate compliance group or they will ask other external consultant to carry out the audit.
External Audits:
- External audits is carried out by the company on its vendors or its contractors
- There will be an initial evaluation audit to access the capability and general suitability of the vendor.
- Regular audit assess the compliance with agreed contractual standards.
- Frequency depends on audits and vendor history.
- Audit leader is with wide experience of GMP & Quality System auditing.
- Audit team depends on the size of the facilities.
- The audit report which is generated is circulated within the company and to the vendor
Regulatory Audits:
- Regulatory audit is carried out by the regulatory bodies , audit is against regulations of manufacture and supply of pharmaceuticals.
- Also carried out by National Regulatory bodies. Example., Therapeutic Goods Administration (TGA) in Australia, Medicines control Agency (UK) etc.,
- Failure causes restrictions and withdrawal.
- After audit a formal report is received.
Audit Methods:
The audit methods are divided into three category, let us have a look on all the different sub categories.
- Input-Process-Output: It breaks what is seen into input, process and output. For example in laboratory process ( Input=sample, Process=analysis and output=result).The quality of the output depends on the control over the input and the process. The output of process is often the input of another process.
- Trace Forward & Trace Back: Trace forward follows the process starting with the inputs, then looking the process and finally finish with the outputs. while in Trace Back it starts with output then process and finally finish with the Input by which they produced.
- Product and Process: 1)Product:over here Auditor may choose particular product and then look at the process which is being followed. While 2): Auditor will choose particular process and select different products, to see how this process is put into practice.
Selection and training of Auditor and Auditee
Auditor Skills
To be a better auditor following qualities or skills must be present in the auditor.
- Open minded and mature.
- Possess sound judgement, analytical skills and tanicity.
- Ability to perceive situations in realistic way.
- Understand complex operations broadly.
- Understand the role of individual units within the overall organization.
- Diplomatic, honest, Professional etc.,
Auditor Training
Some information on auditor training and some of the skills required are as follows.
General Audit Skills
This skills over here includes the following.
- Audit management skills such as Planning , direction and communication.
- Assessment Techniques such as Examination, recording and reporting.
- Inter personal skills such as differ best from the rest.
Specific Technical skills
Skills over here are as follows:
- Depending on the process to be audited for example., procedure for the ethylene oxide sterilization process. Purification of water etc.,
Auditee Skills:
- Generally the training requirement will depend on their involvement in the audit.
- General awareness training for the all staff.,(Responsibilities, Behavior , Answering-Questions)
- Training for those likely to meet the auditors (Security, Reception, Note taker, Information Retrievers)
- For most likely to meet the auditor(Experts, technical staff with technical and inter-personal skills)
Audit policy and program management
- Document Date checking
- Document Type Checking
- Document Title Checking
- Document Title spell Check
- Names checking etc.,
Audit Policy
- Policy states the auditing activities required by the organization.
- Expected demands arising from the audits by regulators, customers or certification bodies
- Some of the key elements of the audit policy includes:
- Responsibilities for the management
- Types of audits to be managed
- Required frequency of audits
- Standards to be used (ISO, GMP, CFR etc.,)
- Conduct and reporting of the audit process, Frequency of the review of the audit program.
Audit Program Management
Responsible person should ensure that...
- Adequate numbers of auditors are available.
- Adequate time is allowed for audit from preparation to closeout.
- Audit program is frequently reviewed and modified.
- Overall target and goals of the audit policy are met.
- Evidences are active and well managed eg., Documentation during regulatory Act.
- System for analyzing audit deficiencies also be active eg., reviewing, strengths and weakness of the auditor.
Preparation for specific audit
Auditor Perspective.
Selection of Personnel
- On technical and general audit skills.
- Health and safety considerations
- Audit leader to a team of auditors
- Experts when team lacking technical knowledge
Audit Standards
- Aware of the Standards and Regulations (ISO, GMP FDA)
- Audit policy already define the standards required.
Scope of the Audit
- Should be clearly define to both.
- Audit program will provide to auditor with the scope i.e, internal audit of warehouse, distribution, facilities, procedure and general requirements.
Agreements
- Audit of vendors subject to various agreements due to business transactions.eg., supply, commercial, technical and confidentiality agreements.
- Establish and review relevant agreement to the scope
- Be aware of any limitations which affect the conduct of audit. eg., restriction of access of certain facilities.
- Made available at opening meeting., procedure list, licenses, Organization charts,
- Audit reports, quality reports, failure reports helpful to identify areas for review.
- Brochure, financial and establishment inspection report (EIR) requested from auditee.
- Questionnaires are useful information gathering tool
- Adequate supporting documents to be supplied eg., Quality manual, SOP, Specific records.
Audit Plans And Checklist
- Produce audit plan with estimate of time required.
- Objective of the audit is not compromised.
- Consider the working days and the time of the auditee
- Use checklist as an aid to the conduct of an audit.
- As with questionnaire should be concise and should not be irrelevant.
Auditee's Perspective
- Selection of personnel: Team should meet the expected needs of the auditors. Substitute should be planned.
- Audit Standard and Scope: Fully aware, Aware of any limitation.
- Information: Identify the document required by the auditor. Previous audit report be reviewed to verify that the are addressed. Provide auditor with dossier which explain quality system and organization.
- Audit Scheduling: To ensure that audit can be conducted, key personnel are available and other audits are not at the same time. Once scheduled communicate the necessary information with all the person involved.
- Pre audit: Period between notification and start of the audit. For deficiencies corrective action to be take and close out prior to the audit.
- Domestic arrangements to be confirmed eg., Meeting rooms, facilities for the auditors etc
Conducting an Audit
How to conduct an audit is explained in brief let us check it out one by one.
From auditors perspective
General Conduct
- Auditor be punctual for the appointment and work as per agreed program
- Views and comments restricted to matters related to the audit.
- Adhere with company rules and working arrangement.
- Points raised during examination not be answer by auditors or escorting personnel.
- Interviewing of personnel also be done.
Opening meeting
- Held with auditor and principal members of the auditee
- Business cards are exchanged and outline of roles is provided.
- Auditors should reiterate the audit purpose style, standard use, acceptance criteria, anticipated time scales.
- Normal working day conditions will exist through the duration of the audit.
- Closing meeting should be scheduled.
- Restrictions to the information or areas should be discussed.
- Auditee may present an overview of company structure, operations and details of changes taken place.
Audit Technique
- Check the documented procedure and compliance with regulations.
- Aware of time available to complete the audit.
- Audit leader assigned to direct the team.
- Maintain mutuality between auditors and auditee
- Findings and queries be discussed and resolved.
- Show deficiencies to auditee before processing.
- Standard not met be specifically referred.
- Make specific record of documents reviewed to answer.
- While reviewing , confidentiality should be respected.
- Point may come where apparent that the necessary standards will not met.
Closing meeting
- Time be made available to the auditors to discuss finding to the audit
- Findings should be presented to the key auditee personnel.
- Presenting both good and bad points in courteous and professional manner.
- Agreements of the facts be established, corrective actions, and their time-frames agreed.
- Discuss method of follow-up before conclusion of audit.
- Finally do not forget to thanks to auditee.
From auditee perspective
General Conduct
- Designated auditee will be accompanied with auditor at all times(for nothing unavailable information, arrangement to provide it early etc.,)
- Do not answered readily to auditors questions.
- Undue stalling for time must be avoided.
- Ensure that auditor adhere to companies policies and procedures.
Opening meeting
- Made available the information as a pre-audit arrangements to auditor.
- Limitations to be brought to attention.
- Auditee established the final audit agenda.
Audit Technique
- Appoint an employee to make notes.
- Organization be prepared to provide responses to the questions.
- Understand the issues and agreed observations.
- Think carefully before answering.
- Documents provided to auditor should be noted and stamped.
- For audits more than one day review its progress.
- Auditee should not attempt to guide the auditor in a specific direction.
Closing Meeting
- Allow auditors to discuss finding in private prior to closing meeting.
- Conduct an overview of points raised during audit.
- Decide the staff to be present.
- Do not respond too quickly to the points made.
- Time frame for corrective actions, reports and responses to be discussed.
- Arrangements for follow-up should be discussed.
- Do not forget to thank the auditor.
After an Audit
Publication and Audit Report
- Auditor should prepare formal written report and send it to the auditee within agreed period of time.
- Along with covering letters.
- Contents as discussed earlier.
- For External Audit completed reports are to be send to all affected customers.
- For Internal Audit report being sent to an agreed set of internal management.
- For Regulatory Audit, Auditee will receive the copy of audit findings in a style of the individual regulatory authorities.
Formats and contents of audit summary
- Header
- Background
- Approach
- Report Format
- Summary of results
- Future work
Auditee response
- Ensure that identified observations are agreed.
- Review the observations.
- Carryout agreed action plan with proposed completion date, to rectify the defects.
- Response document forwarded to the auditor as a follow up to the audit activities
- Applied equally to all audits.
Progress on audit issues
- Its joint responsibility to to ensure compliance.
- But prime responsibility if of auditee for implementing corrective actions.
- Auditor has to review and monitor action plans for closing out.
- Auditor contact auditee if the completion date is slipping.
- Audit is said to be complete only after successful completion of all actions.
- All the successful outcome will be communicated with all.
Conclusion
- To assess the effectiveness of the quality system and to ensure that the requirements of GMP are be met, audits must be perform.
- A good quality audit is that, assess the quality system against the current and anticipated future needs.
- Always established the root cause rather than quick fixes to isolated parts.