QA Audit & Gap Analysis Consulting Services

QA audit consultantQA AUDIT SERVICES

Scope: GMP / cGMP, GLP, GCP, GPP, ISO 13485 / ISO 13488, Medical Device QMS, ISO 14000, ISO 9000, ISO 17025, HACCP / ISO 22000.

Over the years, ICS Inc. has created, edited, reviewed & audited ~10,000 protocols, SOPs, policies, work instructions, checklists & forms. We have also taken lengthy auditing courses (incl. questioning techniques), then trained hundreds of people in QA Implementation strategies. We have also conducted numerous joint inspections with Health Canada & CFIA inspectors – many of which have shared various tips & tricks with us, since we are a third party. (i.e.: things they can share with us, that they can’s directly share with the client / auditee, as that may be perceived as “coaching” and therefore a potential conflict of interest. Also having an outside / third party QA audit reduces the potential of dealing with the “internal politics”, as we have no vested interest in the ultimate findings.

Auditing

Gap Analysis

Helping companies prepare for third-party and/or certification audits

 

QA Audit

Over the years, we have created many internal audit SOPs along with extensive audit checklists. These cover the principles & practices of effective internal audits in accordance with ISO 19011:2001 – Guidelines on auditing management systems. Our SOPs & audit checklists continually get revised after each time we perform an internal audit for a client, or perform a joint audit with certification bodies such as Health Canada for a Drug Establishment Licences, NHP Site Licence, Medical Devices Establishment Licence (MDEL), ACMPR-MMPR Producer’s Licence / Dealer’s Licence, Clinical Trials, or for any other accreditation.

ICS Inc is therefore quite qualified to:

  • Provide an objective and unbiased review, to assess conformance of your operations to the regulations, and determine the level of implementation & effectiveness of the requirements;
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  • Conduct an assessment of your present QA system and procedures;
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  • If requested, extend the assessment to your contractors, including raw material vendors / suppliers, such as for Active Pharmaceutical Ingredients (APIs);
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  • Identify opportunities for improvement, within the scope of the system requirements;
    • .
  • Help prioritize issues based on Risk Management;
    • .
  • Assist with writing & revising the policies, procedures, forms, checklists, internal labels, etc.;  and
    • .
  • Perform regular (semi-annual or annual) follow-ups thereafter, or act as your Quality Assurance Person (QAP), when requested.

Unless you have someone in-house who meets the education, training & experience of an auditor, it is strongly recommend to contract a third-party auditor who is properly qualified in your area of operations.

We have the integrity & ethics, as well as an awareness of existing and potential conflicts of interest; these traits are necessary to do an effective and credible audit.

Auditing services to Health Canada & CFIA regulations

Third-Party Audits of your suppliers and contract manufacturers

As part of your “due diligence”, ICS can let you know whether or not your product or service suppliers are meeting not only their QA requirements, but also their contractual agreements – no matter where they are located throughout the world. These suppliers may include contract manufacturers and/or testing laboratories.

No matter where your suppliers are located, we can most likely provide these services at less travel expense than someone in-house. This is due to our network of strategic alliances of subcontracted auditors, or we may also have other clients in the region that your supplier is located.

QA Gap Analysis Services

Gap analysis inspection

Gap Analysis

This service is recommended as a first step, if you have just finished a rough internal implementation of your QA program, and prior to requesting ICS to come in for a full-blown third-party / external audit. Our goals might then be to:

1.   Assess your firm’s progress towards official audit readiness. Specifically, it will address the areas which appear to be:

  • relatively compliant – or close to compliance;
  • requiring only amendments / revisions / further details; and
  • missing or have critical nonconformances, and therefore should be assigned the highest priority.

2.   Provide a quick snapshot of the overall status of the QA program, based on an overall evaluation / snapshot of each of the sections of QA requirements.

3.   Provide (where practicable) suggestions as part of your firm’s Continual Improvement Program (QIP), and to provide obvious fine-tuning suggestions in order to possibly reduce unnecessary paperwork & increase regulatory efficiency.

4.   To provide a road map which can then be used to help identify:

  • where the time, labour & other resources could be better prioritized for the future. (Many times, it has been found that an outside point of view can provide a more objective evaluation & fresh perspectives.);
  • which areas of the QA program should be tackled before others (i.e.: areas which may take longer to accomplish, since they involve outside parties);
  • whether the protocols, procedures (SOPs), work instructions, checklists, forms, etc. are of appropriate format (before the rest of them are prepared);
  • whether the procedures are of sufficient detail (or too much detail) for the operators to follow; and
  • whether/where the procedures can obviously be streamlined to reduce the potential for redundancies (i.e.: can the number of inspections or QC test parameters be reduced, yet still comply with the regulations?)

5.   To help prioritize the remainder of the QA implementation either by sales $, by unit volume, by process – or by a combination of these.

6.   Our goals are not to “blow big holes” into what efforts have been done to date – but to provide re-assurance (and possibly guidance) in areas that have been done well and to prevent problems at as early stage as possible – when the amount of time & resources to correct them can be greatly minimized (as compared to some time later down the road).

quality assurance audit consultant services

Helping companies prepare for third-party and/or certification audits

No matter how good a QA program one thinks has been created, the Inspector will almost always still find a decent amount of Observations (non-conformance) – hopefully all minor. This is for a variety of factors, but especially the situation if it’s your very first official certification audit. If they don’t have any Observations, then they are either not performing their job completely, or the company is really good at hiding its imperfections.

As such, it’s strongly recommended that one bring in a consulting firm such as ICS prior to any inspections by Health Canada, another certification body, or a customer. This is because it’s always good to have someone viewing the QA program from the perspective of the external auditor, as internal staff may be too close “to see the forest for the trees”.

We then train key staff & management in the protocols, behaviors & ethics to be employed during these external audits. During their inspection, ICS can also act as the technical liaison between the auditor your company.

(For manufacturers, packagers, labellers, importers, distributors & labs)

Audits of validations

 

See our page on Validation Studies

 

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada


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